AUA Annual Meeting 2015

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.

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.

NEW ORLEANS – A constituent of the fertility drug clomiphene citrate restored normal testosterone levels in obese men, without suppressing spermatogenesis, the results of two trials showed.

Significantly more men achieved physiologic testosterone levels with enclomiphene than with a testosterone gel, Dr. Andrew R. McCullough said at the annual meeting of the American Urological Association. None of those who took the drug had any decrease in their baseline sperm count.

“Overall, these data show that testosterone restoration with [enclomiphene] could provide an advantageous clinical profile over gel-induced [testosterone] replacement,” said Dr. McCullough of Albany (N.Y.) Medical College.

The drug is an estrogen receptor antagonist. By blocking estrogen at the level of the hypopituitary axis, enclomiphene increases luteinizing hormone, which, in turn, increases endogenous production of testosterone.

He presented the results of two parallel, double-dummy trials, which randomized a total of 240 men to placebo, oral enclomiphene (Androxal), or a 1.62% transdermal testosterone gel.

Patients were all overweight or obese, and had related secondary hypogonadism, with a mean testosterone level of 200-230 ng/mL. They were a mean of 47 years old, with a mean body mass index of 33 kg/m². Their baseline sperm counts were all normal, ranging from 75 million to 98 million/mL.

In both studies, enclomiphene increased testosterone levels significantly more than the gel. More men in both studies who took enclomiphene reached a normal testosterone level as well (60% vs. 15% and 65% vs. 35%). At the end of the studies, the combined mean testosterone level was 450 ng/mL in the enclomiphene group, compared with 350 ng/mL in the gel group.

“Unlike the exogenous testosterone, however, enclomiphene raised testosterone levels without having any impact on spermatogenesis,” Dr. McCullough noted. At 16 weeks, sperm count in those taking enclomiphene was unchanged from baseline, while it had decreased by 60% in those using the gel. More than half of those in the gel group also became oligospermic (with a sperm count of less than 15 million/mL) by16 weeks. Oligospermia occurred in less than 5% of men taking enclomiphene, similar to placebo. Neither treatment affected testicular volume.

Weight gain, arthralgia, headache, hypertension, and upper respiratory infection occurred in less than 5% of the investigational group – none of these was significantly different than occurred in the gel group.

Repro Therapeutics, which makes Androxal, submitted a new drug application to the Food and Drug Administration in February, seeking approval for treating low testosterone levels in men with secondary hypogonadism. It continues to pursue an adjunctive therapy for men with hypogonadism secondary to type 2 diabetes. “We believe there may be an association between the restoration of normal pituitary function and improvement of metabolic conditions such as type 2 diabetes,” the company said in a press release. “Research has been published” showing that increased insulin resistance, which is implicated in type 2 diabetes, “is associated with the onset of secondary hypogonadism,” the company said.

Dr. McCullough disclosed that he is a consultant for and holds stock in Repros Therapeutics. He also has received research funding from AbbVie, which makes AndroGel.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

NEW ORLEANS – A constituent of the fertility drug clomiphene citrate restored normal testosterone levels in obese men, without suppressing spermatogenesis, the results of two trials showed.

Significantly more men achieved physiologic testosterone levels with enclomiphene than with a testosterone gel, Dr. Andrew R. McCullough said at the annual meeting of the American Urological Association. None of those who took the drug had any decrease in their baseline sperm count.

“Overall, these data show that testosterone restoration with [enclomiphene] could provide an advantageous clinical profile over gel-induced [testosterone] replacement,” said Dr. McCullough of Albany (N.Y.) Medical College.

The drug is an estrogen receptor antagonist. By blocking estrogen at the level of the hypopituitary axis, enclomiphene increases luteinizing hormone, which, in turn, increases endogenous production of testosterone.

He presented the results of two parallel, double-dummy trials, which randomized a total of 240 men to placebo, oral enclomiphene (Androxal), or a 1.62% transdermal testosterone gel.

Patients were all overweight or obese, and had related secondary hypogonadism, with a mean testosterone level of 200-230 ng/mL. They were a mean of 47 years old, with a mean body mass index of 33 kg/m². Their baseline sperm counts were all normal, ranging from 75 million to 98 million/mL.

