The mechanism of action of neuromodulation (percutaneous tibial nerve stimulation [PTNS] or sacral neuromodulation [SNM]) for the treatment of urgency urinary incontinence and/or fecal incontinence is poorly understood. Previously we showed an association between the catechol-O-methyltransferase (COMT) Val158Met (rs4680) single nucleotide polymorphism (SNP) and PTNS response in women with fecal incontinence. We hypothesized that COMT may also be associated with response to SNM.

Healthcare claims are often used to assess medical resource utilization (MRU) and costs but are less suited for evaluating novel diagnostics or therapeutics not issued a unique code, limiting payer decision-making on their real-world value. Complicated urinary tract infections (cUTIs) must be diagnosed and treated early and accurately to reduce their risk of poor outcomes. We aimed to develop and evaluate a claims-based method to identify an uncoded rapid novel diagnostic (ND) for mono/polymicrobial pathogens and sensitivities and assessed MRU and cost outcomes of its use compared with standard culture and sensitivities (SC) for cUTI. Using a 5% 2017-2019 Medicare Limited Dataset, we algorithmically identified Parts A+B beneficiaries with cUTI; identified the specific rapid ND from billed codes, laboratory identifiers and test date; and compared UTI-related MRU and cost for propensity-matched cUTI cohorts whose outpatient UTIs were diagnosed entirely with ND versus with SC for one year following a baseline year. About 11% of ∼1.5M beneficiaries in each year had claims with principal or secondary diagnosis of UTI. 3184 ND tests were identified, representing 0.40% of all UTI tests. Adjusting for sample size, this represented 110% of the laboratories’ reported volume on the diagnostic. 69 ND and 678 SC individuals were propensity-matched. 65.2% of ND and 72.0% of SC had ≥1 additional UTI in the year (p=0.24). Rates of a UTI-related MRU composite (urgent care, emergency, inpatient, skilled nursing) were 115.9 and 199.1 events per 1000 patient-years for ND and SC (p=0.168) and mean allowed total UTI costs (excluding ND and SC) were $629.55 (95%CI: 430.27, 920.90) versus $1,131.39 (1002.16, 1,277.27) (p=0.004). Subgroup analyses suggested greatest benefit for diabetics (p=.012). We demonstrated a claims-based method to identify a novel uncoded diagnostic and found a significant cost benefit compared with the standard diagnostic for patients with cUTIs.

To compare 2-year surgical outcomes of sacrospinous ligament fixation (SSLF) vs. uterosacral ligament suspension (ULS) in women with advanced pelvic organ prolapse (POP). Secondarily, to explore the difference in outcomes between advanced vs. mild POP. A secondary analysis was conducted in a subset of women with stage 3 or 4 (“advanced”) POP from a multicenter randomized trial comparing 1) SSLF vs. ULS and 2) perioperative behavioral with pelvic floor muscle training (BPMT) vs. usual care. Of 377 subjects, 113/186 (60.7%) in the SSLF group and 117/188 (62.7%) in ULS had advanced POP. The primary outcome was 2-year surgical success defined as 1) no apical descent > 1/3 into vaginal canal or anterior/posterior vaginal wall beyond the hymen, 2) no bothersome vaginal bulge symptoms, and 3) no retreatment for POP. Secondary outcomes include individual success components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory (POPDI), and adverse events (AEs). Preoperative stage 2 was considered “mild” POP. Outcomes were evaluated via generalized linear models with a logit link and terms for prolapse severity, surgical group, BPMT assignment, and their interactions, concomitant hysterectomy, and random effect for surgeon. Among women with advanced POP, surgical success did not differ between groups (ULS 58.2% [57/117] vs. SSLF 58.5% [55/113], aOR 1.0; 95% CI 0.5, 1.8). No difference was noted in individual success components (Table). POPDI scores improved in both; no intergroup difference was noted (ULS -72.7 ± 67.4 vs. SSLF -74.1 ± 72.2, adjusted mean difference 2.4; -17.9, 22.6). Serious AEs did not differ (ULS 19.7% vs. SSLF 16.8%, aOR 1.2; 0.6, 2.4) except neurologic pain requiring medication was higher in SSLF (Table). Comparing women with advanced vs. mild POP, success was lower in those with advanced POP compared to mild (58.3% vs. 73.2%, aOR 0.5; 0.3, 0.9). This difference was significant in ULS (58.2% vs. 75.4%, aOR 0.4; 0.2, 0.9), but not in SSLF (58.5% vs. 70.9%, aOR 0.6; 0.3, 1.3) group. Serious AEs did not differ in advanced vs. mild (18.3% vs. 13.9%, aOR 1.4; 0.8, 2.6) POP. At 2 years, surgical success, symptom severity, and serious AEs did not differ between SSLF and ULS in women with advanced POP. Compared to mild POP outcomes, success was lower in advanced POP group.

