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Urology groups endorse two prostate biopsy approaches
CHICAGO - , endorsing both transperineal and transrectal biopsy instead of choosing one over the other.
The new guidelines, issued at the annual meeting of the American Urological Association, contrast with 2021 recommendations from the European Association of Urologists (EAU), which regard the transperineal approach as superior to and safer than the transrectal approach.
The new guidelines state: “Clinicians may use either a transrectal or transperineal biopsy route when performing a biopsy. (Conditional Recommendation; Evidence Level: Grade C).” Grade C is the lowest grade of acceptance the guideline committee could issue, according to Daniel Lin, MD, vice-chair of the AUA guideline panel.
“The AUA looked at all the higher-level data comparing the two procedures. There was a lack of that data,” Dr. Lin, chief of urologic oncology at the University of Washington, Seattle, said in an interview. He said the literature consists mainly of systematic single-center reviews, rather than multicenter randomized trials.
But Hendrik Van Poppel, MD, policy chief for the EAU, said that in Europe, transrectal biopsies are now considered “medical malpractice.”
Philip Cornford, MD, associate professor of urology at the University of Liverpool, England, and chair of the prostate biopsy guidelines panel for the EAU, said the society in 2021 concluded that the transperineal approach is the preferred one.
The EAU stated that transperineal prostate biopsies should be performed “due to the lower risk of infectious complications.” The EAU described the evidence as strong: A meta-analysis of seven studies that included 1,330 patients showed that for patients undergoing transperineal biopsy, infectious complications were significantly reduced.
Dr. Cornford said in essence, the EAU made its decision out of concern about infections, whereas the AUA and SUO based their decision on the ability of the methods to detect cancer.
Advocates for transperineal procedures cite several studies that show that the rate of infection, including sepsis, with such biopsies is virtually zero.
However, Dr. Lin noted that the committee said existing data on infection did not support this position. He also cited a “a fairly compelling” single-center randomized study with 750 patients that showed no difference in infection rates. The study was presented at the AUA meeting.
Agents of death and destruction?
Badar Mian, MD, professor of surgery at Albany (N.Y.) Medical College, who led the study, told an AUA session that urology has been trapped in an “echo chamber” regarding the relative safety of biopsies.
Clinicians hear “loud proclamations, which get repeated and magnified, that there is a real zero risk of complications after transperineal biopsies as compared to the horrendous 5% to 10% or higher rate of transrectal biopsy complications and that you, with your transrectal biopsies, are the cause of death and destruction all around,” Dr. Mian said. “Well, if you step out of the echo chamber, what you’ll find is that the accurate complications amongst the two procedures are not that dramatically different, much less dramatic than what you’ve been told to believe.”
The campaign to end transrectal biopsies in Europe started in 2018 with the death of a Norwegian man who experienced an infection after the procedure. Truls Bjerklund Johansen, MD, who’d performed the biopsy on the patient and who worked with the man’s daughter to change national practice, persuaded the EAU to look at the issue.
Advocates also say transperineal biopsies are better at detecting anterior and apical cancers.
“I would agree the data on cancer detection is less convincing, but that is not the basis of the EAU recommendation,” Dr. Cornford said.
Arvin George, MD, leads the transperineal biopsy program at the University of Michigan, Ann Arbor, and directs the transperineal training program at the AUA’s annual meeting. He said his course was sold out early and included about 60 trainees.
Dr. George said the new guideline statement “is not an unequivocal endorsement for transperineal biopsy as the preferred approach for diagnostic sampling but rather an acknowledgment of this approach as an alternative option.”
He said that although the new position statement should increase awareness of the transperineal approach in the United States, “without a strong recommendation, the guideline statement is unlikely to spark a large switch to the transperineal biopsy but rather supports the continued slow and steady adoption.”
Matthew Allaway, DO, founder of Perineologic, developer of the PrecisionPoint Transperineal Access System, said industry figures show that about 10% of the 1.5 million prostate biopsies performed in the United States annually are performed transperineally, a doubling in 2 years.
Jeremy Grummet, MD, clinical professor of urology at Monash University, Melbourne, and leader of the TREXIT (Transperineal Exit) movement to abandon transrectal procedures, said the AUA guidelines are biased toward “physician convenience.”
Lack of training
The AUA said another reason it did not endorse the transperineal approach was that currently, American urologists lack training and experience with transperineal procedures.
Dr. Grummet blamed major medical centers for any gap in the familiarity of clinicians with transperineal biopsies, which have been available for more than a decade.
“It is incumbent on the leaders of urology departments globally to ensure that their colleagues are trained in transperineal biopsy and have access to the appropriate equipment,” he said in an interview. “Lack of training didn’t seem to prevent the rapid uptake of robotic prostatectomy – a far more complex procedure.”
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO - , endorsing both transperineal and transrectal biopsy instead of choosing one over the other.
The new guidelines, issued at the annual meeting of the American Urological Association, contrast with 2021 recommendations from the European Association of Urologists (EAU), which regard the transperineal approach as superior to and safer than the transrectal approach.
The new guidelines state: “Clinicians may use either a transrectal or transperineal biopsy route when performing a biopsy. (Conditional Recommendation; Evidence Level: Grade C).” Grade C is the lowest grade of acceptance the guideline committee could issue, according to Daniel Lin, MD, vice-chair of the AUA guideline panel.
“The AUA looked at all the higher-level data comparing the two procedures. There was a lack of that data,” Dr. Lin, chief of urologic oncology at the University of Washington, Seattle, said in an interview. He said the literature consists mainly of systematic single-center reviews, rather than multicenter randomized trials.
But Hendrik Van Poppel, MD, policy chief for the EAU, said that in Europe, transrectal biopsies are now considered “medical malpractice.”
Philip Cornford, MD, associate professor of urology at the University of Liverpool, England, and chair of the prostate biopsy guidelines panel for the EAU, said the society in 2021 concluded that the transperineal approach is the preferred one.
The EAU stated that transperineal prostate biopsies should be performed “due to the lower risk of infectious complications.” The EAU described the evidence as strong: A meta-analysis of seven studies that included 1,330 patients showed that for patients undergoing transperineal biopsy, infectious complications were significantly reduced.
Dr. Cornford said in essence, the EAU made its decision out of concern about infections, whereas the AUA and SUO based their decision on the ability of the methods to detect cancer.
Advocates for transperineal procedures cite several studies that show that the rate of infection, including sepsis, with such biopsies is virtually zero.
However, Dr. Lin noted that the committee said existing data on infection did not support this position. He also cited a “a fairly compelling” single-center randomized study with 750 patients that showed no difference in infection rates. The study was presented at the AUA meeting.
Agents of death and destruction?
Badar Mian, MD, professor of surgery at Albany (N.Y.) Medical College, who led the study, told an AUA session that urology has been trapped in an “echo chamber” regarding the relative safety of biopsies.
Clinicians hear “loud proclamations, which get repeated and magnified, that there is a real zero risk of complications after transperineal biopsies as compared to the horrendous 5% to 10% or higher rate of transrectal biopsy complications and that you, with your transrectal biopsies, are the cause of death and destruction all around,” Dr. Mian said. “Well, if you step out of the echo chamber, what you’ll find is that the accurate complications amongst the two procedures are not that dramatically different, much less dramatic than what you’ve been told to believe.”
