TBD Meeting (3016-24)

The number of Americans seeking permanent forms of contraception has surged in the nearly 2 years since the Dobbs v. Jackson Women’s Health Organization Supreme Court decision that overturned a federal right to abortion, according to a study presented on May 5 at the annual meeting of the American Urological Association (AUA) (abstract PD40-03). Several other studies at the conference reported similar findings.

Rates of vasectomy and tubal ligation have increased in states where abortion became illegal after the court’s June 2022 ruling, researchers found. Rates of tubal sterilization had already been higher in states where abortion was illegal compared with those where access to the procedure remained available and was expected to remain so, but the difference widened after the decision. 

“Our study showed trends of increasing utilization of permanent contraception post-Dobbs, with a significant increase in patients less than 30 years old pursuing any type of permanent contraception post-Dobbs,” Jessica N. Schardein, MD, MS, of University of Utah Health in Salt Lake City, told attendees. “Reproductive autonomy is important for people of all genders and may be influenced by legal climate. Understanding the relationship between state-level abortion laws and trends in permanent contraception is crucial for us to determine how to best allocate resources for education and services to ensure reproductive rights for all patients.”

Dr. Schardein told this news organization the increase in vasectomies post-Dobbs was consistent across most states regardless of legal climate, showing that “reproductive health matters to all people,” both women and men.

“We should continue to offer permanent contraception to patients who are not interested in future fertility, regardless of their age or marital status, to ensure reproductive autonomy for those patients,” Dr. Schardein said. “Patients may need increased access to these procedures if the increased rates continue over time.”

Dr. Schardein’s study investigated national trends in the use of permanent contraception before and after the Dobbs ruling. She and her colleagues analyzed data from the Epic Cosmos database of more than 217 million patients from an estimated 27,000 clinics and 1260 hospitals nationwide. The researchers identified all adults who underwent a vasectomy or tubal ligation from July to December 2021 and then from July to December 2022, in the 5 months following the decision.

Among adults aged 18-30 years, rates of vasectomy were 1.59 times higher and rates of tubal ligation were 1.29 times higher after the Dobbs ruling than before it (P < .001). Although overall rates of tubal ligation among single women did not change after Dobbs, rates of vasectomy in single men were 1.13 times higher (P < .001).

States were categorized as not hostile to abortion access (abortion access remained available), hostile (access was restricted or might become illegal), or illegal on the basis of information from the Center for Reproductive Rights. Vasectomies increased in most states, with the biggest gain in Tennessee, where abortions are illegal. 

The increase in vasectomy rates was similar across nonhostile (incidence rate ratio [IRR], 1.43), hostile (IRR, 1.46), and illegal (IRR, 1.41) states (P < .001). Although the rate of increase was similar regardless of legal climate, the rate of vasectomies was higher in hostile and illegal states than in nonhostile states both before and after the Dobbs ruling, according to the researchers.

Rates of tubal ligation did not change as substantially across the United States after Dobbs, remaining unchanged in states hostile to abortion access and rising slightly in nonhostile states (IRR, 1.06) and in states where abortion is now illegal (IRR, 1.12; P < .001 for both).

However, when the researchers looked at tubal ligation in nonhostile states and hostile or illegal states, they found that rates of the procedure were nearly double in the hostile or illegal states both before and after Dobbs, with a bigger increase after Dobbs in illegal states. Tubal ligation rates were 1.85 times higher in illegal states than in nonhostile states after Dobbs, compared with being 1.76 times higher than in nonhostile states before Dobbs.
 

Other Studies Support the Findings 

Another study assessed the change in the volume of vasectomy consultations at six US academic medical centers in the 17 months before and 5 months after Dobbs (abstract PD40-02). The researchers reported that the rate was roughly 7% higher after the ruling than before (143 vs 134 cases per month, respectively). Again, the men seeking vasectomies after Dobbs were younger than those who sought the procedure before Dobbs (median age, 38 vs 39 years; P < .001). Post-Dobbs patients were also significantly more likely to be non-Hispanic White, English-speaking, and privately insured. 

“Younger, childless people are choosing vasectomies as permanent method of birth control,” lead author Kara L. Watts, MD, associate professor of urology at Montefiore Medical Center in Bronx, New York, told attendees. “The impact of this decision is likely to be long-lasting, requiring urologists and medical centers to adjust practice patterns to account for the increased demand.”