AimsThe Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium was established by the National Institutes of Health in 2015 to expand research beyond the detection and treatment of lower urinary tract symptoms (LUTS) to the promotion and preservation of bladder health and prevention of LUTS in girls and women. While many multi‐disciplinary scientific networks focus on pelvic floor dysfunction and LUTS, the PLUS Consortium stands alone in its focus on prevention. This article describes the PLUS approach to developing a conceptual framework to guide the Consortium's initial prevention research agenda.MethodsThe conceptual framework was informed by traditional social ecological models of public health, biopsychosocial models of health, Glass and McAtee's Society‐Behavior‐Biology Nexus, and the World Health Organization's conceptual framework for action on the social determinants of health.ResultsThe PLUS conceptual framework provides a foundation for developing prevention interventions that have the greatest likelihood of promoting and preserving bladder health among diverse populations.ConclusionsPLUS Consortium work is premised on the notion that programs, practices, and policies designed to promote health will have optimal impact if the conceptual foundation upon which efforts are based is comprehensive and informed by multiple disciplines. The PLUS conceptual framework is broadly applicable to domains of health that have historically focused on the treatment of illness and symptoms rather than the promotion of health. It is also applicable to domains of health that have been examined from a predominantly biological or social ecological perspective, without integration of both perspectives.

Background: Bladder health in women and girls is poorly understood, in part, due to absence of a definition for clinical or research purposes. This article describes the process used by a National Institutes of Health funded transdisciplinary research team (The Prevention of Lower Urinary Tract Symptoms [PLUS] Consortium) to develop a definition of bladder health. Methods: The PLUS Consortium identified currently accepted lower urinary tract symptoms (LUTS) and outlined elements of storage and emptying functions of the bladder. Consistent with the World Health Organization’s definition of health, PLUS concluded that absence of LUTS was insufficient and emphasizes the bladder’s ability to adapt to short-term physical, psychosocial, and environmental challenges for the final definition. Definitions for subjective experiences and objective measures of bladder dysfunction and health were drafted. An additional bioregulatory function to protect against infection, neoplasia, chemical, or biologic threats was proposed. Results: PLUS proposes that bladder health be defined as: ‘‘A complete state of physical, mental, and social well-being related to bladder function and not merely the absence of LUTS. Healthy bladder function permits daily activities, adapts to short-term physical or environmental stressors, and allows optimal well-being (e.g., travel, exercise, social, occupational, or other activities).’’ Definitions for each element of bladder function are reported with suggested subjective and objective measures. Conclusions: PLUS used a comprehensive transdisciplinary process to develop a bladder health definition. This will inform instrument development for evaluation of bladder health promotion and prevention of LUTS in research and public health initiatives.

Author(s): Lukacz, ES; Warren, LK; Richter, HE; Brubaker, L; Barber, MD; Norton, P; Weidner, AC; Nguyen, JN; Gantz, MG

BACKGROUND: Female urinary microbiota are associated with urgency urinary incontinence and response to medication. The urinary microbiota of women with stress urinary incontinence has not been described.OBJECTIVE: We sought to study the cross-sectional relationships between urinary microbiota features and demographic and clinical characteristics of women undergoing stress urinary incontinence surgery.STUDY DESIGN: Preoperative urine specimens were collected from women without urinary tract infection and were available from 197 women (174 voided, 23 catheterized) enrolled in a multicenter prospective randomized trial, the Value of Urodynamic Evaluation study. Demographic and clinical variables were obtained including stress and urgency urinary incontinence symptoms, menopausal status, and hormone use. The bacterial composition of the urine was qualitatively assessed by sequencing the bacterial 16S ribosomal RNA gene. Phylogenetic relatedness and microbial alpha diversity were compared to demographics and symptoms using generalized estimating equation models.RESULTS: The majority of 197 urine samples (86%) had detectable bacterial DNA. Bacterial diversity was significantly associated with higher body mass index (P =.02); increased Medical, Epidemiologic, and Social Aspects of Aging urge index score (P =.04); and hormonal status (P <.001). No associations were detected with stress urinary incontinence symptoms. Increased diversity was also associated with a concomitant lower frequency of Lactobacillus in hormone-negative women.CONCLUSION: Women undergoing stress urinary incontinence surgery have detectable urinary microbiota. This cross-sectional analysis revealed that increased diversity of the microbiota was associated with urgency urinary incontinence symptoms, hormonal status, and body mass index. In contrast, the female urinary microbiota were not associated with stress urinary incontinence symptoms.

Author(s): Weber, LeBrun EE; Adam, RA; Barber, MD; Boyles, SH; Iglesia, CB; Lukacz, ES; Moalli, P; Moen, M; Richter, HE; Subak, LL; Sung, VW; Visco, AG; Bradley, CS

We report the cases of 2 women who had urethral bulking injections with polydimethylsiloxane for stress urinary incontinence with intrinsic sphincter deficiency and reported initial improvement of symptoms followed by rapid return of stress urinary incontinence several weeks later associated with extrusion of the bulking material. We hypothesize this unique adverse outcome could represent immune rejection of this urethral bulking agent.

Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months.

Optimal measures for assessing anatomy and defecatory symptoms related to posterior compartment prolapse are unknown. Our objectives were: (1) to test the inter- and intrarater reliability of commonly used or reported anatomic measures of posterior compartment prolapse performed in the clinic setting and under anesthesia; and (2) to examine the correlation between posterior compartment anatomy and defecatory symptoms prior to surgical intervention.