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ACOG Updates Breast Cancer Screening Guidelines
The American College of Obstetricians and Gynecologists (ACOG) has updated its breast cancer screening guidelines, recommending that individuals at an average risk for breast cancer initiate mammography screening at age 40. This change reflects evolving evidence that starting earlier screening yields greater net benefits in reducing breast cancer mortality, particularly for certain racial groups with higher risk factors.
Breast cancer is the second leading cause of cancer deaths in American women overall and the leading cause of cancer deaths among Black and Hispanic women. Although mammography has long been recognized as a life-saving tool by detecting cancer early, there has been debate on when screening should begin due to concerns about overdiagnosis, false positives, and potential harms such as unnecessary biopsies.
Recent evidence has prompted ACOG to revise its recommendation for individuals assigned female at birth, including cisgender women, transgender men, and nonbinary individuals. This updated guidance includes individuals with dense breast tissue or a family history of breast cancer but excludes those with higher risk factors, such as a personal history of breast cancer or previous high-risk lesion on a breast biopsy, genetic mutations linked to higher cancer risk, or a history of high-dose radiation therapy to their chest at a young age.
Under the new guidelines, routine screening mammography should start at age 40 and can be performed annually or every 2 years, based on an informed, shared decision-making process that considers the benefits and potential harms of frequent screening.
Previously, ACOG recommended initiating screening between ages 40 and 50, depending on individual risk factors and preferences, with screening required by age 50 at the latest. However, several factors, including an increasing incidence of breast cancer in younger women, have influenced the decision to lower the recommended starting age.
Increasing Incidence Among Younger Women
Between 2015 and 2019, the incidence of invasive breast cancer in women aged 40-49 years increased by approximately 2% per year.
“There has been a concerning trend of increasing breast cancer diagnoses among women in their 40s, and new data shows that earlier screening could make a significant difference in decreasing breast cancer deaths,” said Eve Zaritsky, MD, FACOG, coauthor of the clinical practice update. “While screening can sometimes cause anxiety for people and even unnecessary follow-up, the benefits of diagnosing breast cancer earlier outweigh those risks enough to warrant starting to get mammograms at age 40.”
Studies commissioned by the US Preventive Services Task Force (USPSTF) show that starting mammography at age 40 provides a greater overall benefit than beginning at age 50. Early screening reduces the number of breast cancer deaths and increases life years gained when weighed against the harms of false positives, overdiagnosis, and benign biopsies.
Addressing Health Inequities
The benefits of earlier screening are expected to be particularly significant for Black women, who have disproportionately high mortality rates from breast cancer. Even though Black women have a lower overall incidence of breast cancer than White women, they have a 40% higher 5-year age-adjusted mortality rate from the disease and a 45% increased incidence of invasive breast cancer before age 50. Black women are also more likely to be diagnosed with aggressive subtypes, such as triple-negative breast cancer, which is harder to detect and treat and occurs at younger ages.
Racial disparities in breast cancer outcomes are deeply rooted in inequities in social determinants of health, such as access to care, housing, and environmental conditions. Black women are also less likely to receive timely or comprehensive treatment than White women, which contributes to worse survival rates even after adjusting for socioeconomic factors and insurance status.
“Our updated recommendation addresses important inequities in breast cancer diagnosis, treatment, and death, and we hope that the earlier initiation of mammography screening across the board will have a great net benefit in outcomes for Black women especially, who have been shown to have the poorest outcomes when it comes to breast cancer, in part because of long-standing inequities in social determinants of health,” added coauthor Cherie C. Hill, MD, FACOG.
ACOG’s updated recommendation aligns with that of other leading organizations, including the USPSTF, the National Comprehensive Cancer Network, the American College of Radiology, and the Society of Breast Imaging. This growing consensus among experts is expected to reduce confusion among clinicians and patients regarding when to begin screening, thus improving screening rates in individuals in the 40- to 49-year age group.
Zaritsky and Hill reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
The American College of Obstetricians and Gynecologists (ACOG) has updated its breast cancer screening guidelines, recommending that individuals at an average risk for breast cancer initiate mammography screening at age 40. This change reflects evolving evidence that starting earlier screening yields greater net benefits in reducing breast cancer mortality, particularly for certain racial groups with higher risk factors.
Breast cancer is the second leading cause of cancer deaths in American women overall and the leading cause of cancer deaths among Black and Hispanic women. Although mammography has long been recognized as a life-saving tool by detecting cancer early, there has been debate on when screening should begin due to concerns about overdiagnosis, false positives, and potential harms such as unnecessary biopsies.
Recent evidence has prompted ACOG to revise its recommendation for individuals assigned female at birth, including cisgender women, transgender men, and nonbinary individuals. This updated guidance includes individuals with dense breast tissue or a family history of breast cancer but excludes those with higher risk factors, such as a personal history of breast cancer or previous high-risk lesion on a breast biopsy, genetic mutations linked to higher cancer risk, or a history of high-dose radiation therapy to their chest at a young age.
Under the new guidelines, routine screening mammography should start at age 40 and can be performed annually or every 2 years, based on an informed, shared decision-making process that considers the benefits and potential harms of frequent screening.
Previously, ACOG recommended initiating screening between ages 40 and 50, depending on individual risk factors and preferences, with screening required by age 50 at the latest. However, several factors, including an increasing incidence of breast cancer in younger women, have influenced the decision to lower the recommended starting age.
Increasing Incidence Among Younger Women
Between 2015 and 2019, the incidence of invasive breast cancer in women aged 40-49 years increased by approximately 2% per year.
“There has been a concerning trend of increasing breast cancer diagnoses among women in their 40s, and new data shows that earlier screening could make a significant difference in decreasing breast cancer deaths,” said Eve Zaritsky, MD, FACOG, coauthor of the clinical practice update. “While screening can sometimes cause anxiety for people and even unnecessary follow-up, the benefits of diagnosing breast cancer earlier outweigh those risks enough to warrant starting to get mammograms at age 40.”
Studies commissioned by the US Preventive Services Task Force (USPSTF) show that starting mammography at age 40 provides a greater overall benefit than beginning at age 50. Early screening reduces the number of breast cancer deaths and increases life years gained when weighed against the harms of false positives, overdiagnosis, and benign biopsies.
Addressing Health Inequities
The benefits of earlier screening are expected to be particularly significant for Black women, who have disproportionately high mortality rates from breast cancer. Even though Black women have a lower overall incidence of breast cancer than White women, they have a 40% higher 5-year age-adjusted mortality rate from the disease and a 45% increased incidence of invasive breast cancer before age 50. Black women are also more likely to be diagnosed with aggressive subtypes, such as triple-negative breast cancer, which is harder to detect and treat and occurs at younger ages.
Racial disparities in breast cancer outcomes are deeply rooted in inequities in social determinants of health, such as access to care, housing, and environmental conditions. Black women are also less likely to receive timely or comprehensive treatment than White women, which contributes to worse survival rates even after adjusting for socioeconomic factors and insurance status.
“Our updated recommendation addresses important inequities in breast cancer diagnosis, treatment, and death, and we hope that the earlier initiation of mammography screening across the board will have a great net benefit in outcomes for Black women especially, who have been shown to have the poorest outcomes when it comes to breast cancer, in part because of long-standing inequities in social determinants of health,” added coauthor Cherie C. Hill, MD, FACOG.
ACOG’s updated recommendation aligns with that of other leading organizations, including the USPSTF, the National Comprehensive Cancer Network, the American College of Radiology, and the Society of Breast Imaging. This growing consensus among experts is expected to reduce confusion among clinicians and patients regarding when to begin screening, thus improving screening rates in individuals in the 40- to 49-year age group.
Zaritsky and Hill reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
The American College of Obstetricians and Gynecologists (ACOG) has updated its breast cancer screening guidelines, recommending that individuals at an average risk for breast cancer initiate mammography screening at age 40. This change reflects evolving evidence that starting earlier screening yields greater net benefits in reducing breast cancer mortality, particularly for certain racial groups with higher risk factors.
Breast cancer is the second leading cause of cancer deaths in American women overall and the leading cause of cancer deaths among Black and Hispanic women. Although mammography has long been recognized as a life-saving tool by detecting cancer early, there has been debate on when screening should begin due to concerns about overdiagnosis, false positives, and potential harms such as unnecessary biopsies.
Recent evidence has prompted ACOG to revise its recommendation for individuals assigned female at birth, including cisgender women, transgender men, and nonbinary individuals. This updated guidance includes individuals with dense breast tissue or a family history of breast cancer but excludes those with higher risk factors, such as a personal history of breast cancer or previous high-risk lesion on a breast biopsy, genetic mutations linked to higher cancer risk, or a history of high-dose radiation therapy to their chest at a young age.
Under the new guidelines, routine screening mammography should start at age 40 and can be performed annually or every 2 years, based on an informed, shared decision-making process that considers the benefits and potential harms of frequent screening.
Previously, ACOG recommended initiating screening between ages 40 and 50, depending on individual risk factors and preferences, with screening required by age 50 at the latest. However, several factors, including an increasing incidence of breast cancer in younger women, have influenced the decision to lower the recommended starting age.
Increasing Incidence Among Younger Women
Between 2015 and 2019, the incidence of invasive breast cancer in women aged 40-49 years increased by approximately 2% per year.
“There has been a concerning trend of increasing breast cancer diagnoses among women in their 40s, and new data shows that earlier screening could make a significant difference in decreasing breast cancer deaths,” said Eve Zaritsky, MD, FACOG, coauthor of the clinical practice update. “While screening can sometimes cause anxiety for people and even unnecessary follow-up, the benefits of diagnosing breast cancer earlier outweigh those risks enough to warrant starting to get mammograms at age 40.”
Studies commissioned by the US Preventive Services Task Force (USPSTF) show that starting mammography at age 40 provides a greater overall benefit than beginning at age 50. Early screening reduces the number of breast cancer deaths and increases life years gained when weighed against the harms of false positives, overdiagnosis, and benign biopsies.
Addressing Health Inequities
The benefits of earlier screening are expected to be particularly significant for Black women, who have disproportionately high mortality rates from breast cancer. Even though Black women have a lower overall incidence of breast cancer than White women, they have a 40% higher 5-year age-adjusted mortality rate from the disease and a 45% increased incidence of invasive breast cancer before age 50. Black women are also more likely to be diagnosed with aggressive subtypes, such as triple-negative breast cancer, which is harder to detect and treat and occurs at younger ages.
Racial disparities in breast cancer outcomes are deeply rooted in inequities in social determinants of health, such as access to care, housing, and environmental conditions. Black women are also less likely to receive timely or comprehensive treatment than White women, which contributes to worse survival rates even after adjusting for socioeconomic factors and insurance status.
“Our updated recommendation addresses important inequities in breast cancer diagnosis, treatment, and death, and we hope that the earlier initiation of mammography screening across the board will have a great net benefit in outcomes for Black women especially, who have been shown to have the poorest outcomes when it comes to breast cancer, in part because of long-standing inequities in social determinants of health,” added coauthor Cherie C. Hill, MD, FACOG.
ACOG’s updated recommendation aligns with that of other leading organizations, including the USPSTF, the National Comprehensive Cancer Network, the American College of Radiology, and the Society of Breast Imaging. This growing consensus among experts is expected to reduce confusion among clinicians and patients regarding when to begin screening, thus improving screening rates in individuals in the 40- to 49-year age group.
Zaritsky and Hill reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
EHR Tool Enhances Primary Aldosteronism Screening in Hypertensive Patients
Primary aldosteronism (PA) is a frequently overlooked yet common cause of secondary hypertension, presenting significant risk for cardiovascular morbidity and mortality.
But fewer than 4% of at-risk patients receive the recommended screening for PA, leaving a substantial gap in early detection and management, according to Adina F. Turcu, MD, MS, associate professor in endocrinology and internal medicine at University of Michigan Health in Ann Arbor.
In response to this clinical challenge, Dr. Turcu and her colleagues developed a best-practice advisory (BPA) to identify patients who were at risk for PA and embedded it into electronic health record at University of Michigan ambulatory clinics. Her team found that use of the tool led to increased rates of screening for PA, particularly among primary care physicians.
Over a 15-month period, Dr. Turcu and her colleagues tested the BPA through a quality improvement study, identifying 14,603 unique candidates for PA screening, with a mean age of 65.5 years and a diverse representation of ethnic backgrounds.
Notably, 48.1% of these candidates had treatment-resistant hypertension, 43.5% exhibited hypokalemia, 10.5% were younger than 35 years, and 3.1% had adrenal nodules. Of these candidates, 14.0% received orders for PA screening, with 70.5% completing the recommended screening within the system, and 17.4% receiving positive screening results.
The study, conducted over 6 months in 2023, targeted adults with hypertension and at least one of the following: Those who took four or more antihypertensive medications, exhibited hypokalemia, were younger than age 35 years, or had adrenal nodules. Patients previously tested for PA were excluded from the analysis.
The noninterruptive BPA was triggered during outpatient visits with clinicians who specialized in hypertension. The advisory would then offer an order set for PA screening and provide a link to interpretation guidance for results. Clinicians had the option to use, ignore, or decline the BPA.
“Although we were hoping for broader uptake of this EHR-embedded BPA, we were delighted to see an increase in PA screening rates to 14% of identified candidates as compared to an average of less than 3% in retrospective studies of similar populations, including in our own institution prior to implementing this BPA,” Dr. Turcu told this news organization.
Physician specialty played a crucial role in the utilization of the BPA. Internists and family medicine physicians accounted for the majority of screening orders, placing 40.0% and 28.1% of these, respectively. Family practitioners and internists predominantly used the embedded order set (80.3% and 68.9%, respectively).
“Hypertension often gets treated rather than screening for [causes of] secondary hypertension prior to treatment,” said Kaniksha Desai, MD, clinical associate professor and endocrinology quality director at Stanford University School of Medicine, Stanford, California, who was not involved in the research. But “primary hyperaldosteronism is a condition that can be treated surgically and has increased long term cardiovascular consequences if not identified. While guidelines recommend screening at-risk patients, this often can get lost in translation in clinical practice due to many factors, including time constraints and volume of patients.”
