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In August 2013, the National Institutes of Health sponsored a conference to address major gaps in our understanding of the epidemiology, pathophysiology, and management of fecal incontinence (FI) and to identify topics for future clinical research. This article is the first of a two-part summary of those proceedings. FI is a common symptom, with a prevalence that ranges from 7 to 15% in community-dwelling men and women, but it is often underreported, as providers seldom screen for FI and patients do not volunteer the symptom, even though the symptoms can have a devastating impact on the quality of life. Rough estimates suggest that FI is associated with a substantial economic burden, particularly in patients who require surgical therapy. Bowel disturbances, particularly diarrhea, the symptom of rectal urgency, and burden of chronic illness are the strongest independent risk factors for FI in the community. Smoking, obesity, and inappropriate cholecystectomy are emerging, potentially modifiable risk factors. Other risk factors for FI include advanced age, female gender, disease burden (comorbidity count, diabetes), anal sphincter trauma (obstetrical injury, prior surgery), and decreased physical activity. Neurological disorders, inflammatory bowel disease, and pelvic floor anatomical disturbances (rectal prolapse) are also associated with FI. The pathophysiological mechanisms responsible for FI include diarrhea, anal and pelvic floor weakness, reduced rectal compliance, and reduced or increased rectal sensation; many patients have multifaceted anorectal dysfunctions. The type (urge, passive or combined), etiology (anorectal disturbance, bowel symptoms, or both), and severity of FI provide the basis for classifying FI; these domains can be integrated to comprehensively characterize the symptom. Several validated scales for classifying symptom severity and its impact on the quality of life are available. Symptom severity scales should incorporate the frequency, volume, consistency, and nature (urge or passive) of stool leakage. Despite the basic understanding of FI, there are still major knowledge gaps in disease epidemiology and pathogenesis, necessitating future clinical research in FI.

Urobiome research has the potential to advance the understanding of a wide range of diseases, including lower urinary tract symptoms and kidney disease. Many scientific areas have benefited from early research method consensus to facilitate the greater, common good. Urobiome research has the potential to advance the understanding of a wide range of diseases, including lower urinary tract symptoms and kidney disease. Many scientific areas have benefited from early research method consensus to facilitate the greater, common good. This consensus document, developed by a group of expert investigators currently engaged in urobiome research (UROBIOME 2020 conference participants), aims to promote standardization and advances in this field by the adoption of common core research practices. We propose a standardized nomenclature as well as considerations for specimen collection, preservation, storage, and processing. Best practices for urobiome study design include our proposal for standard metadata elements as part of core metadata collection. Although it is impractical to follow fixed analytical procedures when analyzing urobiome data, we propose guidelines to document and report data originating from urobiome studies. We offer this first consensus document with every expectation of subsequent revision as our field progresses.

Introduction and hypothesis The purpose of this study is to identify risk factors for mesh erosion in women undergoing minimally invasive sacrocolpopexy (MISC). We hypothesize that erosion is higher in subjects undergoing concomitant hysterectomy. Methods This is a retrospective cohort study of women who underwent MISC between November 2004 and January 2009. Demographics, operative techniques, and outcomes were abstracted from medical records. Multivariable regression identified odds of erosion. Results Of 188 MISC procedures 19(10%) had erosions. Erosion was higher in those with total vaginal hysterectomy (TVH) compared to both post-hysterectomy (23% vs. 5%, p  = 0.003) and supracervical hysterectomy (SCH) (23% vs. 5%, p  = 0.109) groups. In multivariable regression, the odds of erosion for TVH was 5.67 (95% CI: 1.88–17.10) compared to post-hysterectomy. Smoking, the use of collagen-coated mesh, transvaginal dissection, and mesh attachment transvaginally were no longer significant in the multivariable regression model. Conclusion Based on this study, surgeons should consider supracervical hysterectomy over total vaginal hysterectomy as the procedure of choice in association with MISC unless removal of the cervix is otherwise indicated.

