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UROLOGISTS PERFORMING UROGYNECOLOGY AND RECONSTRUCTIVE PELVIC SURGERY PROCEDURES: THE IMPACT OF FELLOWSHIP TRAINING

Jericevic Schwartz, Dora; Gaddam, Rishika; Koo, John; Rosenblum, Nirit; Ginsberg, David; Clemens, J Quentin; Brucker, Benjamin M
INTRODUCTION/UNASSIGNED:Urogynecology and Reconstructive Pelvic Surgery (URPS) became an accredited fellowship in 2013. Our objective was to assess the landscape of URPS procedures performed by URPS fellowship-trained (FT) and non-FT urologists (NFT) since accreditation. MATERIALS AND METHODS/UNASSIGNED:A retrospective cohort study of American Board of Urology case logs of urologists performing URPS procedures from January 2013 through August 2024 was conducted. The annual case volumes of FT and NFT urologists were compared. Multivariable mixed-effects Poisson regression models assessed the impact of covariates on annual case volume. RESULTS/UNASSIGNED:5,816 urologists (393 FT, 5,423 NFT) performing URPS procedures were included, with 513 FT and 5,818 NFT case log submissions. Compared to NFT, FT urologists were predominantly female (48% vs 13%, p<0.01), practiced in metropolitan areas (52% vs 23%, p<0.01) and academic settings (41% vs 7%, p<0.01). FT performed 24% of annual URPS cases on average, rising to 34% when excluding benign prostate hypertrophy (BPH) procedures. Modelling demonstrated that FT performed URPS cases at 4.2 times the annual rate of NFT (RR 4.2, 95% CI 3.6-4.6) on average, rising to 7.6 times when BPH was excluded (RR 7.6, 95% CI 6.7-8.6), controlling for other covariates. Independent of FT status, women performed non-BPH URPS at a 62% higher rate than men, with higher rates also seen among urologists that are younger, recertifying and outside the Northeast. CONCLUSIONS/UNASSIGNED:Although NFT outnumber FT by 14 to one, FT performed eight times more non-BPH URPS cases annually on average and accounted for 34% of total non-BPH volume.
PMID: 42832773
ISSN: 2352-0787
CID: 6073899

Clinical and economic value of onabotulinumtoxinA vs oral pharmacotherapies in overactive bladder in the United States

Chung, Doreen E; Brucker, Benjamin M; Chaplin, Stephen; Li, Qianyi; Singh, Ritu; Wissinger, Erika; Dominguez, Annaliza
AIMS/UNASSIGNED:To evaluate the clinical and economic value of onabotulinumtoxinA (onabotA) vs oral pharmacotherapies for adults with OAB inadequately managed with anticholinergics from a United States (US) Medicare + societal perspective over 1 year. MATERIALS AND METHODS/UNASSIGNED:A Markov model-based 1-year cost per responder (CPR) analysis was conducted for patients achieving complete response (100% reduction in urinary incontinence episodes [i.e. complete dryness]). Comparators included onabotA and oral therapies (vibegron [brand], mirabegron 25/50 mg [brand and generic], and anticholinergics [generic]), using inputs for efficacy, costs, and healthcare resource use. The primary outcome was CPR for a complete response, with secondary outcomes including number of urinary incontinence episodes per patient and number needed to treat (NNT). Uncertainty was evaluated through one-way and probabilistic sensitivity analyses. Scenario analyses assessed results using commercial costs and longer-term effects for selected outcomes. RESULTS/UNASSIGNED:In the base-case analysis, onabotA had the highest complete response rate (23.5%), resulting in the lowest NNT and CPR (4.3; $18,646) vs oral therapies (response 10.9-12.1%; NNT 8.3-9.2; CPR $21,941-$49,524). Scenario and sensitivity analyses were consistent with these findings and supported the base-case results. LIMITATIONS/UNASSIGNED:Model inputs were primarily based on clinical trial data and may not fully reflect real-world practice; differences across trials may limit comparability. The stringent responder definition, use of non-US productivity estimates, 1-year time horizon, and exclusion of neuromodulation therapies may further limit generalizability and scope. CONCLUSIONS/UNASSIGNED:OnabotA demonstrated favorable clinical and economic value relative to oral pharmacotherapies that was consistent across sensitivity and scenario analyses. About 1 in 4 patients treated with onabotA could achieve a 100% response over 1 year compared to 1 in at least 8 with oral pharmacotherapies. These findings support onabotA as a treatment option with demonstrated clinical and economic value for patients who do not achieve adequate symptom relief with oral OAB therapies.
PMID: 42768867
ISSN: 1941-837x
CID: 6073508

