Barriers and facilitators to overactive bladder therapy adherence.

AIMS: To provide an overview of the barriers and facilitators to overactive bladder (OAB) therapy initiation and adherence. METHODS: A PubMed and Embase literature search was conducted to identify barriers to OAB therapy adherence. RESULTS: OAB therapy adherence is associated with improvements in urinary symptoms, and quality of life with reductions in annual costs for OAB-related expenditures. However, adherence rates to behavioral therapies are as low as 32% at 1 year, only 15%-40% of treated patients remain on oral medications at 1 year due to several factors (e.g., inadequate efficacy, tolerability, and cost), and 5%-10% of OAB patients progress to advanced therapies. While some common barriers to therapy adherence are often fixed (e.g., costs, lack of efficacy, time, side effects, treatment fatigue), many are modifiable (e.g., lack of knowledge, poor relationships, negative experiences, poor communication with providers). Patient-centered care may help address some modifiable barriers. Emerging data demonstrate that patient-centered care in the form of treatment navigators improves OAB therapy adherence and progression to advanced therapies in the appropriate patient. CONCLUSIONS: There are numerous modifiable barriers to OAB therapy adherence. A patient-centered lens is needed to elicit patient goals, establish realistic treatment expectations, and tailor therapy to improve therapy adherence, optimize outcomes, and reduce healthcare expenditures. Further research is needed to develop and study low-cost, scalable solutions.

Postoperative complications and recurrence rates after rectal prolapse surgery versus combined rectal prolapse and pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: Our primary objectives were to compare < 30-day postoperative complications and RP recurrence rates after RP-only surgery and combined surgery. Our secondary objectives were to determine preoperative predictors of < 30-day complications and RP recurrence. METHODS: A prospective IRB-approved cohort study was performed at a single tertiary care center from 2017 to 2020. Female patients with symptomatic RP underwent either RP-only surgery or combined surgery based on the discretion of the colorectal and FPMRS surgeons. Primary outcome measures were < 30-day complications separated into Clavien-Dindo (CD) classes and rectal prolapse on physical examination. RESULTS: Seventy women had RP-only surgery and 45 had combined surgery with a mean follow-up time of 208 days. Sixty-eight percent underwent abdominal RP repair, and 32% underwent perineal RP repair. Twenty percent had one or more complications, 14% in the RP-only group and 29% in the combined surgery group (p = 0.06). On multivariate analysis, combined surgery patients had a 30% increased risk of complications compared to RP-only surgery patients (RR = 1.3). Most of these complications were minor (14/17, 82.4%) and categorized as CD I or II, including urinary retention and UTI. Twelve percent of this cohort had RP recurrence, 11% in the RP-only group and 13% in the combined surgery group (p = 0.76). Preoperative risk factors for RP recurrence included a primary complaint of rectal bleeding (RR 5.5) and reporting stools consistent with Bristol Stool Scale of 1 (RR 2.1). CONCLUSION: Patients undergoing combined RP + POP surgery had a higher risk of complications and equivalent RP recurrence rates compared to patients undergoing RP-only surgery.

Surgical approach, complications, and reoperation rates of combined rectal and pelvic organ prolapse surgery.

OBJECTIVES: Our primary objective was to determine rectal prolapse (RP) and pelvic organ prolapse (POP) reoperation rates and postoperative < 30-day complications after combined RP and POP surgery at a single institution. METHODS: This was an IRB-approved retrospective cohort study of all female patients who received combined RP and POP surgery at a single tertiary care center from 2008 to 2019. Recurrence was defined as the need for subsequent repeat RP or POP surgery at any point after the index surgery. Surgical complications were separated into Clavien-Dindo classes. RESULTS: Sixty-three patients were identified, and 18.3% (12/63) had < 30-day complications (55% Clavien-Dindo grade 1; 27% Clavien-Dindo grade 2; 18% Clavien-Dindo grade 4). Of patients undergoing combined abdominal RP and POP repair, no postoperative < 30-day complications were noted in the MIS group compared to 37.5% of those patients in the laparotomy group (p < 0.01). Overall, in those patients who underwent combined RP and POP surgery, the need for subsequent RP surgery for recurrent RP was 14% and the need for subsequent POP surgery for recurrent POP was 4.8% (p = 0.25). CONCLUSION: In this cohort of women undergoing combined RP and POP surgery, a higher proportion required subsequent RP surgery compared to those requiring subsequent POP surgery, although this was not statistically significant. Almost one-fifth of patients undergoing combined RP and POP surgery experienced a < 30-day surgical complication, regardless of whether the approach was perineal or abdominal. For those patients undergoing abdominal repair, < 30-day complications were more likely in those patients who had a laparotomy compared to those who had a minimally invasive surgery.