In both studies, enclomiphene increased testosterone levels significantly more than the gel. More men in both studies who took enclomiphene reached a normal testosterone level as well (60% vs. 15% and 65% vs. 35%). At the end of the studies, the combined mean testosterone level was 450 ng/mL in the enclomiphene group, compared with 350 ng/mL in the gel group.

“Unlike the exogenous testosterone, however, enclomiphene raised testosterone levels without having any impact on spermatogenesis,” Dr. McCullough noted. At 16 weeks, sperm count in those taking enclomiphene was unchanged from baseline, while it had decreased by 60% in those using the gel. More than half of those in the gel group also became oligospermic (with a sperm count of less than 15 million/mL) by16 weeks. Oligospermia occurred in less than 5% of men taking enclomiphene, similar to placebo. Neither treatment affected testicular volume.

Weight gain, arthralgia, headache, hypertension, and upper respiratory infection occurred in less than 5% of the investigational group – none of these was significantly different than occurred in the gel group.

Repro Therapeutics, which makes Androxal, submitted a new drug application to the Food and Drug Administration in February, seeking approval for treating low testosterone levels in men with secondary hypogonadism. It continues to pursue an adjunctive therapy for men with hypogonadism secondary to type 2 diabetes. “We believe there may be an association between the restoration of normal pituitary function and improvement of metabolic conditions such as type 2 diabetes,” the company said in a press release. “Research has been published” showing that increased insulin resistance, which is implicated in type 2 diabetes, “is associated with the onset of secondary hypogonadism,” the company said.

Dr. McCullough disclosed that he is a consultant for and holds stock in Repros Therapeutics. He also has received research funding from AbbVie, which makes AndroGel.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

NEW ORLEANS – A constituent of the fertility drug clomiphene citrate restored normal testosterone levels in obese men, without suppressing spermatogenesis, the results of two trials showed.

Significantly more men achieved physiologic testosterone levels with enclomiphene than with a testosterone gel, Dr. Andrew R. McCullough said at the annual meeting of the American Urological Association. None of those who took the drug had any decrease in their baseline sperm count.

“Overall, these data show that testosterone restoration with [enclomiphene] could provide an advantageous clinical profile over gel-induced [testosterone] replacement,” said Dr. McCullough of Albany (N.Y.) Medical College.

The drug is an estrogen receptor antagonist. By blocking estrogen at the level of the hypopituitary axis, enclomiphene increases luteinizing hormone, which, in turn, increases endogenous production of testosterone.

He presented the results of two parallel, double-dummy trials, which randomized a total of 240 men to placebo, oral enclomiphene (Androxal), or a 1.62% transdermal testosterone gel.

Patients were all overweight or obese, and had related secondary hypogonadism, with a mean testosterone level of 200-230 ng/mL. They were a mean of 47 years old, with a mean body mass index of 33 kg/m². Their baseline sperm counts were all normal, ranging from 75 million to 98 million/mL.

In both studies, enclomiphene increased testosterone levels significantly more than the gel. More men in both studies who took enclomiphene reached a normal testosterone level as well (60% vs. 15% and 65% vs. 35%). At the end of the studies, the combined mean testosterone level was 450 ng/mL in the enclomiphene group, compared with 350 ng/mL in the gel group.

“Unlike the exogenous testosterone, however, enclomiphene raised testosterone levels without having any impact on spermatogenesis,” Dr. McCullough noted. At 16 weeks, sperm count in those taking enclomiphene was unchanged from baseline, while it had decreased by 60% in those using the gel. More than half of those in the gel group also became oligospermic (with a sperm count of less than 15 million/mL) by16 weeks. Oligospermia occurred in less than 5% of men taking enclomiphene, similar to placebo. Neither treatment affected testicular volume.

Weight gain, arthralgia, headache, hypertension, and upper respiratory infection occurred in less than 5% of the investigational group – none of these was significantly different than occurred in the gel group.

