Background:Hospital-onset urinary tract infections (HOUTIs), including catheter-associated (CAUTI) and non-catheter-associated UTI (non-CAUTI), remain a significant source of morbidity and healthcare burden. While CAUTI prevention strategies are well established, non-CAUTIs lack standardized definitions, surveillance protocols, and targeted interventions. To address this gap, consensus recommendations identifying prevention strategies for HOUTIs in adult patients were developed. Methods:A panel of 17 experts in infectious diseases, infection prevention and control, healthcare epidemiology and quality improvement, clinical microbiology, urology, urogynecology, and nursing, participated in a modified Delphi process. An online anonymized survey based on a systematic literature review was completed, before meeting to determine consensus on HOUTI prevention strategies. A further anonymous online survey was shared to finalize recommendations. Thresholds of ≥15/17 panel members in agreement (≥88%) for strong consensus and ≥13/17 (≥76%) for moderate consensus were prospectively set for all statements. Results:Strong consensus was reached on 37 statements spanning surveillance, intervention selection, strategies and maintenance, related care interventions, specimens and cultures, provider training, and outcome assessment. Key topics-particularly those focused on non-CAUTI HOUTI prevention-were identified as important priorities requiring further exploration and research. Conclusions:These recommendations offer the foundation for a structured, scalable framework to reduce the burden of all HOUTIs, while also defining future research priorities. By harmonizing established CAUTI best practices with existing literature, and bridging current evidence gaps for non-CAUTI prevention and management with expert consensus, these recommendations provide a road map for improved prevention strategies for all HOUTIs.

INTRODUCTION:Vaginal estrogen is a highly effective, evidence-based prevention method for postmenopausal women with recurrent urinary tract infections (UTIs), yet studies suggest its underutilization by non-specialist providers. Guided by the Consolidated Framework for Implementation Research (CFIR), this study examined adoption, fidelity, and implementation process variables influencing estrogen prescribing across specialties. METHODS:We conducted a retrospective cohort study of 175 women aged ≥ 65 years with recurrent UTIs seen in the ambulatory setting. Encounters were reviewed for estrogen prescriptions (adoption), documentation of any prevention method (fidelity), and implementation process variables, including reason for visit (acute vs. non-acute) and documentation workflow (structured vs. free-text notes). Estrogen prescriptions and associated factors were compared between specialist (urology, urogynecology) and non-specialist (primary care, general obstetrics-gynecology, other) encounters. RESULTS:Among 175 patients, 111 (63.4%) had seen a specialist, and 64 (36.6%) had not. Non-specialists prescribed 63.3% of antibiotics for 454 UTI encounters but only prescribed vaginal estrogen to 18.3% of patients they evaluated. Overall, 68.6% of patients received estrogen, most during non-acute visits. Estrogen prescribing was higher among patients who saw specialists (88.3% vs. 34.4%, p < 0.001). Non-specialists mostly documented cranberry (58.5%) for prevention of recurrent UTI, whereas specialists predominantly documented estrogen (80.0%). Structured templates were used in 80.0% of specialist notes and none of the non-specialist notes. CONCLUSION:Through the CFIR lens, adoption and fidelity of vaginal estrogen were shaped by clinician knowledge, visit type, and workflow supports. Implementation strategies, like structured documentation templates, referral pathways, and clinical decision support tools, may improve adoption of guideline-based prevention in primary care.

IMPORTANCE:Stool metabolites influencing gut motility and sensation may contribute to fecal incontinence (FI). OBJECTIVE:The objective of this study was to test whether FI is associated with higher levels of butyrate and Clostridiales taxa in stool. STUDY DESIGN:Stool metabolites and microbiota were compared between 96 women with FI and 42 controls. FI frequency and subtype (urgency vs insensible) were measured using a 14-day bowel diary, St. Mark's score, and the Accidental Bowel Leakage questionnaire. Metabolite analysis included targeted analysis (8 short-chain fatty acids including butyrate, 17 bile acids, and 8 tryptophan derivatives) and untargeted analysis. Stool microbiota were characterized using 16S rRNA gene sequencing. Multivariable and exploratory multiomics factor analysis were performed with statistical significance defined as false discovery rate (FDR) ≤0.10. RESULTS:The FI group had a higher proportion of Bristol stool types 2 and 6 than controls (P = 0.005). The mean number of leaks for the FI group was 1.7 ± 1.7 per day, 38% had urgency FI, and 39% had insensible FI. There was no significant difference between groups in butyrate levels and Clostridiales taxa. Multiomics analysis identified glycerolipids (monoacylglycerols and diacylglycerols) associated with FI (FDR = 0.08). In addition, insensible FI was associated with glycerolipids, long-chain saturated and monounsaturated fatty acids, phospholipids, and dipeptides (FDR = 0.08-0.09). The top weighted microbiota associated with these metabolites were Lachnospiraceae and Ruminococcaceae; however, these taxa were not directly associated with FI. CONCLUSION:Butyrate and Clostridiales were not associated with FI. Novel stool metabolite signatures were identified, suggesting new biological pathways and potential therapeutic targets for FI.