Twice as many childless married men underwent vasectomies after Dobbs than before the ruling (11% vs 5%, respectively; P = .001), but substantially more childless single men had the procedure after Dobbs than before it (36% vs 21%; P = .003). Those seeking vasectomies after Dobbs had to wait a median of 8 days longer between consult and procedure (59 vs 51 days pre-Dobbs; P < .001). Several of the same researchers had identified an increase in online searches about vasectomies in the months just after the Dobbs decision.

“We’ve been trying to get men to take more responsibility” for their role in unplanned pregnancies, Ajay K. Nangia, MD, MBBS, professor and vice chair of urology at University of Kansas Medical Center in Overland Park, told this news organization. Dr. Nangia, who helped conduct the study of vasectomy consultations and has spent years on research related to pharmaceutical contraception options for men, said the sudden increase in interest in vasectomies can be ethically fraught. Only 25% of vasectomies can be reversed, and some patients who seek the surgery may not have permanently ruled out having children.

“They’re going into this with their eyes wide open, knowing that it’s not 100% going to be reversible with a vasectomy,” he said. But fear of not having abortion access for their partners is part of their motivation, which creates tension for providers in balancing ethical counseling with the potential paternalism of advising against a vasectomy if they’re not certain that they don’t want children. 

“What happens in that situation, when it’s a political decision making you change your medical decision?” Dr. Nangia said. “I worry about that ethically.”

Dr. Nangia noted that the findings of his study cannot show that the Dobbs decision was the cause of the increase in vasectomies. However, in another abstract from the same session (PD40-01), researchers at The Ohio State University College of Medicine in Columbus presented findings from a survey of 57 men who underwent vasectomies in the preceding 2 years. Those results revealed that abortion access had been a factor among some of the 47% of patients whose procedures were performed after Dobbs. Post-Dobbs patients were significantly more likely to say they sought a vasectomy because of concerns about not being able to get abortion (P = .026) and because they didn’t want “to bring children into the current political climate” (P = .002). 

A study presented on May 6 (abstract MP76-06) involved a retrospective review of all 631 patients who underwent a vasectomy consult at UC San Diego Medical Center from June 2021 to June 2023. More vasectomy consults occurred after the Dobbs decision than before it (56% vs 44%). The gap for vasectomy consults was slightly wider for partnerless patients after vs before Dobbs (58% vs 42%) and substantially larger for childless patients post-Dobbs compared with pre-Dobbs (63% vs 37%). The childless men undergoing vasectomies after Dobbs also were significantly younger than those who had had this procedure before the ruling (mean, 36.4 vs 39.8 years; P <.001). 

“Patients should be counseled on the permanent nature of this procedure, underscoring need for effective and reversible male contraception,” the authors concluded.

Dr. Schardein and Dr. Watts reported no relevant financial conflicts of interest. Dr. Nangia is conducting an idiopathic infertility study with funding from Ferring Pharmaceuticals. None of the studies reported external funding.

A version of this article first appeared on Medscape.com.

The number of Americans seeking permanent forms of contraception has surged in the nearly 2 years since the Dobbs v. Jackson Women’s Health Organization Supreme Court decision that overturned a federal right to abortion, according to a study presented on May 5 at the annual meeting of the American Urological Association (AUA) (abstract PD40-03). Several other studies at the conference reported similar findings.

Rates of vasectomy and tubal ligation have increased in states where abortion became illegal after the court’s June 2022 ruling, researchers found. Rates of tubal sterilization had already been higher in states where abortion was illegal compared with those where access to the procedure remained available and was expected to remain so, but the difference widened after the decision. 

“Our study showed trends of increasing utilization of permanent contraception post-Dobbs, with a significant increase in patients less than 30 years old pursuing any type of permanent contraception post-Dobbs,” Jessica N. Schardein, MD, MS, of University of Utah Health in Salt Lake City, told attendees. “Reproductive autonomy is important for people of all genders and may be influenced by legal climate. Understanding the relationship between state-level abortion laws and trends in permanent contraception is crucial for us to determine how to best allocate resources for education and services to ensure reproductive rights for all patients.”

Dr. Schardein told this news organization the increase in vasectomies post-Dobbs was consistent across most states regardless of legal climate, showing that “reproductive health matters to all people,” both women and men.

“We should continue to offer permanent contraception to patients who are not interested in future fertility, regardless of their age or marital status, to ensure reproductive autonomy for those patients,” Dr. Schardein said. “Patients may need increased access to these procedures if the increased rates continue over time.”

