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Mr. Paprocki is chief executive officer of MEDIQUS Asset Advisors, Inc. in Chicago.

Articles

Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.

"Estimate how much you will need to spend each year during various stages of retirement," advises Ronald J. Paprocki, JD, CFP, CHBC.

Money Matters: A financial guide to approaching retirement

ArteraAI is a multimodal artificial intelligence biomarker test that can predict therapy benefit and prognosticate long-term outcomes in prostate cancer.

Study to evaluate impact of ArteraAI on clinical decision-making for prostate cancer

Pfizer has chosen to no longer pursue an expanded indication for talazoparib plus enzalutamide in non-HRR gene mutated mCRPC in the US as a result of this decision.

FDA does not approve talazoparib plus enzalutamide for non-HRR gene mutated mCRPC

The bkActiv S series is designed to guide nonsurgical urologic, colorectal, and pelvic floor procedures. 

Ultrasound imaging system now available to guide nonsurgical urology procedures

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Clinical Focus

Leonard G. Gomella, MD, FACS; Maha Hussain, MD, FACP, FASCO; Daniel P. Petrylak, MD

18th Annual Interdisciplinary Prostate Cancer Congress® and Other Genitourinary Malignancies

Jason Hafron, MD; Aaron D. Berger, MD; Arpeet Shah, MD

Medical Crossfire® in Adjunctive Testing: Charting a New Course in Prostate Cancer Risk Assessment

® Assistant Editor Janelle Hart spoke with 

, about the presentation, “Feasibility and efficacy of transvaginal onabotulinumtoxinA chemodenervation of the trigone for the third line treatment of refractory overactive bladder,” which was given at the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction Winter Meeting. Dobberfuhl is a urologist at Stanford Hospitals and Clinics and an assistant professor of urology at the Stanford University School of Medicine in California.

“This technique is feasible, it is very well tolerated, and there’s not much of a complication rate, so it appears to be very safe,” says Amy D. Dobberfuhl, MD, MS.

Dr. Dobberfuhl discusses novel onabotulinumtoxinA treatment for refractory OAB

 She discusses the stigmas associated with overactive bladder, and how urologists can take the burden off of primary care physicians to educate patients who have this condition. Rogers is a urologist who specializes in incontinence at Sansum Clinic in Santa Barbara, California.

“We need to improve the fact that 75% of these patients are untreated [or] unmanaged and frustrated,” says Alexandra Rogers, MD.

Destigmatizing Urology: Dr. Alexandra Rogers discusses OAB

. He discusses urinary incontinence in male and female patients and how this condition can trigger major anxieties and avoidance behaviors. Seth is a consultant urological surgeon at St. George’s University hospital, London, UK.

“As health care professionals, we've got…an incredibly important role and responsibility with regards to increasing awareness and education, and then really trying to address the barriers and bring down the barriers,” says Jai Seth, MD.

Destigmatizing Urology: Dr. Seth discusses urinary incontinence

® Assistant Editor Janelle Hart spoke with J

. He discusses onabotulinumtoxinA injection programs as a treatment for urinary incontinence and the bleeding risk associated with these injections for patients who also take blood thinners. Seth is a consultant urological surgeon at St. George’s University hospital, London, UK.

“We're not saying a blanket stop for all patients, but I think we do need to be taking each patient as an individual in terms of their backgrounds,” says Jai Seth, MD.

Dr. Seth assesses the bleeding risk of Botox treatments in patients who take blood thinners

Benjamin M. Brucker, MD, discusses best practices for the onabotulinumtoxinA procedure, spanning all phases of treatment—before, during, and after administration.

From prep to follow-up: Key considerations for administering onabotulinumtoxinA

The CELLEBRATE trial is aiming to provide additional evidence to support the safety and efficacy of iltamiocel. 

Addressing an unmet need: CELLEBRATE trial explores cell-based therapy for recurrent SUI

Yōni.Fit bladder support was granted FDA 510(k) clearance in May 2024.

Published data support safety, efficacy of vaginal insert for SUI

"This trial will be the benchmark for research reporting in the future," says Melissa R. Kaufman, MD, PhD, FACS. 