Repro Therapeutics, which makes Androxal, submitted a new drug application to the Food and Drug Administration in February, seeking approval for treating low testosterone levels in men with secondary hypogonadism. It continues to pursue an adjunctive therapy for men with hypogonadism secondary to type 2 diabetes. “We believe there may be an association between the restoration of normal pituitary function and improvement of metabolic conditions such as type 2 diabetes,” the company said in a press release. “Research has been published” showing that increased insulin resistance, which is implicated in type 2 diabetes, “is associated with the onset of secondary hypogonadism,” the company said.

Dr. McCullough disclosed that he is a consultant for and holds stock in Repros Therapeutics. He also has received research funding from AbbVie, which makes AndroGel.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

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.

Meg Barbor/Frontline Medical News

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.

Meg Barbor/Frontline Medical News

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.

Meg Barbor/Frontline Medical News

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 – 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.

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.

©Bhakpong/thinkstockphotos.com

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.

©Bhakpong/thinkstockphotos.com

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.

©Bhakpong/thinkstockphotos.com

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 – Men with cardiac problems appear to have a high rate of symptomatic hypogonadism, according to a study conducted in one of the nation’s largest cardiology practices.

Low testosterone was seven times more prevalent among those patients than among the general population, Dr. Tobias Köhler said at the annual meeting of the American Urological Association.

Erectile dysfunction – untreated in most cases – along with benign prostatic hypertrophy and lower urinary tract symptoms were highly prevalent among these patients. These findings raise an important question for cardiologists, said Dr. Köhler, who is chief of the division of male infertility at the Southern Illinois University’s Fertility and IVF Center in Carbondale.

“Does this mean we should be screening cardiac patients for hypogonadism and these other issues? The results of this study suggest that we should. We have an opportunity to intervene early here.”

Dr. Köhler conducted the CUPID (Cardio-Urologic Pathology/Prevalence Interplay Determination) study in a large group cardiology practice and assessed symptomatic hypogonadism and urologic symptoms in patients who presented to the cardiology service. He queried patients using the international index of erectile function questionnaire (IIEF), the international prostate symptom score, and the ADAM low testosterone survey. He also obtained measures of cholesterol, total testosterone, free testosterone, and the testosterone/estradiol ratio. Men were considered biochemically hypogonadal if the total testosterone was below 300 ng/dL; the calculated free testosterone was below 6.5 ng/dL; and the ratio was below 10.

He enrolled 200 patents, mean age 67 years. The mean body mass index was 32 kg/m^2. Mean total testosterone was 310 ng/mL, but the range was wide (32 ng/dL to 1,156 ng/dL). Sex hormone binding globulin averaged 42 nmol/mL and calculated free testosterone was 5.4 mg/dL.

More than half of the men were below the lowest reference range in total testosterone (54%), calculated free testosterone (79%), and free testosterone (70%).

About 72% of these men also had symptoms of low testosterone. “This is a sevenfold increase in symptomatic hypogonadism over the general population,” Dr. Köhler said.

Many men had erectile dysfunction, a finding that increased with age. By standards of the National Health and Nutrition Examination Score, 15% of those aged 40-59 years had ED – a significantly increased risk ratio of 3.2 compared to the general population. For older men the rate was still higher, although not significantly so.

“The vast majority of these men were untreated medically,” and had never tried any other form of intervention, Dr. Köhler said. “This is clearly an undertreated population. It represents a big treatment gap and a window of opportunity to treat ED in young men with heart disease.”

With regard to lower urinary tract symptom scores, Dr. Köhler found that low testosterone was primarily associated with storage symptoms. About 25% of those with low testosterone levels had symptoms of frequency and urgency compared with 15% of those with normal levels of testosterone. It was also associated with incomplete voiding.

“A 4-point worsening in storage symptoms was associated with a decrease in calculated free testosterone of 0.88 ng/dL,” he said. Age and body mass index were also significantly associated with low testosterone.

However, erectile dysfunction was not significantly related to low testosterone levels. The only independent predictors for ED were age and the patient’s total number of medications. Similarly, there was no significant relationship between low levels and ejaculatory function; this was predicted only by the IIEF score, coronary artery bypass grafting, and antidepressants.