Dr. Schardein’s study investigated national trends in the use of permanent contraception before and after the Dobbs ruling. She and her colleagues analyzed data from the Epic Cosmos database of more than 217 million patients from an estimated 27,000 clinics and 1260 hospitals nationwide. The researchers identified all adults who underwent a vasectomy or tubal ligation from July to December 2021 and then from July to December 2022, in the 5 months following the decision.

Among adults aged 18-30 years, rates of vasectomy were 1.59 times higher and rates of tubal ligation were 1.29 times higher after the Dobbs ruling than before it (P < .001). Although overall rates of tubal ligation among single women did not change after Dobbs, rates of vasectomy in single men were 1.13 times higher (P < .001).

States were categorized as not hostile to abortion access (abortion access remained available), hostile (access was restricted or might become illegal), or illegal on the basis of information from the Center for Reproductive Rights. Vasectomies increased in most states, with the biggest gain in Tennessee, where abortions are illegal. 

The increase in vasectomy rates was similar across nonhostile (incidence rate ratio [IRR], 1.43), hostile (IRR, 1.46), and illegal (IRR, 1.41) states (P < .001). Although the rate of increase was similar regardless of legal climate, the rate of vasectomies was higher in hostile and illegal states than in nonhostile states both before and after the Dobbs ruling, according to the researchers.

Rates of tubal ligation did not change as substantially across the United States after Dobbs, remaining unchanged in states hostile to abortion access and rising slightly in nonhostile states (IRR, 1.06) and in states where abortion is now illegal (IRR, 1.12; P < .001 for both).

However, when the researchers looked at tubal ligation in nonhostile states and hostile or illegal states, they found that rates of the procedure were nearly double in the hostile or illegal states both before and after Dobbs, with a bigger increase after Dobbs in illegal states. Tubal ligation rates were 1.85 times higher in illegal states than in nonhostile states after Dobbs, compared with being 1.76 times higher than in nonhostile states before Dobbs.
 

Other Studies Support the Findings 

Another study assessed the change in the volume of vasectomy consultations at six US academic medical centers in the 17 months before and 5 months after Dobbs (abstract PD40-02). The researchers reported that the rate was roughly 7% higher after the ruling than before (143 vs 134 cases per month, respectively). Again, the men seeking vasectomies after Dobbs were younger than those who sought the procedure before Dobbs (median age, 38 vs 39 years; P < .001). Post-Dobbs patients were also significantly more likely to be non-Hispanic White, English-speaking, and privately insured. 

“Younger, childless people are choosing vasectomies as permanent method of birth control,” lead author Kara L. Watts, MD, associate professor of urology at Montefiore Medical Center in Bronx, New York, told attendees. “The impact of this decision is likely to be long-lasting, requiring urologists and medical centers to adjust practice patterns to account for the increased demand.”

Twice as many childless married men underwent vasectomies after Dobbs than before the ruling (11% vs 5%, respectively; P = .001), but substantially more childless single men had the procedure after Dobbs than before it (36% vs 21%; P = .003). Those seeking vasectomies after Dobbs had to wait a median of 8 days longer between consult and procedure (59 vs 51 days pre-Dobbs; P < .001). Several of the same researchers had identified an increase in online searches about vasectomies in the months just after the Dobbs decision.

“We’ve been trying to get men to take more responsibility” for their role in unplanned pregnancies, Ajay K. Nangia, MD, MBBS, professor and vice chair of urology at University of Kansas Medical Center in Overland Park, told this news organization. Dr. Nangia, who helped conduct the study of vasectomy consultations and has spent years on research related to pharmaceutical contraception options for men, said the sudden increase in interest in vasectomies can be ethically fraught. Only 25% of vasectomies can be reversed, and some patients who seek the surgery may not have permanently ruled out having children.

“They’re going into this with their eyes wide open, knowing that it’s not 100% going to be reversible with a vasectomy,” he said. But fear of not having abortion access for their partners is part of their motivation, which creates tension for providers in balancing ethical counseling with the potential paternalism of advising against a vasectomy if they’re not certain that they don’t want children. 

“What happens in that situation, when it’s a political decision making you change your medical decision?” Dr. Nangia said. “I worry about that ethically.”