Background The burden of urinary incontinence (UI) on the American public is great. The impact of this condition will only continue to rise as the population ages, yet the quality of care provided at the primary care level has been inadequate to date. The Optimizing Primary Care Tools for Incontinence MAnagement (OPTIMA) study has been designed as a four-pronged, practice-based incontinence intervention aimed at improving the management of UI by primary care providers (PCP). Methods In this pragmatic cluster randomized controlled trial, providers across four Southern California healthcare systems are randomized at the office level to receive incontinence intervention ( n = 24 offices; 72 providers) vs. a non-intervention routine primary care cohort ( n = 24 offices; 72 providers). The intervention includes (i) academic detailing with physician education and individual performance feedback; (ii) clinical decision support with note templates, order sets, and pop-up EHR alerts; (iii) access to co-management with a dedicated advanced practice provider; and (iv) implementation of an electronic referral service in which a specialist screens referrals for appropriateness. To achieve adequate power, the study will require 720 patients (360 patients per arm, average of 15 patients per office). The primary provider outcome is the quality of UI care, as measured by adherence to a set of 13 quality indicators (QIs) on a 6-month chart review. Secondary provider outcomes include specialty referral rates (overall specialist referrals and presence of appropriate delay of referral) and disease-specific knowledge measured by the Pelvic Floor Awareness and Knowledge Survey (PFAKS). Patient self-reported outcomes include disease-specific knowledge measured by PFAKS, UI severity measured by the International Consultation on Incontinence Questionnaire (ICIQ-SF) and Urinary Distress Inventory (UDI-6), UI response to therapy measured by Patient Global Impression of Improvement (PGI-I), and patient-perceived shared decision making via the 9-item Shared Decision Making Questionnaire (SDM-Q-9). Patient outcomes are measured at baseline, 3-, and 6-month timepoints post-appointment with the study provider. Discussion We expect this study to determine the efficacy and impact of comprehensive practice-based interventions on provider quality for UI care. Trial registration The study is registered at ClinicalTrials.gov (NCT05534412). Registered on August 1, 2022.

Given the growing impact of antimicrobial resistance, improvements in diagnosis and treatment of the most common outpatient infection, urinary tract infection (UTI), are of great interest to stakeholders. Regulatory authorities have long accepted a microbial threshold of [10.sup.5] CFU/mL as the standard for diagnosing UTI based on standard urine cultures. However, microbial thresholds considered clinically relevant remain in dispute. The aim of this systematic scoping review is to assess the evidence supporting a threshold of [10.sup.5] CFU/mL, to review microbial threshold guidelines, and highlight knowledge gaps in the diagnosis of UTI. A total of 36 guidelines containing 144 recommendations were identified with 64% of guidelines (n = 23) and 58% of recommendations (n = 83) published in the last six years (2016-2023). Recommendations have changed over time and across variables including the geographical location of the guideline, urine specimen collection method, patient sex, and category of UTI. Guidelines uniformly agreed with suprapubic needle specimen collection; however, there was no consensus for midstream collected urine samples. Guideline microbial thresholds for clinical UTI diagnosis were higher for women at average risk ([10.sup.5] CFU/mL) than for men ([10.sup.2] to [10.sup.5] CFU/mL) and high-risk patients ([10.sup.2] to [10.sup.4] CFU/mL). Guidelines relied heavily on 48 research articles from 20 author teams published between 1956 and 2019 and recommendations frequently cited 23 research articles by 15 author teams published between 1956 and 2013. Evidence supporting [10.sup.5] CFU/mL threshold originated in the mid-1950s from 4 research articles, whereas 18 frequently cited peer-reviewed publications focused their research on the clinical relevance of lower thresholds (101 to <[10.sup.5] CFU/mL). This review demonstrates a lack of consensus for urine culture microbial threshold recommendations for the clinical diagnosis of UTI. Guidelines are primarily based upon sparse and dated evidence. Additional research is needed to inform clinically meaningful diagnostic microbial thresholds in the diagnosis of UTI. Keywords: urinary tract infection, guideline, microbial, diagnostic threshold, uropathogen, scoping systematic review