IMPORTANCE:In the United States alone, 1.6 million people identify as transgender and gender diverse. Although transgender individuals commonly report lower urinary tract symptoms (LUTS), the factors underlying these symptoms are poorly understood. OBJECTIVES:Our primary aim was to compare the severity and effect of LUTS in transgender men/transmasculine individuals taking testosterone therapy with those not taking testosterone. We hypothesize that patients who are using gender-affirming testosterone have less severe LUTS compared with those who are not receiving such treatment. STUDY DESIGN:We conducted a cross-sectional study of transgender individuals assigned female at birth aged 18 years and older receiving care with Obstetrics and Gynecology and Family Medicine within a single tertiary care hospital system. Our primary outcome was LUTS as measured by the Patient Perception of Bladder Condition, a validated single-item questionnaire that queries if participants have bladder symptoms that cause problems. RESULTS:One hundred thirty-one respondents were included in the analysis: 106 currently taking testosterone and 25 not taking testosterone. Mean age (±SD) for all participants was 30.4 ± 7.2 years. Overall, 108 (82.4%) of participants identified as White and 12 (9.2%) identified as Black. Sixty-nine participants (52.7%) identified as men, and 56 (42.8%) identified as nonbinary. Individuals taking testosterone were 5 times less likely to report moderate-to-severe bladder problems compared with those not taking testosterone: (6.6% [7/106] vs 36% [9/25], P <0.001). CONCLUSIONS:Genderaffirming testosterone therapy was associated with less bothersome LUTS in our population of transgender men/transmasculine individuals. Further research will be necessary to elucidate the nature of and underlying reason for this relationship.

IMPORTANCE:Patient-related factors contribute to unnecessary antibiotics for urinary tract infections (UTI). OBJECTIVE:The objective of this study was to determine the effectiveness of an algorithm-based texting platform for reducing the rate of unnecessary antibiotics in women with recurrent UTI. STUDY DESIGN:Adult women with recurrent UTI were randomized in a 1:1 ratio to a texting platform or usual care at an urban academic center (March 2024 to March 2025). Participants in the texting group received access to an automated bidirectional evidence-based platform for symptom triage, shared decision making, and educational videos. Participants in the usual care group received treatment of UTI from their usual clinicians. The primary outcome was the rate of unnecessary antibiotics at 3 months from randomization. RESULTS:Women with recurrent UTI were randomized to the texting platform (n=51) or usual care (n=51). The mean number of UTI episodes was significantly lower in the texting group than in the usual care group (0.47±0.92 vs. 0.82±1.10, P =0.041). The overall rate of unnecessary antibiotics (11.8%, 95% CI, 4.4-23.9 vs. 29.4%, 95% CI, 17.5-43.8, P =0.028) and rate of unnecessary antibiotics for asymptomatic bacteriuria (2.0%, 95% CI, 0-10.4 vs. 19.6%, 95% CI, 9.8-33.1, P =0.004) were lower in the texting group than in the usual care group. In-person visits and nonbillable messages for UTI were lower in the texting group. Quality-of-life scores did not differ between groups. CONCLUSION:An automated algorithmic texting platform reduced the number of UTI episodes, unnecessary antibiotic prescriptions, and health care utilization in women with recurrent UTI.