Dr. Nangia noted that the findings of his study cannot show that the Dobbs decision was the cause of the increase in vasectomies. However, in another abstract from the same session (PD40-01), researchers at The Ohio State University College of Medicine in Columbus presented findings from a survey of 57 men who underwent vasectomies in the preceding 2 years. Those results revealed that abortion access had been a factor among some of the 47% of patients whose procedures were performed after Dobbs. Post-Dobbs patients were significantly more likely to say they sought a vasectomy because of concerns about not being able to get abortion (P = .026) and because they didn’t want “to bring children into the current political climate” (P = .002). 

A study presented on May 6 (abstract MP76-06) involved a retrospective review of all 631 patients who underwent a vasectomy consult at UC San Diego Medical Center from June 2021 to June 2023. More vasectomy consults occurred after the Dobbs decision than before it (56% vs 44%). The gap for vasectomy consults was slightly wider for partnerless patients after vs before Dobbs (58% vs 42%) and substantially larger for childless patients post-Dobbs compared with pre-Dobbs (63% vs 37%). The childless men undergoing vasectomies after Dobbs also were significantly younger than those who had had this procedure before the ruling (mean, 36.4 vs 39.8 years; P <.001). 

“Patients should be counseled on the permanent nature of this procedure, underscoring need for effective and reversible male contraception,” the authors concluded.

Dr. Schardein and Dr. Watts reported no relevant financial conflicts of interest. Dr. Nangia is conducting an idiopathic infertility study with funding from Ferring Pharmaceuticals. None of the studies reported external funding.

A version of this article first appeared on Medscape.com.

The number of Americans seeking permanent forms of contraception has surged in the nearly 2 years since the Dobbs v. Jackson Women’s Health Organization Supreme Court decision that overturned a federal right to abortion, according to a study presented on May 5 at the annual meeting of the American Urological Association (AUA) (abstract PD40-03). Several other studies at the conference reported similar findings.

Rates of vasectomy and tubal ligation have increased in states where abortion became illegal after the court’s June 2022 ruling, researchers found. Rates of tubal sterilization had already been higher in states where abortion was illegal compared with those where access to the procedure remained available and was expected to remain so, but the difference widened after the decision. 

“Our study showed trends of increasing utilization of permanent contraception post-Dobbs, with a significant increase in patients less than 30 years old pursuing any type of permanent contraception post-Dobbs,” Jessica N. Schardein, MD, MS, of University of Utah Health in Salt Lake City, told attendees. “Reproductive autonomy is important for people of all genders and may be influenced by legal climate. Understanding the relationship between state-level abortion laws and trends in permanent contraception is crucial for us to determine how to best allocate resources for education and services to ensure reproductive rights for all patients.”

Dr. Schardein told this news organization the increase in vasectomies post-Dobbs was consistent across most states regardless of legal climate, showing that “reproductive health matters to all people,” both women and men.

“We should continue to offer permanent contraception to patients who are not interested in future fertility, regardless of their age or marital status, to ensure reproductive autonomy for those patients,” Dr. Schardein said. “Patients may need increased access to these procedures if the increased rates continue over time.”

Dr. Schardein’s study investigated national trends in the use of permanent contraception before and after the Dobbs ruling. She and her colleagues analyzed data from the Epic Cosmos database of more than 217 million patients from an estimated 27,000 clinics and 1260 hospitals nationwide. The researchers identified all adults who underwent a vasectomy or tubal ligation from July to December 2021 and then from July to December 2022, in the 5 months following the decision.

Among adults aged 18-30 years, rates of vasectomy were 1.59 times higher and rates of tubal ligation were 1.29 times higher after the Dobbs ruling than before it (P < .001). Although overall rates of tubal ligation among single women did not change after Dobbs, rates of vasectomy in single men were 1.13 times higher (P < .001).

States were categorized as not hostile to abortion access (abortion access remained available), hostile (access was restricted or might become illegal), or illegal on the basis of information from the Center for Reproductive Rights. Vasectomies increased in most states, with the biggest gain in Tennessee, where abortions are illegal. 

The increase in vasectomy rates was similar across nonhostile (incidence rate ratio [IRR], 1.43), hostile (IRR, 1.46), and illegal (IRR, 1.41) states (P < .001). Although the rate of increase was similar regardless of legal climate, the rate of vasectomies was higher in hostile and illegal states than in nonhostile states both before and after the Dobbs ruling, according to the researchers.

