Faculty Bibliography

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.

INTRODUCTION/BACKGROUND:Onabotulinumtoxin A (BTX-A) is a minimally invasive therapy for idiopathic overactive bladder (iOAB). Incomplete bladder emptying is a known risk of the procedure, with an overall rate as high as 20% in male and female patients. Risk factors for incomplete bladder emptying after BTX-A have been reported in the literature, but are widely variable amongst studies and therefore patients at increased risk of this adverse effect cannot easily be identified by clinicians. The aim of this study was to evaluate whether pre-procedure urodynamics (UDS) findings are associated with incomplete bladder emptying after intradetrusor BTX-A injection for iOAB. METHODS:Data were analyzed from the SUFU Research Network (SURN) multi-institutional retrospective database. Men and women undergoing first-time injection of 100 units BTX-A for iOAB in 2016 were included. Subjects were excluded if they did not have record of pre-procedure and post-procedure (within 1 month) post-void residual volume (PVR). The primary outcome was incidence of urinary retention within 1 month after BTX-A, defined as PVR > 300 mL and/or initiation of self-catheterization or indwelling catheter. We assessed the association of pre-procedure UDS parameters with urinary retention using Wilcoxon rank tests, Fisher's exact test, and chi-squared tests. RESULTS:A total of 167 subjects (141 women, 26 men) were included. Ninety-nine subjects (59%) had urodynamic data. Thirty-seven subjects (22%) had urinary retention within 1 month of BTX-A. There were no significant differences in age, gender, race, or body mass index between the retention and non-retention groups. There was no statistically significant difference in median Qmax between those who did and did not have postprocedure retention (10.0 vs. 14.3 mL/s respectively, p = 0.06). Mean PVR at the start of UDS was not statistically significant when comparing the retention and non-retention groups (22.5 vs. 10.0 mL respectively, p = 0.70). Bladder outlet obstruction index (BOOI), bladder contractility index (BCI), and presence of detrusor overactivity (DO) were not found to be associated with posttreatment retention. CONCLUSION/CONCLUSIONS:This retrospective multi-institutional cohort study revealed that of patients who receive UDS before BTX-A, there are no significant UDS parameters or baseline demographic factors associated with incomplete bladder emptying after intradetrusor BTX-A injections for iOAB. Future studies that focus on better defining objective evidence-based predictors of incomplete emptying after BTX are needed to optimize patient perception of efficacy and satisfaction with this therapy.

OBJECTIVE:To determine factors associated with care-seeking in males with urinary incontinence (UI). METHODS:A cross-sectional study was performed using the National Association for Continence (NAFC) sponsored adult patient-reported survey data from November 2018 to January 2019. Descriptive statistics, chi-squared test, and multivariate logistic regression were used to identify factors associated with care-seeking behavior. RESULTS:Four hundred and forty-six men completed the survey during the study period. 84% of care-seeking men had initiated the discussion with their doctor about their UI, with 57% initially seeing their primary care provider. Statistically significant predictors of care-seeking were greater UI frequency (OR 1.68, CI 1.22-2.33), UI duration (OR 2.91, CI 1.88-4.65), cost of UI management (OR 1.53, CI 1.12-2.10), and comfort discussing UI (OR 2.83, 1.41-5.87). The top reasons cited for not seeking care for UI were embarrassment (29%) and the sentiment that UI is just a normal part of aging (22%). Non-care-seeking men were more likely to have their UI associated with feelings of shame and isolation. CONCLUSIONS:The majority of men who sought care for UI initiated the conversation with their PCP. Men with longer UI duration, higher UI frequency, higher cost expenditure on UI management, and those who felt comfortable discussing their UI were more likely to seek care.