The campaign to end transrectal biopsies in Europe started in 2018 with the death of a Norwegian man who experienced an infection after the procedure. Truls Bjerklund Johansen, MD, who’d performed the biopsy on the patient and who worked with the man’s daughter to change national practice, persuaded the EAU to look at the issue.
Advocates also say transperineal biopsies are better at detecting anterior and apical cancers.
“I would agree the data on cancer detection is less convincing, but that is not the basis of the EAU recommendation,” Dr. Cornford said.
Arvin George, MD, leads the transperineal biopsy program at the University of Michigan, Ann Arbor, and directs the transperineal training program at the AUA’s annual meeting. He said his course was sold out early and included about 60 trainees.
Dr. George said the new guideline statement “is not an unequivocal endorsement for transperineal biopsy as the preferred approach for diagnostic sampling but rather an acknowledgment of this approach as an alternative option.”
He said that although the new position statement should increase awareness of the transperineal approach in the United States, “without a strong recommendation, the guideline statement is unlikely to spark a large switch to the transperineal biopsy but rather supports the continued slow and steady adoption.”
Matthew Allaway, DO, founder of Perineologic, developer of the PrecisionPoint Transperineal Access System, said industry figures show that about 10% of the 1.5 million prostate biopsies performed in the United States annually are performed transperineally, a doubling in 2 years.
Jeremy Grummet, MD, clinical professor of urology at Monash University, Melbourne, and leader of the TREXIT (Transperineal Exit) movement to abandon transrectal procedures, said the AUA guidelines are biased toward “physician convenience.”
Lack of training
The AUA said another reason it did not endorse the transperineal approach was that currently, American urologists lack training and experience with transperineal procedures.
Dr. Grummet blamed major medical centers for any gap in the familiarity of clinicians with transperineal biopsies, which have been available for more than a decade.
“It is incumbent on the leaders of urology departments globally to ensure that their colleagues are trained in transperineal biopsy and have access to the appropriate equipment,” he said in an interview. “Lack of training didn’t seem to prevent the rapid uptake of robotic prostatectomy – a far more complex procedure.”
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO - , endorsing both transperineal and transrectal biopsy instead of choosing one over the other.
The new guidelines, issued at the annual meeting of the American Urological Association, contrast with 2021 recommendations from the European Association of Urologists (EAU), which regard the transperineal approach as superior to and safer than the transrectal approach.
The new guidelines state: “Clinicians may use either a transrectal or transperineal biopsy route when performing a biopsy. (Conditional Recommendation; Evidence Level: Grade C).” Grade C is the lowest grade of acceptance the guideline committee could issue, according to Daniel Lin, MD, vice-chair of the AUA guideline panel.
“The AUA looked at all the higher-level data comparing the two procedures. There was a lack of that data,” Dr. Lin, chief of urologic oncology at the University of Washington, Seattle, said in an interview. He said the literature consists mainly of systematic single-center reviews, rather than multicenter randomized trials.
But Hendrik Van Poppel, MD, policy chief for the EAU, said that in Europe, transrectal biopsies are now considered “medical malpractice.”
Philip Cornford, MD, associate professor of urology at the University of Liverpool, England, and chair of the prostate biopsy guidelines panel for the EAU, said the society in 2021 concluded that the transperineal approach is the preferred one.
The EAU stated that transperineal prostate biopsies should be performed “due to the lower risk of infectious complications.” The EAU described the evidence as strong: A meta-analysis of seven studies that included 1,330 patients showed that for patients undergoing transperineal biopsy, infectious complications were significantly reduced.
Dr. Cornford said in essence, the EAU made its decision out of concern about infections, whereas the AUA and SUO based their decision on the ability of the methods to detect cancer.
Advocates for transperineal procedures cite several studies that show that the rate of infection, including sepsis, with such biopsies is virtually zero.
However, Dr. Lin noted that the committee said existing data on infection did not support this position. He also cited a “a fairly compelling” single-center randomized study with 750 patients that showed no difference in infection rates. The study was presented at the AUA meeting.
Agents of death and destruction?
Badar Mian, MD, professor of surgery at Albany (N.Y.) Medical College, who led the study, told an AUA session that urology has been trapped in an “echo chamber” regarding the relative safety of biopsies.
Clinicians hear “loud proclamations, which get repeated and magnified, that there is a real zero risk of complications after transperineal biopsies as compared to the horrendous 5% to 10% or higher rate of transrectal biopsy complications and that you, with your transrectal biopsies, are the cause of death and destruction all around,” Dr. Mian said. “Well, if you step out of the echo chamber, what you’ll find is that the accurate complications amongst the two procedures are not that dramatically different, much less dramatic than what you’ve been told to believe.”
The campaign to end transrectal biopsies in Europe started in 2018 with the death of a Norwegian man who experienced an infection after the procedure. Truls Bjerklund Johansen, MD, who’d performed the biopsy on the patient and who worked with the man’s daughter to change national practice, persuaded the EAU to look at the issue.
Advocates also say transperineal biopsies are better at detecting anterior and apical cancers.
“I would agree the data on cancer detection is less convincing, but that is not the basis of the EAU recommendation,” Dr. Cornford said.
Arvin George, MD, leads the transperineal biopsy program at the University of Michigan, Ann Arbor, and directs the transperineal training program at the AUA’s annual meeting. He said his course was sold out early and included about 60 trainees.
Dr. George said the new guideline statement “is not an unequivocal endorsement for transperineal biopsy as the preferred approach for diagnostic sampling but rather an acknowledgment of this approach as an alternative option.”
He said that although the new position statement should increase awareness of the transperineal approach in the United States, “without a strong recommendation, the guideline statement is unlikely to spark a large switch to the transperineal biopsy but rather supports the continued slow and steady adoption.”
Matthew Allaway, DO, founder of Perineologic, developer of the PrecisionPoint Transperineal Access System, said industry figures show that about 10% of the 1.5 million prostate biopsies performed in the United States annually are performed transperineally, a doubling in 2 years.
Jeremy Grummet, MD, clinical professor of urology at Monash University, Melbourne, and leader of the TREXIT (Transperineal Exit) movement to abandon transrectal procedures, said the AUA guidelines are biased toward “physician convenience.”
Lack of training
The AUA said another reason it did not endorse the transperineal approach was that currently, American urologists lack training and experience with transperineal procedures.
Dr. Grummet blamed major medical centers for any gap in the familiarity of clinicians with transperineal biopsies, which have been available for more than a decade.
“It is incumbent on the leaders of urology departments globally to ensure that their colleagues are trained in transperineal biopsy and have access to the appropriate equipment,” he said in an interview. “Lack of training didn’t seem to prevent the rapid uptake of robotic prostatectomy – a far more complex procedure.”
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT AUA 2023
Mixed results on two treatments for erectile dysfunction
presented at the annual meeting of the American Urological Association.
In a single-blind prospective study that evaluated low-intensity shock-wave therapy, researchers randomly assigned 36 men with ED to receive mechanical therapy (n = 22) or sham treatment (n = 14) on their flaccid penises.
The patients in arm 1 of the study received three treatments of 5,000 shocks (4 Hz, 0.12 mJ/mm2) with the UroGold 1000 device (SoftWave) at weeks 0, 3, and 6. Those in arm 2 received a regimen of 5,000 shocks at week 0 and 3,000 at weeks 2 and 3, which was repeated 3 weeks later. Patients who completed sham treatment were unblinded and crossed over to the opposite arm for active treatment.