Patients who did vs did not undergo screening were more likely to be women, Black, and younger than age 35 years. Additionally, the likelihood of screening was higher among patients with obesity and dyslipidemia, whereas it was lower in those with chronic kidney disease and established cardiovascular complications.
According to Dr. Turcu, the findings from this study suggest that noninterruptive BPAs, especially when integrated into primary care workflows, hold promise as effective tools for PA screening.
When coupled with artificial intelligence to optimize detection yield, these refined BPAs could significantly contribute to personalized care for hypertension, the investigators said.
“Considering that in the United States almost one in two adults has hypertension, such automatized tools become instrumental to busy clinicians, particularly those in primary care,” Dr. Turcu said. “Our results indicate a promising opportunity to meaningfully improve PA awareness and enhance its diagnosis.”
Dr. Turcu reported receiving grants from the National Heart, Lung, and Blood Institute and Doris Duke Foundation, served as an investigator in a CinCor Pharma clinical trial, and received financial support to her institution during the conduct of the study. Dr. Desai reported no relevant financial disclosures.
A version of this article appeared on Medscape.com.
Primary aldosteronism (PA) is a frequently overlooked yet common cause of secondary hypertension, presenting significant risk for cardiovascular morbidity and mortality.
But fewer than 4% of at-risk patients receive the recommended screening for PA, leaving a substantial gap in early detection and management, according to Adina F. Turcu, MD, MS, associate professor in endocrinology and internal medicine at University of Michigan Health in Ann Arbor.
In response to this clinical challenge, Dr. Turcu and her colleagues developed a best-practice advisory (BPA) to identify patients who were at risk for PA and embedded it into electronic health record at University of Michigan ambulatory clinics. Her team found that use of the tool led to increased rates of screening for PA, particularly among primary care physicians.
Over a 15-month period, Dr. Turcu and her colleagues tested the BPA through a quality improvement study, identifying 14,603 unique candidates for PA screening, with a mean age of 65.5 years and a diverse representation of ethnic backgrounds.
Notably, 48.1% of these candidates had treatment-resistant hypertension, 43.5% exhibited hypokalemia, 10.5% were younger than 35 years, and 3.1% had adrenal nodules. Of these candidates, 14.0% received orders for PA screening, with 70.5% completing the recommended screening within the system, and 17.4% receiving positive screening results.
The study, conducted over 6 months in 2023, targeted adults with hypertension and at least one of the following: Those who took four or more antihypertensive medications, exhibited hypokalemia, were younger than age 35 years, or had adrenal nodules. Patients previously tested for PA were excluded from the analysis.
The noninterruptive BPA was triggered during outpatient visits with clinicians who specialized in hypertension. The advisory would then offer an order set for PA screening and provide a link to interpretation guidance for results. Clinicians had the option to use, ignore, or decline the BPA.
“Although we were hoping for broader uptake of this EHR-embedded BPA, we were delighted to see an increase in PA screening rates to 14% of identified candidates as compared to an average of less than 3% in retrospective studies of similar populations, including in our own institution prior to implementing this BPA,” Dr. Turcu told this news organization.
Physician specialty played a crucial role in the utilization of the BPA. Internists and family medicine physicians accounted for the majority of screening orders, placing 40.0% and 28.1% of these, respectively. Family practitioners and internists predominantly used the embedded order set (80.3% and 68.9%, respectively).
“Hypertension often gets treated rather than screening for [causes of] secondary hypertension prior to treatment,” said Kaniksha Desai, MD, clinical associate professor and endocrinology quality director at Stanford University School of Medicine, Stanford, California, who was not involved in the research. But “primary hyperaldosteronism is a condition that can be treated surgically and has increased long term cardiovascular consequences if not identified. While guidelines recommend screening at-risk patients, this often can get lost in translation in clinical practice due to many factors, including time constraints and volume of patients.”
Patients who did vs did not undergo screening were more likely to be women, Black, and younger than age 35 years. Additionally, the likelihood of screening was higher among patients with obesity and dyslipidemia, whereas it was lower in those with chronic kidney disease and established cardiovascular complications.
According to Dr. Turcu, the findings from this study suggest that noninterruptive BPAs, especially when integrated into primary care workflows, hold promise as effective tools for PA screening.
When coupled with artificial intelligence to optimize detection yield, these refined BPAs could significantly contribute to personalized care for hypertension, the investigators said.
“Considering that in the United States almost one in two adults has hypertension, such automatized tools become instrumental to busy clinicians, particularly those in primary care,” Dr. Turcu said. “Our results indicate a promising opportunity to meaningfully improve PA awareness and enhance its diagnosis.”
Dr. Turcu reported receiving grants from the National Heart, Lung, and Blood Institute and Doris Duke Foundation, served as an investigator in a CinCor Pharma clinical trial, and received financial support to her institution during the conduct of the study. Dr. Desai reported no relevant financial disclosures.
A version of this article appeared on Medscape.com.
Primary aldosteronism (PA) is a frequently overlooked yet common cause of secondary hypertension, presenting significant risk for cardiovascular morbidity and mortality.
But fewer than 4% of at-risk patients receive the recommended screening for PA, leaving a substantial gap in early detection and management, according to Adina F. Turcu, MD, MS, associate professor in endocrinology and internal medicine at University of Michigan Health in Ann Arbor.
In response to this clinical challenge, Dr. Turcu and her colleagues developed a best-practice advisory (BPA) to identify patients who were at risk for PA and embedded it into electronic health record at University of Michigan ambulatory clinics. Her team found that use of the tool led to increased rates of screening for PA, particularly among primary care physicians.
Over a 15-month period, Dr. Turcu and her colleagues tested the BPA through a quality improvement study, identifying 14,603 unique candidates for PA screening, with a mean age of 65.5 years and a diverse representation of ethnic backgrounds.
Notably, 48.1% of these candidates had treatment-resistant hypertension, 43.5% exhibited hypokalemia, 10.5% were younger than 35 years, and 3.1% had adrenal nodules. Of these candidates, 14.0% received orders for PA screening, with 70.5% completing the recommended screening within the system, and 17.4% receiving positive screening results.
The study, conducted over 6 months in 2023, targeted adults with hypertension and at least one of the following: Those who took four or more antihypertensive medications, exhibited hypokalemia, were younger than age 35 years, or had adrenal nodules. Patients previously tested for PA were excluded from the analysis.
The noninterruptive BPA was triggered during outpatient visits with clinicians who specialized in hypertension. The advisory would then offer an order set for PA screening and provide a link to interpretation guidance for results. Clinicians had the option to use, ignore, or decline the BPA.
“Although we were hoping for broader uptake of this EHR-embedded BPA, we were delighted to see an increase in PA screening rates to 14% of identified candidates as compared to an average of less than 3% in retrospective studies of similar populations, including in our own institution prior to implementing this BPA,” Dr. Turcu told this news organization.
Physician specialty played a crucial role in the utilization of the BPA. Internists and family medicine physicians accounted for the majority of screening orders, placing 40.0% and 28.1% of these, respectively. Family practitioners and internists predominantly used the embedded order set (80.3% and 68.9%, respectively).
“Hypertension often gets treated rather than screening for [causes of] secondary hypertension prior to treatment,” said Kaniksha Desai, MD, clinical associate professor and endocrinology quality director at Stanford University School of Medicine, Stanford, California, who was not involved in the research. But “primary hyperaldosteronism is a condition that can be treated surgically and has increased long term cardiovascular consequences if not identified. While guidelines recommend screening at-risk patients, this often can get lost in translation in clinical practice due to many factors, including time constraints and volume of patients.”
Patients who did vs did not undergo screening were more likely to be women, Black, and younger than age 35 years. Additionally, the likelihood of screening was higher among patients with obesity and dyslipidemia, whereas it was lower in those with chronic kidney disease and established cardiovascular complications.
According to Dr. Turcu, the findings from this study suggest that noninterruptive BPAs, especially when integrated into primary care workflows, hold promise as effective tools for PA screening.
When coupled with artificial intelligence to optimize detection yield, these refined BPAs could significantly contribute to personalized care for hypertension, the investigators said.
“Considering that in the United States almost one in two adults has hypertension, such automatized tools become instrumental to busy clinicians, particularly those in primary care,” Dr. Turcu said. “Our results indicate a promising opportunity to meaningfully improve PA awareness and enhance its diagnosis.”
Dr. Turcu reported receiving grants from the National Heart, Lung, and Blood Institute and Doris Duke Foundation, served as an investigator in a CinCor Pharma clinical trial, and received financial support to her institution during the conduct of the study. Dr. Desai reported no relevant financial disclosures.
A version of this article appeared on Medscape.com.
Procedures may ease postmenopausal pain better than drugs
a new study shows.
“This study provides us a better understanding of pain management strategies for pre versus postmenopausal women,” said Tian Yu, MD, who presented the research at the annual pain medicine meeting of the American Society of Regional Anesthesia and Pain Medicine. “With our postmenopausal patients, we may no longer jump the gun and give them a lot of medications; we may first turn to physical therapy or procedural intervention, which they seem to benefit much more from than pharmacological therapy.”Pain perception is a multifaceted phenomenon influenced by age, gender, individual variations, and hormonal changes. Pain management in women, particularly in the context of menopausal status, still lacks consensus.
Menopause primarily results from diminished production of estrogen by the ovaries, leading to spinal and joint pain, hot flashes, night sweats, chronic fatigue, increased osteoclastic activity with a heightened risk for osteoporosis, psychological symptoms, and elevated risk for cardiovascular disease.
For their retrospective cohort study, Dr. Yu, department of anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, Illinois, and his colleagues looked at 1215 women who had been treated for different chronic pain conditions for at least 3 months. The researchers used a predefined age cutoff of 51 years (considered the national average) to categorize participants as either premenopausal (n = 248) or postmenopausal (n = 967). Pain scores and subjective improvement were assessed after pharmacological and procedural interventions.
According to Dr. Yu, the results revealed distinct patterns in pain scores and response to interventions between the two groups.
Although postmenopausal women initially reported higher mean pain scores upon presentation (8.037 vs 7.613 in premenopausal women), they reported more improvement following intervention (63% vs 59%; P = .029). They responded more favorably to both procedural and pharmacological interventions, but were prescribed muscle relaxants, tricyclic antidepressants, and benzodiazepines less frequently than premenopausal women, Dr. Yu’s group found.
“So even though postmenopausal women had a higher initial pain score, they had better pain improvement after procedural intervention, although they were prescribed fewer pharmacological interventions,” Dr. Yu said.
The fact that postmenopausal women typically are older than women who have not reached menopause could act as a confounding factor in this study in terms of disease prevalence and intervention, Dr. Yu said. Additionally, the study’s reliance on a broad menopausal age cutoff of 51 years may limit the true characterization of menopausal status.
While acknowledging study limitations, the findings suggest a potential shift toward prioritizing nonpharmacological interventions in postmenopausal women. Further investigation into physical therapy and other approaches could provide a more comprehensive understanding of pain management strategies in this population.
“We hope to take these findings into consideration during our practice to better individualize care,” Yu said.
Robert Wenham, MD, MS, chair of gynecologic oncology, Moffitt Cancer Center, Tampa, Florida, who was not involved in the study, said: “Despite the many methodological challenges it has, including using age as a surrogate for menopause, I applaud the authors for investigating how pain and pain management may be individualized for women.”
Dr. Wenham added that he hoped the findings would prompt additional studies “that specifically address populations based on hormonal status and other confounding factors, so that interventional avenues may be identified for clinical trials.”
Dr. Yu and Dr. Wenham report no relevant financial relationships.
A version of this article appeared on Medscape.com.
a new study shows.
“This study provides us a better understanding of pain management strategies for pre versus postmenopausal women,” said Tian Yu, MD, who presented the research at the annual pain medicine meeting of the American Society of Regional Anesthesia and Pain Medicine. “With our postmenopausal patients, we may no longer jump the gun and give them a lot of medications; we may first turn to physical therapy or procedural intervention, which they seem to benefit much more from than pharmacological therapy.”Pain perception is a multifaceted phenomenon influenced by age, gender, individual variations, and hormonal changes. Pain management in women, particularly in the context of menopausal status, still lacks consensus.
Menopause primarily results from diminished production of estrogen by the ovaries, leading to spinal and joint pain, hot flashes, night sweats, chronic fatigue, increased osteoclastic activity with a heightened risk for osteoporosis, psychological symptoms, and elevated risk for cardiovascular disease.
For their retrospective cohort study, Dr. Yu, department of anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, Illinois, and his colleagues looked at 1215 women who had been treated for different chronic pain conditions for at least 3 months. The researchers used a predefined age cutoff of 51 years (considered the national average) to categorize participants as either premenopausal (n = 248) or postmenopausal (n = 967). Pain scores and subjective improvement were assessed after pharmacological and procedural interventions.
According to Dr. Yu, the results revealed distinct patterns in pain scores and response to interventions between the two groups.
Although postmenopausal women initially reported higher mean pain scores upon presentation (8.037 vs 7.613 in premenopausal women), they reported more improvement following intervention (63% vs 59%; P = .029). They responded more favorably to both procedural and pharmacological interventions, but were prescribed muscle relaxants, tricyclic antidepressants, and benzodiazepines less frequently than premenopausal women, Dr. Yu’s group found.
“So even though postmenopausal women had a higher initial pain score, they had better pain improvement after procedural intervention, although they were prescribed fewer pharmacological interventions,” Dr. Yu said.
The fact that postmenopausal women typically are older than women who have not reached menopause could act as a confounding factor in this study in terms of disease prevalence and intervention, Dr. Yu said. Additionally, the study’s reliance on a broad menopausal age cutoff of 51 years may limit the true characterization of menopausal status.
While acknowledging study limitations, the findings suggest a potential shift toward prioritizing nonpharmacological interventions in postmenopausal women. Further investigation into physical therapy and other approaches could provide a more comprehensive understanding of pain management strategies in this population.
“We hope to take these findings into consideration during our practice to better individualize care,” Yu said.