Abstract Objective: Ordering urine cultures in the absence of urinary symptoms contributes to unnecessary antibiotic prescribing for urinary tract infection (UTI). The aim of this study was to develop and implement an electronic health record (EHR)-integrated, nurse-led clinical decision support (CDS) tool for UTI symptom triage to support outpatient antibiotic stewardship. Design: Exploratory sequential mixed-methods study. Setting: Urban academic family medicine practice. Participants: Eleven nurses. Methods: In the qualitative phase, workflow mapping and semi-structured interviews informed development of an EHR-integrated CDS consisting of a symptom score calculator and triage algorithm. In the quantitative phase, implementation was evaluated using a pre–post design with interrupted time series analysis over 15 months. Implementation outcomes included adoption, fidelity, and usability. Clinical outcomes included symptom documentation, urine testing practices, and antibiotic prescribing. Safety outcomes included pyelonephritis within 30 days. Results: Qualitative analysis identified four barriers: incomplete symptom documentation, reflexive urine testing, medicolegal concerns about missing pyelonephritis, and patient pressure for antibiotics. The CDS was adopted by all nurses, with 77.8% fidelity and high usability. Documentation of ≥2 UTI-specific symptoms increased at implementation with sustained improvement (slope + 2.4%/month; 95% CI, 0.1–4.7). Urine cultures without microscopy showed sustained reduction (slope −5.5%/month; 95% CI, −7.9 to −3.2). Antibiotic prescribing for asymptomatic bacteriuria decreased (20% to 3%; P = .003) with no increase in pyelonephritis. Conclusions: Nurse-led, EHR-integrated clinical decision support for UTI triage was associated with sustained improvements in symptom documentation, reduced unnecessary urine culture ordering, and decreased antibiotic treatment of asymptomatic bacteriuria without compromising safety.

OBJECTIVE:To compare the long-term pelvic floor subjective and objective outcomes of immediate and delayed pushing in the second stage of labor. METHODS:This was a multicenter randomized controlled trial that included nulliparous patients at 37 weeks of gestation or more in labor with neuraxial analgesia. Participants were randomized in the second stage of labor to immediate pushing or pushing after a 60-minute delay. Pelvic floor assessments were performed 1-5 days, 4-8 weeks, and 2-3 years postpartum. Pelvic organ prolapse quantification (POP-Q) measurements and validated questionnaire score (PFDI-20 [Pelvic Floor Distress Inventory], PFIQ-7 [Pelvic Floor Impact Questionnaire], FISI [Fecal Incontinence Severity Index], and MMHQ [Modified Manchester Health Questionnaire]) assessments were compared within and between the immediate and delayed pushing groups. Pelvic floor questionnaire assessments were performed 1-5 days and 2-3 years postpartum. The POP-Q examinations were performed at 4-8 weeks and 2-3 years postpartum. Changes in questionnaire scores were adjusted for birth weight exceeding 4,000 g and duration of pushing. RESULTS:A total of 2,414 participants were randomized between 2014 and 2017. Three hundred fifty-six women (14.7%) completed pelvic floor assessments at 2-3 years, 175 in the immediate pushing group and 181 in the delayed pushing group. Patients with an interval pregnancy were excluded (n=236). There was no significant difference in POP-Q stage at 2-3 years postpartum. Intergroup and intragroup changes in total and subscale scores for the PFIQ, FISI, and MMHQ were not significantly different at 2-3 years postpartum (-12.8±47.2 vs -22.0±58.7, P =.09; -1.2±8.0 vs -0.6±7.7, P =.56; and 3.1±22.5 vs -0.1±20.2, P =.53, respectively). The changes in PFDI-20 score were not significantly different (3.4±29.1 vs 0.4±36.2, P=.40). However, the Colorectal-Anal Distress Inventory subscale score change was significantly different (2.4±16.0 vs -5.7±15.7, P =.01). CONCLUSION:Among nulliparous patients in the second stage of labor with neuraxial analgesia, immediate compared with delayed pushing did not result in significant differences in POP-Q measures and most pelvic floor symptoms at 2-3 years. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov , NCT02137200.

ImportanceA patient-centered care model is needed for recurrent urinary tract infection (UTI) management.ObjectiveThe aim of this study was to develop a conceptual model for a digital platform to implement evidence-based guidelines for recurrent UTI management.Study DesignThis was a qualitative, 3-stage mixed methods study that included (1) developing an evidence-based prototype texting platform; (2) qualitative feedback from recurrent UTI patients using the platform; and (3) quantitative data on acceptability (proportion of patients engaging with the platform), accuracy (proportion of patient messages interpreted accurately by the platform), and usability (score 0-100).ResultsThirty-one women with recurrent UTI (median age, 71 years; range, 60-74 years) participated in testing over 4 months. The prototype platform was modified through iterative rounds of qualitative and quantitative analysis until engagement >= 85%, accuracy >= 90%, and usability score of >= 80 were achieved in 10 patients. Qualitative feedback indicated that patients valued rapid access to treatment through fewest possible health encounters during an acute episode, evidence-based education about prevention, and ability to participate in self-management with support from health care providers. Based on this feedback, a conceptual model consisting of 3 main components was developed: (1) an algorithm to triage acute symptoms, (2) educational videos emphasizing prevention strategies, and (3) supportive messages. Patient feedback identified 4 key implementation outcomes-usability, acceptability (engagement), fidelity (accuracy), and cost-and 3 clinical outcomes-self-efficacy, health care utilization, and rate of unnecessary antibiotics for testing the model.ConclusionThe proposed model can be used to implement and test a patient-centered evidence-based digital platform for the management of recurrent UTI.