Differences Between Men and Women With Urinary Incontinence as They Seek Medical Care

LaPier, Zoe; Jericevic, Dora; Kumar, Aarti; Lang, Diane; Gregg, Steven; Brucker, Benjamin; Escobar, Christina
OBJECTIVE:To compare characteristics between men and women as they seek medical care for their urinary incontinence (UI), examining patients' experience both with primary care (PCP) and UI specialists. METHODS:This is a cross-sectional study utilizing the National Association for Continence (NAFC)-sponsored adult patient-reported survey data from March 2020 to April 2020. Descriptive statistics were calculated as percentages, and comparisons were performed using a chi-squared test for categorical variables. The statistical significance level was set at p < 0.05. RESULTS:Two hundred sixty-six individuals with UI who had sought medical care completed the survey during the study period. One hundred twenty-four (47%) were women (W) and 142 (53%) were men (M). The study population was older, with the majority of respondents either 45-64 (35%) or 65+ (48%). Most participants sought care for their UI within 2 years of UI onset (59%) and first spoke to their PCP about their UI (64.7%). Women were more likely to endorse a severe emotional impact (OR 1.63, CI 1.04-2.56, p = 0.04) and physical impact (OR 1.90, CI 1.19-3.04, p = 0.01) of their UI on their life. In patients who spoke to their PCP about their UI, women were more likely to bring it up at a routine checkup, while men were more likely to make an appointment to discuss their UI. Men were more likely to endorse that their PCP had spoken to them about a wide range of treatment options and were more likely to have been started on a treatment plan. Men were also more likely to be started on a medication for their UI by their PCP compared to women. PCP referral rates to specialty care were higher amongst men. For those who received a referral, there was a high rate of specialist follow-up (94.0% vs. 98.5% p = 0.19). Men were mostly referred to urology (W 47% vs. 94% M, p < 0.01), with women more frequently referred to gynecology (W 15.9% vs. 0% M, p < 0.01) and urogynecology (W 25.0% vs. 0.9% M, p < 0.01). Specialists were more likely to speak about absorbent products with men compared to women (M 52.5% vs. W 30.7%, p = 0.002). CONCLUSIONS:Though women endorsed more severe impact of UI on their life, men were more likely to be counseled on a wide range of treatment options, started on a treatment plan, prescribed medication for their UI, and be referred to specialty care for treatment of their UI. TRIAL REGISTRATION/BACKGROUND:This study was not registered with clinicaltrials.gov because it used previously collected, deidentified data. CLINICALTRIALS/RESULTS:gov indicates that observational studies should be registered as a Patient Registry for prospective data collection, which does not apply to this study as the patients included in this survey are not followed.
PMID: 42670578
ISSN: 1520-6777
CID: 6071918

Outcomes of Hyperbaric Oxygen Therapy at 2.0 Versus 2.5 ATA for Hemorrhagic Radiation Cystitis

Soriano, Vanessa H; Laspro, Matteo; Lee, Wen-Yu; Parker, Shawn; Taneja, Samir S; Brucker, Benjamin; Gorenstein, Scott; Chiu, Ernest S
PURPOSE/OBJECTIVE:Hemorrhagic radiation cystitis (HRC), a complication of pelvic radiation therapy, results from hypoxic and ischemic injury and causes urinary symptoms like hematuria, dysuria, frequency, urgency, and retention. Hyperbaric Oxygen Therapy (HBOT), where patients breathe 100% oxygen at increased atmospheric pressure, enhances tissue oxygenation, promoting neovascularization and reducing inflammation. The optimal pressure remains unclear, though pressures above 1.41 ATA are efficacious, with higher pressures increasing side effect risks. This study compares the efficacy and side effects of 2.0 versus 2.5 ATA therapy at two sites. MATERIALS AND METHODS/METHODS:A retrospective chart review of 93 patients treated for HRC at two sites was conducted. Data on demographics, efficacy (symptom reduction), and side effects were analyzed using GraphPad Prism. Chi-squared and Mann-Whitney tests were used for statistical analysis. Mixed effects logistic regression models were used. RESULTS AND CONCLUSIONS/CONCLUSIONS:Fewer patients treated at 2.5 ATA experienced gross hematuria within 1-year post-therapy compared to those treated at 2.0 ATA (p < 0.05). However, time to hematuria recurrence showed no difference between the groups (10.2 vs. 9.6 months). No difference was observed in other urinary symptoms. Adverse events were increased at 2.5 ATA when analyzed with a mixed effects logistic regression model. Other treatment parameters, including treatment number and duration, were similar across groups. These findings suggest an association between 2.5 ATA treatment and lower rates of hematuria recurrence, but further randomized studies are necessary to determine causality. Future studies should also assess quality of life and explore variations in treatment protocol for efficacy and safety. CLINICAL TRIAL REGISTRATION/BACKGROUND:As this is a retrospective study, no clinical trial registration is necessary.
PMID: 41603214
ISSN: 1520-6777
CID: 6003452

