Faculty Bibliography

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.

OBJECTIVE:To determine how a patient's demographics, including insurance type, race/ethnicity, gender, and age, may impact the choice of medication prescribed for overactive bladder. METHODS:We queried the AUA Quality Registry for adults between 2014 and 2020 with a diagnosis of overactive bladder for >1 year, excluding neurogenic causes. Variables included age, race/ethnicity, gender, insurance type, medication first prescribed, year of prescription, provider metropolitan status, and provider practice type. Primary outcome was which factors were associated with increased odds of beta-3 prescription as first medication choice. RESULTS:We found 1,453,566 patients with overactive bladder, 641,122 (44.1%) with complete data. Of these, 112,021 (17.5%) were prescribed medication. On multivariate analysis, patients with Medicaid, Medicare, and other/self-pay insurance were less likely to receive a beta-3 versus an anticholinergic compared to private or military insurance. Compared to white patients, Asian, Black, and other races were less likely to receive a beta-3, as were patients outside of metropolitan areas. Age >50, prescriptions after 2014, and non-academic settings were associated with increased odds of beta-3 prescription. There was no difference between genders. CONCLUSIONS:Many nonclinical factors, including insurance type and race, may affect which medication is first prescribed for overactive bladder. This is useful for practicing urologists and may help lower barriers to beta-3 prescription through policy change and advocacy.

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.

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.

BACKGROUND/UNASSIGNED:Physicians often report low levels of confidence in diagnosing and treating female sexual dysfunction (FSD), which may stem from inadequate education and exposure to the topic. AIM/UNASSIGNED:The study sought to determine the extent to which FSD is covered in undergraduate medical education and evaluate student comfort with the topic and familiarity with treatments. METHODS/UNASSIGNED:We created a novel, 50-question survey to be administered online to any current U.S. medical student. Obstetrician-gynecologist clerkship directors at 146 U.S. medical schools were contacted and asked to invite any current student at their school to participate. A link to the electronic REDCap (Research Electronic Data Capture) survey was distributed to eligible students via the clerkship directors. The survey collected data regarding (1) coverage of FSD and male sexual dysfunction (MSD) in preclinical and clinical curricula, (2) student self-ratings of comfort in hypothetical scenarios in which a patient exhibits symptoms of FSD or MSD, and (3) student familiarity with treatments for FSD and MSD. OUTCOMES/UNASSIGNED:Outcomes included the proportion of students reporting that their school covered FSD/MSD in its preclinical/clinical curriculum, the mean comfort ratings for each of the FSD and MSD scenarios, and the proportion of students indicating knowledge of various FSD and MSD treatments. RESULTS/UNASSIGNED:.006). CLINICAL IMPLICATIONS/UNASSIGNED:There are important gaps in the coverage of FSD in undergraduate medical education that may be mitigated through improvements to curriculum and increased exposure to patients with FSD. STRENGTHS AND LIMITATIONS/UNASSIGNED:This is the first study, to our knowledge, to directly survey medical students regarding their educational experience and comfort with FSD. Our study was limited by a small sample size, the use of a novel and nonvalidated questionnaire, and the potential for bias given our sampling method. CONCLUSION/UNASSIGNED:Medical schools must work toward improving instruction in FSD for their students to address these disparities and improve students' comfort with the topic.