Faculty Bibliography

OBJECTIVE:To describe and assess the outcomes of dorsal onlay oral mucosa graft urethroplasty for female urethral stricture. METHODS:We retrospectively reviewed the charts of all female patients who underwent dorsal onlay oral (buccal or lingual) mucosa urethroplasty for urethral stricture between 2011 and 2020 at two academic institutions. The primary endpoint was clinical success defined as any subjective improvement in LUTS self-assessed by the patients 1-3 months after catheter removal. Four surgeons performed the urethroplasties using a standardized technique: suprameatal incision, dissection and longitudinal opening of the dorsal aspect of the urethra, harvest of the oral mucosa graft, graft onlay sutured into the urethral opening. RESULTS:Nineteen patients were included. The clinical success rate was 94.7% at 1-3 months and 90.9% at 1 year. After a median follow-up of 12 months (range 1-49) there was one recurrence (5.3%), clinical success was achieved in 17 patients (89.5%) and both the maximum urinary flow rate and post void residual were significantly improved (15.2 vs 7.4 ml/s preoperatively; P = .008 and 71.5 vs 161.1 ml preoperatively; P = .001 respectively). The de novo stress urinary incontinence rate was 15.7% at 1-3 months and 9.1% at 1 year. CONCLUSION/CONCLUSIONS:Dorsal onlay oral mucosa graft urethroplasty for female urethral stricture appears feasible across multiple surgeons and is associated with a low perioperative morbidity, satisfactory functional outcomes and a low recurrence rate. Other series with larger sample size and longer follow-up are needed to confirm these findings.

INTRODUCTION AND HYPOTHESIS/OBJECTIVE:To evaluate whether the studies contributing to the national treatment guidelines on pelvic organ prolapse adequately represent the racial and/or ethnic makeup of the American population. METHODS:This analysis examines the racial and ethnic makeup of all primary study cohorts contributing to the American College of Obstetricians and Gynecologists/American Urogynecologic Society Practice Bulletin No. 214 on pelvic organ prolapse. References were excluded if they lacked a primary patient population or were from outside the US. Mean proportional representation of racial/ethnic groups was compared to the 2018 United States Census data on race/ethnicity. The representation quotient was also calculated to evaluate for relative representation of each group. Descriptive statistics were used. RESULTS:Of the 110 references, 53 primary studies were included in the final analysis with 30 studies reporting on race/ethnicity. On average, 82% (SD = 15%) of study populations were White, while Blacks, Hispanics, and Asians represented 67% (SD = 7%), 4% (SD = 8%), and < 1% (SD = 1%), respectively, differing significantly from the 2018 US Census (p < 0.01.) The representation quotients for White women was 1.36, demonstrating a 36% overrepresentation, while Black, Hispanic, and Asian women were underrepresented among studies of all evidence levels, with representative quotients of 0.50, 0.23, and 0.09, respectively. CONCLUSIONS:Our study demonstrates a significant underrepresentation of non-White populations in primary cohorts of studies contributing to the ACOG/AUGS Practice Bulletin No. 214 on POP. This analysis reinforces that more efforts are required to include and report on racial and ethnically diverse cohorts to better serve all patients.

Objective: To compare the safety and efficacy of a dermal bovine tissue transvaginal graft, XenformTM (TVG), to traditional native tissue repair (NTR) in women surgically treated for anterior and/or apical pelvic organ prolapse (POP) Methods: This was a prospective, non-randomized, parallel cohort, a multicenter trial where subjects received TVG or NTR. The primary endpoint of the study was to achieve non-inferiority (NI) of transvaginal repair with TVG to NTR at 36 months compared to baseline. Treatment success was based on a composite of objective (leading edge of prolapse at or above the hymen; no POP re-treatment) and subjective (no symptoms of vaginal bulging) outcomes measured at 12, 24, and 36 months. The non-inferiority margin was set at 12%. A propensity score stratification method was applied to achieve balance inpatient and surgeon characteristics between treatment groups. A co-primary outcome was the rate of serious device or serious procedurerelated adverse events (SAE) within 36 months. Secondary endpoints included evaluation of graft-and procedure-related complications between baseline and 36 months Results: The primary outcome, treatment success at 36 months, was 83.6% in TVG and 80.5% in NTR, demonstrating NI (0.2%, 90%CI[-5.6%, 5.9%]) (Table 1). Composite and objective success in apical compartment rate minimally declined with time in both groups (Figure1). The overall rate of SAEs was 5.3% (12/228) vs 2.7% (13/485) in the TVG vs NTR groups, respectively, and TVG was NI to NTR at the preset margin of 12% (2.0%, 90% CI[-0.8%, 4.7%]). Overall AE rates were similar between the TVG and NTR arms: 46.5% (106/228) in TVG subjects and 46.4% (225/485) in NTR subjects. The majority of AEs occurred within the first 6 months following surgery, 77.4% (82/106) for TVG subjects and 67.1% (151/225) for NTR subjects with the most frequently reported AE being de novo voiding dysfunction. There were no reports of graft erosion, and graft exposure rates were low (0.9% [2/228]).
Conclusion(s): Biologic TVG for the treatment of anterior and/or apical vaginal prolapse was as effective as NTR and as safe as NTR with respect to the rate of the serious device-and/or serious procedure-related AEs at 36 months