Robert Wenham, MD, MS, chair of gynecologic oncology, Moffitt Cancer Center, Tampa, Florida, who was not involved in the study, said: “Despite the many methodological challenges it has, including using age as a surrogate for menopause, I applaud the authors for investigating how pain and pain management may be individualized for women.”
Dr. Wenham added that he hoped the findings would prompt additional studies “that specifically address populations based on hormonal status and other confounding factors, so that interventional avenues may be identified for clinical trials.”
Dr. Yu and Dr. Wenham report no relevant financial relationships.
A version of this article appeared on Medscape.com.
a new study shows.
“This study provides us a better understanding of pain management strategies for pre versus postmenopausal women,” said Tian Yu, MD, who presented the research at the annual pain medicine meeting of the American Society of Regional Anesthesia and Pain Medicine. “With our postmenopausal patients, we may no longer jump the gun and give them a lot of medications; we may first turn to physical therapy or procedural intervention, which they seem to benefit much more from than pharmacological therapy.”Pain perception is a multifaceted phenomenon influenced by age, gender, individual variations, and hormonal changes. Pain management in women, particularly in the context of menopausal status, still lacks consensus.
Menopause primarily results from diminished production of estrogen by the ovaries, leading to spinal and joint pain, hot flashes, night sweats, chronic fatigue, increased osteoclastic activity with a heightened risk for osteoporosis, psychological symptoms, and elevated risk for cardiovascular disease.
For their retrospective cohort study, Dr. Yu, department of anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, Illinois, and his colleagues looked at 1215 women who had been treated for different chronic pain conditions for at least 3 months. The researchers used a predefined age cutoff of 51 years (considered the national average) to categorize participants as either premenopausal (n = 248) or postmenopausal (n = 967). Pain scores and subjective improvement were assessed after pharmacological and procedural interventions.
According to Dr. Yu, the results revealed distinct patterns in pain scores and response to interventions between the two groups.
Although postmenopausal women initially reported higher mean pain scores upon presentation (8.037 vs 7.613 in premenopausal women), they reported more improvement following intervention (63% vs 59%; P = .029). They responded more favorably to both procedural and pharmacological interventions, but were prescribed muscle relaxants, tricyclic antidepressants, and benzodiazepines less frequently than premenopausal women, Dr. Yu’s group found.
“So even though postmenopausal women had a higher initial pain score, they had better pain improvement after procedural intervention, although they were prescribed fewer pharmacological interventions,” Dr. Yu said.
The fact that postmenopausal women typically are older than women who have not reached menopause could act as a confounding factor in this study in terms of disease prevalence and intervention, Dr. Yu said. Additionally, the study’s reliance on a broad menopausal age cutoff of 51 years may limit the true characterization of menopausal status.
While acknowledging study limitations, the findings suggest a potential shift toward prioritizing nonpharmacological interventions in postmenopausal women. Further investigation into physical therapy and other approaches could provide a more comprehensive understanding of pain management strategies in this population.
“We hope to take these findings into consideration during our practice to better individualize care,” Yu said.
Robert Wenham, MD, MS, chair of gynecologic oncology, Moffitt Cancer Center, Tampa, Florida, who was not involved in the study, said: “Despite the many methodological challenges it has, including using age as a surrogate for menopause, I applaud the authors for investigating how pain and pain management may be individualized for women.”
Dr. Wenham added that he hoped the findings would prompt additional studies “that specifically address populations based on hormonal status and other confounding factors, so that interventional avenues may be identified for clinical trials.”
Dr. Yu and Dr. Wenham report no relevant financial relationships.
A version of this article appeared on Medscape.com.
Adverse events related to embryo transfer catheters may be underreported to the FDA
, according to a new study presented at the American Society for Reproductive Medicine’s 2023 meeting.
ETCs are medical devices used routinely in assisted reproduction. The findings highlight the need for increased vigilance in tracking and reporting adverse events associated with these devices, according to the investigators.
“With hundreds of thousands of embryo transfers being performed per year, surveillance of the safety, performance, and quality of embryo transfer catheter devices is critical and should not be taken for granted,” said Anita Madison, MD, MPH, from the division of reproductive endocrinology and infertility at Johns Hopkins School of Medicine, Baltimore, who led the study. “There are a variety of transfer catheters with different indications, with little data on the superiority and safety of the brands compared to one another.”
Although the number of reported adverse events associated with ETCs is relatively small, the problems can significantly affect patient care, the researchers said.
Dr. Madison and her colleagues used the Manufacturer and User Facility Device Experience (MAUDE) database to identify adverse events associated with ETC devices. The MAUDE database is a voluntary reporting system that holds hundreds of thousands of medical device reports of suspected device-associated deaths, injuries, and malfunctions reported to the FDA annually.
For each adverse event in the database linked to an ECT, the researchers collected information related to the brand of the device, the nature of the event, and the nature of the reporter. The researchers omitted the device and manufacturer names from the presentation of the study findings, delineating them only as “Brand 1,” “Brand 2,” “Brand 3,” “Brand 4,” or “Other.”
Problems with devices included contamination, packaging problems, malfunction, mechanical flaws, and material separation. Patient-level adverse events included retaining of foreign body, trauma, malfunction, or failed embryo transfer.
Between 2014 and 2023, Dr. Madison and her colleagues identified 101 adverse events associated with ECTs in the database. About 25% of these occurred in 2018, with 27 cases reported. Contamination was the most prevalent problem, found in 68 reports; oil was the most common contaminant.
The distribution of types of adverse events varied, depending on ETC brand. A breakdown of occurrences revealed high numbers for Brand 2, with 52 adverse events. Although Brand 3 accounted for only 16 adverse events, the majority of these were related to device separation.
“That finding stood out,” Dr. Madison said.
Nearly 1 in 4 (22%) of all reported incidents led to overt patient harm. Retention of a foreign body was the prime type of injury, occurring in 12 cases. Malfunction and injury were found in four cases each, with two failed embryo transfers reported, Dr. Madison said.
Because the majority of these adverse event reports were submitted by manufacturers (87%) and were rarely submitted by end users (for example, physicians, lab staff), the researchers said their findings likely underestimate such problems.
“I’m surprised the [number of reported adverse events] is as low as it is,” said Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank, Scottsdale, Ariz., who was not part of the study team. “Laboratories are required to report failed devices; they have to have a plan for that.”
“It just comes down to underreporting,” added Valerie L. Baker, MD, director in the Division of Reproductive Endocrinology and Infertility at Johns Hopkins Medicine, Lutherville, Md., who was not affiliated with the study.
“In two of these reports, they failed to transfer the embryo; they actually lost the embryo,” Dr. Pomeroy added. “That’s drastic for those patients; it’s a serious problem that needs to be addressed.”
Citing these findings, the authors underscored the need for heightened surveillance of ETC devices and recommend further studies to assess the sensitivity of these procedures for attempting pregnancy. They urge physicians and lab staff involved in these procedures to exercise continued vigilance and to improve the reporting of problems with ETC devices.
Dr. Madison, Dr. Baker, and Dr. Pomeroy report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to a new study presented at the American Society for Reproductive Medicine’s 2023 meeting.
ETCs are medical devices used routinely in assisted reproduction. The findings highlight the need for increased vigilance in tracking and reporting adverse events associated with these devices, according to the investigators.
“With hundreds of thousands of embryo transfers being performed per year, surveillance of the safety, performance, and quality of embryo transfer catheter devices is critical and should not be taken for granted,” said Anita Madison, MD, MPH, from the division of reproductive endocrinology and infertility at Johns Hopkins School of Medicine, Baltimore, who led the study. “There are a variety of transfer catheters with different indications, with little data on the superiority and safety of the brands compared to one another.”
Although the number of reported adverse events associated with ETCs is relatively small, the problems can significantly affect patient care, the researchers said.
Dr. Madison and her colleagues used the Manufacturer and User Facility Device Experience (MAUDE) database to identify adverse events associated with ETC devices. The MAUDE database is a voluntary reporting system that holds hundreds of thousands of medical device reports of suspected device-associated deaths, injuries, and malfunctions reported to the FDA annually.
For each adverse event in the database linked to an ECT, the researchers collected information related to the brand of the device, the nature of the event, and the nature of the reporter. The researchers omitted the device and manufacturer names from the presentation of the study findings, delineating them only as “Brand 1,” “Brand 2,” “Brand 3,” “Brand 4,” or “Other.”
Problems with devices included contamination, packaging problems, malfunction, mechanical flaws, and material separation. Patient-level adverse events included retaining of foreign body, trauma, malfunction, or failed embryo transfer.
Between 2014 and 2023, Dr. Madison and her colleagues identified 101 adverse events associated with ECTs in the database. About 25% of these occurred in 2018, with 27 cases reported. Contamination was the most prevalent problem, found in 68 reports; oil was the most common contaminant.
The distribution of types of adverse events varied, depending on ETC brand. A breakdown of occurrences revealed high numbers for Brand 2, with 52 adverse events. Although Brand 3 accounted for only 16 adverse events, the majority of these were related to device separation.
“That finding stood out,” Dr. Madison said.
Nearly 1 in 4 (22%) of all reported incidents led to overt patient harm. Retention of a foreign body was the prime type of injury, occurring in 12 cases. Malfunction and injury were found in four cases each, with two failed embryo transfers reported, Dr. Madison said.
Because the majority of these adverse event reports were submitted by manufacturers (87%) and were rarely submitted by end users (for example, physicians, lab staff), the researchers said their findings likely underestimate such problems.
“I’m surprised the [number of reported adverse events] is as low as it is,” said Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank, Scottsdale, Ariz., who was not part of the study team. “Laboratories are required to report failed devices; they have to have a plan for that.”
“It just comes down to underreporting,” added Valerie L. Baker, MD, director in the Division of Reproductive Endocrinology and Infertility at Johns Hopkins Medicine, Lutherville, Md., who was not affiliated with the study.
“In two of these reports, they failed to transfer the embryo; they actually lost the embryo,” Dr. Pomeroy added. “That’s drastic for those patients; it’s a serious problem that needs to be addressed.”
Citing these findings, the authors underscored the need for heightened surveillance of ETC devices and recommend further studies to assess the sensitivity of these procedures for attempting pregnancy. They urge physicians and lab staff involved in these procedures to exercise continued vigilance and to improve the reporting of problems with ETC devices.
Dr. Madison, Dr. Baker, and Dr. Pomeroy report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to a new study presented at the American Society for Reproductive Medicine’s 2023 meeting.
ETCs are medical devices used routinely in assisted reproduction. The findings highlight the need for increased vigilance in tracking and reporting adverse events associated with these devices, according to the investigators.
“With hundreds of thousands of embryo transfers being performed per year, surveillance of the safety, performance, and quality of embryo transfer catheter devices is critical and should not be taken for granted,” said Anita Madison, MD, MPH, from the division of reproductive endocrinology and infertility at Johns Hopkins School of Medicine, Baltimore, who led the study. “There are a variety of transfer catheters with different indications, with little data on the superiority and safety of the brands compared to one another.”
Although the number of reported adverse events associated with ETCs is relatively small, the problems can significantly affect patient care, the researchers said.
Dr. Madison and her colleagues used the Manufacturer and User Facility Device Experience (MAUDE) database to identify adverse events associated with ETC devices. The MAUDE database is a voluntary reporting system that holds hundreds of thousands of medical device reports of suspected device-associated deaths, injuries, and malfunctions reported to the FDA annually.
For each adverse event in the database linked to an ECT, the researchers collected information related to the brand of the device, the nature of the event, and the nature of the reporter. The researchers omitted the device and manufacturer names from the presentation of the study findings, delineating them only as “Brand 1,” “Brand 2,” “Brand 3,” “Brand 4,” or “Other.”
Problems with devices included contamination, packaging problems, malfunction, mechanical flaws, and material separation. Patient-level adverse events included retaining of foreign body, trauma, malfunction, or failed embryo transfer.
Between 2014 and 2023, Dr. Madison and her colleagues identified 101 adverse events associated with ECTs in the database. About 25% of these occurred in 2018, with 27 cases reported. Contamination was the most prevalent problem, found in 68 reports; oil was the most common contaminant.
The distribution of types of adverse events varied, depending on ETC brand. A breakdown of occurrences revealed high numbers for Brand 2, with 52 adverse events. Although Brand 3 accounted for only 16 adverse events, the majority of these were related to device separation.
“That finding stood out,” Dr. Madison said.
Nearly 1 in 4 (22%) of all reported incidents led to overt patient harm. Retention of a foreign body was the prime type of injury, occurring in 12 cases. Malfunction and injury were found in four cases each, with two failed embryo transfers reported, Dr. Madison said.
Because the majority of these adverse event reports were submitted by manufacturers (87%) and were rarely submitted by end users (for example, physicians, lab staff), the researchers said their findings likely underestimate such problems.
“I’m surprised the [number of reported adverse events] is as low as it is,” said Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank, Scottsdale, Ariz., who was not part of the study team. “Laboratories are required to report failed devices; they have to have a plan for that.”
“It just comes down to underreporting,” added Valerie L. Baker, MD, director in the Division of Reproductive Endocrinology and Infertility at Johns Hopkins Medicine, Lutherville, Md., who was not affiliated with the study.
“In two of these reports, they failed to transfer the embryo; they actually lost the embryo,” Dr. Pomeroy added. “That’s drastic for those patients; it’s a serious problem that needs to be addressed.”
Citing these findings, the authors underscored the need for heightened surveillance of ETC devices and recommend further studies to assess the sensitivity of these procedures for attempting pregnancy. They urge physicians and lab staff involved in these procedures to exercise continued vigilance and to improve the reporting of problems with ETC devices.
Dr. Madison, Dr. Baker, and Dr. Pomeroy report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ASRM 2023
Lack of racial, ethnic diversity in cryopreserved donor sperm in the U.S.
, according to a study presented at the American Society for Reproductive Medicine’s 2023 meeting.
“This really highlights the need to identify barriers to increase recruitment of these donors so that we can support family-building for all populations,” said Lauren Gibbs, MD, a resident in the department of obstetrics and gynecology at the Morehouse School of Medicine in Atlanta.