At weeks 20 and 32, the researchers assessed changes in gray-scale ultrasound erectile tissue homogeneity of the corpora cavernosa using visual grading scores as well as changes in color Duplex Doppler ultrasound assessments of artery blood flow parameters between baseline and follow-up.
Better blood flow – But is that enough?
After shock-wave therapy, more men experienced either improvements in or no worsening of blood flow parameters relative to baseline than after sham treatment. The decrease in end-diastolic volume was statistically significant for men in the active treatment arm 2 at week 32 (P = .003), according to the researchers.
The number of men whose visual grading scores for ultrasound gray-scale images improved in the proximal region was consistently higher with active treatment than with placebo (arm 1: 88.9% vs. 11.1%; arm 2: 40% vs. 20%), with statistical significance in arm 1 at weeks 20 (P = .005) and 32 (P = .001). Patients who received sham treatment and who subsequently received active shock-wave therapy also had improved scores on gray-scale ultrasound (arm 1: 33.3% vs. 11.1%; arm 2: 40% vs. 20%).
Scores on the International Index of Erectile Function (IIEF) were nominally higher for men in active treatment whose visual grading scores had improved compared with those who did not show improvement.
The most common adverse event was transient discomfort after the shock-wave treatment, according to the researchers.
The study provides “a glimpse into the concept” that the mechanotransduction from a shock wave results in biochemical changes, including “activation of stem cells within the corpus cavernosum,” said Irwin Goldstein, MD, director of San Diego Sexual Medicine and clinical professor of surgery at the University of California, San Diego, who led the trial. “If I can activate stem cells,” he added, “theoretically, I can improve the health of tissue.”
Dr. Goldstein noted that the study is the first to use before-and-after objective gray-scale ultrasound imaging along with color Doppler ultrasound. “We could see gray scale changes and peak systolic velocity changes even with a small group,” he said.
Dr. Goldstein added that the trial is the first in which zero energy was used in the sham phase instead of less energy than active treatment. With the sham treatment, there was no benefit on the gray scale, which he said is “very important.”
He said his team is in the process of submitting a proposal for a larger prospective trial to confirm the findings.
Although the results are promising, the study did not evaluate what matters most to men, said Louis Kuritzky, MD, a family medicine physician and assistant professor emeritus at HCA UCF Family Medicine Residency, in Gainesville, Fla.
“Men don’t care what the flow velocity is – they care [whether] they get an erection sufficient for penetration and completion of intercourse. That trial did not look at those endpoints. It looked at surrogates. Those are encouraging, but that’s not what I think a clinician would base their decision upon about whether or not a patient should possibly participate in shock therapy.”
Plasma injections a bust
The trial that assessed platelet-rich plasma was not encouraging. The results of the prospective, double-blind, randomized, placebo-controlled trial suggest that PRP is safe but not effective.
A proprietary version of the PRP injection is marketed as the “Priapus shot,” or the “P-shot,” despite a lack of solid evidence the therapy helps.
Brian Ledesma, MD, an andrology research fellow at the University of Miami, led the study, which received a “best abstract” award at the meeting. “We wanted to actually check and see – does this work or not?” Dr. Ledesma said of PRP injections generally.
Dr. Ledesma and his colleagues randomly assigned 61 men with mild to moderate ED to receive two intracavernosal injections of PRP 1 month apart (n = 28) or placebo treatment (n = 33). The primary outcome was change in IIEF score and the percentage of men meeting minimum clinically important difference (MCID) at 1 month. Complete data were available for 24 men who received PRP and for 28 who received placebo injections.
There was no significant difference in outcomes between the groups. IIEF scores changed from 17.4 (95% confidence interval [CI], –15.8 to 19.0) to 21 (95% CI, 17.9-24.0) for men who received PRP and from 18.6 (95% CI, 17.3-19.8) to 21.6 (95% CI, 19.1-24.1) for men in the placebo group (P = .756). Fourteen men (58.3%) in the PRP group, compared with 15 (53.6%) in the placebo group, met MCID. No differences were seen in mean penile Doppler parameters between PRP and placebo. The two adverse events reported in the trial were minor – a hematoma and “a new plaque that did not cause any curvature of the penis,” Dr. Ledesma said.
Platelet-rich plasma may be “really popular, but, objectively speaking, so far, we don’t have any evidence showing that it actually works.”
The study showed that “PRP was not more efficacious than placebo.” This treatment is “really popular, but, objectively speaking, so far, we don’t have any evidence showing that it actually works.”
Based on these findings, he said, “We would recommend sticking to the data primary care providers should tell their patients, ‘Don’t waste your money,’ because it’s pretty expensive.”
Dr. Kuritzky said more studies are needed for a definitive answer. “I think the results of PRP have been largely disappointing across most of the spheres of influence in which it’s been tried. So, it’s not so surprising to me that this trial would, again, not prove efficacious, but I’d have to hold judgment, dependent upon other trials,” he said.
Dr. Ledesma and his colleagues are conducting a prospective, randomized, double-blind trial “investigating whether PRP combined with shock-wave therapy could make a difference.” He said the trial, which is funded by the National Institutes of Health, is in the enrollment phase; results are expected in mid-2024.
Charles Runels, MD, who pioneered the P-Shot and other popular cosmetic procedures, defended the effectiveness of the injections.
“One of the legitimate criticisms of all of the review articles regarding PRP therapies in every field is that there is a significant variability in what people call PRP. The P-Shot represents a very specific protocol in the methods of preparing PRP, activating PRP, and injecting the PRP – all of which differ significantly from what was done in Ledesma’s study and which could account for their lack of results,” Dr. Runels said in an interview.
Dr. Runels added that “multiple studies” do show benefit of the injection of PRP for both erectile dysfunction and Peyronie’s disease and support the success of his protocol. “Also, all of our providers – there are over 3,000 people in our Cellular Medicine Association – offer money back to our patients if there are not satisfactory results,” he said.
Dr. Kuritzky said that when patients ask him about investigational treatments for ED, he tells them to stick to the more traditional approaches, such as phosphodiesterase type 5 inhibitors, intracorporeal injections, and vacuum devices.
But, he added, if other therapies are shown to be safe and effective “in a large population of men with diverse etiologies associated with their erectile dysfunction, including advanced age, diabetes, dyslipidemia, hypertension, cigarette smoking, then I think [they] could be recommended on a more consistent basis.”
Both studies were independently supported. Dr. Goldstein, Dr. Kuritzky, and Dr. Ledesma reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
presented at the annual meeting of the American Urological Association.
In a single-blind prospective study that evaluated low-intensity shock-wave therapy, researchers randomly assigned 36 men with ED to receive mechanical therapy (n = 22) or sham treatment (n = 14) on their flaccid penises.
The patients in arm 1 of the study received three treatments of 5,000 shocks (4 Hz, 0.12 mJ/mm2) with the UroGold 1000 device (SoftWave) at weeks 0, 3, and 6. Those in arm 2 received a regimen of 5,000 shocks at week 0 and 3,000 at weeks 2 and 3, which was repeated 3 weeks later. Patients who completed sham treatment were unblinded and crossed over to the opposite arm for active treatment.