Dr. Köhler’s work has inspired the cardiology practice to participate in a number of changes. “They have amended their review of symptoms to include questions about erectile dysfunction, and we are now also participating in the ZEN trial – the first-in-man study of pudendal artery stents for ED. It looks like we can cure ED with these – in the right patients.”

He also has continued CUPID as a prospective cohort study that will follow the group. “Some of these men will elect testosterone replacement and some will not. This gives us a great opportunity to assess cardiac outcomes and interventions – I’m especially interested in the role of exercise.”

Dr. Köhler had no financial disclosures.

msullivan@frontlinemedcom.com

NEW ORLEANS – Men with cardiac problems appear to have a high rate of symptomatic hypogonadism, according to a study conducted in one of the nation’s largest cardiology practices.

Low testosterone was seven times more prevalent among those patients than among the general population, Dr. Tobias Köhler said at the annual meeting of the American Urological Association.

Erectile dysfunction – untreated in most cases – along with benign prostatic hypertrophy and lower urinary tract symptoms were highly prevalent among these patients. These findings raise an important question for cardiologists, said Dr. Köhler, who is chief of the division of male infertility at the Southern Illinois University’s Fertility and IVF Center in Carbondale.

“Does this mean we should be screening cardiac patients for hypogonadism and these other issues? The results of this study suggest that we should. We have an opportunity to intervene early here.”

Dr. Köhler conducted the CUPID (Cardio-Urologic Pathology/Prevalence Interplay Determination) study in a large group cardiology practice and assessed symptomatic hypogonadism and urologic symptoms in patients who presented to the cardiology service. He queried patients using the international index of erectile function questionnaire (IIEF), the international prostate symptom score, and the ADAM low testosterone survey. He also obtained measures of cholesterol, total testosterone, free testosterone, and the testosterone/estradiol ratio. Men were considered biochemically hypogonadal if the total testosterone was below 300 ng/dL; the calculated free testosterone was below 6.5 ng/dL; and the ratio was below 10.

He enrolled 200 patents, mean age 67 years. The mean body mass index was 32 kg/m^2. Mean total testosterone was 310 ng/mL, but the range was wide (32 ng/dL to 1,156 ng/dL). Sex hormone binding globulin averaged 42 nmol/mL and calculated free testosterone was 5.4 mg/dL.

More than half of the men were below the lowest reference range in total testosterone (54%), calculated free testosterone (79%), and free testosterone (70%).

About 72% of these men also had symptoms of low testosterone. “This is a sevenfold increase in symptomatic hypogonadism over the general population,” Dr. Köhler said.

Many men had erectile dysfunction, a finding that increased with age. By standards of the National Health and Nutrition Examination Score, 15% of those aged 40-59 years had ED – a significantly increased risk ratio of 3.2 compared to the general population. For older men the rate was still higher, although not significantly so.

“The vast majority of these men were untreated medically,” and had never tried any other form of intervention, Dr. Köhler said. “This is clearly an undertreated population. It represents a big treatment gap and a window of opportunity to treat ED in young men with heart disease.”

With regard to lower urinary tract symptom scores, Dr. Köhler found that low testosterone was primarily associated with storage symptoms. About 25% of those with low testosterone levels had symptoms of frequency and urgency compared with 15% of those with normal levels of testosterone. It was also associated with incomplete voiding.

“A 4-point worsening in storage symptoms was associated with a decrease in calculated free testosterone of 0.88 ng/dL,” he said. Age and body mass index were also significantly associated with low testosterone.

However, erectile dysfunction was not significantly related to low testosterone levels. The only independent predictors for ED were age and the patient’s total number of medications. Similarly, there was no significant relationship between low levels and ejaculatory function; this was predicted only by the IIEF score, coronary artery bypass grafting, and antidepressants.

Dr. Köhler’s work has inspired the cardiology practice to participate in a number of changes. “They have amended their review of symptoms to include questions about erectile dysfunction, and we are now also participating in the ZEN trial – the first-in-man study of pudendal artery stents for ED. It looks like we can cure ED with these – in the right patients.”