Frailty, Specialized Care, and Sociodemographic Factors: Disparities in Oral Pharmacotherapy Class Utilization Among Medicare Part D Beneficiaries With Overactive Bladder in the United States.

OBJECTIVE: To describe the prevalence of frailty among Medicare beneficiaries with overactive bladder (OAB), analyze oral therapy patterns, and examine potential disparities in treatment. METHODS: This retrospective cohort study utilized the 20% Research Identifiable File Medicare Part D prescription claims dataset (2013-2018). Using the Claims-Based Frailty Index (CFI), Medicare beneficiaries ≥65 years old with OAB were categorized as not frail (CFI <0.15), prefrail (0.15 ≤CFI<0.25), and frail (CFI >0.25). Logistic regression models assessed associations between frailty and pharmacotherapy utilization. RESULTS: Among 111,761 patients (15.8% of the OAB cohort) receiving oral pharmacotherapy (anticholinergic oral medications or mirabegron), 71% were women, 83% were White, and 11.9% were frail. After controlling for age, copayments and dual eligibility status, frail status (OR 1.16; 95% CI [1.09-1.24]), urology (OR 2.05; 95% CI [1.94-2.16]) or gynecology (OR 1.74; 95% CI [1.6-1.9]) prescribers and residing in the Southern United States (OR 1.53; CI [1.49-1.61]) were associated with higher likelihood of mirabegron utilization. Black (OR 0.79; 95% CI [0.74-0.85]) and American Indian/Alaska Native (OR 0.54; 95% CI [0.39-0.74]) patients were less likely to utilize Mirabegron than White beneficiaries. CONCLUSION: Frail beneficiaries and those with urology and gynecology prescribers showed higher likelihoods of beta-3 agonist utilization. Despite adjustments, Black and American Indian/Alaskan Native patients were less likely to fill mirabegron prescriptions, suggesting disparities in treatment. Our findings highlight the need for policies, interventions, and initiatives to promote equitable OAB oral therapy utilization in vulnerable populations.

Pelvic Floor Disorders Among Minority Women: Differences in Prevalence, Severity and Health-Related Social Needs.

OBJECTIVE: To characterize prevalence and severity of pelvic floor disorders (PFDs) in various health care settings and to examine unmet health-related social needs (HRSN) among minority women. MATERIALS AND METHODS: Minority women with PFDs were recruited from our academic urogynecology clinic, a general urology clinic at our institution's safety net hospital, and a community outreach mobile clinic. Questions from the Urinary Distress Index-6, Pelvic Organ Prolapse Distress Inventory-6, and Female Genitourinary Pain Index were used to identify patients with stress urinary incontinence, overactive bladder (OAB), and chronic pelvic pain syndrome (CPPS). RESULTS: Sixty-one (46.6%) women identified as Hispanic, 53 (40.4%) as Black, and 17 (12.9%) as Other. Overall, self-reported PFDs included stress urinary incontinence in 45%, OAB in 74.8%, and CPPS in 24.4% of women. Hispanic women were more likely to report OAB symptoms, compared to Black women (odds ratio (OR) 3.4 [1.2-10.2], P = .03) or Other women (OR = 5.1 [1.3-20.4], P = .02). Participants held a median of 5 unmet HRSN. Minority women facing issues with family and community support, transportation, and utilities were more likely to report CPPS symptoms, compared to those without psychosocial issues (support OR: 4.8 [1.7-13.7], P = .002; transportation OR: 2.0 [1.0-8.2], P = .05; utility OR: 7.0 [1.9-28.1], P = .005). CONCLUSION: Minority women with PFDs may have several unmet HRSNs which impact their ability to receive appropriate medical care. Our findings may assist in the development of effective strategies to improve health care outcomes for women dealing with PFDs.