Artificial urinary sphincter for SUI shows safety, efficacy in prospective study

The investigators reported an overall incidence of AEs of 29.6%.

Safety, efficacy of vibegron sustained in men with OAB treated for BPH

The real-world, phase 4 COMPOSUR study (NCT05067478) found that nearly 60% of patients taking vibegron remained on treatment at 1 year.

2025 American Urological Association (AUA) Annual Meeting

, explained the background and key findings from the study and shared his thoughts on the implications of these findings for clinical practice.

“There's been a long history of concern regarding sustainability of long-term pharmacotherapy for patients for overactive bladder. The results, frankly, when you even look at 6 months, are quite abysmal in terms of patients retaining on prescribed therapy, like 30%,” he commented.

Data from the COMPOSUR study found that persistence with vibegron was 59.8% (95% CI, 54.7% to 64.6%) at 12 months. Among patients with prior anticholinergic medications, persistence was 61.3% (95% CI, 52.4% to 69%), and among those with prior mibegron, persistence was 59% (95% CI, 52.6% to 64.9%).

Dmochowski is a professor of urology and surgery at Vanderbilt University Medical Center in Nashville, Tennessee,

Roger R. Dmochowski, MD, MMHC, FACS, explained the background and key findings from the COMPOSUR study and shared his thoughts on the implications of these findings for clinical practice.

Roger Dmochowski, MD, on real-world persistence with vibegron for OAB

In total, the COMPOSUR study enrolled 403 patients, of whom 234 (58.1%) completed the trial. The primary reason for discontinuation was patient decision (62.1%).

To be eligible for enrollment, patients needed to be 18 years or older with OAB with or without urge urinary incontinence. They also needed to be starting a new course of vibegron and had previously received anticholinergics or mirabegron with or without anticholinergics.

Additional results from the study also showed that 69% of patients reported being consistently satisfied with treatment. The mean score of the OAB-SAT-q satisfaction domain was 65.6 (SD, 24.7). Treatment was also generally safe and well-tolerated. Overall, 36% of patients experienced a treatment-emergent adverse event (AE), and 2% of patients experienced a serious AE.

According to Dmochowski, these data can inform shared decision-making discussions with patients.

He noted, “Patients always have concerns, "Do I have to take medications all the time?", etc. This is one of the ways that we can actually give them some direct feedback.”

Dmochowski reports the following disclosures: Sumitomo Pharma America, Inc; Caldera Medical, Inc; Coloplast Corp; Medtronic, Inc; AbbVie Inc; Axonics, Inc; and others.

1. Dmochowski RR, Rovner ES, Kennelly MJ, et al. Real-world outcomes of vibegron in patients with overactive bladder: Results from the phase 4 COMPOSUR study. 

. 2025;213(5S):e1030. doi:10.1097/01.JU.0001110076.71872.1a.14

Videos

Nearly 60% of patients taking vibegron remained on treatment at 1 year.

In a study presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction 2025 Winter Meeting in Rancho Mirage, California, investigators presented data on the β-3 agonist vibegron (Gemtesa) for the treatment of overactive bladder (OAB).

 recently interviewed 2 of the study’s authors, Grace Khaner and Melissa A. Laudano, MD. In the interview, they gave their thoughts on the potential for expanding the use of vibegron early in treatment for OAB.

“As we think about our aging population, who has increasing polypharmacy, the fewer drug-drug interactions of vibegron and the better [adverse event] profile compared with other overactive bladder medications make it a great option for treating our patients early in their treatment algorithm for overactive bladder. So now, when I see patients, I am less concerned about the [adverse events] that they may experience when starting these medications, and it really helps me to get them to treatment early on. That really improves our patient satisfaction with the care that they're getting for their overactive bladder symptoms,” said Laudano, an attending physician and an associate professor of urology at Montefiore Medical Center and Albert Einstein College of Medicine.