At weeks 20 and 32, the researchers assessed changes in gray-scale ultrasound erectile tissue homogeneity of the corpora cavernosa using visual grading scores as well as changes in color Duplex Doppler ultrasound assessments of artery blood flow parameters between baseline and follow-up.
Better blood flow – But is that enough?
After shock-wave therapy, more men experienced either improvements in or no worsening of blood flow parameters relative to baseline than after sham treatment. The decrease in end-diastolic volume was statistically significant for men in the active treatment arm 2 at week 32 (P = .003), according to the researchers.
The number of men whose visual grading scores for ultrasound gray-scale images improved in the proximal region was consistently higher with active treatment than with placebo (arm 1: 88.9% vs. 11.1%; arm 2: 40% vs. 20%), with statistical significance in arm 1 at weeks 20 (P = .005) and 32 (P = .001). Patients who received sham treatment and who subsequently received active shock-wave therapy also had improved scores on gray-scale ultrasound (arm 1: 33.3% vs. 11.1%; arm 2: 40% vs. 20%).
Scores on the International Index of Erectile Function (IIEF) were nominally higher for men in active treatment whose visual grading scores had improved compared with those who did not show improvement.
The most common adverse event was transient discomfort after the shock-wave treatment, according to the researchers.
The study provides “a glimpse into the concept” that the mechanotransduction from a shock wave results in biochemical changes, including “activation of stem cells within the corpus cavernosum,” said Irwin Goldstein, MD, director of San Diego Sexual Medicine and clinical professor of surgery at the University of California, San Diego, who led the trial. “If I can activate stem cells,” he added, “theoretically, I can improve the health of tissue.”
Dr. Goldstein noted that the study is the first to use before-and-after objective gray-scale ultrasound imaging along with color Doppler ultrasound. “We could see gray scale changes and peak systolic velocity changes even with a small group,” he said.
Dr. Goldstein added that the trial is the first in which zero energy was used in the sham phase instead of less energy than active treatment. With the sham treatment, there was no benefit on the gray scale, which he said is “very important.”
He said his team is in the process of submitting a proposal for a larger prospective trial to confirm the findings.
Although the results are promising, the study did not evaluate what matters most to men, said Louis Kuritzky, MD, a family medicine physician and assistant professor emeritus at HCA UCF Family Medicine Residency, in Gainesville, Fla.
“Men don’t care what the flow velocity is – they care [whether] they get an erection sufficient for penetration and completion of intercourse. That trial did not look at those endpoints. It looked at surrogates. Those are encouraging, but that’s not what I think a clinician would base their decision upon about whether or not a patient should possibly participate in shock therapy.”
Plasma injections a bust
The trial that assessed platelet-rich plasma was not encouraging. The results of the prospective, double-blind, randomized, placebo-controlled trial suggest that PRP is safe but not effective.
A proprietary version of the PRP injection is marketed as the “Priapus shot,” or the “P-shot,” despite a lack of solid evidence the therapy helps.
Brian Ledesma, MD, an andrology research fellow at the University of Miami, led the study, which received a “best abstract” award at the meeting. “We wanted to actually check and see – does this work or not?” Dr. Ledesma said of PRP injections generally.
Dr. Ledesma and his colleagues randomly assigned 61 men with mild to moderate ED to receive two intracavernosal injections of PRP 1 month apart (n = 28) or placebo treatment (n = 33). The primary outcome was change in IIEF score and the percentage of men meeting minimum clinically important difference (MCID) at 1 month. Complete data were available for 24 men who received PRP and for 28 who received placebo injections.
There was no significant difference in outcomes between the groups. IIEF scores changed from 17.4 (95% confidence interval [CI], –15.8 to 19.0) to 21 (95% CI, 17.9-24.0) for men who received PRP and from 18.6 (95% CI, 17.3-19.8) to 21.6 (95% CI, 19.1-24.1) for men in the placebo group (P = .756). Fourteen men (58.3%) in the PRP group, compared with 15 (53.6%) in the placebo group, met MCID. No differences were seen in mean penile Doppler parameters between PRP and placebo. The two adverse events reported in the trial were minor – a hematoma and “a new plaque that did not cause any curvature of the penis,” Dr. Ledesma said.
Platelet-rich plasma may be “really popular, but, objectively speaking, so far, we don’t have any evidence showing that it actually works.”
The study showed that “PRP was not more efficacious than placebo.” This treatment is “really popular, but, objectively speaking, so far, we don’t have any evidence showing that it actually works.”
Based on these findings, he said, “We would recommend sticking to the data primary care providers should tell their patients, ‘Don’t waste your money,’ because it’s pretty expensive.”
Dr. Kuritzky said more studies are needed for a definitive answer. “I think the results of PRP have been largely disappointing across most of the spheres of influence in which it’s been tried. So, it’s not so surprising to me that this trial would, again, not prove efficacious, but I’d have to hold judgment, dependent upon other trials,” he said.
Dr. Ledesma and his colleagues are conducting a prospective, randomized, double-blind trial “investigating whether PRP combined with shock-wave therapy could make a difference.” He said the trial, which is funded by the National Institutes of Health, is in the enrollment phase; results are expected in mid-2024.
Charles Runels, MD, who pioneered the P-Shot and other popular cosmetic procedures, defended the effectiveness of the injections.
“One of the legitimate criticisms of all of the review articles regarding PRP therapies in every field is that there is a significant variability in what people call PRP. The P-Shot represents a very specific protocol in the methods of preparing PRP, activating PRP, and injecting the PRP – all of which differ significantly from what was done in Ledesma’s study and which could account for their lack of results,” Dr. Runels said in an interview.
Dr. Runels added that “multiple studies” do show benefit of the injection of PRP for both erectile dysfunction and Peyronie’s disease and support the success of his protocol. “Also, all of our providers – there are over 3,000 people in our Cellular Medicine Association – offer money back to our patients if there are not satisfactory results,” he said.
Dr. Kuritzky said that when patients ask him about investigational treatments for ED, he tells them to stick to the more traditional approaches, such as phosphodiesterase type 5 inhibitors, intracorporeal injections, and vacuum devices.
But, he added, if other therapies are shown to be safe and effective “in a large population of men with diverse etiologies associated with their erectile dysfunction, including advanced age, diabetes, dyslipidemia, hypertension, cigarette smoking, then I think [they] could be recommended on a more consistent basis.”
Both studies were independently supported. Dr. Goldstein, Dr. Kuritzky, and Dr. Ledesma reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
presented at the annual meeting of the American Urological Association.
In a single-blind prospective study that evaluated low-intensity shock-wave therapy, researchers randomly assigned 36 men with ED to receive mechanical therapy (n = 22) or sham treatment (n = 14) on their flaccid penises.
The patients in arm 1 of the study received three treatments of 5,000 shocks (4 Hz, 0.12 mJ/mm2) with the UroGold 1000 device (SoftWave) at weeks 0, 3, and 6. Those in arm 2 received a regimen of 5,000 shocks at week 0 and 3,000 at weeks 2 and 3, which was repeated 3 weeks later. Patients who completed sham treatment were unblinded and crossed over to the opposite arm for active treatment.
At weeks 20 and 32, the researchers assessed changes in gray-scale ultrasound erectile tissue homogeneity of the corpora cavernosa using visual grading scores as well as changes in color Duplex Doppler ultrasound assessments of artery blood flow parameters between baseline and follow-up.
Better blood flow – But is that enough?