Rates of tubal ligation did not change as substantially across the United States after Dobbs, remaining unchanged in states hostile to abortion access and rising slightly in nonhostile states (IRR, 1.06) and in states where abortion is now illegal (IRR, 1.12; P < .001 for both).

However, when the researchers looked at tubal ligation in nonhostile states and hostile or illegal states, they found that rates of the procedure were nearly double in the hostile or illegal states both before and after Dobbs, with a bigger increase after Dobbs in illegal states. Tubal ligation rates were 1.85 times higher in illegal states than in nonhostile states after Dobbs, compared with being 1.76 times higher than in nonhostile states before Dobbs.
 

Other Studies Support the Findings 

Another study assessed the change in the volume of vasectomy consultations at six US academic medical centers in the 17 months before and 5 months after Dobbs (abstract PD40-02). The researchers reported that the rate was roughly 7% higher after the ruling than before (143 vs 134 cases per month, respectively). Again, the men seeking vasectomies after Dobbs were younger than those who sought the procedure before Dobbs (median age, 38 vs 39 years; P < .001). Post-Dobbs patients were also significantly more likely to be non-Hispanic White, English-speaking, and privately insured. 

“Younger, childless people are choosing vasectomies as permanent method of birth control,” lead author Kara L. Watts, MD, associate professor of urology at Montefiore Medical Center in Bronx, New York, told attendees. “The impact of this decision is likely to be long-lasting, requiring urologists and medical centers to adjust practice patterns to account for the increased demand.”

Twice as many childless married men underwent vasectomies after Dobbs than before the ruling (11% vs 5%, respectively; P = .001), but substantially more childless single men had the procedure after Dobbs than before it (36% vs 21%; P = .003). Those seeking vasectomies after Dobbs had to wait a median of 8 days longer between consult and procedure (59 vs 51 days pre-Dobbs; P < .001). Several of the same researchers had identified an increase in online searches about vasectomies in the months just after the Dobbs decision.

“We’ve been trying to get men to take more responsibility” for their role in unplanned pregnancies, Ajay K. Nangia, MD, MBBS, professor and vice chair of urology at University of Kansas Medical Center in Overland Park, told this news organization. Dr. Nangia, who helped conduct the study of vasectomy consultations and has spent years on research related to pharmaceutical contraception options for men, said the sudden increase in interest in vasectomies can be ethically fraught. Only 25% of vasectomies can be reversed, and some patients who seek the surgery may not have permanently ruled out having children.

“They’re going into this with their eyes wide open, knowing that it’s not 100% going to be reversible with a vasectomy,” he said. But fear of not having abortion access for their partners is part of their motivation, which creates tension for providers in balancing ethical counseling with the potential paternalism of advising against a vasectomy if they’re not certain that they don’t want children. 

“What happens in that situation, when it’s a political decision making you change your medical decision?” Dr. Nangia said. “I worry about that ethically.”

Dr. Nangia noted that the findings of his study cannot show that the Dobbs decision was the cause of the increase in vasectomies. However, in another abstract from the same session (PD40-01), researchers at The Ohio State University College of Medicine in Columbus presented findings from a survey of 57 men who underwent vasectomies in the preceding 2 years. Those results revealed that abortion access had been a factor among some of the 47% of patients whose procedures were performed after Dobbs. Post-Dobbs patients were significantly more likely to say they sought a vasectomy because of concerns about not being able to get abortion (P = .026) and because they didn’t want “to bring children into the current political climate” (P = .002). 

A study presented on May 6 (abstract MP76-06) involved a retrospective review of all 631 patients who underwent a vasectomy consult at UC San Diego Medical Center from June 2021 to June 2023. More vasectomy consults occurred after the Dobbs decision than before it (56% vs 44%). The gap for vasectomy consults was slightly wider for partnerless patients after vs before Dobbs (58% vs 42%) and substantially larger for childless patients post-Dobbs compared with pre-Dobbs (63% vs 37%). The childless men undergoing vasectomies after Dobbs also were significantly younger than those who had had this procedure before the ruling (mean, 36.4 vs 39.8 years; P <.001). 

“Patients should be counseled on the permanent nature of this procedure, underscoring need for effective and reversible male contraception,” the authors concluded.

Dr. Schardein and Dr. Watts reported no relevant financial conflicts of interest. Dr. Nangia is conducting an idiopathic infertility study with funding from Ferring Pharmaceuticals. None of the studies reported external funding.

A version of this article first appeared on Medscape.com.