Grace Khaner and Melissa A. Laudano, MD, discuss expanding the use of vibegron in OAB treatment

Experts discuss expanding use of vibegron for OAB

“There are other medications available to treat overactive bladder, but some of them do have this really difficult-to-tolerate [adverse event] profile, and with new research showing some of them are having these long-term cognitive effects. So if we're able to initiate patients early on a medication that, as far as we know, does not have those effects, like Dr Laudano was saying, we can really improve patient satisfaction and patient outcomes over time with their urinary symptoms and other health issues,” added Khaner, a medical student at Albert Einstein College of Medicine in Bronx, New York.

1. Khaner G, Malviya N, Clearwater W, Laudano M. Prescribing patterns for vibegron, a selective beta3 agonist, used in the treatment of overactive bladder. Presented at: Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction 2025 Winter Meeting. February 26-March 1, 2025. Rancho Mirage, California. Abstract NM113

Grace Khaner and Melissa A. Laudano, MD, share their thoughts on the potential for expanding the use of vibegron early in treatment for OAB.

The release of the first overactive bladder (OAB) guidelines is associated with an increase in OAB diagnoses, a decrease in anticholinergic medication use, and a rise in beta-3 agonist use, according to findings from a recent study.

, discusses these findings in-depth, sharing insights into key takeaways, limitations, and potential future directions.

“That was our primary aim: to try to look at the overall trends of OAB therapy utilization before and after the 2014 AUA/SUFU OAB guidelines and the amendment, and then also publication of the OAB clinical care pathway, which was in 2016,” explained Enemchukwu, an associate professor of urology, and by courtesy, of obstetrics and gynecology (urogynecology), at Stanford Medicine in Palo Alto, California.

Data showed that from 2013 to 2017, there was a 369% increase in the number of new OAB diagnoses. Further, the rate of third-line therapies also almost doubled from 2013 to 2018 (9 to 17 procedures per 1000 OAB patients, 

Ekene Enemchukwu, MD, MPH, FACS, URPS, discusses these findings in-depth, sharing insights into key takeaways, limitations, and potential future directions. 

Ekene Enemchukwu, MD, on guideline-associated trends in OAB therapy use

Data from the study also showed that prescriptions for oral medications peaked in 2016 and subsequently declined by 17% from 2016 and 2018.

The authors noted, “In 2013, the 2 most prescribed oral medications were oxybutynin (46%) and solifenacin (31.8%). By 2018, mirabegron (18.5%) surpassed solifenacin (16.5%), with oxybutynin still accounting for most prescriptions written (55%). Eighty percent of all initial mirabegron prescriptions were filled by patients over the age of 65.”

However, Enemhukwu cautions that these data can only show associations. There may be other factors—such as the publication of a study showing a link between the development of incident dementia and long term use of anticholinergics, as well as a new CPT code for onabotulinumtoxinA—that may have contributed to these trends.

Next steps, according to Enemchukwu, include re-assessing these findings in the context of the recently published 2024 OAB guideline.

She noted, “Putting that all together, what we wanted to see is a baseline of what we had before the 2014 OAB guideline amendment and after [to] see what those trends are. Now [we're] interested in seeing what these trends are going to be now that we have the new guidelines out that have a completely different set-up, with a paradigm shift of moving from step theory therapy to a menu of treatment options that are all couched in shared decision-making.”

1. Mohamud H, Sinclair, S, Gunamany S, et al. Trends in overactive bladder therapy: Associations between clinical care pathways, practice guidelines, and therapy utilization patterns. 

. 2025;44(2):319-329. doi:10.1002/nau.25627

, Grace Khaner and Melissa A. Laudano, MD, discussed a study of prescribing patterns for the β-3 agonist vibegron (Gemtesa) for the treatment of overactive bladder.

For the study, which was presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction 2025 Winter Meeting in Rancho Mirage, California, Khaner, Laudano, and their coauthors looked at prescribing data in a Medicare Part D claims data set.

“We found that the location that prescribers were registered in, as well as their fellowship training, was significantly associated with higher vibegron prescription rates,” said Khaner, a medical student at Albert Einstein College of Medicine in Bronx, New York.