After shock-wave therapy, more men experienced either improvements in or no worsening of blood flow parameters relative to baseline than after sham treatment. The decrease in end-diastolic volume was statistically significant for men in the active treatment arm 2 at week 32 (P = .003), according to the researchers.
The number of men whose visual grading scores for ultrasound gray-scale images improved in the proximal region was consistently higher with active treatment than with placebo (arm 1: 88.9% vs. 11.1%; arm 2: 40% vs. 20%), with statistical significance in arm 1 at weeks 20 (P = .005) and 32 (P = .001). Patients who received sham treatment and who subsequently received active shock-wave therapy also had improved scores on gray-scale ultrasound (arm 1: 33.3% vs. 11.1%; arm 2: 40% vs. 20%).
Scores on the International Index of Erectile Function (IIEF) were nominally higher for men in active treatment whose visual grading scores had improved compared with those who did not show improvement.
The most common adverse event was transient discomfort after the shock-wave treatment, according to the researchers.
The study provides “a glimpse into the concept” that the mechanotransduction from a shock wave results in biochemical changes, including “activation of stem cells within the corpus cavernosum,” said Irwin Goldstein, MD, director of San Diego Sexual Medicine and clinical professor of surgery at the University of California, San Diego, who led the trial. “If I can activate stem cells,” he added, “theoretically, I can improve the health of tissue.”
Dr. Goldstein noted that the study is the first to use before-and-after objective gray-scale ultrasound imaging along with color Doppler ultrasound. “We could see gray scale changes and peak systolic velocity changes even with a small group,” he said.
Dr. Goldstein added that the trial is the first in which zero energy was used in the sham phase instead of less energy than active treatment. With the sham treatment, there was no benefit on the gray scale, which he said is “very important.”
He said his team is in the process of submitting a proposal for a larger prospective trial to confirm the findings.
Although the results are promising, the study did not evaluate what matters most to men, said Louis Kuritzky, MD, a family medicine physician and assistant professor emeritus at HCA UCF Family Medicine Residency, in Gainesville, Fla.
“Men don’t care what the flow velocity is – they care [whether] they get an erection sufficient for penetration and completion of intercourse. That trial did not look at those endpoints. It looked at surrogates. Those are encouraging, but that’s not what I think a clinician would base their decision upon about whether or not a patient should possibly participate in shock therapy.”
Plasma injections a bust
The trial that assessed platelet-rich plasma was not encouraging. The results of the prospective, double-blind, randomized, placebo-controlled trial suggest that PRP is safe but not effective.
A proprietary version of the PRP injection is marketed as the “Priapus shot,” or the “P-shot,” despite a lack of solid evidence the therapy helps.
Brian Ledesma, MD, an andrology research fellow at the University of Miami, led the study, which received a “best abstract” award at the meeting. “We wanted to actually check and see – does this work or not?” Dr. Ledesma said of PRP injections generally.
Dr. Ledesma and his colleagues randomly assigned 61 men with mild to moderate ED to receive two intracavernosal injections of PRP 1 month apart (n = 28) or placebo treatment (n = 33). The primary outcome was change in IIEF score and the percentage of men meeting minimum clinically important difference (MCID) at 1 month. Complete data were available for 24 men who received PRP and for 28 who received placebo injections.
There was no significant difference in outcomes between the groups. IIEF scores changed from 17.4 (95% confidence interval [CI], –15.8 to 19.0) to 21 (95% CI, 17.9-24.0) for men who received PRP and from 18.6 (95% CI, 17.3-19.8) to 21.6 (95% CI, 19.1-24.1) for men in the placebo group (P = .756). Fourteen men (58.3%) in the PRP group, compared with 15 (53.6%) in the placebo group, met MCID. No differences were seen in mean penile Doppler parameters between PRP and placebo. The two adverse events reported in the trial were minor – a hematoma and “a new plaque that did not cause any curvature of the penis,” Dr. Ledesma said.
Platelet-rich plasma may be “really popular, but, objectively speaking, so far, we don’t have any evidence showing that it actually works.”
The study showed that “PRP was not more efficacious than placebo.” This treatment is “really popular, but, objectively speaking, so far, we don’t have any evidence showing that it actually works.”
Based on these findings, he said, “We would recommend sticking to the data primary care providers should tell their patients, ‘Don’t waste your money,’ because it’s pretty expensive.”
Dr. Kuritzky said more studies are needed for a definitive answer. “I think the results of PRP have been largely disappointing across most of the spheres of influence in which it’s been tried. So, it’s not so surprising to me that this trial would, again, not prove efficacious, but I’d have to hold judgment, dependent upon other trials,” he said.
Dr. Ledesma and his colleagues are conducting a prospective, randomized, double-blind trial “investigating whether PRP combined with shock-wave therapy could make a difference.” He said the trial, which is funded by the National Institutes of Health, is in the enrollment phase; results are expected in mid-2024.
Charles Runels, MD, who pioneered the P-Shot and other popular cosmetic procedures, defended the effectiveness of the injections.
“One of the legitimate criticisms of all of the review articles regarding PRP therapies in every field is that there is a significant variability in what people call PRP. The P-Shot represents a very specific protocol in the methods of preparing PRP, activating PRP, and injecting the PRP – all of which differ significantly from what was done in Ledesma’s study and which could account for their lack of results,” Dr. Runels said in an interview.
Dr. Runels added that “multiple studies” do show benefit of the injection of PRP for both erectile dysfunction and Peyronie’s disease and support the success of his protocol. “Also, all of our providers – there are over 3,000 people in our Cellular Medicine Association – offer money back to our patients if there are not satisfactory results,” he said.
Dr. Kuritzky said that when patients ask him about investigational treatments for ED, he tells them to stick to the more traditional approaches, such as phosphodiesterase type 5 inhibitors, intracorporeal injections, and vacuum devices.
But, he added, if other therapies are shown to be safe and effective “in a large population of men with diverse etiologies associated with their erectile dysfunction, including advanced age, diabetes, dyslipidemia, hypertension, cigarette smoking, then I think [they] could be recommended on a more consistent basis.”
Both studies were independently supported. Dr. Goldstein, Dr. Kuritzky, and Dr. Ledesma reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM AUA 2023
Prostate biopsies a laughing (gas) matter?
An old dog – nitrous oxide – can learn new tricks, managing pain in men undergoing transrectal biopsies, researchers reported at the annual meeting of the American Urological Association.
said Heidi Rayala, MD, PhD, assistant professor of surgery at Harvard Medical School, Boston, who helped conduct the study.
Nitrous oxide is best known as a pain medication and anesthetic during dental procedures and childbirth, after trauma, and in end-of-life care.
In the new study, Dr. Rayala and her colleagues at Harvard and Beth Israel-Deaconess Medical Center, Boston, randomly assigned 128 men to self-administered nitrous oxide (SANO) or oxygen as a placebo. Patients in the SANO group had a smaller change in post-biopsy pain score (Visual Analog Scale for pain, 0.43 vs. 1.03; P = .03) and lower odds of experiencing pain during the procedure (odds ratio, 0.45; confidence interval, 0.21-0.97; P = .04).
A comparison of anxiety scores in the two groups failed to find a statistically significant difference between SANO and placebo. However, more men who received nitrous oxide said they tolerated the procedure “better than expected” (61% vs. 41%; P = 0.02), according to the researchers.