Background: Prior studies have failed to demonstrate clinical or statistical difference in fecal incontinence (FI) symptom improvement with neuromodulation by percutaneous tibial nerve stimulation vs sham. The results of these studies may be indicative of a placebo or sham effect and led us to investigate possible genetic biomarkers of placebo response among women with FI. Objective: To evaluate the relationship between response to percutaneous tibial nerve stimulation or sham and genetic polymorphisms associated with placebo response in women with FI. Findings were validated using an independent cohort of women treated for urgency urinary incontinence with sacral neuromodulation. Study design: Blood specimens were utilized from a subset of women in the Neuromodulation for Accidental Bowel Leakage trial who provided blood samples and consented to their use in future studies (N=96). DNA was extracted and genotyping was performed on single nucleotide polymorphisms (previously associated with placebo response in the following genes: catechol-O-methyltransferase, tryptophan hydroxylase-2, brain-derived neurotropic factor, fatty acid amide hydrolase, mu-opiod receptors. An additive linear regression interaction model adjusted for body mass index, race, baseline fecal incontinence episodes or St. Mark's score was used to identify single nucleotide polymorphism by treatment interaction effects significantly associated with change from baseline in St. Mark's score after a 12-week intervention and secondary outcomes. In the absence of significant interaction, single nucleotide polymorphism main effects were tested. Replication of the findings was assessed with an independent cohort of women participating in a randomized trial of urgency urinary incontinence sacral neuromodulation vs onabotulinumtoxinA for treatment of urgency urinary incontinence. Results: There were no differences in age, body mass index, fecal incontinence episodes, or St. Mark's score at baseline or follow-up between percutaneous tibial nerve stimulation (n=64) vs sham (n=32) participants. There was a significant interaction (P<.1) between the catechol-O-methyltransferase single nucleotide polymorphism and treatment group for improvement in St. Mark's score (interaction P=.02), improvement in fecal incontinence episodes (interaction P=.01), and Patient Global Impression of Improvement (interaction P=.06). Percutaneous tibial nerve stimulation treated participants with the catechol-O-methyltransferase Met allele had the greatest improvements (St. Mark's score improvement: 1.72, 95% confidence interval=[-0.04 to 3.49], P=.06; fecal incontinence episode improvement: 2.36 episodes per week, 95% confidence interval=[0.97-3.75], P=.001; and Patient Global Impression of Improvement: odds ratio (OR)=2.00; 95% confidence interval=[0.96-4.14], P=.06). There was no association between catechol-O-methyltransferase and treatment response in sham treated participants. No significant interaction or main effects were observed for other single nucleotide polymorphisms. In an independent study of urinary incontinence, there were positive significant associations for Patient Global Impression of Improvement urinary leak (OR 2.41, 95% confidence interval =[1.27-4.55], P=.007) and Patient Global Impression of Improvement bladder function (OR 2.10, 95% confidence interval =[1.10-4.01], P=.03 with the Met allele in women treated with sacral neuromodulation . No association was seen in the onabotulinumtoxinA group. Conclusion: Unexpectedly, women who were homozygous for the catechol-O-methyltransferase Met allele (Met/Met) had a significantly higher likelihood of responding to FI treatment via neuromodulation by percutaneous tibial nerve stimulation, but not to sham treatment. This finding was confirmed in a separate study, which found that UI treatment response to neuromodulation by sacral neuromodulation was significantly more likely in women with the catechol-O-methyltransferase Met allele (Met/Met) genotype.