Comparative revision rates of inflatable penile prostheses using woven Dacron® fabric cylinders.

PURPOSE: American Medical Systems (AMS) CX and LGX penile prostheses use woven Dacron® fabric to produce girth, and length and girth expansion, respectively. Cylinder expansion, while desirable, can result in wear of the material which, over time, may lead to device failure. Therefore, we compared girth and length expanding vs girth expanding cylinder survival rates. In addition, we determined the impact of parylene coating on penile prosthesis revision performed for mechanical reasons. MATERIALS AND METHODS: All patient information forms from AMS 700™ CX and LGX/Ultrex penile prosthesis implantation performed in the United States from January 1997 through August 2008 were retrospectively analyzed (55,013). Device failure was defined as time to first revision. Survival rates of the 2 groups were analyzed and compared, and survival curves were generated. RESULTS: AMS 700 Ultrex/LGX parylene and CX parylene devices demonstrated equivalent estimated survival rates (88.7% vs 89.5%, respectively, log rank p=0.6811). The parylene coated CX and Ultrex/LGX devices outperformed the nonparylene coated devices on survival analysis. CONCLUSIONS: This analysis demonstrated no significant difference in 7-year survival between current generation girth expanding (700 CX) and length and girth expanding (700 LGX/Ultrex) prostheses. This analysis also demonstrated that the parylene coating of the cylinder wall contact surfaces significantly reduced the revision rate of the 700 CX and 700 LGX/Ultrex inflatable penile prostheses.

Workforce Diversity in Female Pelvic Medicine and Reconstructive Surgery: An Analysis of the American Urological Association Census Data.

OBJECTIVE: To describe the current state of workforce diversity in Female Pelvic Medicine and Reconstructive Surgery (FPMRS) using the 2014-2019 American Urological Association (AUA) census data. MATERIALS: We evaluated FPMRS workforce diversity using the AUA census data from 2014 to 2019. Underrepresented in medicine (URiM) groups were categorized as individuals who self-identified as non-Hispanic Black/African American, Hispanic, Multiracial, and Other. The FPMRS workforce was then compared to the overall urologic workforce and the other urologic subspecialties (oncology, pediatric urology, and endourology) and assessed by AUA section. RESULTS: In 2019, 602 urologists self-identified as FPMRS providers. Of these 12.4% (n = 74) were categorized as URiM urologists compared to 8% of the overall urologic workforce. Women who represent 9.9% of all urologists were overrepresented in FPMRS workforce (46.5%). FPMRS had the largest proportion of URiM and women urologists when compared to the other subspecialty areas. CONCLUSION: The FPMRS urologic subspecialty has the highest percentage of women and URiM urologists compared to all other urologic subspecialty areas. Engagement initiatives and targeted programs may offer insights into this trend. Further research is required to determine the impact of such programs in attracting URiM and women to FPMRS.

Racial and Socioeconomic Factors Influence Utilization of Advanced Therapies in Commercially Insured OAB Patients: An Analysis of Over 800,000 OAB Patients.

OBJECTIVE: To determine if racial and/or socioeconomic factors influence advanced therapy utilization for refractory overactive bladder (OAB) among the commercially insured. METHODS: We queried Optum, a national claims database, between 2003 and 2017. Non-neurogenic OAB patients were identified using ICD-9/10 diagnosis codes. Demographic and treatment data were collected, including oral medication therapies (anticholinergic, beta3 agonists), and advanced therapies (OnabotulinumtoxinA [BTX], Sacral Nerve Stimulation [SNS], percutaneous tibial nerve stimulation [PTNS]). Associations between patient sociodemographic factors and advanced therapy utilization were explored. RESULTS: Of 4,229,617 OAB patients, 807,612 (19%) received medical therapies, of which 95% received oral medications only and only 4.7% received advanced therapies. Asians had the lowest use of oral therapy use (14% vs 18%-19% in other races/ethnicities, P <0.05), and advanced therapy use (0.44% vs 0.71%-0.93%, P <0.05). Asians and Hispanics were least likely to utilize SNS therapy and most likely to use PTNS compared to Blacks and Whites. BTX use was similar between races/ethnicities (P <0.05). Female gender (OR 1.65 [CI 1.61,1.69]), younger age (<65) (OR 1.28 [1.25,1.31]), higher annual income ≥$40K (OR 1.09 [1.06,1.12]) and prior use of oral medications (OR 3.30 [3.21,3.38] for 1 medication) were significantly associated with receiving advanced therapies. Non-white race (OR 0.89 [0.87,0.91]), lower education level (less than a bachelor's degree) (OR 0.97 [0.94,0.99]), and Northeast region were associated with a lower likelihood of receiving advanced therapies (P <0.05 for all). CONCLUSION: Among commercially insured, racial and socioeconomic factors predict utilization of advanced OAB therapies, including race/ethnicity, age, gender, education level, and region.

Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports.

OBJECTIVES: Energy-based devices have gained momentum as minimally invasive procedures to treat both medical and cosmetic pelvic floor disorders including genitourinary syndrome of menopause, vaginal laxity, stress urinary incontinence, dyspareunia, and vulvar disorders such as lichen diseases and vestibulitis. However, the FDA recently issued a statement cautioning patients and providers that the safety and efficacy of energy-based devices for the treatment of vaginal symptoms has not been well established. Additionally, the FDA sent letters to the manufactures of energy-based devices with notifications that they could be violating the marketing standards of the FDA. The existing data on side effects is insufficient and limited to observational studies. We sought to characterize the safety events of vaginal energy-based devices by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database and specifically look at those events that occurred prior to the July 30, 2018 warning. METHODS: The MAUDE database was queried between September 30, 2013 and October 31, 2019 for all vaginal energy-based devices. The incidence of safety events was reported for these devices and the most common complaints were described and characterized. Event reporting was analyzed before and after July 30, 2018. RESULTS: Forty-two unique and relevant medical device reports (MDRs) were retrieved. The Mona Lisa Touch had the highest number of MDRs (40.5%) followed by ThermiVa (16.7%) and Viveve (14.2%). Each medical device report was associated with a single patient experience and within the 42 medical device reports, there were 85 complaints. A majority of the MDR complaints (52.9%) were also indications for energy-based devices procedures, which include vaginal pain, dyspareunia, lichen sclerosis, and urinary frequency. Two-thirds of the complaints (68.2%) were related to pain, but serious adverse events such as third-degree burns (3.5%) were rare. Most of the reportable events occurred before July 30, 2018 (83.3%), but most were reported after July 30, 2018 (78.6%). CONCLUSIONS: MAUDE-reported data suggests that the majority of patient complaints after vaginal energy-based device treatment include vaginal pain, bladder pain, and urinary symptoms. This study suggests that the majority of complaints are not severe, and some may be related to progression of the disease. The few severe adverse events reported in the MAUDE database may have contributed to the FDA warning regarding energy-based devices. Recall bias after the FDA warning, as well as the potential for litigation, may have prompted an increase in adverse event reporting after July 30, 2018.

Video Summary:http://links.lww.com/MENO/A650.

Sacral Nerve Stimulation in Parkinson's Disease Patients With Overactive Bladder Symptoms.

OBJECTIVE: To assess the efficacy, safety, and outcomes of sacral nerve stimulation (SNS) for Parkinson's disease (PD) patients with overactive bladder symptoms. METHODS: We retrospectively reviewed PD patients who underwent Stage I SNS. Demographics, urodynamic data, and baseline voiding function were analyzed. Efficacy and safety of treatment were determined by rate of progression to Stage II, explantation, and surgical revision. Long-term outcomes were assessed using voiding diaries and/or clinic notes. RESULTS: Sixty percent (9/15) experienced ≥50% improvement in urinary parameters and proceeded to Stage II. There was no significant difference in age, body mass index, comorbidities, PD disease duration, or levodopa equivalent daily dose between successful and nonsuccessful Stage I patients. However, 100% of female patients experienced Stage I success compared to 44% of male PD patients (P = .04). Individuals with >12-month follow-up experienced an average reduction of 6 voids/day. No patients required revision or explantation of their device at latest clinic follow-up (22.2 ± 7.8 months). Higher maximal urethral closure pressures, detrusor pressure at maximum flow rate (PdetQmax), post-void residual volume, and mean bladder outlet obstruction index were observed in the Stage I trial failures. CONCLUSION: At our institution, PD patients have a similar rate of progression to Stage II compared to the general population. SNS is an effective therapy that should be considered among the treatment options for PD patients with overactive bladder symptoms. Urodynamic parameters associated with obstruction may be predictive of SNS failure in PD patients and may help guide patient selection, however further studies are needed.