Dr. Rayala said that the researchers used the Nitrouseal system (Sedation Systems), in which the patient holds a mask to their face and works with staff to adjust the gas levels to the desired amount. The system is governed to max out at 50% nitrous oxide, ensuring “minimal sedation concentrations, so anesthesia personnel are not required,” she said.
“At levels of less than 50%, patients respond normally to verbal commands and maintain normal airway reflexes,” Dr. Rayala added. “This provides an advantage in that patients do not require the presence of anesthesia personnel.” And because the body eliminates the gas within about 5 minutes, patients do not require an escort home, she said.
This system is also self-scavenging to protect the operating urologist and other personnel from environmental exposure to nitrous oxide.
Dr. Rayala said that three patients (2.3%) found the mask uncomfortable, but in follow-up studies the clinicians have done a better job of preparing patients for the feeling of the mask, making a marked difference. Headaches and nausea are the most commonly reported complaints at concentrations above 50%.
“We did not have patients report headaches or nausea in new study (by the BIDMC group),” she said. This study has been submitted for publication.
Clinicians outside the United States have been quicker to embrace nitrous oxide for prostate procedures.
In a randomized controlled trial, researchers in Australia found no significant improvement in pain scores at 15 minutes from the use of nitrous oxide during transrectal biopsies; however, improvements were seen in patient-reported discomfort, overall experience, and willingness to undergo repeat biopsies.
Stephen McCombie, MD, a consultant at Perth Urology Clinic, Australia, who has been adapting the nitrous oxide protocol for transrectal biopsies to transperineal procedures, said that the Beth Israel study “adds to the evidence to support adjunct use of mild inhalational anesthetics and analgesics during prostate biopsies to improve the patient experience of the procedure.”
He said that the role for these agents may grow with the global trend away from transrectal prostate biopsies and toward transperineal biopsies, largely driven by increasing rates of sepsis after transrectal biopsies.
“While transperineal biopsies can be more painful then transrectal biopsies when performed under local anesthesia, perhaps due to biopsies being taken through the highly sensate perineum as opposed to above the dentate line, optimization of the technique can significantly reduce the discomfort associated with the procedure, which may be further reduced with these agents,” Dr. McCombie said.
“Studies indicate that transperineal biopsies can be more painful than the traditional transrectal biopsies,” Dr. Rayala said. “We do offer transperineal biopsies at BIDMC, and we are gearing up to repeat the SANO study” for those patients.
Dr. Rayala and Dr. McCombie have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An old dog – nitrous oxide – can learn new tricks, managing pain in men undergoing transrectal biopsies, researchers reported at the annual meeting of the American Urological Association.
said Heidi Rayala, MD, PhD, assistant professor of surgery at Harvard Medical School, Boston, who helped conduct the study.
Nitrous oxide is best known as a pain medication and anesthetic during dental procedures and childbirth, after trauma, and in end-of-life care.
In the new study, Dr. Rayala and her colleagues at Harvard and Beth Israel-Deaconess Medical Center, Boston, randomly assigned 128 men to self-administered nitrous oxide (SANO) or oxygen as a placebo. Patients in the SANO group had a smaller change in post-biopsy pain score (Visual Analog Scale for pain, 0.43 vs. 1.03; P = .03) and lower odds of experiencing pain during the procedure (odds ratio, 0.45; confidence interval, 0.21-0.97; P = .04).
A comparison of anxiety scores in the two groups failed to find a statistically significant difference between SANO and placebo. However, more men who received nitrous oxide said they tolerated the procedure “better than expected” (61% vs. 41%; P = 0.02), according to the researchers.
Dr. Rayala said that the researchers used the Nitrouseal system (Sedation Systems), in which the patient holds a mask to their face and works with staff to adjust the gas levels to the desired amount. The system is governed to max out at 50% nitrous oxide, ensuring “minimal sedation concentrations, so anesthesia personnel are not required,” she said.
“At levels of less than 50%, patients respond normally to verbal commands and maintain normal airway reflexes,” Dr. Rayala added. “This provides an advantage in that patients do not require the presence of anesthesia personnel.” And because the body eliminates the gas within about 5 minutes, patients do not require an escort home, she said.
This system is also self-scavenging to protect the operating urologist and other personnel from environmental exposure to nitrous oxide.
Dr. Rayala said that three patients (2.3%) found the mask uncomfortable, but in follow-up studies the clinicians have done a better job of preparing patients for the feeling of the mask, making a marked difference. Headaches and nausea are the most commonly reported complaints at concentrations above 50%.
“We did not have patients report headaches or nausea in new study (by the BIDMC group),” she said. This study has been submitted for publication.
Clinicians outside the United States have been quicker to embrace nitrous oxide for prostate procedures.
In a randomized controlled trial, researchers in Australia found no significant improvement in pain scores at 15 minutes from the use of nitrous oxide during transrectal biopsies; however, improvements were seen in patient-reported discomfort, overall experience, and willingness to undergo repeat biopsies.
Stephen McCombie, MD, a consultant at Perth Urology Clinic, Australia, who has been adapting the nitrous oxide protocol for transrectal biopsies to transperineal procedures, said that the Beth Israel study “adds to the evidence to support adjunct use of mild inhalational anesthetics and analgesics during prostate biopsies to improve the patient experience of the procedure.”
He said that the role for these agents may grow with the global trend away from transrectal prostate biopsies and toward transperineal biopsies, largely driven by increasing rates of sepsis after transrectal biopsies.
“While transperineal biopsies can be more painful then transrectal biopsies when performed under local anesthesia, perhaps due to biopsies being taken through the highly sensate perineum as opposed to above the dentate line, optimization of the technique can significantly reduce the discomfort associated with the procedure, which may be further reduced with these agents,” Dr. McCombie said.
“Studies indicate that transperineal biopsies can be more painful than the traditional transrectal biopsies,” Dr. Rayala said. “We do offer transperineal biopsies at BIDMC, and we are gearing up to repeat the SANO study” for those patients.
Dr. Rayala and Dr. McCombie have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An old dog – nitrous oxide – can learn new tricks, managing pain in men undergoing transrectal biopsies, researchers reported at the annual meeting of the American Urological Association.
said Heidi Rayala, MD, PhD, assistant professor of surgery at Harvard Medical School, Boston, who helped conduct the study.
Nitrous oxide is best known as a pain medication and anesthetic during dental procedures and childbirth, after trauma, and in end-of-life care.
In the new study, Dr. Rayala and her colleagues at Harvard and Beth Israel-Deaconess Medical Center, Boston, randomly assigned 128 men to self-administered nitrous oxide (SANO) or oxygen as a placebo. Patients in the SANO group had a smaller change in post-biopsy pain score (Visual Analog Scale for pain, 0.43 vs. 1.03; P = .03) and lower odds of experiencing pain during the procedure (odds ratio, 0.45; confidence interval, 0.21-0.97; P = .04).
A comparison of anxiety scores in the two groups failed to find a statistically significant difference between SANO and placebo. However, more men who received nitrous oxide said they tolerated the procedure “better than expected” (61% vs. 41%; P = 0.02), according to the researchers.
Dr. Rayala said that the researchers used the Nitrouseal system (Sedation Systems), in which the patient holds a mask to their face and works with staff to adjust the gas levels to the desired amount. The system is governed to max out at 50% nitrous oxide, ensuring “minimal sedation concentrations, so anesthesia personnel are not required,” she said.