Purpose of Review/UNASSIGNED:To summarize the available literature regarding telehealth interventions in the management of pelvic floor disorders. Recent Findings/UNASSIGNED:Most Female Pelvic Medicine and Reconstructive Surgery (FPMRS) patients own and feel comfortable operating the technology required to participate in telehealth interventions and would be willing to interact remotely with their providers. Telehealth may be an appropriate and effective tool for patient education about bladder and pelvic physiology and pathophysiology, remote pelvic floor muscle strengthening when in-person physical therapy is not accessible, overactive bladder follow-up and medication management, and for postoperative care following uncomplicated incontinence and prolapse surgery. Summary/UNASSIGNED:There is a growing body of literature specific to FPMRS supporting various telehealth interventions that could reasonably be expected to improve access to sub-specialty care while maintaining or improving healthcare quality and reducing costs to the patient and the healthcare system.

OBJECTIVES/OBJECTIVE:To determine whether catheterization rates after intradetrusor onabotulinumtoxinA injection for nonneurogenic overactive bladder and urgency incontinence differ between women with urgency urinary incontinence only and women with urgency-predominant mixed urinary incontinence. METHODS:This was a retrospective cohort study of patients that underwent intradetrusor onabotulinumtoxinA injection of 100 U for nonneurogenic urgency urinary incontinence. The primary outcome was the difference in catheterization rates between women with urgency urinary incontinence alone compared with women with urgency-predominant mixed urinary incontinence. Descriptive statistics and multivariate logistic regression analysis were performed. RESULTS:Of the 177 women included in the final analysis, 105 had urgency urinary incontinence and 72 had urgency-predominant mixed urinary incontinence. The overall catheterization rate after onabotulinumtoxinA injection was 11.3%, with significantly fewer women with mixed urinary incontinence requiring catheterization when compared with women with urgency urinary incontinence alone (4.2% vs 16.2%; P = 0.03), despite an older population (P = 0.02). Patient-reported improvement (P = 0.37) and decision to continue onabotulinumtoxinA treatments (P = 0.89) were similar between groups. Multivariate logistic regression analysis revealed that women with mixed urinary incontinence had significantly lower odds of requiring catheterization after onabotulinumtoxinA injections than women with urgency urinary incontinence alone (odds ratio, 0.16; 95% confidence interval, 0.04-0.67; P = 0.01). CONCLUSIONS:Findings suggest that the presence of symptomatic stress urinary incontinence is associated with lower rates of catheterization after intradetrusor onabotulinumtoxinA, but does not compromise efficacy of treatment for urgency-predominant mixed urinary incontinence.

Introduction: The introduction of beta3-adrenergic receptor (AR) agonists has improved management of overactive bladder (OAB) by providing efficacious treatment of symptoms while minimizing adverse events associated with anticholinergics. However, beta-ARs are also found outside the bladder (eg, beta1-ARs on cardiomyocytes), which could lead to off-target activity. Results in humans indicate that mirabegron, a beta3-AR agonist approved for the treatment of OAB, stimulates beta1-ARs at a supratherapeutic dose. Further, onset of action of mirabegron 25 mg may take up to 8 weeks, potentially necessitating dose titration upward. Vibegron is a novel, selective beta3-AR agonist with a rapid, 2-week onset of efficacy at a single dose. Here we assessed the potency and maximal effect of vibegron and mirabegron for beta3-ARs and the selectivity for each beta-AR.
Method(s): Functional cellular assays for vibegron and mirabegron activity were performed using Chinese hamster ovary (CHO) cells expressing beta1-or beta2-ARs and human embryonic kidney (HEK) 293 cells expressing beta3-ARs. Cells were incubated with vibegron, mirabegron, or the appropriate control (isoproterenol for beta1 and beta3, procaterol for beta2). Responses were quantified using homogeneous time-resolved fluorescence of cyclic adenosine monophosphate. Half-maximal effective concentration (EC50) and maximum response (Emax) values were determined by nonlinear least-squares regression analysis.
Result(s): Treatment of HEK293 cells with vibegron or mirabegron resulted in concentration-dependent responses at beta3-ARs (Figure). Mean (SEM) EC50 values at the beta3-AR were 2.13 (0.25) nM for vibegron and 10.0 (0.56) nM for mirabegron. At a concentration of 10 muM, beta3-adrenergic activity relative to isoproterenol was 104% for vibegron and 88% for mirabegron. In CHO cells, beta1-adrenergic activity was 0% and 3% for vibegron and mirabegron, respectively, and beta2-adrenergic activity was 2% and 15%. Emax for vibegron and mirabegron at the beta3-AR was estimated to be 99.2% and 80.4%, respectively.
Conclusion(s): Vibegron showed no measurable beta1 and low beta2 activity compared with mirabegron, which showed measurable beta1 and some beta2 activity. Both vibegron and mirabegron showed significant selectivity at beta3-ARs as expected; however, vibegron demonstrated near-exclusive beta3 activity and was approximately 5 times more potent than mirabegron at activating beta3-ARs. Vibegron also showed higher maximum beta3 response, approximating 100%