Dr. Gibbs and her colleagues compared the racial and ethnic makeup of sperm donors from online and self-reported profiles at 14 of the largest donor banks in the United States for March and April of 2023. Historical data were pulled from two large, national banks. The investigators compared these data to census estimates from 2021 for men between the ages of 18 and 44 years.
Donors who identified as Hispanic (10.9%) or Black (3.3%) were significantly underrepresented as compared to the U.S. population, of which Hispanic men compose 22% and Black men make up 13.3%.
Asian donors were overrepresented, making up 21.9% of the donors but only 6.5% of the U.S. population. White donors were proportionately represented in relation to national demographics, making up 56.6% of the donors and representing 55% of the U.S. population, according to the researchers. None of the donors identified as Native/Hawaiian/Pacific Islander or American Indian/Alaskan Natives; these groups represent 0.22% and 0.79% of the U.S. population, respectively.
“Next steps will be figuring out why this is happening and how to address it,” said Valerie L Baker, MD, director in the division of reproductive endocrinology and infertility at Johns Hopkins Medicine in Lutherville, Md., who was not involved in the study.
The study sheds light on the need to identify and address the barriers that discourage potential donors from underrepresented groups from participating in sperm donation, according to Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank in Scottsdale, Ariz.
“Sometimes there are inhibitors of different ethnic groups to want to act as sperm or egg donors, so trying to understand if that’s the case is important; but I’m sure a lot of it is also related to access,” Dr. Pomeroy, who was not part of the study team, said in an interview.
Longitudinal data from the two national donor banks did not indicate any significant increase or decrease in donation trends across the 5-year period from 2018 to 2022, highlighting the persisting issue of representation disparities. Dr. Gibbs said strategies need to be developed to increase recruitment of donors from underrepresented groups. Increasing the diversity of the donor pool will ultimately support family-building options for all patients, according to Dr. Gibbs.
Funding for the study was provided by the EMD Serono REI Diversity Fellowship Grant. Dr. Gibbs reports no relevant financial relationships.
, according to a study presented at the American Society for Reproductive Medicine’s 2023 meeting.
“This really highlights the need to identify barriers to increase recruitment of these donors so that we can support family-building for all populations,” said Lauren Gibbs, MD, a resident in the department of obstetrics and gynecology at the Morehouse School of Medicine in Atlanta.
Dr. Gibbs and her colleagues compared the racial and ethnic makeup of sperm donors from online and self-reported profiles at 14 of the largest donor banks in the United States for March and April of 2023. Historical data were pulled from two large, national banks. The investigators compared these data to census estimates from 2021 for men between the ages of 18 and 44 years.
Donors who identified as Hispanic (10.9%) or Black (3.3%) were significantly underrepresented as compared to the U.S. population, of which Hispanic men compose 22% and Black men make up 13.3%.
Asian donors were overrepresented, making up 21.9% of the donors but only 6.5% of the U.S. population. White donors were proportionately represented in relation to national demographics, making up 56.6% of the donors and representing 55% of the U.S. population, according to the researchers. None of the donors identified as Native/Hawaiian/Pacific Islander or American Indian/Alaskan Natives; these groups represent 0.22% and 0.79% of the U.S. population, respectively.
“Next steps will be figuring out why this is happening and how to address it,” said Valerie L Baker, MD, director in the division of reproductive endocrinology and infertility at Johns Hopkins Medicine in Lutherville, Md., who was not involved in the study.
The study sheds light on the need to identify and address the barriers that discourage potential donors from underrepresented groups from participating in sperm donation, according to Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank in Scottsdale, Ariz.
“Sometimes there are inhibitors of different ethnic groups to want to act as sperm or egg donors, so trying to understand if that’s the case is important; but I’m sure a lot of it is also related to access,” Dr. Pomeroy, who was not part of the study team, said in an interview.
Longitudinal data from the two national donor banks did not indicate any significant increase or decrease in donation trends across the 5-year period from 2018 to 2022, highlighting the persisting issue of representation disparities. Dr. Gibbs said strategies need to be developed to increase recruitment of donors from underrepresented groups. Increasing the diversity of the donor pool will ultimately support family-building options for all patients, according to Dr. Gibbs.
Funding for the study was provided by the EMD Serono REI Diversity Fellowship Grant. Dr. Gibbs reports no relevant financial relationships.
, according to a study presented at the American Society for Reproductive Medicine’s 2023 meeting.
“This really highlights the need to identify barriers to increase recruitment of these donors so that we can support family-building for all populations,” said Lauren Gibbs, MD, a resident in the department of obstetrics and gynecology at the Morehouse School of Medicine in Atlanta.
Dr. Gibbs and her colleagues compared the racial and ethnic makeup of sperm donors from online and self-reported profiles at 14 of the largest donor banks in the United States for March and April of 2023. Historical data were pulled from two large, national banks. The investigators compared these data to census estimates from 2021 for men between the ages of 18 and 44 years.
Donors who identified as Hispanic (10.9%) or Black (3.3%) were significantly underrepresented as compared to the U.S. population, of which Hispanic men compose 22% and Black men make up 13.3%.
Asian donors were overrepresented, making up 21.9% of the donors but only 6.5% of the U.S. population. White donors were proportionately represented in relation to national demographics, making up 56.6% of the donors and representing 55% of the U.S. population, according to the researchers. None of the donors identified as Native/Hawaiian/Pacific Islander or American Indian/Alaskan Natives; these groups represent 0.22% and 0.79% of the U.S. population, respectively.
“Next steps will be figuring out why this is happening and how to address it,” said Valerie L Baker, MD, director in the division of reproductive endocrinology and infertility at Johns Hopkins Medicine in Lutherville, Md., who was not involved in the study.
The study sheds light on the need to identify and address the barriers that discourage potential donors from underrepresented groups from participating in sperm donation, according to Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank in Scottsdale, Ariz.
“Sometimes there are inhibitors of different ethnic groups to want to act as sperm or egg donors, so trying to understand if that’s the case is important; but I’m sure a lot of it is also related to access,” Dr. Pomeroy, who was not part of the study team, said in an interview.
Longitudinal data from the two national donor banks did not indicate any significant increase or decrease in donation trends across the 5-year period from 2018 to 2022, highlighting the persisting issue of representation disparities. Dr. Gibbs said strategies need to be developed to increase recruitment of donors from underrepresented groups. Increasing the diversity of the donor pool will ultimately support family-building options for all patients, according to Dr. Gibbs.
Funding for the study was provided by the EMD Serono REI Diversity Fellowship Grant. Dr. Gibbs reports no relevant financial relationships.
FROM ASRM 2023
AUA: Testosterone solution increases sex drive, energy, and testosterone in hypogonadal men
NEW ORLEANS – Testosterone 2% solution resulted in improved sex drive and increased energy in most hypogonadal men, according to a study presented by Dr. Gerald B. Brock at the annual meeting of the American Urological Association. In addition, testosterone levels returned to the normal range in this cohort, he reported.
“The treatment of hypogonadism has become very controversial in the U.S., Canada, and worldwide,” said Dr. Brock, a professor in the division of urology, department of surgery at St. Joseph’s Health Centre in London, Ontario. “Part of the problem is a lack of well-designed, placebo-controlled multicenter trials that specifically look at the symptomatic benefit [of testosterone replacement therapy] in these men. Symptoms are what drive men in for treatment, and as a result, we think it’s important to evaluate that endpoint.”
Dr. Brock and his colleagues assessed a broad population of hypogonadal men in order to determine the effect of testosterone solution 2% vs. placebo on serum total testosterone (TT) concentration, sexual drive, and energy.
In this multicenter, randomized, double-blind study, hypogonadal men ≥18 years (serum TT < 300 ng/dL) were assigned testosterone or placebo for 12 weeks. Men enrolled were required to have at least one symptom of testosterone deficiency (decreased energy or decreased sexual drive).
The primary objective was to compare the effect of testosterone and placebo on the proportion of hypogonadal men with serum TT levels falling within the normal range (300-1,050 ng/dL) after 12 weeks of treatment.
At entry into the study, men were given 60 mg of testosterone solution 2% or placebo, once daily. Two screening visits were conducted (baseline and randomization), and subsequent visits at weeks 2, 4, 6, 8, and 12 of treatment.
“An important part of this protocol was that the testosterone was dose-adjusted in a blinded fashion,” Dr. Brock said. “Based on results, patients could either be upped or lowered in their testosterone levels by 30-mg intervals at the 2-week interval visits.” Dosage adjustments were based on an algorithm used at weeks 4 and 8, using blinded TT levels determined at the preceding visit.
Secondary endpoints measured the effect of testosterone on sexual drive and energy level using two new patient-reported outcome instruments: the Sexual Arousal, Interest, and Drive (SAID) scale, for patients with low sex drive, and the Hypogonadism Energy Diary (HED), for patients with low sexual energy and overall energy. “Looking at these two facets was one of the novel aspects of the study,” Dr. Brock said.
Both SAID and HED were self-administered through the use of a handheld device. The SAID scale measures five items: thinking about sex (two items), arousal (one item), and level of interest in sex and sex drive (two items) as recalled in the past 7 days. Each item received a score of 1-5, and all scores were averaged to constitute the total SAID score.
HED was administered through two questions asked three times per day for 7 days, and addressed patients’ real-time energy levels (extent to which the respondent feels energetic or has feelings of tiredness/exhaustion). Each item was scored 0-10, and the total score was the sum of 7-day average scores for six items.
Exploratory measures included assessments of Patient Global Impression of Improvement (PGI-I), International Index of Erectile Dysfunction (IIEF), and the Psychosexual Daily Questionnaire (PDQ).
Overall, 715 patients (mean age, 55 years) were randomized to placebo (n = 357) or testosterone (n = 358); 82% (n = 294) of men assigned to placebo and 84% (n = 302) assigned to testosterone completed the 12-week study.
The study population was predominantly white, with a wide international enrollment. Low energy or decreased sex drive were present in roughly 75% of the study population, 50% of whom had previously received testosterone.
Comorbidities were common among participants – 30% had diabetes, 50% had hypertension, 38% had high cholesterol, and about 90% had hypogonadism from unknown reasons. “This was really a good representation of the general hypogonadal population,” Dr. Brock said.
“The results at 12 weeks were as expected,” he said. Normalization of testosterone (300-1,050 ng/dL) was found in 217 men (73%) in the active arm, compared with 43 (15%) in the placebo arm (P < 0.001).
“But perhaps the more exciting analyses show that the SAID and HED scales showed significant improvement,” he noted. “The preset levels of 0.01 were met with the SAID scale, and we received a significance level of 0.019 for the HED scale.”
Upon evaluation of exploratory measures, Dr. Brock and his coinvestigators found a significant difference between treatment groups across all domains of IIEF – orgasmic and erectile function, sexual desire, and intercourse and overall satisfaction (P < .05). The PDQ showed that statistical significance was reached in sexual desire, enjoyment, and sexual activity in the treated group compared with placebo (P < .05). The PGI-I also showed a significant effect of testosterone solution on energy level and sexual drive (P < .001 for treatment group difference).
“Perhaps the most important aspect of this trial is the safety, especially with all of the controversy about cardiovascular concerns,” Dr. Brock said. “There was no evidence of cardiovascular events in the treated arm and a single ischemic stroke in the placebo arm among the 356 patients in that group.”
Dr. Brock and his colleagues found that testosterone solution 2% therapy in hypogonadal men resulted in TT levels returning to the normal range in most of the cases. The testosterone solution also led to statistically significant improvements in sex drive and energy levels.
“The safety in this study was clear, and as a result, I think this is an important study that gives us new insight into the treatment of the hypogonadal male,” he asserted.
This study was funded by Eli Lilly. Dr. Brock has served as a consultant, done research in clinical trials, and served on advisory boards for several pharmaceutical companies. He owns stock in Lilly, in addition to Pfizer, Johnson & Johnson, GlaxoSmithKline, Abbott, and Astellas Pharma.
NEW ORLEANS – Testosterone 2% solution resulted in improved sex drive and increased energy in most hypogonadal men, according to a study presented by Dr. Gerald B. Brock at the annual meeting of the American Urological Association. In addition, testosterone levels returned to the normal range in this cohort, he reported.
“The treatment of hypogonadism has become very controversial in the U.S., Canada, and worldwide,” said Dr. Brock, a professor in the division of urology, department of surgery at St. Joseph’s Health Centre in London, Ontario. “Part of the problem is a lack of well-designed, placebo-controlled multicenter trials that specifically look at the symptomatic benefit [of testosterone replacement therapy] in these men. Symptoms are what drive men in for treatment, and as a result, we think it’s important to evaluate that endpoint.”
Dr. Brock and his colleagues assessed a broad population of hypogonadal men in order to determine the effect of testosterone solution 2% vs. placebo on serum total testosterone (TT) concentration, sexual drive, and energy.
In this multicenter, randomized, double-blind study, hypogonadal men ≥18 years (serum TT < 300 ng/dL) were assigned testosterone or placebo for 12 weeks. Men enrolled were required to have at least one symptom of testosterone deficiency (decreased energy or decreased sexual drive).
The primary objective was to compare the effect of testosterone and placebo on the proportion of hypogonadal men with serum TT levels falling within the normal range (300-1,050 ng/dL) after 12 weeks of treatment.
At entry into the study, men were given 60 mg of testosterone solution 2% or placebo, once daily. Two screening visits were conducted (baseline and randomization), and subsequent visits at weeks 2, 4, 6, 8, and 12 of treatment.
“An important part of this protocol was that the testosterone was dose-adjusted in a blinded fashion,” Dr. Brock said. “Based on results, patients could either be upped or lowered in their testosterone levels by 30-mg intervals at the 2-week interval visits.” Dosage adjustments were based on an algorithm used at weeks 4 and 8, using blinded TT levels determined at the preceding visit.