INTRODUCTION/BACKGROUND:With increased access to gender affirming care, the rate of vaginoplasties in the US has risen rapidly. Although some retrospective studies report high rates of lower urinary tract symptoms (LUTS) after gender affirming vaginoplasty, the type and severity of symptoms has not been well-described. The purpose of this study was to prospectively characterize postoperative changes in lower urinary tract function after robotic peritoneal flap vaginoplasty as measured by the American Urological Association Symptom Index questionnaire (AUASI), Urogenital Distress Inventory 6 (UDI6), and additional measures. METHODS:This was a prospective observational study of patients undergoing gender affirming robotic peritoneal flap vaginoplasty enrolled between August 2020 to September 2021. LUTS were evaluated pre- and postoperatively (1, 3, 6, and 12-month) via the AUASI, UDI6, uroflowmetry, and post void residual (PVR) measurements. Averages and 95% confidence intervals over time were estimated and compared through univariate mixed-effect linear regression models. RESULTS:A total of 43 patients were enrolled. The average patient age was 31.1 ± 9.1 years. Overall AUASI Score declined over time (p = 0.002; -0.42,-0.09), though the decrease was less than the clinically minimum importance difference (MID) of 3 points. Preoperative AUASI was 8.1 ± 5.2, 1 month: 8.1 (95% CI: -1.9,1.8); 3 months: 5.2 (-5.0,-1.2); 6 months: 5.7 (-4.6,-0.62); 12 months: 5.2 (-4.9,-0.81). Similarly, UDI6 score declined over time (p = 0.002; -1.12,-0.26), though the decrease was less than MID of 16.7 points. UDI6 score preoperatively was 16.3 ± 1.8; 1 month post op: 16.5 (-5.2,5.0); 3 months: 16.2 (-5.6,5.1); 6 months: 11.6 (-10,1.0), and at 12 months: 8.1 (-13,-2.3). Overall uroflowmetric outcomes measured at postoperative visits including post void residual volume, maximum flow velocity, and average flow velocity did not show any difference at any postoperative time point when compared with preoperative measurements. CONCLUSIONS:In this study both the AUASI and UDI6 declined over time from initial preoperative evaluation to the 12 month follow up period, although the changes in AUASI and UDI6 score did not reach MID. Additionally, urodynamic measurements remained unchanged postoperatively. This data suggests that robotic peritoneal flap vaginoplasty has no effect on lower urinary tract function.

OBJECTIVE:Functional and anatomic bladder outlet obstruction (BOO) in women are more prevalent than previously suspected and remain a diagnostic challenge. Several urodynamic diagnostic criteria for female BOO have been proposed, but studies validating the criteria by assessing treatment outcomes are lacking. We sought to correlate video urodynamic (VUD) diagnostic criteria with symptom improvement in women with functional bladder outlet obstruction. METHODS:A retrospective cohort study of women diagnosed with primary bladder neck obstruction (PBNO) by VUD criteria who underwent bladder neck incision (BNI) between 2010 and 2022 was performed. Patient demographic, clinical, and urodynamic characteristics were collected before and after treatment and analyzed. RESULTS:O, p = 0.21). CONCLUSIONS:The diagnosis of PBNO by VUD criteria for obstruction correlated with treatment outcomes with success in 88.5% and 56% becoming catheter independent. Successful treatment was independent of preoperative PdetQmax.

INTRODUCTION/BACKGROUND:Bladder outlet obstruction (BOO) in women includes functional and anatomic etiologies. Primary bladder neck obstruction (PBNO), Fowler's syndrome (FS), and dysfunctional voiding (DV) are some examples of functional obstructions, whereas pelvic organ prolapse (POP), periurethral masses, and intragenic causes are some of the anatomic causes. METHODS:This literature review describes the etiologies of female BOO, unique aspects of the workup and diagnosis, and the data for the standard surgical treatments and newer surgical techniques to treat women. Urethral stenosis and sling-related obstruction are treated in the other articles of this series. Where possible the focus is the efficacy and outcomes. RESULTS:Treatment of PBNO using a transurethral incision of the bladder neck and injection of botulinum toxin in the bladder neck decreases the BOO. After the failure of conservative approaches, sacral neuromodulation (SNM) is effective for FS, while DV may benefit from SNM or botulinum toxin injections. Concerning POP, most surgeries have been reported to significantly improve a pre-existent BOO but the level of evidence is low. Benign urethral and periurethral masses may provoke BOO, and surgical excision usually resolves this condition. CONCLUSION/CONCLUSIONS:Although most surgical treatments of BOO for functional and benign anatomical etiologies in women seem to be effective, data are scarce even for more common conditions like POP. Further studies are required to give better advice on the choice of surgical technique for these patients.

OnabotulinumtoxinA (onabotA) is approved in the US for 12 therapeutic indications. Real-world data on onabotA multi-indication use are limited, often leading to delayed or reduced treatment. This study provides real-world evidence on the safety of onabotA when treating multiple indications concomitantly. SYNCHRONIZE was a multicenter, retrospective, chart-review study evaluating onabotA's safety for adults treated for ≥2 therapeutic indications within a 3-month period. The primary outcome was treatment-emergent adverse events (TEAEs) within 6 months post-treatment. A total of 279 patients were included. The most common concomitant indications treated were cervical dystonia and chronic migraine (43.4%). The average 3-month cumulative dose for multiple indications was 282.2 U. The treatment interval for multiple indications was ≤24 h for most patients (62.4%). Overall, 28.7% of patients reported ≥1 TEAE with no apparent trends in TEAEs and dose interval or cumulative dose. Reported TEAEs included UTI (5.7%), neck pain (5.0%), and headache (4.3%). No patient had a lack of effect according to clinical objective measurements. SYNCHRONIZE described the real-world safety of onabotA for patients treated concomitantly for ≥2 indications within a 3-month period. TEAEs were generally consistent with the known safety profiles of individual indications. No new safety signals were identified).