In a recent interview with Urology Times®, Grace Khaner and Melissa A. Laudano, discussed a study of prescribing patterns for the β-3 agonist vibegron (Gemtesa) for the treatment of overactive bladder

Investigators characterize vibegron prescribing patterns for OAB

The investigators also found that prescribers who were located in urbanized areas prescribed vibegron at higher rates.

“I think a contributing factor that underlies all of this is that subspecialists in general are more concentrated in urban areas, and so the higher prescription rates that we see of vibegron in these urban areas might indicate that people in less rural areas just don't have as much access to prescribers who would be comfortable giving these medications out. It's possible that PCPs [primary care physicians] are the main prescribers in these less urbanized areas, just given the general distribution of health care professionals and so these variables kind of work in tandem, where it's likely that there might be less education regarding vibegron prescriptions or just new medications for overactive bladder in general, which can make it difficult for all patients to have access to these medications, depending on who their main access to health care is,” Khaner said.

Laudano added, “There also may be the possibility that in some of the rural areas that there may be less access to vibegron due just to availability/stocking in pharmacies, which may dissuade some of those providers from prescribing this medication. Our hope is that now that we see the excellent results associated with vibegron, that we may have more access for patients across the board.” Laudano is an attending physician and an associate professor of urology at Montefiore Medical Center and Albert Einstein College of Medicine.

"We found that the location that prescribers were registered in, as well as their fellowship training, was significantly associated with higher vibegron prescription rates,” says Grace Khaner.

Six-month data evaluating a battery-free percutaneous sacral neuromodulation (pSNM) device indicated that 84.2% of patients implanted achieved a 50% or greater reduction in urgent leaks.

The data on Neuspera’s pSNM device were presented at the 2025 Winter Meeting of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) in Rancho Mirage, California, and were shared in a news release from Neuspera Medical.

®, study investigator Colin Goudelocke, MD, was asked how he envisioned the integration of Neurspera's pSNM into the current treatment paradigm for urge urinary incontinence, and what he saw as key factors that might influence its adoption among urologists and patients. He commented that in contrast to previous years, when there was dearth of treatments for overactive bladder, today, “It's almost an embarrassment of riches.”

“I'd always rather have too many choices, too many tools in the toolbox, rather than too few,” Goudelocke added.

Colin Goudelocke, MD, discusses Neuspera's percutaneous sacral neuromodulation device.

Expert outlines advantages of batteryless sacral neuromodulation device

However, having so many options raises the question of which treatment is appropriate for which patient, he said. For a device such as Neuspera’s pSNM, which is much smaller due to its lack of a battery, patients who might particularly benefit include those with lower body mass index and who are more active, Goudelocke noted.

“I sometimes have patients who are really, really active, and they'll get hit by something or struck by something at the site of their generator, and that can cause some discomfort or pain,” he said.

Goudelocke also commented that Neuspera’s system might be appealing to patients who want to take an active role in their treatment. In contrast, “There probably are patients that do want just a “set it and forget it” neuromodulator, and this is not going to be the right thing for them,” he said.

Another consideration is cosmesis. “There are patients who want to know, ‘am I going to see it when I’m in a changing room or changing clothes? Is it going to show through a bathing suit’”? Goudelocke said.

On the clinician side, Goudelocke highlighted the benefit of not having to put a generator in when implanting the device.

“For someone that might be looking at getting into sacral neuromodulation, and has had some reluctance in the past, this does simplify the procedure somewhat…and I think that might be attractive to some people,” Goudelocke said.

1. Neuspera Medical announces landmark six-month clinical trial results for the first battery-free percutaneous sacral neuromodulation (pSNM) system for urgency urinary incontinence management. News release. Neuspera Medical Inc. February 26, 2025. Accessed February 28, 2025. https://www.prnewswire.com/news-releases/neuspera-medical-announces-landmark-six-month-clinical-trial-results-for-the-first-battery-free-percutaneous-sacral-neuromodulation-psnm-system-for-urgency-urinary-incontinence-management-302385607.html

“For someone that might be looking at getting into sacral neuromodulation, and has had some reluctance in the past, this does simplify the procedure somewhat," says Colin Goudelocke, MD.