Secondary endpoints measured the effect of testosterone on sexual drive and energy level using two new patient-reported outcome instruments: the Sexual Arousal, Interest, and Drive (SAID) scale, for patients with low sex drive, and the Hypogonadism Energy Diary (HED), for patients with low sexual energy and overall energy. “Looking at these two facets was one of the novel aspects of the study,” Dr. Brock said.
Both SAID and HED were self-administered through the use of a handheld device. The SAID scale measures five items: thinking about sex (two items), arousal (one item), and level of interest in sex and sex drive (two items) as recalled in the past 7 days. Each item received a score of 1-5, and all scores were averaged to constitute the total SAID score.
HED was administered through two questions asked three times per day for 7 days, and addressed patients’ real-time energy levels (extent to which the respondent feels energetic or has feelings of tiredness/exhaustion). Each item was scored 0-10, and the total score was the sum of 7-day average scores for six items.
Exploratory measures included assessments of Patient Global Impression of Improvement (PGI-I), International Index of Erectile Dysfunction (IIEF), and the Psychosexual Daily Questionnaire (PDQ).
Overall, 715 patients (mean age, 55 years) were randomized to placebo (n = 357) or testosterone (n = 358); 82% (n = 294) of men assigned to placebo and 84% (n = 302) assigned to testosterone completed the 12-week study.
The study population was predominantly white, with a wide international enrollment. Low energy or decreased sex drive were present in roughly 75% of the study population, 50% of whom had previously received testosterone.
Comorbidities were common among participants – 30% had diabetes, 50% had hypertension, 38% had high cholesterol, and about 90% had hypogonadism from unknown reasons. “This was really a good representation of the general hypogonadal population,” Dr. Brock said.
“The results at 12 weeks were as expected,” he said. Normalization of testosterone (300-1,050 ng/dL) was found in 217 men (73%) in the active arm, compared with 43 (15%) in the placebo arm (P < 0.001).
“But perhaps the more exciting analyses show that the SAID and HED scales showed significant improvement,” he noted. “The preset levels of 0.01 were met with the SAID scale, and we received a significance level of 0.019 for the HED scale.”
Upon evaluation of exploratory measures, Dr. Brock and his coinvestigators found a significant difference between treatment groups across all domains of IIEF – orgasmic and erectile function, sexual desire, and intercourse and overall satisfaction (P < .05). The PDQ showed that statistical significance was reached in sexual desire, enjoyment, and sexual activity in the treated group compared with placebo (P < .05). The PGI-I also showed a significant effect of testosterone solution on energy level and sexual drive (P < .001 for treatment group difference).
“Perhaps the most important aspect of this trial is the safety, especially with all of the controversy about cardiovascular concerns,” Dr. Brock said. “There was no evidence of cardiovascular events in the treated arm and a single ischemic stroke in the placebo arm among the 356 patients in that group.”
Dr. Brock and his colleagues found that testosterone solution 2% therapy in hypogonadal men resulted in TT levels returning to the normal range in most of the cases. The testosterone solution also led to statistically significant improvements in sex drive and energy levels.
“The safety in this study was clear, and as a result, I think this is an important study that gives us new insight into the treatment of the hypogonadal male,” he asserted.
This study was funded by Eli Lilly. Dr. Brock has served as a consultant, done research in clinical trials, and served on advisory boards for several pharmaceutical companies. He owns stock in Lilly, in addition to Pfizer, Johnson & Johnson, GlaxoSmithKline, Abbott, and Astellas Pharma.
NEW ORLEANS – Testosterone 2% solution resulted in improved sex drive and increased energy in most hypogonadal men, according to a study presented by Dr. Gerald B. Brock at the annual meeting of the American Urological Association. In addition, testosterone levels returned to the normal range in this cohort, he reported.
“The treatment of hypogonadism has become very controversial in the U.S., Canada, and worldwide,” said Dr. Brock, a professor in the division of urology, department of surgery at St. Joseph’s Health Centre in London, Ontario. “Part of the problem is a lack of well-designed, placebo-controlled multicenter trials that specifically look at the symptomatic benefit [of testosterone replacement therapy] in these men. Symptoms are what drive men in for treatment, and as a result, we think it’s important to evaluate that endpoint.”
Dr. Brock and his colleagues assessed a broad population of hypogonadal men in order to determine the effect of testosterone solution 2% vs. placebo on serum total testosterone (TT) concentration, sexual drive, and energy.
In this multicenter, randomized, double-blind study, hypogonadal men ≥18 years (serum TT < 300 ng/dL) were assigned testosterone or placebo for 12 weeks. Men enrolled were required to have at least one symptom of testosterone deficiency (decreased energy or decreased sexual drive).
The primary objective was to compare the effect of testosterone and placebo on the proportion of hypogonadal men with serum TT levels falling within the normal range (300-1,050 ng/dL) after 12 weeks of treatment.
At entry into the study, men were given 60 mg of testosterone solution 2% or placebo, once daily. Two screening visits were conducted (baseline and randomization), and subsequent visits at weeks 2, 4, 6, 8, and 12 of treatment.
“An important part of this protocol was that the testosterone was dose-adjusted in a blinded fashion,” Dr. Brock said. “Based on results, patients could either be upped or lowered in their testosterone levels by 30-mg intervals at the 2-week interval visits.” Dosage adjustments were based on an algorithm used at weeks 4 and 8, using blinded TT levels determined at the preceding visit.
Secondary endpoints measured the effect of testosterone on sexual drive and energy level using two new patient-reported outcome instruments: the Sexual Arousal, Interest, and Drive (SAID) scale, for patients with low sex drive, and the Hypogonadism Energy Diary (HED), for patients with low sexual energy and overall energy. “Looking at these two facets was one of the novel aspects of the study,” Dr. Brock said.
Both SAID and HED were self-administered through the use of a handheld device. The SAID scale measures five items: thinking about sex (two items), arousal (one item), and level of interest in sex and sex drive (two items) as recalled in the past 7 days. Each item received a score of 1-5, and all scores were averaged to constitute the total SAID score.
HED was administered through two questions asked three times per day for 7 days, and addressed patients’ real-time energy levels (extent to which the respondent feels energetic or has feelings of tiredness/exhaustion). Each item was scored 0-10, and the total score was the sum of 7-day average scores for six items.
Exploratory measures included assessments of Patient Global Impression of Improvement (PGI-I), International Index of Erectile Dysfunction (IIEF), and the Psychosexual Daily Questionnaire (PDQ).
Overall, 715 patients (mean age, 55 years) were randomized to placebo (n = 357) or testosterone (n = 358); 82% (n = 294) of men assigned to placebo and 84% (n = 302) assigned to testosterone completed the 12-week study.
The study population was predominantly white, with a wide international enrollment. Low energy or decreased sex drive were present in roughly 75% of the study population, 50% of whom had previously received testosterone.
Comorbidities were common among participants – 30% had diabetes, 50% had hypertension, 38% had high cholesterol, and about 90% had hypogonadism from unknown reasons. “This was really a good representation of the general hypogonadal population,” Dr. Brock said.
“The results at 12 weeks were as expected,” he said. Normalization of testosterone (300-1,050 ng/dL) was found in 217 men (73%) in the active arm, compared with 43 (15%) in the placebo arm (P < 0.001).
“But perhaps the more exciting analyses show that the SAID and HED scales showed significant improvement,” he noted. “The preset levels of 0.01 were met with the SAID scale, and we received a significance level of 0.019 for the HED scale.”
Upon evaluation of exploratory measures, Dr. Brock and his coinvestigators found a significant difference between treatment groups across all domains of IIEF – orgasmic and erectile function, sexual desire, and intercourse and overall satisfaction (P < .05). The PDQ showed that statistical significance was reached in sexual desire, enjoyment, and sexual activity in the treated group compared with placebo (P < .05). The PGI-I also showed a significant effect of testosterone solution on energy level and sexual drive (P < .001 for treatment group difference).
“Perhaps the most important aspect of this trial is the safety, especially with all of the controversy about cardiovascular concerns,” Dr. Brock said. “There was no evidence of cardiovascular events in the treated arm and a single ischemic stroke in the placebo arm among the 356 patients in that group.”
Dr. Brock and his colleagues found that testosterone solution 2% therapy in hypogonadal men resulted in TT levels returning to the normal range in most of the cases. The testosterone solution also led to statistically significant improvements in sex drive and energy levels.
“The safety in this study was clear, and as a result, I think this is an important study that gives us new insight into the treatment of the hypogonadal male,” he asserted.
This study was funded by Eli Lilly. Dr. Brock has served as a consultant, done research in clinical trials, and served on advisory boards for several pharmaceutical companies. He owns stock in Lilly, in addition to Pfizer, Johnson & Johnson, GlaxoSmithKline, Abbott, and Astellas Pharma.
AT THE AUA ANNUAL MEETING
Key clinical point: Testosterone 2% solution appears to be a safe and effective treatment for most hypogonadal men.
Major finding: Normalization of testosterone (300-1050 ng/dL) was found in 217 men (73%) in the active arm, compared with 43 (15%) in the placebo arm (P < .001).
Data source: A multicenter, randomized, double-blind study of hypogonadal men ≥18 years (serum total testosterone <300 ng/dL) assigned testosterone or placebo for 12 weeks.
Disclosures: This study was funded by Eli Lilly. Dr. Brock has served as a consultant, done research in clinical trials, and served on advisory boards for several pharmaceutical companies. He owns stock in Lilly, in addition to Pfizer, Johnson & Johnson, GlaxoSmithKline, Abbott, and Astellas Pharma.
AUA: Long-term use of Botox may decrease urinary incontinence
NEW ORLEANS – Long-term treatment with onabotulinumtoxinA significantly decreased daily urinary incontinence episodes in patients with overactive bladder syndrome, with no increase in adverse effects tied to repeated treatment, according to Dr. Victor W. Nitti.
Dr. Nitti and his colleagues conducted a multicenter extension study evaluating the long-term efficacy and safety of repeated treatments with onabotulinumtoxinA (onabotA) in patients with overactive bladder (OAB).
After completion of either of two 24-week, randomized phase III trials, patients were eligible to enter a 3-year extension study in which they could receive multiple onabotA treatments at 100 units per dose, Dr Nitti reported at the annual meeting of the American Urological Association.
Patients were treated “as needed” based on their request, and their fulfillment of the prespecified qualification criteria. “Patients requesting treatment had to have at least two urgency incontinence episodes in a 3-day diary, at least 12 weeks since their last treatment, and their postvoid residual had to be less than 200 cc,” said Dr. Nitti, professor of urology at New York University, New York. Therefore, the total number of treatments delivered during the study differed among patients depending on need.
Coprimary endpoints included change from baseline in urinary incontinence episodes per day at week 12 and the proportion of patients reporting improvement or great improvement in their urinary incontinence (UI) at 12 weeks. Data were assessed for six subpopulations of patients based on the number of onabotA treatments (one to six) needed during the study; duration of effect (time to request for retreatment) in all six cycles also was evaluated in order to assess the consistency of response to repeated treatments.
Local anesthesia was administered to patients, and onabotA was delivered via injection into the muscle of the bladder. “Once the botulinum toxin gets into the terminal nerve, it will prevent the release of neurotransmitters, particularly acetylcholine; when acetylcholine is not released, there is less of a trigger for the bladder to contract,” he explained.
Of the 829 patients enrolled, 51.7% completed the 3-year study. About 5% did not complete the study because of an adverse event, and only 5.7% dropped out because of a lack of efficacy. “Over the 31/2-year period, patients were lost to follow-up, had protocol violations, and sites closed. So most of the reasons for discontinuation weren’t due to lack of efficacy or adverse events,” Dr. Nitti said.
The baseline mean UI episodes per day was a little over 5.5 for all treatment cycles; consistent reductions in UI episodes were observed in the overall population results regardless of the number of treatments received, with overall reduction between 3.1 and 3.8 episodes per day.
“Also consistent was the number of patients who reported being greatly improved or improved on the treatment benefit scale, which remained at right around 80% regardless of treatment cycle,” he added.
Patients who received fewer treatments had a longer duration of effect than those who received more treatments. The overall median duration of effect was 7.6 months, and 34.2% of the patients reported control of their urinary incontinence symptoms for at least 6 months. The median time to request retreatment was >6 to ≤12 months for 37.2%, and >12 months for 28.5% of patients. Urinary tract infection was the most common adverse event observed.
Based on these data, Dr. Nitti and his colleagues concluded that long-term treatment of OAB with onabotA resulted in decreased daily urinary incontinence episodes, with no increase in adverse events tied to recurrent treatment.
Dr. Nitti disclosed financial relationships with Allergan, and numerous other pharmaceutical and device companies.
NEW ORLEANS – Long-term treatment with onabotulinumtoxinA significantly decreased daily urinary incontinence episodes in patients with overactive bladder syndrome, with no increase in adverse effects tied to repeated treatment, according to Dr. Victor W. Nitti.
Dr. Nitti and his colleagues conducted a multicenter extension study evaluating the long-term efficacy and safety of repeated treatments with onabotulinumtoxinA (onabotA) in patients with overactive bladder (OAB).
After completion of either of two 24-week, randomized phase III trials, patients were eligible to enter a 3-year extension study in which they could receive multiple onabotA treatments at 100 units per dose, Dr Nitti reported at the annual meeting of the American Urological Association.
Patients were treated “as needed” based on their request, and their fulfillment of the prespecified qualification criteria. “Patients requesting treatment had to have at least two urgency incontinence episodes in a 3-day diary, at least 12 weeks since their last treatment, and their postvoid residual had to be less than 200 cc,” said Dr. Nitti, professor of urology at New York University, New York. Therefore, the total number of treatments delivered during the study differed among patients depending on need.
Coprimary endpoints included change from baseline in urinary incontinence episodes per day at week 12 and the proportion of patients reporting improvement or great improvement in their urinary incontinence (UI) at 12 weeks. Data were assessed for six subpopulations of patients based on the number of onabotA treatments (one to six) needed during the study; duration of effect (time to request for retreatment) in all six cycles also was evaluated in order to assess the consistency of response to repeated treatments.