OBJECTIVE:The aim of this study was to compare the efficacy of a non-hormone alternative, vaginal hyaluronic acid (HLA), to a standard-of-care therapy, vaginal estrogen, for the treatment of genitourinary syndrome of menopause (GSM). METHODS:This was a randomized, parallel arm pilot trial. Women with GSM were randomized to an HLA vaginal suppository or vaginal estrogen cream for 12 wk to compare the primary outcome, the vulvovaginal symptom questionnaire (VSQ) score. Secondary outcomes included the following: the female sexual function index (FSFI), the vaginal symptom index (VSI), visual analog scale (VAS) for dyspareunia, vaginal itching, and vaginal dryness, patient global impression of improvement (PGI-I) at follow-up, vaginal maturation index, and vaginal pH. Differences between treatment groups were estimated using the two-sided, two-sample t -test and 95% confidence intervals. RESULTS:Forty-nine women were randomized and 45 participants (vaginal estrogen = 23, vaginal HLA = 22) provided data at week 12. Baseline characteristics were similar in both groups. On the VSQ, there was no observed difference in overall scores between the HLA and vaginal estrogen groups at 12 wk ( P = 0.81). Improvement was seen within both treatment groups on the VSQ after 12 wk. The VAS score, total VSI score, total FSFI score, and vaginal pH improved over time; however, improvement did not differ between study arms. Over 90% participants noted improvement on the PGI-I in both groups ( P = 0.61). No treatment-related serious adverse events occurred. CONCLUSIONS:There were no clinically meaningful differences between vaginal HLA and vaginal estrogen for the treatment of GSM after 12 wk. Vaginal HLA may be a promising non-hormone therapy for GSM.

IMPORTANCE/OBJECTIVE:Urinary incontinence (UI) is a common and treatable medical condition among women, but only approximately one third of women seek care. OBJECTIVE:The objective of this study was to determine factors associated with care-seeking behavior in women with UI. STUDY DESIGN/METHODS:This was a cross-sectional study using patient-reported survey data collected by the National Association for Continence from November 2018 to January 2019. This survey included 60 questions and was conducted using SurveyMonkey. Descriptive statistics were used for baseline characteristics, the χ2 test was used for categorical variables, and multivariate logistic regression was used to determine predictors of care-seeking behavior. RESULTS:Four hundred eighty-five women completed the survey, 30.7% were not care seeking, and 69.3% were care seeking for UI. Most women were 55 years or older and had UI for more than 4 years. Care-seeking women had more overactive bladder symptoms. Women who sought care were more likely to report feelings of anger, depression, hopelessness, isolation, and report greater social effects from UI than non-care-seeking women. Less than 10% of women who sought care were asked about their UI by a medical professional. In the multivariate logistic regression expenditure of $5 or more on monthly incontinence maintenance, daily UI and older age were associated with seeking care. CONCLUSIONS:Most women in our study population sought care for UI. Factors associated with seeking care were expenditure greater than $5 per month on incontinence, daily UI, and age. This information demonstrates the need for effective implementation of screening interventions to increase treatment access.

INTRODUCTION/UNASSIGNED:Overactive bladder (OAB) patients who do not achieve satisfactory results with second-line OAB medications should be offered third-line therapies (percutaneous tibial nerve stimulation, sacral neuromodulation, onabotulinumtoxinA bladder injection [BTX-A]). We aimed to determine which clinical factors affect progression from second- to third-line OAB therapy. METHODS/UNASSIGNED:Between 2014 and 2020, the AUA Quality Registry was queried for adult patients with idiopathic OAB. For the primary outcome, patient and provider factors associated with increased odds of progression from second- to third-line therapy were assessed. Secondary outcomes included median time for progression to third-line therapy and third-line therapy utilization across subgroups. RESULTS/UNASSIGNED:A total of 641,122 patients met inclusion criteria and were included in analysis. Of these, only 7487 (1.2%) received third-line therapy after receiving second-line therapy. On multivariate analysis, patients aged 65 to 79, women, White race, history of dual anticholinergic and β3 agonist therapy, metropolitan area, government insurance, and single specialty practice had the greatest odds of progressing to third-line therapy. Black and Asian race, male gender, and rural setting had lower odds of progressing to third-line therapy. BTX-A was the most common therapy overall (40% BTX-A, 32% sacral neuromodulation, 28% percutaneous tibial nerve stimulation). The median time of progression from second- to third-line therapy was 15.4 months (IQR 5.9, 32.4). Patients < 50 years old and women progressed fastest to third-line therapy. CONCLUSIONS/UNASSIGNED:Very few patients received third-line therapies, and the time to progression from second- to third-line therapies is > 1 year. The study findings highlight a potential need to improve third-line therapy implementation.