Emmanuel Chartier-Kastler, MD, PhD, shares the background and key findings from the study, “First in woman implantation of the new artificial urinary sphincter Uroactive (Uromems): Preliminary data at 12 months post-activation follow-up of the first patient.” 

Emmanuel Chartier-Kastler, MD, shares initial data on UroActive System in women with SUI

, shares the background and key findings from the study, “First in woman implantation of the new artificial urinary sphincter Uroactive (Uromems): Preliminary data at 12 months post-activation follow-up of the first patient.” These data were presented at the Society of Urodynamics, Female Pelvic Medicine, & Urogenital Recontruction (SUFU) 2025 Winter Meeting in Rancho Mirage, California.

Chartier-Kastler is a professor of urology and chairman of the department at Hôpital Pitié Salpétrière at Sorbonne Université in Paris, France.

Could you describe the background/rationale of this study?

Artificial urinary sphincter is part of the armamentarium for the treatment of stress urinary incontinence in women who suffer sphincter deficiency. The legacy device, AMS 800 from Boston Scientific, past AMS, [has been] used [for] more than 35 years, at least in France, because it's marketed and leveled for that. We, at least in my department, but also in routine practice in France and some countries in Europe implant it in women who are suffering severe incontinence and who are bothered by incontinence when they walk, when they stand up, or when they suffer some irritable urgency. This device, AMS 800 is a very good device, as there is a need for pump in the major labia and there is a fixed pressure with the pressure regulating balloon.

The new device we are presenting at this SUFU meeting, [is] an electronic one. The male study has been done, the pilot study. We did also the pilot study in women. I will present the first woman with more than 1-year follow-up with this electronic device, including a cuff, exactly as with the legacy device. The control of the pressure and the control of the voiding phase is made through a control unit which is placed at the abdominal level, subcutaneously. The patient will be able to void using a patient remote control to open the curve, which will spontaneously open when they push on the button, and the system will close by itself when the time of voiding phase is finished. This is exactly the same device as we use for the pilot study in men, but in women, the main challenge is that the cuff has to be implanted around the bladder neck. The bladder neck dissection is a challenging dissection in some patients who suffered past surgeries. We are used to do it since a long time, because we used a previous device. When you know how to dissect bladder necks, the implantation of this device is not easy, but it's quite easy to learn and to do and the patient is able to become quickly dry, not wearing a pad anymore.

I will present the result of the first woman who has been implanted with this new device, I would say it's worldwide, the first patient who has been implanted with an electronic device which has been activated and followed at least 1 year. This patient, she was suffering tremendous incontinence, with 4 pads per day and 125 grams of leaks at the 1-hour pad test, which is a way to evaluate the severity of incontinence. After implantation, which went well without any injury of the bladder neck or the bladder or the vagina, she has been activated at 6 weeks. After activation, she started to be dry and not to leak anymore, so she doesn't wear any more pads.

Now, at 1 year, the 1-hour pad test has been done again, as it's part of the protocol, and she suffered 4 g of incontinence on this test, opposed to 125 g at the beginning. She's voiding using the patient remote control. She is able to use a specific programming of the system, where at night she pushes on the lying down button. It means that at night, she reduced the pressure inside the system to protect the urethra. When she wakes up in the morning, she starts again to use daytime pressure to be fully dry in everyday activities.

This transcript was AI generated and edited by human editors for clarity.

“Now, at 1 year, the 1-hour pad test has been done again, as it's part of the protocol, and she suffered 4 g of incontinence on this test, opposed to 125 g at the beginning,” says Emmanuel Chartier-Kastler, MD, PhD. 

Colin Goudelocke, MD, describes the advantages of a batteryless neurostimulator evaluated in the study “Treatment of OAB symptoms using Neuspera’s ultra-miniaturized system: 6-month results of the SANS-UUI phase II study"

Smaller size, patient control advantages of neurostimulator for OAB

 describes the advantages of a batteryless neurostimulator evaluated in the study “Treatment of OAB symptoms using Neuspera’s ultra-miniaturized system: 6-month results of the SANS-UUI phase II study,” which was presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction 2025 Winter Meeting. Goudelocke is a urologist with Ochsner Health Center in Covington, Louisiana.