Local anesthesia was administered to patients, and onabotA was delivered via injection into the muscle of the bladder. “Once the botulinum toxin gets into the terminal nerve, it will prevent the release of neurotransmitters, particularly acetylcholine; when acetylcholine is not released, there is less of a trigger for the bladder to contract,” he explained.
Of the 829 patients enrolled, 51.7% completed the 3-year study. About 5% did not complete the study because of an adverse event, and only 5.7% dropped out because of a lack of efficacy. “Over the 31/2-year period, patients were lost to follow-up, had protocol violations, and sites closed. So most of the reasons for discontinuation weren’t due to lack of efficacy or adverse events,” Dr. Nitti said.
The baseline mean UI episodes per day was a little over 5.5 for all treatment cycles; consistent reductions in UI episodes were observed in the overall population results regardless of the number of treatments received, with overall reduction between 3.1 and 3.8 episodes per day.
“Also consistent was the number of patients who reported being greatly improved or improved on the treatment benefit scale, which remained at right around 80% regardless of treatment cycle,” he added.
Patients who received fewer treatments had a longer duration of effect than those who received more treatments. The overall median duration of effect was 7.6 months, and 34.2% of the patients reported control of their urinary incontinence symptoms for at least 6 months. The median time to request retreatment was >6 to ≤12 months for 37.2%, and >12 months for 28.5% of patients. Urinary tract infection was the most common adverse event observed.
Based on these data, Dr. Nitti and his colleagues concluded that long-term treatment of OAB with onabotA resulted in decreased daily urinary incontinence episodes, with no increase in adverse events tied to recurrent treatment.
Dr. Nitti disclosed financial relationships with Allergan, and numerous other pharmaceutical and device companies.
NEW ORLEANS – Long-term treatment with onabotulinumtoxinA significantly decreased daily urinary incontinence episodes in patients with overactive bladder syndrome, with no increase in adverse effects tied to repeated treatment, according to Dr. Victor W. Nitti.
Dr. Nitti and his colleagues conducted a multicenter extension study evaluating the long-term efficacy and safety of repeated treatments with onabotulinumtoxinA (onabotA) in patients with overactive bladder (OAB).
After completion of either of two 24-week, randomized phase III trials, patients were eligible to enter a 3-year extension study in which they could receive multiple onabotA treatments at 100 units per dose, Dr Nitti reported at the annual meeting of the American Urological Association.
Patients were treated “as needed” based on their request, and their fulfillment of the prespecified qualification criteria. “Patients requesting treatment had to have at least two urgency incontinence episodes in a 3-day diary, at least 12 weeks since their last treatment, and their postvoid residual had to be less than 200 cc,” said Dr. Nitti, professor of urology at New York University, New York. Therefore, the total number of treatments delivered during the study differed among patients depending on need.
Coprimary endpoints included change from baseline in urinary incontinence episodes per day at week 12 and the proportion of patients reporting improvement or great improvement in their urinary incontinence (UI) at 12 weeks. Data were assessed for six subpopulations of patients based on the number of onabotA treatments (one to six) needed during the study; duration of effect (time to request for retreatment) in all six cycles also was evaluated in order to assess the consistency of response to repeated treatments.
Local anesthesia was administered to patients, and onabotA was delivered via injection into the muscle of the bladder. “Once the botulinum toxin gets into the terminal nerve, it will prevent the release of neurotransmitters, particularly acetylcholine; when acetylcholine is not released, there is less of a trigger for the bladder to contract,” he explained.
Of the 829 patients enrolled, 51.7% completed the 3-year study. About 5% did not complete the study because of an adverse event, and only 5.7% dropped out because of a lack of efficacy. “Over the 31/2-year period, patients were lost to follow-up, had protocol violations, and sites closed. So most of the reasons for discontinuation weren’t due to lack of efficacy or adverse events,” Dr. Nitti said.
The baseline mean UI episodes per day was a little over 5.5 for all treatment cycles; consistent reductions in UI episodes were observed in the overall population results regardless of the number of treatments received, with overall reduction between 3.1 and 3.8 episodes per day.
“Also consistent was the number of patients who reported being greatly improved or improved on the treatment benefit scale, which remained at right around 80% regardless of treatment cycle,” he added.
Patients who received fewer treatments had a longer duration of effect than those who received more treatments. The overall median duration of effect was 7.6 months, and 34.2% of the patients reported control of their urinary incontinence symptoms for at least 6 months. The median time to request retreatment was >6 to ≤12 months for 37.2%, and >12 months for 28.5% of patients. Urinary tract infection was the most common adverse event observed.
Based on these data, Dr. Nitti and his colleagues concluded that long-term treatment of OAB with onabotA resulted in decreased daily urinary incontinence episodes, with no increase in adverse events tied to recurrent treatment.
Dr. Nitti disclosed financial relationships with Allergan, and numerous other pharmaceutical and device companies.
AT THE AUA ANNUAL MEETING
Key clinical point: OnabotulinumtoxinA delivered via injection into the muscle of the bladder appears to be a good option for patients with overactive bladder syndrome (OAB) experiencing daily urinary incontinence (UI) episodes.
Major finding: Consistent reductions in UI episodes were observed in the overall population results, regardless of the number of treatments received. Overall, reductions were between 3.1 and 3.8 episodes per day.
Data source: A multicenter extension study of more than 400 patients with OAB experiencing daily UI episodes.
Disclosures: Dr. Nitti disclosed financial relationships with Allergan, and numerous other pharmaceutical and device companies.
Urine assay ruled out high-grade prostate cancer
NEW ORLEANS – A urine assay test can provide a high negative predictive value to rule out the presence of high-grade, clinically significant prostate cancer without the need for a digital rectal exam or prostate massage, according to a study presented by Dr. James McKiernan at the annual meeting of the American Urological Association.
“There is an unmet medical need in prostate cancer biomarker development, and new biomarkers should be designed to detect high-grade prostate cancer, not all prostate cancer,” said Dr. McKiernan, director of urologic oncology at Columbia University Medical Center in New York.
He and his colleagues designed a novel noninvasive urine exosome gene expression assay (EXO106) and evaluated its performance in testing for high-grade prostate cancers (CaP) among a group of male patients.
Unmet need in prostate cancer
“The role of PSA [prostate-specific antigen] screening in the United States is controversial, with a high false-positive rate,” said Dr. McKiernan. Over 1 million prostate biopsies are performed annually in the United States, and the vast majority of them reveal low-grade or very-low-risk prostate cancer.
Serious complications associated with prostate biopsy, including hospitalization and infection, are increasing, and unnecessary or potentially unnecessary treatments for low-risk disease continue at a relatively high rate.
The role of exosomes in EXO106
Dr. McKiernan and his colleagues sought to utilize exosomes in the development of a urine assay test to predict high-grade CaP. Exosomes are lipid bilayer-protected vesicles, which makes them stable under varying conditions and protects them from degradation: they contain RNA, DNA, and protein.
“Exosomes exist in all cells, both malignant and benign, and are believed to be involved in intracellular communication both locally and at a distance,” Dr. McKiernan said.
The EXO106 assay is a simple voided urine test developed over the past 4 years; it does not require a digital rectal exam (DRE) or prostate massage. Exosomes were separated from the urine tested in this population by a process of ultrafiltration, and then the expression level of genes of interest was determined.
The EXO106 assay relied on an expression level of three genes – ERG qPRC, PCA3 qPCR, and SPDEF qPCR. Multivariate analysis was performed to correlate the expression level in the exosomes of these three genes with the presence or absence of high-grade cancer on prostate biopsy.
Study design
In this study, the intended use of the EXO106 risk score was to predict the presence of high-grade (Gleason Score [GS] ≥ 7) prostate cancer for men aged 50 years or older with a PSA between 2 and 10 ng/mL, with either a normal or abnormal DRE, who were referred for their first-ever prostate biopsy – this was not a rebiopsy population. First catch, non-DRE, random urine was collected at all sites, kept stable without chemical preservatives, and then shipped to a central lab for analysis.
The objective of this national trial was to evaluate whether the use of this assay could improve upon the standard of care (SOC) to detect high-grade prostate cancer. The SOC in this study was defined by typical clinical practice based on PSA, age, race, and family history.
“The primary study endpoint was to calculate the area under the receiver operating characteristic curve (AUC) for the combination of the EXO106 assay and the standard of care, and to determine if this was significantly better than the standard of care alone at detecting high-grade prostate cancer [(AUC (EXO106 + SOC) > AUC (SOC)],” Dr. McKiernan explained.
The secondary endpoint was to establish a binary cut-point to determine a normal and abnormal level for the EXO106 assay and then to interrogate the negative predictive value (NPV) of this binary cut-point.
The study evaluated 519 patients (median age, 63; median PSA, 5.12 ng/mL), of whom 17% were African-American, 82% had a normal DRE, and 23% had a family history of CaP. Nearly half (48%) of the biopsies overall were positive, and 28% of biopsies in the cohort were positive for high-grade CaP (GS ≥ 7).
Results
The PSA alone was found to be a relatively noneffective discriminator for high-grade CaP, with an AUC of .545, with .50 indicating absolute lack of discriminating power.
The EXO106 assay alone had a .711 AUC by itself and .725, compared with the SOC. “This met the primary objective as being significantly better than the SOC alone for determining the presence or absence of high-grade prostate cancer,” Dr. McKiernan said.
The binary cut-point resulted in an NPV of 91%. “So if a patient underwent this assay alone and the assay was normal, there was a 91% chance that they did not have high-grade prostate cancer,” he explained. “If this was applied in routine clinical practice in this cohort, it would reduce the unnecessary biopsy rate by 26%.”
This study revealed that exosomal mRNA can be isolated from human urine and analyzed without the use of a DRE or prostate massage. “This test, measuring the mRNA expression of PCA3, ERG, and SPDEF, can provide a high NPV to rule out the presence of high-grade clinically significant prostate cancer. Furthermore, out of 148 cases of GS7 or higher, only three patients with GS-predominant pattern 4 were missed, for a false-negative rate of less than 5%,” he reported.
Dr. McKiernan and his colleagues concluded that this novel, noninvasive urine exosome gene signature demonstrated excellent discrimination for the diagnosis of GS7 or higher prostate cancer for men presenting with indeterminate PSA results who would be candidates for first-time biopsy.
This study was performed in collaboration with and funded by Exosome Diagnostics, with coordination efforts through the Prostate Cancer Foundation.
NEW ORLEANS – A urine assay test can provide a high negative predictive value to rule out the presence of high-grade, clinically significant prostate cancer without the need for a digital rectal exam or prostate massage, according to a study presented by Dr. James McKiernan at the annual meeting of the American Urological Association.
“There is an unmet medical need in prostate cancer biomarker development, and new biomarkers should be designed to detect high-grade prostate cancer, not all prostate cancer,” said Dr. McKiernan, director of urologic oncology at Columbia University Medical Center in New York.
He and his colleagues designed a novel noninvasive urine exosome gene expression assay (EXO106) and evaluated its performance in testing for high-grade prostate cancers (CaP) among a group of male patients.
Unmet need in prostate cancer
“The role of PSA [prostate-specific antigen] screening in the United States is controversial, with a high false-positive rate,” said Dr. McKiernan. Over 1 million prostate biopsies are performed annually in the United States, and the vast majority of them reveal low-grade or very-low-risk prostate cancer.
Serious complications associated with prostate biopsy, including hospitalization and infection, are increasing, and unnecessary or potentially unnecessary treatments for low-risk disease continue at a relatively high rate.
The role of exosomes in EXO106
Dr. McKiernan and his colleagues sought to utilize exosomes in the development of a urine assay test to predict high-grade CaP. Exosomes are lipid bilayer-protected vesicles, which makes them stable under varying conditions and protects them from degradation: they contain RNA, DNA, and protein.
“Exosomes exist in all cells, both malignant and benign, and are believed to be involved in intracellular communication both locally and at a distance,” Dr. McKiernan said.
The EXO106 assay is a simple voided urine test developed over the past 4 years; it does not require a digital rectal exam (DRE) or prostate massage. Exosomes were separated from the urine tested in this population by a process of ultrafiltration, and then the expression level of genes of interest was determined.
The EXO106 assay relied on an expression level of three genes – ERG qPRC, PCA3 qPCR, and SPDEF qPCR. Multivariate analysis was performed to correlate the expression level in the exosomes of these three genes with the presence or absence of high-grade cancer on prostate biopsy.
Study design
In this study, the intended use of the EXO106 risk score was to predict the presence of high-grade (Gleason Score [GS] ≥ 7) prostate cancer for men aged 50 years or older with a PSA between 2 and 10 ng/mL, with either a normal or abnormal DRE, who were referred for their first-ever prostate biopsy – this was not a rebiopsy population. First catch, non-DRE, random urine was collected at all sites, kept stable without chemical preservatives, and then shipped to a central lab for analysis.
The objective of this national trial was to evaluate whether the use of this assay could improve upon the standard of care (SOC) to detect high-grade prostate cancer. The SOC in this study was defined by typical clinical practice based on PSA, age, race, and family history.
“The primary study endpoint was to calculate the area under the receiver operating characteristic curve (AUC) for the combination of the EXO106 assay and the standard of care, and to determine if this was significantly better than the standard of care alone at detecting high-grade prostate cancer [(AUC (EXO106 + SOC) > AUC (SOC)],” Dr. McKiernan explained.
The secondary endpoint was to establish a binary cut-point to determine a normal and abnormal level for the EXO106 assay and then to interrogate the negative predictive value (NPV) of this binary cut-point.
The study evaluated 519 patients (median age, 63; median PSA, 5.12 ng/mL), of whom 17% were African-American, 82% had a normal DRE, and 23% had a family history of CaP. Nearly half (48%) of the biopsies overall were positive, and 28% of biopsies in the cohort were positive for high-grade CaP (GS ≥ 7).
Results
The PSA alone was found to be a relatively noneffective discriminator for high-grade CaP, with an AUC of .545, with .50 indicating absolute lack of discriminating power.
The EXO106 assay alone had a .711 AUC by itself and .725, compared with the SOC. “This met the primary objective as being significantly better than the SOC alone for determining the presence or absence of high-grade prostate cancer,” Dr. McKiernan said.