First-line conservative treatment for stress urinary incontinence (SUI) in women is behavioral intervention, including pelvic-floor muscle (PFM) exercise and bladder control strategies. The purposes of this study were: (1) to describe adherence and barriers to exercise and bladder control strategy adherence and (2) to identify predictors of exercise adherence. This study was a planned secondary analysis of data from a multisite, randomized trial comparing intravaginal continence pessary, multicomponent behavioral therapy, and combined therapy in women with stress-predominant urinary incontinence (UI). Data were analyzed from the groups who received behavioral intervention alone (n=146) or combined with continence pessary therapy (n=150). Adherence was measured during supervised treatment and at 3, 6, and 12 months post-randomization. Barriers to adherence were surveyed during treatment and at the 3-month time point. Regression analyses were performed to identify predictors of exercise adherence during supervised treatment and at the 3- and 12-month time points. During supervised treatment, ≥86% of the women exercised ≥5 days a week, and ≥80% performed at least 30 contractions on days they exercised. At 3, 6, and 12 months post-randomization, 95%, 88%, and 80% of women, respectively, indicated they were still performing PFM exercises. During supervised treatment and at 3 months post-randomization, ≥87% of the women reported using learned bladder control strategies to prevent SUI. In addition, the majority endorsed at least one barrier to PFM exercise, most commonly \"trouble remembering to do exercises.\" Predictors of exercise adherence changed over time. During supervised intervention, less frequent baseline UI and higher baseline 36-Item Short-Form Health Survey (SF-36) mental scores predicted exercise adherence. At 3 months post-randomization, women who dropped out of the study had weaker PFMs at baseline. At 12 months post-randomization, only \"trouble remembering\" was associated with exercise adherence. Adherence and barrier questionnaires were not validated. Adherence to PFM exercises and bladder control strategies for SUI can be high and sustained over time. However, behavioral interventions to help women link exercise to environmental and behavioral cues may only be beneficial over the short term.

The urogenital microbiome is an understudied yet important human microbiome niche. Research has been stimulated by the relatively recent discovery that urine is not sterile; urinary tract microbes have been linked to health problems, including urinary infections, incontinence, and cancer. Replicability is a well-established challenge in microbiome research with a variety of contributing factors at all stages, from sample collection to code execution. Here, we focus on voided urine sample storage conditions for urogenital microbiome analysis. Using urine samples collected from 10 adult females, we investigated the microbiome preservation efficacy of AssayAssure Genelock (Genelock), compared with no preservative, under different temperature conditions. We varied temperature over 48 h in order to examine the impact of conditions samples may experience with home voided urine collection and shipping to a central biorepository. The following common lab and shipping conditions were investigated: −20°C, ambient temperature, 4°C, freeze-thaw cycle, and heat cycle. At 48 h, all samples were stored at −80°C until processing. After generating 16S rRNA gene amplicon sequencing data using the highly sensitive KatharoSeq protocol, we observed individual variation in both alpha and beta diversity metrics below interhuman differences, corroborating reports of individual microbiome variability in other specimen types. While there was no significant difference in beta diversity when comparing Genelock versus no preservative, we did observe a higher concordance with Genelock samples shipped at colder temperatures (–20°C and 4°C) when compared with the samples shipped at −20°C without preservative. Our results indicate that Genelock does not introduce a significant amount of microbial bias when used on a range of temperatures and is most effective at colder temperatures. IMPORTANCE The urogenital microbiome is an understudied yet important human microbiome niche. Research has been stimulated by the relatively recent discovery that urine is not sterile; urinary tract microbes have been linked to health problems, including urinary infections, incontinence, and cancer. The quality of life and economic impact of UTIs and urgency incontinence alone are enormous, with$3.5 billion and $ 82.6 billion, respectively, spent in the United States. annually. Given the low biomass of urine, novelty of the field, and limited reproducibility evidence, it is critical to study urine sample storage conditions to optimize scientific rigor. Efficient and reliable preservation methods inform methods for home self-sample collection and shipping, increasing the potential use in larger-scale studies. Here, we examined both buffer and temperature variation effects on 16S rRNA gene amplicon sequencing results from urogenital samples, providing data on the consequences of common storage methods on urogenital microbiome results.