The medication vibegron led to improvements in symptoms of overactive bladder and overall quality of life in men undergoing treatment for benign prostatic hyperplasia, according to findings from a phase 3 trial presented at the annual meeting of the American Urological Association (AUA) and data published in the Journal of Urology.

“Vibegron was associated with significant reductions in daily micturition and urgency episodes, as well as our secondary endpoints,” David R. Staskin, MD, an associate professor of urology at Tufts University School of Medicine in Boston, told attendees. “Symptoms really did improve compared to placebo as early as week 2.”

Vibegron is a selective beta-3 adrenergic receptor agonist approved in 2020 by the US Food and Drug Administration for the treatment of overactive bladder.

However, treating overactive bladder symptoms in patients undergoing benign prostatic hyperplasia treatment is more complex because benign prostatic hyperplasia itself can contribute to overactive bladder symptoms, said Kara Watts, MD, an associate professor of urology at Montefiore Einstein in New York City, who was not involved in the new research.

“Management of overactive bladder in this setting may require treatment of benign prostatic hyperplasia as well, but a discussion of the relationship between benign prostatic hyperplasia and overactive bladder symptoms is important,” Dr. Watts told this news organization. “Beyond consideration of treatment for benign prostatic hyperplasia — which can be in the form of medications or surgeries to reduce the size of the prostate — treatment of overactive bladder can include behavioral modification,” such as avoiding bladder irritants, timed voiding, managing constipation, and nighttime liquid restriction,” as well as “medications, percutaneous tibial nerve stimulation, and occasionally more invasive options.”

Vibegron “represents a very attractive and effective pharmaceutical management option for overactive bladder,” both in patients with and without benign prostatic hyperplasia, Dr. Watts said. “It has a favorable side-effect profile compared to other oral agents that can be prescribed for overactive bladder, such as anticholinergics, and also has the added benefit of a much lower risk of urinary retention in comparison to most other oral agents.”

Among 1104 men at least 45 years old who were undergoing treatment for benign prostatic hyperplasia and had symptoms of overactive bladder, 538 received 75 mg of vibegron and 542 received a placebo. The men in the vibegron group showed 2.04 fewer mean daily urinations at 12 weeks and 2.2 fewer at 24 weeks compared to 1.3 fewer at both 12 and 24 weeks for men in the placebo group (P < .0001), according to the researchers.

The drug also reduced urgency of urination. Mean daily episodes of urgency were 2.88 fewer at 12 weeks and 3.07 fewer at 24 weeks in the vibegron group compared to 1.93 and 2.17 fewer, respectively, in the placebo group (P < .0001).

In secondary endpoints, those taking vibegron experienced 0.22 fewer episodes of nocturia (P = .002), 0.8 fewer episodes of urgency incontinence (P = .003), a 0.9-point difference in improvement in the International Prostate Symptom Score (P < .0001), and about 15 mL more volume voided (P < .0001) compared to those receiving placebo, the researchers reported.

“The clinical significance of these findings is that vibegron represents an effective pharmacologic option for managing overactive bladder in the context of concomitant benign prostatic hyperplasia, which is a broader context than its original approval for overactive bladder alone,” Dr. Watts said.

Data from 969 patients on the overactive bladder quality-of-life questionnaire found that the symptom bother score was 6.2 points better for men in the vibegron group than those who took a placebo (P < .0001) at 12 weeks. Similarly, the total health-related quality-of-life score was 4.3 points better in the vibegron group (P < .0001). Measures of concern, coping, and sleep also improved significantly in the men taking vibegron and remained significant at 24 weeks (P < .0001).

Rates of adverse events were similar in the vibegron (45%) and placebo (39%) groups. The most common adverse event was hypertension, which occurred in 9% of the vibegron group and 8.3% of men in the placebo group.

The research was funded by Sumitomo Pharma America, Inc., which makes vibegron. Dr. Staskin is a consultant for Astellas, AzuraBio, Sumitomo Pharma America, Inc., and UroCure; is a lecturer for Astellas and Sumitomo; and holds other interests in UroCure, AzuraBio, and Quillitin Pharma. Three co-authors are Sumitomo employees; one is an investigator for Sumitomo, and another has consulted for Hologic, received research funding from Allergan/AbbVie and Uromedica, and been involved in clinical trials on behalf of Sumitomo. Dr. Watts reported no relevant financial conflicts of interest.

A version of this article first appeared on Medscape.com.