“At levels of less than 50%, patients respond normally to verbal commands and maintain normal airway reflexes,” Dr. Rayala added. “This provides an advantage in that patients do not require the presence of anesthesia personnel.” And because the body eliminates the gas within about 5 minutes, patients do not require an escort home, she said.
This system is also self-scavenging to protect the operating urologist and other personnel from environmental exposure to nitrous oxide.
Dr. Rayala said that three patients (2.3%) found the mask uncomfortable, but in follow-up studies the clinicians have done a better job of preparing patients for the feeling of the mask, making a marked difference. Headaches and nausea are the most commonly reported complaints at concentrations above 50%.
“We did not have patients report headaches or nausea in new study (by the BIDMC group),” she said. This study has been submitted for publication.
Clinicians outside the United States have been quicker to embrace nitrous oxide for prostate procedures.
In a randomized controlled trial, researchers in Australia found no significant improvement in pain scores at 15 minutes from the use of nitrous oxide during transrectal biopsies; however, improvements were seen in patient-reported discomfort, overall experience, and willingness to undergo repeat biopsies.
Stephen McCombie, MD, a consultant at Perth Urology Clinic, Australia, who has been adapting the nitrous oxide protocol for transrectal biopsies to transperineal procedures, said that the Beth Israel study “adds to the evidence to support adjunct use of mild inhalational anesthetics and analgesics during prostate biopsies to improve the patient experience of the procedure.”
He said that the role for these agents may grow with the global trend away from transrectal prostate biopsies and toward transperineal biopsies, largely driven by increasing rates of sepsis after transrectal biopsies.
“While transperineal biopsies can be more painful then transrectal biopsies when performed under local anesthesia, perhaps due to biopsies being taken through the highly sensate perineum as opposed to above the dentate line, optimization of the technique can significantly reduce the discomfort associated with the procedure, which may be further reduced with these agents,” Dr. McCombie said.
“Studies indicate that transperineal biopsies can be more painful than the traditional transrectal biopsies,” Dr. Rayala said. “We do offer transperineal biopsies at BIDMC, and we are gearing up to repeat the SANO study” for those patients.
Dr. Rayala and Dr. McCombie have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT AUA 2023
Wireless neurostimulation safe for urge incontinence
CHICAGO – , according to new findings presented at the 2023 annual meeting of the American Urological Association.
As many as half of women in the United States aged 60 and older will experience urinary incontinence. Of those, roughly one in four experience urge urinary incontinence, marked by a sudden need to void that cannot be fully suppressed.
Researchers studied the benefits of the RENOVA iStim (BlueWind Medical) implantable tibial neuromodulation system for the treatment of overactive bladder in the OASIS trial.
Study investigator Roger R. Dmochowski, MD, MMHC, professor of urology and surgery and associate surgeon-in-chief at Vanderbilt University Medical Center, Nashville, Tenn., said the first-line treatment of urinary incontinence is lifestyle changes to retrain the bladder or physical therapy, including pelvic floor and Kegel exercises, per AUA guidelines. He said the success rate is about 30% and is not sustained. Second-line treatments include medications, which most (60%) patients stop taking by 6 months.
More than three-quarters of the 151 women who received the device responded to therapy at 1 year, and 84.6% of the patients showed improvement, according to Dr. Dmochowski.
The participants (mean age, 58.8) demonstrated a mean baseline of 4.8 urge incidents per day (standard deviation, 2.9) and 10 voids/day (SD, 3.3). No device or procedure-related serious adverse events were reported at 12 months. Half of the women no longer had symptoms on three consecutive days, Dr. Dmochowski said.
Because urge urinary incontinence is a chronic condition, “treatment with the BlueWind System will be ongoing, with frequency determined based on the patient’s response,” Dr. Dmochowski said. “The patient is then empowered to control when and where they perform therapy.”
“The device is activated by the external wearable. It’s like an on-off switch. It has a receiver within it that basically has the capacity to be turned on and off by the wearable, which is the control device. The device is in an off-position until the wearable is applied,” he said.
He said the device should be worn twice a day for about 20 minutes, with many patients using it less.
Only one implanted tibial neuromodulation device has been approved by the Food and Drug Administration – eCOIN (Valencia Technologies). The RENOVA iStim is an investigational device under review by the FDA, Dr. Dmochowski said.
In installing the device, Dr. Dmochowski said urologists use a subfascial technique to enable direct visualization of the tibial nerve and suture fixation that increases the possibility of a predictable placement. Patients use an external wearable, which activates the implant, without concern for battery longevity or replacement.
“This therapy is not associated with any adverse effects and may be beneficial for patients who do not respond to other treatments for OAB such as medications or Botox,” said Carol E. Bretschneider, MD, a urogynecologic and pelvic surgeon at Northwestern Medicine Central DuPage Hospital, outside Chicago. “Neurostimulators can be a great advanced therapy option for patients who do not respond to more conservative treatments or cannot take or tolerate a medication.”
The devices do not stimulate or strengthen muscles but act by modulating the reflexes that influence the bladder, sphincter, and pelvic floor, added Dr. Bretschneider, who was not involved in the study.
Other treatments for urge incontinence can include acupuncture, or percutaneous tibial nerve stimulation, to target the posterior tibial nerve in the ankle, which shares the same nerve root that controls the bladder, according to Aron Liaw, MD, a reconstructive urologist and assistant professor of urology at Wayne State University in Detroit. This treatment has been shown to be at least as effective as available medications, but with fewer side effects, he said.
But regular stimulation is necessary to achieve and preserve efficacy, he said.
Dr. Liaw, who was not involved in the neuromodulation study, said the benefits of a device like Renova iStim are that implantation is relatively easy and can be performed in office settings, and patients can then treat themselves at home. However, because the new study did not compare the device to other treatments or a placebo device, its relative benefits are unclear, he said,
Other treatments for urge urinary incontinence, such as bladder Botox and sacral neuromodulation, also are minimally invasive and have proven benefit, “so a device like this could well be less effective with little other advantage,” he said.
“Lifestyle changes can make a big difference, but making big lifestyle changes is not always easy,” added Dr. Liaw. “I have found neuromodulation [to be] very effective, especially in conjunction with lifestyle changes.”
BlueWind Medical funds the OASIS trial. Dr. Dmochowski reported he received no grants nor has any relevant financial relationships. Dr. Bretschneider and Dr. Liaw report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – , according to new findings presented at the 2023 annual meeting of the American Urological Association.
As many as half of women in the United States aged 60 and older will experience urinary incontinence. Of those, roughly one in four experience urge urinary incontinence, marked by a sudden need to void that cannot be fully suppressed.
Researchers studied the benefits of the RENOVA iStim (BlueWind Medical) implantable tibial neuromodulation system for the treatment of overactive bladder in the OASIS trial.
Study investigator Roger R. Dmochowski, MD, MMHC, professor of urology and surgery and associate surgeon-in-chief at Vanderbilt University Medical Center, Nashville, Tenn., said the first-line treatment of urinary incontinence is lifestyle changes to retrain the bladder or physical therapy, including pelvic floor and Kegel exercises, per AUA guidelines. He said the success rate is about 30% and is not sustained. Second-line treatments include medications, which most (60%) patients stop taking by 6 months.
