Faculty Bibliography

PURPOSE/OBJECTIVE:Intradetrusor injections of onabotulinumtoxinA are efficacious for the treatment of overactive bladder with urgency urinary incontinence in adults refractory to or intolerant of anticholinergics. Delivery of onabotulinumtoxinA via instillation would reduce the need for intradetrusor injections. The objective of this trial was to assess the efficacy and safety of intravesical instillation of an onabotulinumtoxinA + hydrogel admixture. MATERIALS AND METHODS/METHODS:After review of a stage 1 safety phase by an independent committee, participants were recruited into stage 2 and randomized to either onabotulinumtoxinA 100, 300, 400, or 500 U, or placebo, all with hydrogel admixture. End points included change from baseline to week 12 in the number of urinary incontinence episodes (primary); micturition, urgency urinary, and nocturia episodes/day; volume voided per micturition; proportion of participants with a ≥50% decrease from baseline in urinary incontinence episodes/day; and Overactive Bladder Questionnaire total score. Adverse events were reported. RESULTS:Change from baseline to week 12 in number of urinary incontinence episodes was -2.72 with placebo and ranged from -0.89 to -1.85 in the onabotulinumtoxinA + hydrogel treatment groups. No difference from placebo was observed for any efficacy end point. The proportions of participants with treatment-emergent adverse events were similar among all groups, with asymptomatic bacteriuria the highest reported (6.7%-15.5%). There were no reports of urinary retention or elevated post-void residual volume. CONCLUSIONS:Intravesical instillation of an onabotulinumtoxinA + hydrogel admixture for the treatment of refractory overactive bladder was well tolerated, but it showed no improvement over placebo.

INTRODUCTION/BACKGROUND:Onabotulinumtoxin A (BTX-A) is an effective therapy for overactive bladder (OAB), however, adverse events may prevent patients from initiating therapy. The study objective was to report real-world rates of incomplete emptying and urinary tract infection (UTI) in men and women undergoing BTX-A for OAB. METHODS:Eleven clinical sites performed a retrospective study of adults undergoing first-time BTX-A injection (100 units) for idiopathic OAB in 2016. Exclusions included: postvoid residual (PVR) > 150 ml, prior BTX-A, pelvic radiation, or need for preprocedure catheterization. Primary outcomes at 6 months were incomplete emptying (clean intermittent catheterization [CIC] or PVR ≥ 300 ml without the need for CIC); and UTI (symptoms with either positive culture or urinalysis or empiric treatment). We compared rates of incomplete emptying and UTI within and between sexes, using univariate and multivariable models. RESULTS:278 patients (48 men and 230 women) met inclusion criteria. Mean age was 65.5 years (range: 24-95). 35% of men and 17% of women had incomplete emptying. Men had 2.4 (95% CI: 1.04-5.49) higher odds of incomplete emptying than women. 17% of men and 23.5% of women had ≥1 UTI, the majority of which occurred within the first month following injection. The strongest predictor of UTI was a history of prior UTI (OR: 4.2 [95% CI: 1.7-10.3]). CONCLUSIONS:In this multicenter retrospective study, rates of incomplete emptying and UTI were higher than many previously published studies. Men were at particular risk for incomplete emptying. Prior UTI was the primary risk factor for postprocedure UTI.

Background/UNASSIGNED:-adrenergic agonists vibegron and mirabegron have shown favorable safety profiles and efficacy for the treatment of overactive bladder. However, β-adrenergic receptors are also found outside the bladder, which could lead to off-target activity. Objective/UNASSIGNED:-adrenergic receptors. Methods/UNASSIGNED:, procaterol). Responses were quantified using homogeneous time-resolved fluorescence of cyclic adenosine monophosphate and were normalized to the respective control. Half-maximal effective concentration and maximum response values were determined by nonlinear least-squares regression analysis. Results/UNASSIGNED:-adrenergic activity was 2% and 15%, respectively. Conclusions/UNASSIGNED:response.

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.

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 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.

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.

CONTEXT/BACKGROUND:The role of overactive bladder (OAB) treatment in women beyond antimuscarinics has been evaluated extensively. Beta-3 agonists, botulinum toxin-A (BTX-A), and nerve stimulation are indicated in these patients. However, data on male patients in this clinical scenario are scarce. OBJECTIVE:The aim of this systematic review was to evaluate the evidence on treatment options beyond antimuscarinics in men with OAB. EVIDENCE ACQUISITION/METHODS:A search of PubMed, EMBASE, Scopus, Web of science, Cochrane Central Register of Controlled Trials, and Cochrane Central Database of Systematic Reviews databases was performed for relevant articles published between January 2000 and October 2020, using the following Medical Subject Headings: "male/man," "LUTS," "overactive bladder," "storage symptoms," "urgency," "nocturia," "incontinence," "beta-3 agonist," "PDE-5 inhibitors," "botulinum toxin," "sacral nerve stimulation/neurostimulation," "percutaneous/transcutaneous tibial nerve stimulation," "PTENS," and "combination therapy." Evidence acquisition was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. PROSPERO registration number is CRD42020201223. EVIDENCE SYNTHESIS/RESULTS:-blocker tamsulosin improved the mean number of micturitions per day (-0.27, 95% CI: -0.46 to -0.09, p <  0.05), urgency episodes (-0.50, 95% CI: -0.77 to -0.22, p <  0.05), total OAB symptom score (-0.66, 95% CI: -1.00 to -0.38, p <  0.05), and mean volume voided (+10.76 ml, 95% CI: 4.87-16.64, p <  0.05). MIRA treatment is well tolerated in men. Other pharmacological treatment options, such as phosphodiesterase-5 (PDE-5) inhibitors, should be considered investigational. BTX-A seems to be effective as third-line treatment in male OAB patients. A higher rate of intermittent self-catheterization (5-42%) is observed in male than in female patients. Data on nerve stimulation are scarce. CONCLUSIONS:MIRA has the most robust data in terms of safety and efficacy in this patient population. Preliminary data in men suggest that BTX-A is indicated as an interventional treatment. Evidence for PDE-5 inhibitors and nerve stimulation is too limited to provide recommendations. Future studies in this population should aim to better define the best treatment sequence and to identify predictors for treatment response and failure, to determine a therapeutic approach tailored to patients' characteristics. PATIENT SUMMARY/UNASSIGNED:Overactive bladder is highly prevalent in men. Mirabegron 50 mg is the treatment option supported by the highest level of evidence when antimuscarinics failed. Botulinum toxin A injections seems to be an effective treatment as interventional option. Roles of nerve stimulation and phosphodiesterase inhibitors in male OAB patients are still to be defined.