Mixed urinary incontinence, which includes both stress and urgency urinary incontinence, adversely affects quality of life and can be difficult to manage. Studies comparing procedural-based treatments for mixed urinary incontinence are lacking. To determine whether intradetrusor onabotulinumtoxinA is more effective than midurethral sling for the treatment of mixed urinary incontinence in females. Randomized, superiority trial involving females (aged ≥21 years) with moderate to severe bother from both stress and urgency urinary incontinence who had unsuccessful conservative treatments and oral medications. The study was conducted at 7 US sites with enrollment between July 2020 and September 2022; the last date of follow-up was December 29, 2023. Intradetrusor injection of onabotulinumtoxinA, 100 U (treatment focused on the urgency component), vs surgical synthetic mesh midurethral sling (treatment focused on the stress component). Recipients of onabotulinumtoxinA could receive an additional injection between 3 and 6 months. All participants could receive additional treatment (including crossover to the alternative treatment) between 6 and 12 months. The primary outcome was change at 6 months in mixed incontinence symptoms as measured by the Urogenital Distress Inventory (UDI) total score (0-300 points; higher scores indicate worse symptoms; minimal clinically important difference, 26.1). Secondary outcomes included stress and irritative UDI subscores. Among 150 females randomized, 137 were treated, had postbaseline outcome data, and were included in the primary analysis (mean [SD] age, 59.0 [11.5] years). Both groups demonstrated mean improvement in UDI total score at 6 months with no significant difference between groups (onabotulinumtoxinA: −66.8 points [95% CI, −84.9 to −48.8]; sling: −84.9 [95% CI, −100.5 to −69.3]; mean difference, 18.1 points [95% CI, −4.6 to 40.7]; P = .12). For secondary outcomes, greater UDI stress score improvement was seen with the sling (−45.2 [95% CI, −53.7 to −36.8]) compared with onabotulinumtoxinA (−25.1 [95% CI, −34.1 to −16.1]) (P < .001); however, no significant difference was seen between groups in UDI irritative score (onabotulinumtoxinA: −32.9 [95% CI, −40.3 to −25.6] vs sling: –27.4 [95% CI, −34.6 to −20.3]; P = .27). In the onabotulinumtoxinA group, 12.7% and 28.2% received a second injection by 6 and 12 months, respectively. By 12 months, 30.3% in the sling group received onabotulinumtoxinA, and 15.5% in the onabotulinumtoxinA group received a sling. Overall, adverse events were not different between groups. There was no observed difference in UDI total score improvement at 6 months between the onabotulinumtoxinA and midurethral sling groups in females with moderate to severe mixed urinary incontinence who previously did not respond to conservative treatments. These findings may help inform treatment decisions based on patient preference in partnership with clinician recommendations. ClinicalTrials.gov Identifier: NCT04171531

Importance:Mixed urinary incontinence, which includes both stress and urgency urinary incontinence, adversely affects quality of life and can be difficult to manage. Studies comparing procedural-based treatments for mixed urinary incontinence are lacking. Objective:To determine whether intradetrusor onabotulinumtoxinA is more effective than midurethral sling for the treatment of mixed urinary incontinence in females. Design, Setting, and Participants:Randomized, superiority trial involving females (aged ≥21 years) with moderate to severe bother from both stress and urgency urinary incontinence who had unsuccessful conservative treatments and oral medications. The study was conducted at 7 US sites with enrollment between July 2020 and September 2022; the last date of follow-up was December 29, 2023. Interventions:Intradetrusor injection of onabotulinumtoxinA, 100 U (treatment focused on the urgency component), vs surgical synthetic mesh midurethral sling (treatment focused on the stress component). Recipients of onabotulinumtoxinA could receive an additional injection between 3 and 6 months. All participants could receive additional treatment (including crossover to the alternative treatment) between 6 and 12 months. Main Outcomes and Measures:The primary outcome was change at 6 months in mixed incontinence symptoms as measured by the Urogenital Distress Inventory (UDI) total score (0-300 points; higher scores indicate worse symptoms; minimal clinically important difference, 26.1). Secondary outcomes included stress and irritative UDI subscores. Results:Among 150 females randomized, 137 were treated, had postbaseline outcome data, and were included in the primary analysis (mean [SD] age, 59.0 [11.5] years). Both groups demonstrated mean improvement in UDI total score at 6 months with no significant difference between groups (onabotulinumtoxinA: -66.8 points [95% CI, -84.9 to -48.8]; sling: -84.9 [95% CI, -100.5 to -69.3]; mean difference, 18.1 points [95% CI, -4.6 to 40.7]; P = .12). For secondary outcomes, greater UDI stress score improvement was seen with the sling (-45.2 [95% CI, -53.7 to -36.8]) compared with onabotulinumtoxinA (-25.1 [95% CI, -34.1 to -16.1]) (P < .001); however, no significant difference was seen between groups in UDI irritative score (onabotulinumtoxinA: -32.9 [95% CI, -40.3 to -25.6] vs sling: -27.4 [95% CI, -34.6 to -20.3]; P = .27). In the onabotulinumtoxinA group, 12.7% and 28.2% received a second injection by 6 and 12 months, respectively. By 12 months, 30.3% in the sling group received onabotulinumtoxinA, and 15.5% in the onabotulinumtoxinA group received a sling. Overall, adverse events were not different between groups. Conclusions and Relevance:There was no observed difference in UDI total score improvement at 6 months between the onabotulinumtoxinA and midurethral sling groups in females with moderate to severe mixed urinary incontinence who previously did not respond to conservative treatments. These findings may help inform treatment decisions based on patient preference in partnership with clinician recommendations. Trial Registration:ClinicalTrials.gov Identifier: NCT04171531.