OBJECTIVES/GOALS: Women and healthcare providers from underserved rural and urban communities participated in Community Engagement (CE) studios to offer perspectives for increasing research participation of women from diverse backgrounds prior to initiating recruitment for a randomized-controlled trial comparing treatments for urgency urinary incontinence. METHODS/STUDY POPULATION: CE studios are listening sessions to gather patient or community input on specific study areas of interest before implementation. Ten CE studios were held via Zoom at five study sites (Rhode Island, Washington DC, Alabama, New Mexico, and Southern California). Each site held two studios: 1) women living with urgency urinary incontinence, 2) clinicians providing care in their areas. Participants gave recommendations on ways to increase study participation of women from diverse racial and ethnic backgrounds with a focus on recruitment and retention, identification of barriers to participation, and suggested approaches to overcome those barriers. Summaries were compiled from each CE studio to identify similar and contrasting recommendations across sites. RESULTS/ANTICIPATED RESULTS: A total of 80 participants (47 community women experiencing urgency urinary incontinence, and 33 healthcare professionals) participated across all sites. Studio participants discussed anticipated barriers for participant recruitment and retention with a focus on solutions to those barriers. Based on these suggestions, we created recruitment materials using pictures, videos, and simple terminology. We created educational content to help providers with current best practices for urinary urgency incontinence. We have allowed most study visits to be conducted virtually, identified affiliated clinics in various locations to improve proximity to undeserved communities, and have earmarked additional funds to help offset travel costs including gas, public transportation, and childcare. DISCUSSION/SIGNIFICANCE: CE studios have provided pragmatic patient- and provider-centered recommendations that have been incorporated into functional strategies to improve research participation and diversity. CTSA CE core expertise can support successful CE studio planning and implementation.

Background Bladder health is an understudied state and difficult to measure due to lack of valid and reliable instruments. While condition specific questionnaires assess presence, severity and degree of bother from lower urinary tract symptoms, the absence of symptoms is insufficient to assume bladder health. This study describes the methodology used to validate a novel bladder health instrument to measure the spectrum of bladder health from very healthy to very unhealthy in population based and clinical research. Methods Three samples of women are being recruited: a sample from a nationally representative general population and two locally recruited clinical center samples—women with a targeted range of symptom severity and type, and a postpartum group. The general population sample includes 694 women, 18 years or older, randomly selected from a US Postal delivery sequence file. Participants are randomly assigned to electronic or paper versions of the bladder health instrument along with a battery of criterion questionnaires and a demographic survey; followed by a retest or a two-day voiding symptom diary. A total of 354 women around 7 clinical centers are being recruited across a spectrum of self-reported symptoms and randomized to mode of completion. They complete the two-day voiding symptom diary as well as a one-day frequency volume diary prior to an in-person evaluation with a standardized cough stress test, non-invasive urine flowmetry, chemical urine analysis and post void residual measurement. Independent judge ratings of bladder health are obtained by interview with a qualified health care provider. A total of 154 postpartum women recruited around 6 of the centers are completing similar assessments within 6–12 weeks postpartum. Dimensional validity will be evaluated using factor analysis and principal components analysis with varimax rotation, and internal consistency with Cronbach’s alpha. Criterion validity will be assessed using multitrait-multimethod matrix including correlations across multiple data sources and multiple types of measures. Discussion We aim to validate a bladder health instrument to measure the degree of bladder health within the general population and among women (including postpartum) recruited from local clinical centers. Trial registration NCT04016298 Posted July 11, 2019 ( https://www.clinicaltrials.gov/ct2/show/NCT04016298?cond=bladder+health&draw=2&rank=1 ).

Standardized conditions for collection, preservation and storage of urine for microbiome research have not been established. We aimed to identify the effects of the use of preservative AssayAssure® (AA), and the effects of storage time and temperatures on reproducibility of urine microbiome results. We sequenced the V3–4 segment of the 16S rRNA gene to characterize the bacterial community in the urine of a cohort of women. Each woman provided a single voided urine sample, which was divided into aliquots and stored with and without AA, at three different temperatures (room temperature [RT], 4 °C, or −20 °C), and for various time periods up to 4 days. There were significant microbiome differences in urine specimens stored with and without AA at all temperatures, but the most significant differences were observed in alpha diversity (estimated number of taxa) at RT. Specimens preserved at 4 °C and −20 °C for up to 4 days with or without AA had no significant alpha diversity differences. However, significant alpha diversity differences were observed in samples stored without AA at RT. Generally, there was greater microbiome preservation with AA than without AA at all time points and temperatures, although not all results were statistically significant. Addition of AA preservative, shorter storage times, and colder temperatures are most favorable for urinary microbiome reproducibility.