Transvaginal Suture-Based Repair.

An estimated 300,000 women undergo pelvic organ prolapse (POP) surgery in the United States every year at a cost of more than 1 billion dollars per year. The prevalence of POP is approximately 2.9% to 8%, and increases with age. Apical support is required to achieve successful prolapse repair. As the search for the safest, most durable, surgical repair continues, transvaginal native tissue repairs have the advantage of providing minimally invasive surgical repairs without the added risk of abdominal, laparoscopic, or robotic surgery while avoiding the risk of mesh augmentation.

Rates and Risk Factors for Future Stress Urinary Incontinence Surgery after Pelvic Organ Prolapse Repair in a Large Population-based Cohort in California.

OBJECTIVES: To determine the rate and risk factors for future stress urinary incontinence (SUI) surgery in a large population-based cohort of previously continent women following pelvic organ prolapse (POP) repair without concomitant SUI treatment. METHODS: Data from the Office of Statewide Health Planning and Development were used to identify all women who underwent anterior, apical, or combined anteroapical POP repair without concomitant SUI procedures in the state of California between 2005 and 2011 with at least 1-year follow-up. Patient and surgical characteristics were explored for associations with subsequent SUI procedures. RESULTS: Of 41,689 women undergoing anterior or apical POP surgery, 1,504 (3.6%) underwent subsequent SUI surgery with a mean follow-up time of 4.1 years. Age (odds ratio [OR] 1.01), obesity (OR 1.98), use of mesh at the time of POP repair (OR 2.04), diabetes mellitus (OR 1.19), white race, and combined anteroapical repair (OR 1.30) were associated with increased odds of future SUI surgery. CONCLUSION: The rate of subsequent surgery for de novo SUI following POP repair on a population level is low. Patient and surgical characteristics may alter a woman's individual risk and should be considered in surgical planning.

Safety and efficacy of sling for persistent stress urinary incontinence after bulking injection.

OBJECTIVES: To evaluate the impact of injectable agents on subsequent incontinence surgery outcomes to assess safety and efficacy of this treatment combination. Periurethral bulking agents are a minimally invasive treatment option for stress urinary incontinence (SUI), but often lack durability necessitating further surgical intervention. METHODS: Retrospective review of 43 patients with SUI following bulking agent who underwent subsequent sling placement from November 2000 to September 2009 were evaluated for demographics, symptoms, urodynamics (UDS), bulking agent characteristics, concomitant procedures, pad requirements per day (PPD), subjective outcomes, and complications. RESULTS: Mean patient age was 67 years, with mean follow-up of 37.3 months. All demonstrated SUI, and mixed urinary incontinence (MUI) was noted in 81.4%. Almost half (48.8%) had undergone a prior antiincontinence procedure. Mean number of injections was 3. After a bulking injection, 25 autologous fascia pubovaginal slings, 13 midurethral slings, and 5 biological pubovaginal slings were placed. Concomitant pelvic surgery was performed in 37.2%. Postoperatively, mean PPD decreased from 5.3 to 0.65, with a 60.5% subjective cure rate (no pads or leakage under any circumstances). No association was seen between number or type of injection, or type of sling with regards to patient outcomes. Results were significantly related to concomitant surgery (P = .007). SUI recurred in 8 patients (18.6%), which was not statistically associated with other parameters. Complications included urinary retention (8 patients) de novo urgency (1 patient), UTI (4 patients), abdominal wound infection (3 patients), and cystotomy (1 patient). CONCLUSIONS: Prior treatment with bulking agents does not appear to negatively affect outcomes for future antiincontinence surgery in our patient population.