Introduction: Overactive bladder (OAB) affects 10-19% of adults, strongly influencing quality of life. Voiding diaries may provide valuable information on the OAB patient, identifying modifiable behavior factors and the timing and severity of symptoms that can help guide treatment. The primary aim of this prospective cohort study is to report the percent of patients completing a diary, and secondary aim is to assess what factors may predict completion.
Method(s): 93 patients undergoing workup for OAB between 2016 and 2020 were enrolled and asked to complete a three-day voiding diary. They were provided standard written and oral instructions, in addition to urine collection device and a printed diary template. Completed voiding diary, OAB-q questionnaire, and demographic factors were collected and analyzed.
Result(s): Of the 93 patients enrolled, 61 (65.6%) completed at least one day of a voiding diary. Two of these patients (3.3%) returned diaries that could not be interpreted. There was no difference in OAB-q score for those completing diary and those who did not (76.7 vs 79, p=0.86). In addition, no significant differences were seen in age, BMI, ethnicity, gender or prior surgeries between those who did and did not complete the diary.
Conclusion(s): Voiding diaries are used in the workup of OAB to quantify symptoms and determine their cause. We found a completion rate of 65.6% among patients with bothersome OAB. No demographic differences were observed between those who did and did not complete a diary. Further study of barriers to completion could aid in higher capture rates and improved diagnostic evaluation of the OAB patient

Introduction: Urodynamics (UDS) is the study of urine transport, storage, and evacuation and is the gold standard in assessment of bladder function. Per AUA guidelines, UDS are not to be used in the initial workup of the uncomplicated patient with OAB, however their role in more complex patients remains uncertain. The primary aim of this study is to assess the impact of UDS on diagnosis and treatment plans of complex patients with OAB.
Method(s): Patients undergoing workup for OAB between 2016 and 2018 were prospectively enrolled and completed a voiding diary and UDS. Physicians first provided a diagnosis and treatment plan based on patient history, clinical data and voiding diary alone. The patients then underwent UDS and the physician provided a diagnosis and treatment plan after reviewing the additional testing. The impact of UDS on diagnosis and treatment plan were analyzed.
Result(s): 26 patients underwent evaluation with voiding diary and UDS with prospective documentation of diagnosis and treatment plan. All patients had previously trialed oral OAB medications10 (38.4%), complained of mixed incontinence 11 (42.3%), or were considering third line therapy 14 (53.8%). After UDS were performed, 13 (50%) had a modification in diagnosis and 11 (42.3%) had a change in treatment plan. The most common change in diagnosis was observation of voiding phase dysfunction in 4 (15.4%). Treatment plans changed for 6 patients with mixed incontinence primarily by elucidating severity of stress vs urgency incontinence when it was difficult to determine from patient report and available clinical data. Plans also changed for 1 patient found to have underactive bladder and 2 with bladder outlet obstruction. 9 (34.6%) patients went on to third line therapy.
Conclusion(s): UDS done for patients with complex OAB symptoms led to modification in patient diagnosis in 50% of patients and change in treatment plan in 42.3%. Change to diagnosis and management plan may reflect the utility of UDS especially in complicated patients (ie mixed incontinence) or who have failed second line therapies

PURPOSE/OBJECTIVE:To evaluate if question phrasing and patient numeracy impact estimation of urinary frequency. MATERIALS AND METHODS/METHODS:We conducted a prospective study looking at reliability of a patient interview in assessing urinary frequency. Prior to completing a voiding diary, patients estimated daytime and nighttime frequency in 3 ways: 1) how many times they urinated 2) how many hours they waited in between urinations 3) how many times they urinated over the course of 4 hours. Numeracy was assessed using the Lipkus Numeracy Scale. RESULTS:Seventy-one patients completed the study. Correlation of estimates from questions 1, 2 and 3 to the diary were not statistically different. Prediction of nighttime frequency was better than daytime for all questions (correlation coefficients 0.751, 0.754 and 0.670 vs 0.596, 0.575, and 0.460). When compared to the diary, Question 1 underestimated (8.5 vs 9.7, p=0.014) while Question 2 overestimated (11.8 vs 9.7, p=0.027) recorded voids on a diary. All questions overpredicted nighttime frequency with 2.6, 2.9 and 3.9 predicted vs 1.6 recorded voids (p <0.001). Although not statistically significant, for each question, the predicted frequency of numerate patients was more correlated to the diary than those of innumerate patients. CONCLUSIONS:When compared to a voiding diary for daytime urinary frequency, asking patients how many times they urinated underestimated, and asking patients how many hours they waited between urinations overestimated the number recorded voids. Regardless of phrasing, patients overestimated nighttime urination. Patients in our functional urology population have limited numeracy, which may impact accuracy of urinary frequency estimation.