INTRODUCTION:We developed an algorithm-based mobile texting platform for promoting self-management in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). Our aim was to measure the feasibility, usability, and potential utility of the platform. METHODS:A texting platform that delivered 4 treatment modules (education and behavioral modification, cognitive behavioral therapy, pelvic floor physical therapy, and guided mindfulness practices) and an automated weekly message over 6 weeks was developed. Feasibility and usability were determined using patient engagement (proportion of platform messages to which patients responded) and System Usability Scale. Satisfaction with patient-physician communication questionnaire, Pain Self-Efficacy Scale, and Interstitial Cystitis Symptom and Problem Index were administered before and after the intervention. RESULTS:Engagement with the platform in 52 female patients with IC/BPS (median age [IQR] 40 [30-48] years) was 76.9%. The commonest module selected by patients was pelvic floor physical therapy (50%) followed by cognitive behavioral therapy (34%) and guided mindfulness (15%). System usability score (median, IQR) was 87 (83-95), indicating high usability. Satisfaction with patient-physician communication improved significantly (median change, 4; IQR, 1-9; P < .001). Pain self-efficacy score improved from moderate impairment at baseline to minimal impairment at 6 weeks (median change, 10; IQR, 2-18; P < .001). Urinary symptoms scores also improved (median change Interstitial Cystitis Symptom Index, -3; IQR, -5 to -1.5; P < .001, Problem Index, -2; IQR, 5.5 to -0.5; P < .001). CONCLUSIONS:An automated mobile platform has the potential for improving access to self-management strategies and easing clinicians' challenge of counseling patients with IC/BPS during time-limited in-person visits. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT05260112.

OBJECTIVE:The impact of frailty and compromised mobility on immediate postoperative complications, geriatric outcomes, and treatment failure after prolapse surgery remains uncertain. The objective of this study was to prospectively characterize frailty and mobility and their impact on immediate postoperative complications, geriatric outcomes, and treatment success in older patients undergoing major urogynecologic surgery for pelvic organ prolapse. STUDY DESIGN:A nested prospective cohort study within a 3-arm randomized clinical trial was conducted at 9 clinical sites in 146 participants. Participants aged ≥65 years with symptomatic vaginal vault prolapse underwent baseline assessments of frailty and compromised mobility. Frailty was measured using the Robinson Frailty Index. The Robinson Frailty Index score ranges from 0 to 7 and scores ≥2 were considered prefrail/frail. Compromised mobility was defined as Timed Up and Go ≥15 seconds, use of an assistive device, or observed gait difficulties. The primary outcome was immediate postoperative moderate to severe adverse events assessed according to the Clavien-Dindo Severity Classification (grade≥II). Geriatric-specific outcomes included 30-day postoperative complications, need for increased social support assessed 6 weeks postoperatively, falls, new admission to skilled nursing facilities, all-cause hospital admissions, and mortality. Treatment outcome was time to composite treatment failure. Geriatric and treatment outcomes were assessed biannually for 36 up to 60 months. RESULTS:146 supplemental study participants underwent randomized prolapse surgery in the main trial: 50 in the transvaginal native tissue repair, 47 in the abdominal sacral colpopexy, and 48 in the transvaginal mesh repair arms. Compared with nonfrail subjects, prefrail/frail participants experienced no difference in geriatric-specific outcomes. Prefrail/frail participants living alone before surgery were more likely to require support (family/friends or assistance) in the first 6 weeks after surgery (19% vs 6%, P=.04). Prefrail/frail and compromised mobility participants had a shorter time to surgical treatment failure than did nonfrail or noncompromised patients (frail vs nonfrail adjusted hazard ratio, 2.1; 95% confidence interval, 1.2, 3.6). CONCLUSION:Despite measurable frailty or compromised mobility, many older patients underwent prolapse surgery with few complications; however, enhanced social support was needed in the first 6 weeks after surgery. Treatment failure was higher in patients with preoperative frailty, suggesting that frailty is important to incorporate in surgical treatment planning for the correction of pelvic organ prolapse in older patients.