The Role of Urodynamics in Assessing Lower Urinary Tract Symptoms Post-Radical Prostatectomy: A Review

Schwartz, Dora Jericevic; Rahematpura, Suditi; Brucker, Benjamin
INTRODUCTION/BACKGROUND:This review examines the role of urodynamics (UDS) in evaluating lower urinary tract symptoms (LUTS) following radical prostatectomy. We first present typical urodynamic findings in post-prostatectomy men, then discuss applications of UDS, and finally examine treatment pathways for post-prostatectomy LUTS beyond stress urinary incontinence (SUI) surgery. METHODS:A narrative review was performed focusing on the current primary literature and society guidelines on the role of UDS post-prostatectomy. RESULTS:LUTS after prostatectomy are common, most frequently storage LUTS, specifically SUI. For the index patient with clinically suspected SUI after prostate treatment, routine UDS before SUI surgery have not been shown to impact postsurgical continence outcomes. In cases where there is diagnostic uncertainty following noninvasive lower urinary tract evaluation, UDS plays an important role. UDS are highly beneficial in complex scenarios, such as severe mixed LUTS, prior radiation therapy, impaired bladder compliance, detrusor underactivity, and/or previous SUI surgery. Fluoroscopy during UDS and cystoscopy can provide additional clarity and confirmation of the diagnosis suggested by UDS. CONCLUSION/CONCLUSIONS:UDS are useful adjuncts in appropriately selected post-prostatectomy patients with LUTS, typically with complicating factors.
PMID: 41068999
ISSN: 1520-6777
CID: 5952302

Two-year real-world retrospective safety evaluation with onabotulinumtoxinA across multiple therapeutic indications: findings from the SYNCHRONIZE study

Forde, Grace; Ifantides, Kimberly Becker; Mayadev, Angeli; Patel, Atul T; Rhyne, Christopher; Brown, Theodore; Singh, Ritu; Nelson, Mariana; Ukah, Ahunna; Battucci, Simona; Brucker, Benjamin M
OnabotulinumtoxinA (onabotA) is approved for the treatment of various therapeutic indications, which require retreatment. In clinical practice, many patients receive onabotA for multiple therapeutic indications concomitantly over extended time periods; however, there is limited long-term utilization and safety data for treating comorbid indications. SYNCHRONIZE, a 2-year, multicenter, retrospective observational chart review study in 10 US clinics, describes onabotA real-world utilization and safety in adults treated for ≥2 therapeutic indications within repeating 3-month periods for up to 7 treatments. This analysis assessed the long-term onabotA safety profile for multiple therapeutic indications by analyzing the incidence of treatment-emergent adverse events (TEAEs). Of 279 patients treated for ≥2 different therapeutic indications across all treatment combination groups in Period1, there was a gradual decrease to 80 patients at the last treatment period. The overall mean onabotA treatments over the study period was 9.3 (range: 2-48). Across treatment periods, most patients had a treatment interval between different indications of ≤24 h (range: 62-98 %) and received ≥200-<400U of cumulative 3-month dosages for multiple indications (range: 43 %-50 %) with a mean 3-month dose from 231.8 to 287.0 U. In total, 28.7 % of patients reported ≥1 TEAE after Period1; this proportion remained broadly constant across treatments (range: 28.3-31.8 %). Overall, the most common TEAEs across treatments were UTIs (range: 0.7-5.7 %), neck pain (range: 3.7-9.1 %), headache (range: 2.9-6.5 %), and migraine (range: 2.5-6.4 %). There was no apparent trend between TEAE incidence and treatment intervals nor cumulative 3-month dose categories for multiple indications. No patients were determined to have lack of effect based on clinical objective measurement. OnabotA showed a safety profile with no new signals in patients treated concomitantly for ≥2 therapeutic indications over repeat treatments up to 2 years. TEAEs across treatment periods were commonly related to the site of injection and were consistent with those previously reported for individual indications.
PMID: 41276227
ISSN: 1879-3150
CID: 5967732

Correction to: Vibegron in overactive bladder: a comprehensive review of efficacy, safety and patient-reported outcomes