The binary cut-point resulted in an NPV of 91%. “So if a patient underwent this assay alone and the assay was normal, there was a 91% chance that they did not have high-grade prostate cancer,” he explained. “If this was applied in routine clinical practice in this cohort, it would reduce the unnecessary biopsy rate by 26%.”
This study revealed that exosomal mRNA can be isolated from human urine and analyzed without the use of a DRE or prostate massage. “This test, measuring the mRNA expression of PCA3, ERG, and SPDEF, can provide a high NPV to rule out the presence of high-grade clinically significant prostate cancer. Furthermore, out of 148 cases of GS7 or higher, only three patients with GS-predominant pattern 4 were missed, for a false-negative rate of less than 5%,” he reported.
Dr. McKiernan and his colleagues concluded that this novel, noninvasive urine exosome gene signature demonstrated excellent discrimination for the diagnosis of GS7 or higher prostate cancer for men presenting with indeterminate PSA results who would be candidates for first-time biopsy.
This study was performed in collaboration with and funded by Exosome Diagnostics, with coordination efforts through the Prostate Cancer Foundation.
NEW ORLEANS – A urine assay test can provide a high negative predictive value to rule out the presence of high-grade, clinically significant prostate cancer without the need for a digital rectal exam or prostate massage, according to a study presented by Dr. James McKiernan at the annual meeting of the American Urological Association.
“There is an unmet medical need in prostate cancer biomarker development, and new biomarkers should be designed to detect high-grade prostate cancer, not all prostate cancer,” said Dr. McKiernan, director of urologic oncology at Columbia University Medical Center in New York.
He and his colleagues designed a novel noninvasive urine exosome gene expression assay (EXO106) and evaluated its performance in testing for high-grade prostate cancers (CaP) among a group of male patients.
Unmet need in prostate cancer
“The role of PSA [prostate-specific antigen] screening in the United States is controversial, with a high false-positive rate,” said Dr. McKiernan. Over 1 million prostate biopsies are performed annually in the United States, and the vast majority of them reveal low-grade or very-low-risk prostate cancer.
Serious complications associated with prostate biopsy, including hospitalization and infection, are increasing, and unnecessary or potentially unnecessary treatments for low-risk disease continue at a relatively high rate.
The role of exosomes in EXO106
Dr. McKiernan and his colleagues sought to utilize exosomes in the development of a urine assay test to predict high-grade CaP. Exosomes are lipid bilayer-protected vesicles, which makes them stable under varying conditions and protects them from degradation: they contain RNA, DNA, and protein.
“Exosomes exist in all cells, both malignant and benign, and are believed to be involved in intracellular communication both locally and at a distance,” Dr. McKiernan said.
The EXO106 assay is a simple voided urine test developed over the past 4 years; it does not require a digital rectal exam (DRE) or prostate massage. Exosomes were separated from the urine tested in this population by a process of ultrafiltration, and then the expression level of genes of interest was determined.
The EXO106 assay relied on an expression level of three genes – ERG qPRC, PCA3 qPCR, and SPDEF qPCR. Multivariate analysis was performed to correlate the expression level in the exosomes of these three genes with the presence or absence of high-grade cancer on prostate biopsy.
Study design
In this study, the intended use of the EXO106 risk score was to predict the presence of high-grade (Gleason Score [GS] ≥ 7) prostate cancer for men aged 50 years or older with a PSA between 2 and 10 ng/mL, with either a normal or abnormal DRE, who were referred for their first-ever prostate biopsy – this was not a rebiopsy population. First catch, non-DRE, random urine was collected at all sites, kept stable without chemical preservatives, and then shipped to a central lab for analysis.
The objective of this national trial was to evaluate whether the use of this assay could improve upon the standard of care (SOC) to detect high-grade prostate cancer. The SOC in this study was defined by typical clinical practice based on PSA, age, race, and family history.
“The primary study endpoint was to calculate the area under the receiver operating characteristic curve (AUC) for the combination of the EXO106 assay and the standard of care, and to determine if this was significantly better than the standard of care alone at detecting high-grade prostate cancer [(AUC (EXO106 + SOC) > AUC (SOC)],” Dr. McKiernan explained.
The secondary endpoint was to establish a binary cut-point to determine a normal and abnormal level for the EXO106 assay and then to interrogate the negative predictive value (NPV) of this binary cut-point.
The study evaluated 519 patients (median age, 63; median PSA, 5.12 ng/mL), of whom 17% were African-American, 82% had a normal DRE, and 23% had a family history of CaP. Nearly half (48%) of the biopsies overall were positive, and 28% of biopsies in the cohort were positive for high-grade CaP (GS ≥ 7).
Results
The PSA alone was found to be a relatively noneffective discriminator for high-grade CaP, with an AUC of .545, with .50 indicating absolute lack of discriminating power.
The EXO106 assay alone had a .711 AUC by itself and .725, compared with the SOC. “This met the primary objective as being significantly better than the SOC alone for determining the presence or absence of high-grade prostate cancer,” Dr. McKiernan said.
The binary cut-point resulted in an NPV of 91%. “So if a patient underwent this assay alone and the assay was normal, there was a 91% chance that they did not have high-grade prostate cancer,” he explained. “If this was applied in routine clinical practice in this cohort, it would reduce the unnecessary biopsy rate by 26%.”
This study revealed that exosomal mRNA can be isolated from human urine and analyzed without the use of a DRE or prostate massage. “This test, measuring the mRNA expression of PCA3, ERG, and SPDEF, can provide a high NPV to rule out the presence of high-grade clinically significant prostate cancer. Furthermore, out of 148 cases of GS7 or higher, only three patients with GS-predominant pattern 4 were missed, for a false-negative rate of less than 5%,” he reported.
Dr. McKiernan and his colleagues concluded that this novel, noninvasive urine exosome gene signature demonstrated excellent discrimination for the diagnosis of GS7 or higher prostate cancer for men presenting with indeterminate PSA results who would be candidates for first-time biopsy.
This study was performed in collaboration with and funded by Exosome Diagnostics, with coordination efforts through the Prostate Cancer Foundation.
AT THE AUA ANNUAL MEETING
Key clinical point: A urine assay test reliably ruled out the presence of high-grade, clinically significant prostate cancer.
Major finding: The urine assay had a negative predictive value for high-grade prostate cancer of 91%.
Data source: Evaluation of 519 patients with a median PSA of 5.12 ng/mL.
Disclosures: This study was performed in collaboration with and funded by Exosome Diagnostics, with coordination efforts through the Prostate Cancer Foundation.
AUA: Renal mass biopsy trend tied to nonsurgical RCC treatment
NEW ORLEANS – Renal mass biopsy has traditionally played a restricted diagnostic role, but with its improved diagnostic accuracy, it is becoming a viable clinical tool in the modern era, according to Dr. Matthew Maurice.
“We were seeking to understand the current role of biopsy in the management of renal masses, said Dr. Maurice, a urology resident at University Hospitals Case Medical Center in Cleveland. “We used the National Cancer Database and looked at data from 2003 to 2011; what we saw was a rise in renal mass biopsy in the final 3 years of the study. It’s a very small increase, but a statistically significant increase, with people in 2011 having 1.3 times higher odds of being biopsied than they would have had in 2003.”
Dr. Maurice and his colleagues at Case Medical conducted a study examining renal mass biopsy use in the modern era, and presented their findings in a poster at the annual meeting of the American Urological Association.
Using the National Cancer Database (NCDB), Dr. Maurice and his colleagues identified all patients diagnosed with renal cell carcinoma (RCC) between 2003 and 2011. Patients within the RCC cohort were then classified as having undergone renal biopsy or not. Renal biopsy utilization rates were plotted over time, and patient, disease, provider, and treatment variables were evaluated via univariate and multivariate logistic regression models to determine the predictors of renal biopsy.
Out of 304,583 patients with kidney cancer, 35,942 patients (11.8%) underwent renal mass biopsy. From 2009 to 2011, Dr. Maurice and his coinvestigators observed a significant increase in biopsy use; patients diagnosed with a renal mass in 2011 had 1.3 times higher odds of being biopsied compared with those diagnosed in 2003 (odds radio, 1.3, confidence interval, 1.3-1.4, P < .01).
Eventual treatment was the strongest predictor of biopsy utilization. “Patients receiving observation or thermal ablative therapy (either cryoablation or radiofrequency ablation) were much more likely to receive biopsy than were those who received surgical therapy such as radical or partial nephrectomy,” Dr. Maurice explained. “So it seems like those treatments are driving the use of renal biopsy utilization in contemporary patients.”
Compared to patients treated with partial nephrectomy, patients managed with observation, cryoablation, or radiofrequency ablation had 4.2, 8.0, and 19.1 times the odds of being biopsied, respectively (OR, 4.2, CI, 4.0-4.5, P < .01; OR, 8.0, CI, 8.0-8.1, P < .01; OR, 19.1, CI, 18.4-19.7, P < .01). Patients with other known cancers, bulky lymph node involvement, or small masses ranging from 2 to 4 cm in size were also more likely to be biopsied (P < .01).
“Nonacademic hospitals were more likely to biopsy,” he added. “It could be that these hospitals are using observation and thermal ablative therapies more frequently.” Conversely, wealthier patients, patients treated at academic hospitals, and patients treated in the Northeast were significantly less likely to be biopsied. (P < .01).
On the basis of the data analyzed in this study, Dr. Maurice and his colleagues concluded that there is a trend in use of renal mass biopsy in nonacademic centers in recent years, particularly among patients with small renal masses and in those who eventually undergo observation or focal ablative therapies. Lesser indications predicting the usage of renal mass biopsy include the existence of other primary cancers and bulky lymph nodes.
Dr. Maurice reported no relevant financial relationships.
NEW ORLEANS – Renal mass biopsy has traditionally played a restricted diagnostic role, but with its improved diagnostic accuracy, it is becoming a viable clinical tool in the modern era, according to Dr. Matthew Maurice.
“We were seeking to understand the current role of biopsy in the management of renal masses, said Dr. Maurice, a urology resident at University Hospitals Case Medical Center in Cleveland. “We used the National Cancer Database and looked at data from 2003 to 2011; what we saw was a rise in renal mass biopsy in the final 3 years of the study. It’s a very small increase, but a statistically significant increase, with people in 2011 having 1.3 times higher odds of being biopsied than they would have had in 2003.”
Dr. Maurice and his colleagues at Case Medical conducted a study examining renal mass biopsy use in the modern era, and presented their findings in a poster at the annual meeting of the American Urological Association.
Using the National Cancer Database (NCDB), Dr. Maurice and his colleagues identified all patients diagnosed with renal cell carcinoma (RCC) between 2003 and 2011. Patients within the RCC cohort were then classified as having undergone renal biopsy or not. Renal biopsy utilization rates were plotted over time, and patient, disease, provider, and treatment variables were evaluated via univariate and multivariate logistic regression models to determine the predictors of renal biopsy.
Out of 304,583 patients with kidney cancer, 35,942 patients (11.8%) underwent renal mass biopsy. From 2009 to 2011, Dr. Maurice and his coinvestigators observed a significant increase in biopsy use; patients diagnosed with a renal mass in 2011 had 1.3 times higher odds of being biopsied compared with those diagnosed in 2003 (odds radio, 1.3, confidence interval, 1.3-1.4, P < .01).
Eventual treatment was the strongest predictor of biopsy utilization. “Patients receiving observation or thermal ablative therapy (either cryoablation or radiofrequency ablation) were much more likely to receive biopsy than were those who received surgical therapy such as radical or partial nephrectomy,” Dr. Maurice explained. “So it seems like those treatments are driving the use of renal biopsy utilization in contemporary patients.”
Compared to patients treated with partial nephrectomy, patients managed with observation, cryoablation, or radiofrequency ablation had 4.2, 8.0, and 19.1 times the odds of being biopsied, respectively (OR, 4.2, CI, 4.0-4.5, P < .01; OR, 8.0, CI, 8.0-8.1, P < .01; OR, 19.1, CI, 18.4-19.7, P < .01). Patients with other known cancers, bulky lymph node involvement, or small masses ranging from 2 to 4 cm in size were also more likely to be biopsied (P < .01).
“Nonacademic hospitals were more likely to biopsy,” he added. “It could be that these hospitals are using observation and thermal ablative therapies more frequently.” Conversely, wealthier patients, patients treated at academic hospitals, and patients treated in the Northeast were significantly less likely to be biopsied. (P < .01).
On the basis of the data analyzed in this study, Dr. Maurice and his colleagues concluded that there is a trend in use of renal mass biopsy in nonacademic centers in recent years, particularly among patients with small renal masses and in those who eventually undergo observation or focal ablative therapies. Lesser indications predicting the usage of renal mass biopsy include the existence of other primary cancers and bulky lymph nodes.
Dr. Maurice reported no relevant financial relationships.
NEW ORLEANS – Renal mass biopsy has traditionally played a restricted diagnostic role, but with its improved diagnostic accuracy, it is becoming a viable clinical tool in the modern era, according to Dr. Matthew Maurice.
“We were seeking to understand the current role of biopsy in the management of renal masses, said Dr. Maurice, a urology resident at University Hospitals Case Medical Center in Cleveland. “We used the National Cancer Database and looked at data from 2003 to 2011; what we saw was a rise in renal mass biopsy in the final 3 years of the study. It’s a very small increase, but a statistically significant increase, with people in 2011 having 1.3 times higher odds of being biopsied than they would have had in 2003.”
Dr. Maurice and his colleagues at Case Medical conducted a study examining renal mass biopsy use in the modern era, and presented their findings in a poster at the annual meeting of the American Urological Association.
Using the National Cancer Database (NCDB), Dr. Maurice and his colleagues identified all patients diagnosed with renal cell carcinoma (RCC) between 2003 and 2011. Patients within the RCC cohort were then classified as having undergone renal biopsy or not. Renal biopsy utilization rates were plotted over time, and patient, disease, provider, and treatment variables were evaluated via univariate and multivariate logistic regression models to determine the predictors of renal biopsy.