More than three-quarters of the 151 women who received the device responded to therapy at 1 year, and 84.6% of the patients showed improvement, according to Dr. Dmochowski.
The participants (mean age, 58.8) demonstrated a mean baseline of 4.8 urge incidents per day (standard deviation, 2.9) and 10 voids/day (SD, 3.3). No device or procedure-related serious adverse events were reported at 12 months. Half of the women no longer had symptoms on three consecutive days, Dr. Dmochowski said.
Because urge urinary incontinence is a chronic condition, “treatment with the BlueWind System will be ongoing, with frequency determined based on the patient’s response,” Dr. Dmochowski said. “The patient is then empowered to control when and where they perform therapy.”
“The device is activated by the external wearable. It’s like an on-off switch. It has a receiver within it that basically has the capacity to be turned on and off by the wearable, which is the control device. The device is in an off-position until the wearable is applied,” he said.
He said the device should be worn twice a day for about 20 minutes, with many patients using it less.
Only one implanted tibial neuromodulation device has been approved by the Food and Drug Administration – eCOIN (Valencia Technologies). The RENOVA iStim is an investigational device under review by the FDA, Dr. Dmochowski said.
In installing the device, Dr. Dmochowski said urologists use a subfascial technique to enable direct visualization of the tibial nerve and suture fixation that increases the possibility of a predictable placement. Patients use an external wearable, which activates the implant, without concern for battery longevity or replacement.
“This therapy is not associated with any adverse effects and may be beneficial for patients who do not respond to other treatments for OAB such as medications or Botox,” said Carol E. Bretschneider, MD, a urogynecologic and pelvic surgeon at Northwestern Medicine Central DuPage Hospital, outside Chicago. “Neurostimulators can be a great advanced therapy option for patients who do not respond to more conservative treatments or cannot take or tolerate a medication.”
The devices do not stimulate or strengthen muscles but act by modulating the reflexes that influence the bladder, sphincter, and pelvic floor, added Dr. Bretschneider, who was not involved in the study.
Other treatments for urge incontinence can include acupuncture, or percutaneous tibial nerve stimulation, to target the posterior tibial nerve in the ankle, which shares the same nerve root that controls the bladder, according to Aron Liaw, MD, a reconstructive urologist and assistant professor of urology at Wayne State University in Detroit. This treatment has been shown to be at least as effective as available medications, but with fewer side effects, he said.
But regular stimulation is necessary to achieve and preserve efficacy, he said.
Dr. Liaw, who was not involved in the neuromodulation study, said the benefits of a device like Renova iStim are that implantation is relatively easy and can be performed in office settings, and patients can then treat themselves at home. However, because the new study did not compare the device to other treatments or a placebo device, its relative benefits are unclear, he said,
Other treatments for urge urinary incontinence, such as bladder Botox and sacral neuromodulation, also are minimally invasive and have proven benefit, “so a device like this could well be less effective with little other advantage,” he said.
“Lifestyle changes can make a big difference, but making big lifestyle changes is not always easy,” added Dr. Liaw. “I have found neuromodulation [to be] very effective, especially in conjunction with lifestyle changes.”
BlueWind Medical funds the OASIS trial. Dr. Dmochowski reported he received no grants nor has any relevant financial relationships. Dr. Bretschneider and Dr. Liaw report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – , according to new findings presented at the 2023 annual meeting of the American Urological Association.
As many as half of women in the United States aged 60 and older will experience urinary incontinence. Of those, roughly one in four experience urge urinary incontinence, marked by a sudden need to void that cannot be fully suppressed.
Researchers studied the benefits of the RENOVA iStim (BlueWind Medical) implantable tibial neuromodulation system for the treatment of overactive bladder in the OASIS trial.
Study investigator Roger R. Dmochowski, MD, MMHC, professor of urology and surgery and associate surgeon-in-chief at Vanderbilt University Medical Center, Nashville, Tenn., said the first-line treatment of urinary incontinence is lifestyle changes to retrain the bladder or physical therapy, including pelvic floor and Kegel exercises, per AUA guidelines. He said the success rate is about 30% and is not sustained. Second-line treatments include medications, which most (60%) patients stop taking by 6 months.
More than three-quarters of the 151 women who received the device responded to therapy at 1 year, and 84.6% of the patients showed improvement, according to Dr. Dmochowski.
The participants (mean age, 58.8) demonstrated a mean baseline of 4.8 urge incidents per day (standard deviation, 2.9) and 10 voids/day (SD, 3.3). No device or procedure-related serious adverse events were reported at 12 months. Half of the women no longer had symptoms on three consecutive days, Dr. Dmochowski said.
Because urge urinary incontinence is a chronic condition, “treatment with the BlueWind System will be ongoing, with frequency determined based on the patient’s response,” Dr. Dmochowski said. “The patient is then empowered to control when and where they perform therapy.”
“The device is activated by the external wearable. It’s like an on-off switch. It has a receiver within it that basically has the capacity to be turned on and off by the wearable, which is the control device. The device is in an off-position until the wearable is applied,” he said.
He said the device should be worn twice a day for about 20 minutes, with many patients using it less.
Only one implanted tibial neuromodulation device has been approved by the Food and Drug Administration – eCOIN (Valencia Technologies). The RENOVA iStim is an investigational device under review by the FDA, Dr. Dmochowski said.
In installing the device, Dr. Dmochowski said urologists use a subfascial technique to enable direct visualization of the tibial nerve and suture fixation that increases the possibility of a predictable placement. Patients use an external wearable, which activates the implant, without concern for battery longevity or replacement.
“This therapy is not associated with any adverse effects and may be beneficial for patients who do not respond to other treatments for OAB such as medications or Botox,” said Carol E. Bretschneider, MD, a urogynecologic and pelvic surgeon at Northwestern Medicine Central DuPage Hospital, outside Chicago. “Neurostimulators can be a great advanced therapy option for patients who do not respond to more conservative treatments or cannot take or tolerate a medication.”
The devices do not stimulate or strengthen muscles but act by modulating the reflexes that influence the bladder, sphincter, and pelvic floor, added Dr. Bretschneider, who was not involved in the study.
Other treatments for urge incontinence can include acupuncture, or percutaneous tibial nerve stimulation, to target the posterior tibial nerve in the ankle, which shares the same nerve root that controls the bladder, according to Aron Liaw, MD, a reconstructive urologist and assistant professor of urology at Wayne State University in Detroit. This treatment has been shown to be at least as effective as available medications, but with fewer side effects, he said.
But regular stimulation is necessary to achieve and preserve efficacy, he said.
Dr. Liaw, who was not involved in the neuromodulation study, said the benefits of a device like Renova iStim are that implantation is relatively easy and can be performed in office settings, and patients can then treat themselves at home. However, because the new study did not compare the device to other treatments or a placebo device, its relative benefits are unclear, he said,
Other treatments for urge urinary incontinence, such as bladder Botox and sacral neuromodulation, also are minimally invasive and have proven benefit, “so a device like this could well be less effective with little other advantage,” he said.
“Lifestyle changes can make a big difference, but making big lifestyle changes is not always easy,” added Dr. Liaw. “I have found neuromodulation [to be] very effective, especially in conjunction with lifestyle changes.”
BlueWind Medical funds the OASIS trial. Dr. Dmochowski reported he received no grants nor has any relevant financial relationships. Dr. Bretschneider and Dr. Liaw report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT AUA 2023