ImportanceThis review aimed to describe research initiatives, evolution, and processes of the Eunice Kennedy Shriver National Institute of Child Health and Human Development-supported Pelvic Floor Disorders Network (PFDN). This may be of interest and inform researchers wishing to conduct multisite coordinated research initiatives as well as to provide perspective to all urogynecologists regarding how the PFDN has evolved and functions.Study DesignPrincipal investigators of several PFDN clinical sites and Data Coordinating Center describe more than 20 years of development and maturation of the PFDN.ResultsOver two decades, the PFDN used an intentionally driven approach to answering clinically important questions to inform the surgical and nonsurgical care of women with pelvic floor disorders (PFDs) including pelvic organ prolapse, urinary incontinence, and fecal incontinence. From its inception, the PFDN refined network procedures and processes affecting trial design, protocol development, and standardization of outcomes and publications. This strategy resulted in a credible, robust, and productive portfolio of randomized clinical trials, secondary analyses, prospective cohort, and supplementary studies emphasizing the use of validated patient-reported outcomes, longer-term outcomes, an increase in translational science aims, and standardized long-term collection of adverse events.ConclusionsThe processes the PFDN has developed and implemented have led to impactful research initiatives in women's PFDs. Patient participants and research coordinators have been an integral part of this contribution. Through consistent funding and committed investigators, the state of science in the surgical and nonsurgical care and understanding of PFD pathophysiology has been advanced.

Urgency urinary incontinence (UUI), a risk factor for falls, affects 40

Transgender men and transmasculine individuals report a variety of lower urinary tract symptoms (LUTS), but little is known about LUTS in this population. One of the obstacles is the lack of validated questionnaires. This study was aimed at validating the International Consultation on Incontinence Questionnaire–Lower Urinary Tract Symptoms (ICIQ-LUTS), which measures filling, voiding, and incontinence symptoms, in transmasculine individuals. This is an observational validation study that included transmasculine individuals receiving care within a single tertiary care hospital system. Construct validity was assessed by comparing the ICIQ-LUTS with severity of LUTS as measured by the Urinary Distress Inventory–Short Form (UDI-6), and concurrent validity by the association between ICIQ-LUTS and the Patient Perception of Bladder Condition (PPBC). Discriminant validity was determined by comparing ICIQ-LUTS scores in those with and those without self-reported LUTS. Spearman correlation, t test, and Kruskal–Wallis test were used for data analysis. A total of 131 respondents were included in the analysis. Only two individuals (1.5

IMPORTANCE:Although there is a known association between urinary incontinence (UI) and fall risk, it is unclear if having both UI and fecal incontinence, or dual incontinence (DI), increases this risk. OBJECTIVE:The objective of our study was to elucidate a relationship between DI and falls. STUDY DESIGN:This was a retrospective cohort study at a tertiary academic health system of female patients 65 years and older presenting for a new patient visit to a urogynecology health care professional for UI from 2019 to 2021. Demographic data and responses to intake questionnaires on fall and markers of frailty were extracted. Multivariable logistic regression was performed to identify factors associated with fall adjusting for covariates identified upon univariate comparison. RESULTS:A total of 2,814 women were included in the analysis; 2,661 patients reported UI alone, and 153 reported DI. A greater proportion of women with DI reported a fall in the past year compared with those with UI alone (22.9% vs 12.2%, P < 0.001). Univariable comparison showed that these 2 groups differed regarding age, body mass index, and estimated median household income. On multivariable logistic regression, DI was significantly associated with falls (adjusted odds ratio 2.56; 95% confidence interval, 1.02-5.46). Other factors independently associated with falls in older women with UI include (adjusted odds ratio, 95% confidence interval): lower income groups (2.35, 1.50-3.67 for $20,000-$40,000, compared with $100,000 and higher-income group), difficulty with activities of daily living (1.60, 1.25-2.13), and unintentional weight loss (1.68, 1.05-2.68). CONCLUSION:Patients with DI have a 2-fold higher risk of fall compared with patients with UI alone.