Compared to the published data for traditional SNM, what specific aspects of the patient experience do you believe are most impactful in terms of improved adherence and long-term satisfaction?

This is an ultra-small device. It's the smallest, I think. You can imagine if you're subtracting out the largest part of the device, it's not surprising that it's smaller. [The lack of] a battery makes it ultra small. That's really important. As someone who really believes in sacral neuromodulation therapy, I don't want to lead people astray. Most patients are very happy with traditional sacral neuromodulation. But there are issues, there are problems, and for that subset of the population, most of the issues that we do see with neuromodulation, frankly, they're usually with the generator. Most infections that I see are generator site infections. Most of the pain that patients experience is at the side of the generator. A lot of times we have movement; we sometimes call it "twiddler syndrome," where people will tend to, if the pocket is a little bit bigger than the battery, they can actually twist that battery around. They kind of twiddle with it. I think that that term was actually coined in people doing the same with their pacemakers, but it's true sometimes in sacral neuromodulation. Most of the issues that patients experience, frankly, they tend to be with the battery. So to the extent that this device might remove some of those issues, that's really going to be impactful.

Second, it's kind of interesting, because in 1 approach to sacral neuromodulation, some devices have sort of taken an approach where we really want to sort of remove the patient as much as possible, sort of almost the "set it and forget it" version of this. Can we make it as hands off for the patient as possible? Because it's an externally driven device, and because the patient is actually applying it to their skin, on average, for about 2 hours per day, the patients are really involved in the therapy. I don't see that as a bug. I actually see that as a benefit. Patients are actually in control of their therapy. They're actually, in their mind—and I think there's some reality this—they're administering their therapy every day. I think there are some advantages to that patient control, to a patient actually being able to direct her therapy or to direct his therapy. That may actually be borne out by the data. This is interesting, and I think this is a little bit of speculation on my part, but as I said before, this therapy, I think, looks really good in compare comparison to other sacral neuromodulation trials. We saw about an 84% response rate. For me, that's sort of what I would expect from a clinical trial of a sacral neuromodulator. Of those respondents, so of that 84%, 84% are what they are characterizing as "super responders," meaning they had at least 75% improvement.Most of our clinical trials, we define a 50% improvement in symptoms. They're giving this this new category of 75% improvement as super responders. And the 84% is a really high number. Furthermore, 42% of patients were dry. This is very interesting. I enrolled patients in this clinical trial. I didn't have any access, obviously, to all of the data. I just knew, until this was published, I just knew my patients. But I kept noticing, and in fact, in my conversations with the people that were running the trial, I kept noting, I said, it's really interesting. I have some patients who have responded, I have some patients who haven't responded. And again, my response rates in my own patients that I implanted seemed pretty in line with this, but I kept noticing that the patients that are getting better seem to me like they're getting a lot better. The ones who didn't respond didn't respond, and I understand that, but the ones who were responding were really, really better, way better than 50%. I kept making the comment, "I'll be really interested to see when these data come out, whether or not that's the experience across the entire group," and that seems to be the case here. Purely speculative, but I'm really kind of curious. Is it something about that? Is there something about the patient having control over her therapy, the patient being able to feel like "I'm doing this to myself, and I'm getting better, and I'm feeling this stimulation." I think it's a really interesting question. This study is in no way meant to answer that kind of question. But I think it's really, really intriguing that in a study where patients have all of this control, we have this higher rate of "super responders," which I think is really interesting.

"[The lack of] a battery makes it ultra small. That's really important," says Colin Goudelocke, MD.

Colin Goudelocke, MD, discusses the significance of the findings of the study “Treatment of OAB symptoms using Neuspera’s ultra-miniaturized system: 6-month results of the SANS-UUI phase II study"

Batteryless neurostimulator found efficacious at 6-month follow-up

"I think we're all going to be very eager to see what happens to these patients over time," says Colin Goudelocke, MD.

OAB and Incontinence

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