Out of 304,583 patients with kidney cancer, 35,942 patients (11.8%) underwent renal mass biopsy. From 2009 to 2011, Dr. Maurice and his coinvestigators observed a significant increase in biopsy use; patients diagnosed with a renal mass in 2011 had 1.3 times higher odds of being biopsied compared with those diagnosed in 2003 (odds radio, 1.3, confidence interval, 1.3-1.4, P < .01).
Eventual treatment was the strongest predictor of biopsy utilization. “Patients receiving observation or thermal ablative therapy (either cryoablation or radiofrequency ablation) were much more likely to receive biopsy than were those who received surgical therapy such as radical or partial nephrectomy,” Dr. Maurice explained. “So it seems like those treatments are driving the use of renal biopsy utilization in contemporary patients.”
Compared to patients treated with partial nephrectomy, patients managed with observation, cryoablation, or radiofrequency ablation had 4.2, 8.0, and 19.1 times the odds of being biopsied, respectively (OR, 4.2, CI, 4.0-4.5, P < .01; OR, 8.0, CI, 8.0-8.1, P < .01; OR, 19.1, CI, 18.4-19.7, P < .01). Patients with other known cancers, bulky lymph node involvement, or small masses ranging from 2 to 4 cm in size were also more likely to be biopsied (P < .01).
“Nonacademic hospitals were more likely to biopsy,” he added. “It could be that these hospitals are using observation and thermal ablative therapies more frequently.” Conversely, wealthier patients, patients treated at academic hospitals, and patients treated in the Northeast were significantly less likely to be biopsied. (P < .01).
On the basis of the data analyzed in this study, Dr. Maurice and his colleagues concluded that there is a trend in use of renal mass biopsy in nonacademic centers in recent years, particularly among patients with small renal masses and in those who eventually undergo observation or focal ablative therapies. Lesser indications predicting the usage of renal mass biopsy include the existence of other primary cancers and bulky lymph nodes.
Dr. Maurice reported no relevant financial relationships.
AT THE AUA ANNUAL MEETING
Key clinical point: Use of renal mass biopsy is increasing and the increase is likely linked to choice of treatment (observation or thermal ablative therapy).
Major finding: Patients diagnosed with renal mass had 1.3 times higher odds of being biopsied in 2011 than they would have had in 2003.
Data source: Sample from 2003-2011 National Cancer Database of 304,583 patients with kidney cancer, 35,942 of whom underwent renal mass biopsy.
Disclosures: Dr. Maurice reported no relevant financial relationships.
ERAS protocol superior for postop cystectomy pain management
NEW ORLEANS – The enhanced recovery after surgery (ERAS) protocol resulted in significantly less opioid use for pain management for radical cystectomy patients, compared with traditional postop approaches, according to Dr. Hooman Djaladat.
“The whole idea behind the ERAS protocol was to diminish hospital stay and send the patients home sooner, with no increase in complications or readmission rates,” said Dr. Djaladat, associate professor of clinical urology at the University of Southern California, Los Angeles.
ERAS protocols are multimodal perioperative care pathways, the aim of which is early recovery after surgery by maintaining preoperative organ function and reducing the profound stress response following surgery. The key elements of ERAS protocols include preoperative counseling, optimization of nutrition, standardized analgesic and anesthetic regimens, and early mobilization.
Opioids have traditionally been the standard for pain management after radical cystectomy (RC) for bladder cancer, but opioid use is often accompanied by side effects such as respiratory depression, nausea, vomiting, confusion, and ileus – the leading cause of prolonged hospital stay.
Dr. Djaladat and his colleagues at USC compared the amount of opioid use, pain score, and postoperative ileus in consecutive ERAS and traditional postop RC patients at USC, and presented their findings in a poster at the annual meeting of the American Urological Association.
Study Methods
Dr. Djaladat and his colleagues retrospectively evaluated 205 open-RC patients, 124 of whom underwent pain management as outlined by ERAS protocol (May 2012 to December 2013) and 81 who underwent traditional pain management with opioids (February 2010 to September 2013); the two groups were matched according to patient demographics, and those with a history of opioid use prior to surgery were not included in the study.
Traditional pain management protocol relied primarily on intravenous and epidural opioids, with acetaminophen and ketorolac as supplements as needed. Patient-controlled analgesia also was used if necessary.
The ERAS protocol utilized predominantly acetaminophen and ketorolac started intraoperatively, supplemented by consistent use of local anesthetic through subfascial catheters. Opioids were used only for breakthrough pain.
All opioids used (oxycodone, hydromorphone, tramadol, hydrocodone, morphine, and fentanyl) were converted to intravenous morphine equivalents. Opioid use and pain scores were examined and compared up to postoperative day 4.
“Bottom line, a traditional pathway has been mostly opioid controlled, but ERAS protocol is mostly focused on nonopioid control,” said Dr. Djaladat. “We believe that opioids cause a lot of problems.”
Results
Length of hospital stay in the ERAS cohort was half that in the traditional cohort (4 days vs. 8 days, P < .0001). Additionally, mean morphine equivalent use in the ERAS group was about one-quarter of that observed in the traditional patients (4.9 mg/day vs. 20.87 mg/day, P < .0001).
Postoperative ileus was higher in the traditional group, compared with the ERAS group (22.2% vs. 7.3%, P < .0028). “One of the most important contributing factors to decreased ileus is less narcotic,” he said.
ERAS patients reported higher mean visual analogous (VAS) pain scores per day than traditional patients (3.1 vs. 1.14 on a 4-point scale, P < .0001). VAS scores are the modality by which patients’ pain is measured subjectively. However, Dr. Djaladat suggested in an interview that the statistically significant difference in VAS scores did not necessarily reflect a substantial difference in pain from a clinical perspective.
Dr. Djaladat and his colleagues observed that patients on ERAS protocol used significantly fewer opioid analgesics, which may have potentially contributed to decreased postoperative ileus and shorter lengths of hospital stay, he suggested. They affirm, however, that multi-institutional studies would aid in externally validating these results.
“We find that ERAS is sufficient to manage pain immediately and at the time of discharge, with less narcotic use, in patients who have just undergone radical cystectomy,” Dr. Djaladat reported.
Dr. Djaladat disclosed no relevant financial relationships.
NEW ORLEANS – The enhanced recovery after surgery (ERAS) protocol resulted in significantly less opioid use for pain management for radical cystectomy patients, compared with traditional postop approaches, according to Dr. Hooman Djaladat.
“The whole idea behind the ERAS protocol was to diminish hospital stay and send the patients home sooner, with no increase in complications or readmission rates,” said Dr. Djaladat, associate professor of clinical urology at the University of Southern California, Los Angeles.
ERAS protocols are multimodal perioperative care pathways, the aim of which is early recovery after surgery by maintaining preoperative organ function and reducing the profound stress response following surgery. The key elements of ERAS protocols include preoperative counseling, optimization of nutrition, standardized analgesic and anesthetic regimens, and early mobilization.
Opioids have traditionally been the standard for pain management after radical cystectomy (RC) for bladder cancer, but opioid use is often accompanied by side effects such as respiratory depression, nausea, vomiting, confusion, and ileus – the leading cause of prolonged hospital stay.
Dr. Djaladat and his colleagues at USC compared the amount of opioid use, pain score, and postoperative ileus in consecutive ERAS and traditional postop RC patients at USC, and presented their findings in a poster at the annual meeting of the American Urological Association.
Study Methods
Dr. Djaladat and his colleagues retrospectively evaluated 205 open-RC patients, 124 of whom underwent pain management as outlined by ERAS protocol (May 2012 to December 2013) and 81 who underwent traditional pain management with opioids (February 2010 to September 2013); the two groups were matched according to patient demographics, and those with a history of opioid use prior to surgery were not included in the study.
Traditional pain management protocol relied primarily on intravenous and epidural opioids, with acetaminophen and ketorolac as supplements as needed. Patient-controlled analgesia also was used if necessary.
The ERAS protocol utilized predominantly acetaminophen and ketorolac started intraoperatively, supplemented by consistent use of local anesthetic through subfascial catheters. Opioids were used only for breakthrough pain.
All opioids used (oxycodone, hydromorphone, tramadol, hydrocodone, morphine, and fentanyl) were converted to intravenous morphine equivalents. Opioid use and pain scores were examined and compared up to postoperative day 4.
“Bottom line, a traditional pathway has been mostly opioid controlled, but ERAS protocol is mostly focused on nonopioid control,” said Dr. Djaladat. “We believe that opioids cause a lot of problems.”
Results
Length of hospital stay in the ERAS cohort was half that in the traditional cohort (4 days vs. 8 days, P < .0001). Additionally, mean morphine equivalent use in the ERAS group was about one-quarter of that observed in the traditional patients (4.9 mg/day vs. 20.87 mg/day, P < .0001).
Postoperative ileus was higher in the traditional group, compared with the ERAS group (22.2% vs. 7.3%, P < .0028). “One of the most important contributing factors to decreased ileus is less narcotic,” he said.
ERAS patients reported higher mean visual analogous (VAS) pain scores per day than traditional patients (3.1 vs. 1.14 on a 4-point scale, P < .0001). VAS scores are the modality by which patients’ pain is measured subjectively. However, Dr. Djaladat suggested in an interview that the statistically significant difference in VAS scores did not necessarily reflect a substantial difference in pain from a clinical perspective.
Dr. Djaladat and his colleagues observed that patients on ERAS protocol used significantly fewer opioid analgesics, which may have potentially contributed to decreased postoperative ileus and shorter lengths of hospital stay, he suggested. They affirm, however, that multi-institutional studies would aid in externally validating these results.
“We find that ERAS is sufficient to manage pain immediately and at the time of discharge, with less narcotic use, in patients who have just undergone radical cystectomy,” Dr. Djaladat reported.
Dr. Djaladat disclosed no relevant financial relationships.
NEW ORLEANS – The enhanced recovery after surgery (ERAS) protocol resulted in significantly less opioid use for pain management for radical cystectomy patients, compared with traditional postop approaches, according to Dr. Hooman Djaladat.
“The whole idea behind the ERAS protocol was to diminish hospital stay and send the patients home sooner, with no increase in complications or readmission rates,” said Dr. Djaladat, associate professor of clinical urology at the University of Southern California, Los Angeles.
ERAS protocols are multimodal perioperative care pathways, the aim of which is early recovery after surgery by maintaining preoperative organ function and reducing the profound stress response following surgery. The key elements of ERAS protocols include preoperative counseling, optimization of nutrition, standardized analgesic and anesthetic regimens, and early mobilization.
Opioids have traditionally been the standard for pain management after radical cystectomy (RC) for bladder cancer, but opioid use is often accompanied by side effects such as respiratory depression, nausea, vomiting, confusion, and ileus – the leading cause of prolonged hospital stay.
Dr. Djaladat and his colleagues at USC compared the amount of opioid use, pain score, and postoperative ileus in consecutive ERAS and traditional postop RC patients at USC, and presented their findings in a poster at the annual meeting of the American Urological Association.
Study Methods
Dr. Djaladat and his colleagues retrospectively evaluated 205 open-RC patients, 124 of whom underwent pain management as outlined by ERAS protocol (May 2012 to December 2013) and 81 who underwent traditional pain management with opioids (February 2010 to September 2013); the two groups were matched according to patient demographics, and those with a history of opioid use prior to surgery were not included in the study.
Traditional pain management protocol relied primarily on intravenous and epidural opioids, with acetaminophen and ketorolac as supplements as needed. Patient-controlled analgesia also was used if necessary.
The ERAS protocol utilized predominantly acetaminophen and ketorolac started intraoperatively, supplemented by consistent use of local anesthetic through subfascial catheters. Opioids were used only for breakthrough pain.
All opioids used (oxycodone, hydromorphone, tramadol, hydrocodone, morphine, and fentanyl) were converted to intravenous morphine equivalents. Opioid use and pain scores were examined and compared up to postoperative day 4.
“Bottom line, a traditional pathway has been mostly opioid controlled, but ERAS protocol is mostly focused on nonopioid control,” said Dr. Djaladat. “We believe that opioids cause a lot of problems.”
Results
Length of hospital stay in the ERAS cohort was half that in the traditional cohort (4 days vs. 8 days, P < .0001). Additionally, mean morphine equivalent use in the ERAS group was about one-quarter of that observed in the traditional patients (4.9 mg/day vs. 20.87 mg/day, P < .0001).
Postoperative ileus was higher in the traditional group, compared with the ERAS group (22.2% vs. 7.3%, P < .0028). “One of the most important contributing factors to decreased ileus is less narcotic,” he said.
ERAS patients reported higher mean visual analogous (VAS) pain scores per day than traditional patients (3.1 vs. 1.14 on a 4-point scale, P < .0001). VAS scores are the modality by which patients’ pain is measured subjectively. However, Dr. Djaladat suggested in an interview that the statistically significant difference in VAS scores did not necessarily reflect a substantial difference in pain from a clinical perspective.
Dr. Djaladat and his colleagues observed that patients on ERAS protocol used significantly fewer opioid analgesics, which may have potentially contributed to decreased postoperative ileus and shorter lengths of hospital stay, he suggested. They affirm, however, that multi-institutional studies would aid in externally validating these results.
“We find that ERAS is sufficient to manage pain immediately and at the time of discharge, with less narcotic use, in patients who have just undergone radical cystectomy,” Dr. Djaladat reported.
Dr. Djaladat disclosed no relevant financial relationships.
AT THE AUA ANNUAL MEETING
Key clinical point: Consider ERAS protocol for patients after radical cystectomy to reduce hospital stays and complications.
Major finding: Length of hospital stay in the ERAS cohort was half that in the traditional cohort (4 vs. 8 days). Mean morphine equivalent use in the ERAS group was about one-quarter of that observed in the traditional patients (4.9 vs. 20.87 mg/day).
Data source: Comparative study of 205 well matched, open radical cystectomy patients, 124 of whom underwent pain management as outlined by ERAS protocol and 81 who underwent traditional pain management with opioids.
Disclosures: Dr. Djaladat disclosed no relevant financial relationships.