He also has continued CUPID as a prospective cohort study that will follow the group. “Some of these men will elect testosterone replacement and some will not. This gives us a great opportunity to assess cardiac outcomes and interventions – I’m especially interested in the role of exercise.”

Dr. Köhler had no financial disclosures.

msullivan@frontlinemedcom.com

NEW ORLEANS – Men with cardiac problems appear to have a high rate of symptomatic hypogonadism, according to a study conducted in one of the nation’s largest cardiology practices.

Low testosterone was seven times more prevalent among those patients than among the general population, Dr. Tobias Köhler said at the annual meeting of the American Urological Association.

Erectile dysfunction – untreated in most cases – along with benign prostatic hypertrophy and lower urinary tract symptoms were highly prevalent among these patients. These findings raise an important question for cardiologists, said Dr. Köhler, who is chief of the division of male infertility at the Southern Illinois University’s Fertility and IVF Center in Carbondale.

“Does this mean we should be screening cardiac patients for hypogonadism and these other issues? The results of this study suggest that we should. We have an opportunity to intervene early here.”

Dr. Köhler conducted the CUPID (Cardio-Urologic Pathology/Prevalence Interplay Determination) study in a large group cardiology practice and assessed symptomatic hypogonadism and urologic symptoms in patients who presented to the cardiology service. He queried patients using the international index of erectile function questionnaire (IIEF), the international prostate symptom score, and the ADAM low testosterone survey. He also obtained measures of cholesterol, total testosterone, free testosterone, and the testosterone/estradiol ratio. Men were considered biochemically hypogonadal if the total testosterone was below 300 ng/dL; the calculated free testosterone was below 6.5 ng/dL; and the ratio was below 10.

He enrolled 200 patents, mean age 67 years. The mean body mass index was 32 kg/m^2. Mean total testosterone was 310 ng/mL, but the range was wide (32 ng/dL to 1,156 ng/dL). Sex hormone binding globulin averaged 42 nmol/mL and calculated free testosterone was 5.4 mg/dL.

More than half of the men were below the lowest reference range in total testosterone (54%), calculated free testosterone (79%), and free testosterone (70%).

About 72% of these men also had symptoms of low testosterone. “This is a sevenfold increase in symptomatic hypogonadism over the general population,” Dr. Köhler said.

Many men had erectile dysfunction, a finding that increased with age. By standards of the National Health and Nutrition Examination Score, 15% of those aged 40-59 years had ED – a significantly increased risk ratio of 3.2 compared to the general population. For older men the rate was still higher, although not significantly so.

“The vast majority of these men were untreated medically,” and had never tried any other form of intervention, Dr. Köhler said. “This is clearly an undertreated population. It represents a big treatment gap and a window of opportunity to treat ED in young men with heart disease.”

With regard to lower urinary tract symptom scores, Dr. Köhler found that low testosterone was primarily associated with storage symptoms. About 25% of those with low testosterone levels had symptoms of frequency and urgency compared with 15% of those with normal levels of testosterone. It was also associated with incomplete voiding.

“A 4-point worsening in storage symptoms was associated with a decrease in calculated free testosterone of 0.88 ng/dL,” he said. Age and body mass index were also significantly associated with low testosterone.

However, erectile dysfunction was not significantly related to low testosterone levels. The only independent predictors for ED were age and the patient’s total number of medications. Similarly, there was no significant relationship between low levels and ejaculatory function; this was predicted only by the IIEF score, coronary artery bypass grafting, and antidepressants.

Dr. Köhler’s work has inspired the cardiology practice to participate in a number of changes. “They have amended their review of symptoms to include questions about erectile dysfunction, and we are now also participating in the ZEN trial – the first-in-man study of pudendal artery stents for ED. It looks like we can cure ED with these – in the right patients.”

He also has continued CUPID as a prospective cohort study that will follow the group. “Some of these men will elect testosterone replacement and some will not. This gives us a great opportunity to assess cardiac outcomes and interventions – I’m especially interested in the role of exercise.”

Dr. Köhler had no financial disclosures.

msullivan@frontlinemedcom.com