Peyronnet, Benoit; Brucker, Benjamin M; De Nunzio, Cosimo; Gratzke, Christian; Heesakkers, John; Michel, Martin C; Serati, Maurizio; Staskin, David; Chapple, Christopher
PMID: 41182437
ISSN: 1433-8726
CID: 5959412

Primary Bladder Neck Obstruction in Women: A Systematic Review

Schwartz, Dora Jericevic; Parkinson, Maxine; Brucker, Benjamin M
PURPOSE OF REVIEW/OBJECTIVE:To systematically evaluate and synthesize the existing literature on treatment outcomes for primary bladder neck obstruction (PBNO) in women, given the absence of prior systematic reviews focused on this population. RECENT FINDINGS/RESULTS:Current treatment options for PBNO in women include nonsurgical alpha-adrenergic receptor blockers (AB), surgical bladder neck incision (BNI), and investigational use of onabotulinumtoxinA injections (BTX-BN). Success rates for AB and BNI are approximately 50% and 75%, respectively, while BTX-BN appears to have lower efficacy. The existing studies on PBNO treatment in women are characterized by significant heterogeneity and a lack of high-quality evidence. Standardization is needed across multiple domains, including the definition of PBNO in women, the recommended diagnostic workup, and the establishment of criteria for treatment success and failure. Investigation of risk factors for treatment failure is also needed to better inform patient counseling and management.
PMID: 41102538
ISSN: 1534-6285
CID: 5955172

Vibegron in overactive bladder: a comprehensive review of efficacy, safety and patient-reported outcomes

Peyronnet, Benoit; Brucker, Benjamin M; De Nunzio, Cosimo; Gratzke, Christian; Heesakkers, John; Michel, Martin C; Serati, Maurizio; Staskin, David; Chapple, Christopher
INTRODUCTION/BACKGROUND:AR selectivity and enhances detrusor relaxation without compromising voiding function. This review summarises the clinical and real-world evidence supporting the efficacy, safety and patient-reported benefits of vibegron in OAB. METHODS:A comprehensive search of the PubMed database was conducted in December 2024 using the keyword "vibegron". This search yielded 123 entries, which were subsequently screened by title for relevance to the objectives of this narrative review. All relevant articles identified through this process were included. RESULTS:AR selectivity and lack of cytochrome P450 interactions offer advantages in specific patient groups. Ongoing research, including real-world phase IV studies, aims to further define the long-term effectiveness and safety of vibegron in clinical practice. CONCLUSION/CONCLUSIONS:Vibegron represents an important advance in the pharmacologic management of OAB, providing a well-tolerated and effective alternative to existing therapies.
PMCID:12380879
PMID: 40856729
ISSN: 1433-8726
CID: 5910042

Expert Opinions on Best Practices for Overactive Bladder Management with onabotulinumtoxinA

Eilber, Karyn S; Brucker, Benjamin M; Pezzella, Andrea; Lucente, Vincent; Benson, Kevin; Kennelly, Michael J
OnabotulinumtoxinA is an FDA-approved treatment for adults with overactive bladder (OAB) who have an inadequate response to, or are intolerant of, oral pharmacotherapies including anticholinergics or beta-3 agonists. However, procedural practices of onabotulinumtoxinA intradetrusor injection vary among practitioners and can affect patient experience. To address this, a panel of six high-volume intravesical onabotulinumtoxinA providers with 100 years of combined experience convened to discuss the best office practices when treating patients with OAB. These key best practices include counseling patients on available OAB therapies, including onabotulinumtoxinA, at the initial consultation in accordance with established AUA and SUFU guidelines in a way that is easily understood. An office setting is preferred over a hospital or surgery center when performing the procedure. Staff involvement, from scheduling to post-procedure, is essential for establishing the relationships necessary to optimize patient experience and encourage compliance and retreatment. Experts generally recommend using a viscous lidocaine bladder instillation for an anesthetic 15 min prior to the reconstitution of onabotulinumtoxinA with 5 to 10 mL of normal saline. A range of one to 20 injection sites is acceptable, with a smaller number preferred. Starting in the lower bladder, experts recommend using a slower speed of injection to improve distribution and decrease patient discomfort. Subsequent treatments should be regularly scheduled at six-month intervals with the option of re-treating earlier if symptoms return, but no sooner than 12 weeks. For office intravesical onabotulinumtoxinA procedures, optimization of the patient experience by the physician and their staff, starting with the initial visit through the post-treatment follow-up, is key to long-term patient compliance.
PMCID:12031249
PMID: 40278705
ISSN: 2072-6651
CID: 5830712