Importance The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined. Objective To compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy. Design, Setting, and Participants This was a multisite, 3-arm, superiority and noninferiority randomized clinical trial. Outcomes were assessed biannually up to 60 months, until the last participant reached 36 months of follow-up. Settings included 9 clinical sites in the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Between February 2016 and April 2019, women with symptomatic vaginal vault prolapse after hysterectomy who desired surgical correction were randomized. Data were analyzed from November 2022 to January 2023. Interventions Mesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair. Main Outcomes and Measures The primary outcome was time until composite treatment failure (including retreatment for prolapse, prolapse beyond the hymen, or prolapse symptoms) evaluated with survival models. Secondary outcomes included patient-reported symptom-specific results, objective measures, and adverse events. Results Of 376 randomized participants (mean [SD] age, 66.1 [8.7] years), 360 (96%) had surgery, and 296 (82%) completed follow-up. Adjusted 36-month failure incidence was 28% (95% CI, 20%-37%) for sacrocolpopexy, 29% (95% CI, 21%-38%) for transvaginal mesh, and 43% (95% CI, 35%-53%) for native tissue repair. Sacrocolpopexy was found to be superior to native tissue repair (adjusted hazard ratio [aHR], 0.57; 99% CI, 0.33-0.98; P = .01). Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60; 99% CI, 0.34-1.03; P = .02) but was noninferior to sacrocolpopexy (aHR, 1.05; 97% CI, 0-1.65; P = .01). All 3 surgeries resulted in sustained benefits in subjective outcomes. Mesh exposure rates were low (4 of 120 [3%] for sacrocolpopexy and 6 of 115 [5%] for transvaginal mesh) as were the rates of dyspareunia. Conclusions and Relevance Among participants undergoing apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates at study completion; both had lower failure rates than native tissue repair, although only sacrocolpopexy met a statistically significant difference. Low rates of mesh complications and adverse events corroborated the overall safety of each approach. Trial Registration ClinicalTrials.gov Identifier: NCT02676973

BACKGROUND:Serious illness conversations (SICs) in the outpatient setting may improve mood and quality of life among patients with cancer and decrease aggressive end-of-life care. Interventions informed by behavioral economics may increase rates of SICs between oncology clinicians and patients, but the impact of these interventions on end-of-life spending is unknown. METHODS:This study is a secondary analysis of a stepped-wedge cluster randomized, controlled trial that involved nine medical oncology practices and their high-risk patients at a large academic institution between June 2019 and April 2020. The study included 1187 patients who were identified by a machine-learning algorithm as high risk of 180-day mortality and who died by December 2020. The patients were randomly assigned to standard of care (controls) or to a behavioral intervention designed to increase clinician-initiated SICs. We abstracted spending - defined as inflation-adjusted costs for acute care (inpatient plus emergency room), office/outpatient care, intravenous systemic therapy, other therapy (e.g., radiation), long-term care, and hospice - from the institution's accounting system, and we captured spending at inpatient, outpatient, and pharmacy settings. To evaluate intervention impacts on spending, we used a two-part model, first using logistic regression to model zero versus nonzero spending and second using generalized linear mixed models with gamma distribution and log-link function to model daily mean spending in the last 180days of life. Models were adjusted for clinic and wedge fixed effects, and they were clustered at the oncologist level. For all patients with at least one SIC within 6 months of death, we also calculated their mean daily spending before and after SIC. RESULTS:Median age at death was 68years (interquartile range, 15.5), 317 patients (27%) were Black or of ethnicities other than white, and 448 patients (38%) had an SIC. The intervention was associated with lower unadjusted mean daily spending in the last 6 months of life for the intervention group versus controls ($377.96 vs. $449.92; adjusted mean difference, -$75.33; 95% confidence interval, -$136.42 to -$14.23; P=0.02), translating to $13,747 total adjusted savings per decedent and $13 million in cumulative savings across all decedents in the intervention group. Compared with controls, patients in the intervention group incurred lower mean daily spending for systemic therapy (adjusted difference, -$44.59; P=0.001), office/outpatient care (-$9.62; P=0.001), and other therapy (-$8.65; P=0.04). The intervention was not associated with differences in end-of-life spending for acute care, long-term care, or hospice. Results were consistent for spending in the last 1 and 3 months of life and after adjusting for age, race, and ethnicity. For patients with SICs, mean daily spending decreased by $37.92 following the first SIC ($329.87 vs. $291.95). CONCLUSIONS:A machine learning-based, behaviorally informed intervention to prompt SICs led to end-of-life savings among patients with cancer, driven by decreased systemic therapy and outpatient spending. (Funded by the Penn Center for Precision Medicine and the National Institutes of Health; ClinicalTrials.gov number, NCT03984773.).