The medication vibegron led to improvements in symptoms of overactive bladder and overall quality of life in men undergoing treatment for benign prostatic hyperplasia, according to findings from a phase 3 trial presented at the annual meeting of the American Urological Association (AUA) and data published in the Journal of Urology.

“Vibegron was associated with significant reductions in daily micturition and urgency episodes, as well as our secondary endpoints,” David R. Staskin, MD, an associate professor of urology at Tufts University School of Medicine in Boston, told attendees. “Symptoms really did improve compared to placebo as early as week 2.”

Vibegron is a selective beta-3 adrenergic receptor agonist approved in 2020 by the US Food and Drug Administration for the treatment of overactive bladder.

However, treating overactive bladder symptoms in patients undergoing benign prostatic hyperplasia treatment is more complex because benign prostatic hyperplasia itself can contribute to overactive bladder symptoms, said Kara Watts, MD, an associate professor of urology at Montefiore Einstein in New York City, who was not involved in the new research.

“Management of overactive bladder in this setting may require treatment of benign prostatic hyperplasia as well, but a discussion of the relationship between benign prostatic hyperplasia and overactive bladder symptoms is important,” Dr. Watts told this news organization. “Beyond consideration of treatment for benign prostatic hyperplasia — which can be in the form of medications or surgeries to reduce the size of the prostate — treatment of overactive bladder can include behavioral modification,” such as avoiding bladder irritants, timed voiding, managing constipation, and nighttime liquid restriction,” as well as “medications, percutaneous tibial nerve stimulation, and occasionally more invasive options.”

Vibegron “represents a very attractive and effective pharmaceutical management option for overactive bladder,” both in patients with and without benign prostatic hyperplasia, Dr. Watts said. “It has a favorable side-effect profile compared to other oral agents that can be prescribed for overactive bladder, such as anticholinergics, and also has the added benefit of a much lower risk of urinary retention in comparison to most other oral agents.”

Among 1104 men at least 45 years old who were undergoing treatment for benign prostatic hyperplasia and had symptoms of overactive bladder, 538 received 75 mg of vibegron and 542 received a placebo. The men in the vibegron group showed 2.04 fewer mean daily urinations at 12 weeks and 2.2 fewer at 24 weeks compared to 1.3 fewer at both 12 and 24 weeks for men in the placebo group (P < .0001), according to the researchers.

The drug also reduced urgency of urination. Mean daily episodes of urgency were 2.88 fewer at 12 weeks and 3.07 fewer at 24 weeks in the vibegron group compared to 1.93 and 2.17 fewer, respectively, in the placebo group (P < .0001).

In secondary endpoints, those taking vibegron experienced 0.22 fewer episodes of nocturia (P = .002), 0.8 fewer episodes of urgency incontinence (P = .003), a 0.9-point difference in improvement in the International Prostate Symptom Score (P < .0001), and about 15 mL more volume voided (P < .0001) compared to those receiving placebo, the researchers reported.

“The clinical significance of these findings is that vibegron represents an effective pharmacologic option for managing overactive bladder in the context of concomitant benign prostatic hyperplasia, which is a broader context than its original approval for overactive bladder alone,” Dr. Watts said.

Data from 969 patients on the overactive bladder quality-of-life questionnaire found that the symptom bother score was 6.2 points better for men in the vibegron group than those who took a placebo (P < .0001) at 12 weeks. Similarly, the total health-related quality-of-life score was 4.3 points better in the vibegron group (P < .0001). Measures of concern, coping, and sleep also improved significantly in the men taking vibegron and remained significant at 24 weeks (P < .0001).

Rates of adverse events were similar in the vibegron (45%) and placebo (39%) groups. The most common adverse event was hypertension, which occurred in 9% of the vibegron group and 8.3% of men in the placebo group.

The research was funded by Sumitomo Pharma America, Inc., which makes vibegron. Dr. Staskin is a consultant for Astellas, AzuraBio, Sumitomo Pharma America, Inc., and UroCure; is a lecturer for Astellas and Sumitomo; and holds other interests in UroCure, AzuraBio, and Quillitin Pharma. Three co-authors are Sumitomo employees; one is an investigator for Sumitomo, and another has consulted for Hologic, received research funding from Allergan/AbbVie and Uromedica, and been involved in clinical trials on behalf of Sumitomo. Dr. Watts reported no relevant financial conflicts of interest.

A version of this article first appeared on Medscape.com.

The medication vibegron led to improvements in symptoms of overactive bladder and overall quality of life in men undergoing treatment for benign prostatic hyperplasia, according to findings from a phase 3 trial presented at the annual meeting of the American Urological Association (AUA) and data published in the Journal of Urology.

“Vibegron was associated with significant reductions in daily micturition and urgency episodes, as well as our secondary endpoints,” David R. Staskin, MD, an associate professor of urology at Tufts University School of Medicine in Boston, told attendees. “Symptoms really did improve compared to placebo as early as week 2.”

Vibegron is a selective beta-3 adrenergic receptor agonist approved in 2020 by the US Food and Drug Administration for the treatment of overactive bladder.

However, treating overactive bladder symptoms in patients undergoing benign prostatic hyperplasia treatment is more complex because benign prostatic hyperplasia itself can contribute to overactive bladder symptoms, said Kara Watts, MD, an associate professor of urology at Montefiore Einstein in New York City, who was not involved in the new research.

“Management of overactive bladder in this setting may require treatment of benign prostatic hyperplasia as well, but a discussion of the relationship between benign prostatic hyperplasia and overactive bladder symptoms is important,” Dr. Watts told this news organization. “Beyond consideration of treatment for benign prostatic hyperplasia — which can be in the form of medications or surgeries to reduce the size of the prostate — treatment of overactive bladder can include behavioral modification,” such as avoiding bladder irritants, timed voiding, managing constipation, and nighttime liquid restriction,” as well as “medications, percutaneous tibial nerve stimulation, and occasionally more invasive options.”

Vibegron “represents a very attractive and effective pharmaceutical management option for overactive bladder,” both in patients with and without benign prostatic hyperplasia, Dr. Watts said. “It has a favorable side-effect profile compared to other oral agents that can be prescribed for overactive bladder, such as anticholinergics, and also has the added benefit of a much lower risk of urinary retention in comparison to most other oral agents.”

Among 1104 men at least 45 years old who were undergoing treatment for benign prostatic hyperplasia and had symptoms of overactive bladder, 538 received 75 mg of vibegron and 542 received a placebo. The men in the vibegron group showed 2.04 fewer mean daily urinations at 12 weeks and 2.2 fewer at 24 weeks compared to 1.3 fewer at both 12 and 24 weeks for men in the placebo group (P < .0001), according to the researchers.

The drug also reduced urgency of urination. Mean daily episodes of urgency were 2.88 fewer at 12 weeks and 3.07 fewer at 24 weeks in the vibegron group compared to 1.93 and 2.17 fewer, respectively, in the placebo group (P < .0001).

In secondary endpoints, those taking vibegron experienced 0.22 fewer episodes of nocturia (P = .002), 0.8 fewer episodes of urgency incontinence (P = .003), a 0.9-point difference in improvement in the International Prostate Symptom Score (P < .0001), and about 15 mL more volume voided (P < .0001) compared to those receiving placebo, the researchers reported.

“The clinical significance of these findings is that vibegron represents an effective pharmacologic option for managing overactive bladder in the context of concomitant benign prostatic hyperplasia, which is a broader context than its original approval for overactive bladder alone,” Dr. Watts said.

Data from 969 patients on the overactive bladder quality-of-life questionnaire found that the symptom bother score was 6.2 points better for men in the vibegron group than those who took a placebo (P < .0001) at 12 weeks. Similarly, the total health-related quality-of-life score was 4.3 points better in the vibegron group (P < .0001). Measures of concern, coping, and sleep also improved significantly in the men taking vibegron and remained significant at 24 weeks (P < .0001).

Rates of adverse events were similar in the vibegron (45%) and placebo (39%) groups. The most common adverse event was hypertension, which occurred in 9% of the vibegron group and 8.3% of men in the placebo group.

The research was funded by Sumitomo Pharma America, Inc., which makes vibegron. Dr. Staskin is a consultant for Astellas, AzuraBio, Sumitomo Pharma America, Inc., and UroCure; is a lecturer for Astellas and Sumitomo; and holds other interests in UroCure, AzuraBio, and Quillitin Pharma. Three co-authors are Sumitomo employees; one is an investigator for Sumitomo, and another has consulted for Hologic, received research funding from Allergan/AbbVie and Uromedica, and been involved in clinical trials on behalf of Sumitomo. Dr. Watts reported no relevant financial conflicts of interest.

A version of this article first appeared on Medscape.com.