Development of a patient-centered text message-based platform for the self-management of interstitial cystitis/bladder pain syndrome symptoms.

OBJECTIVE: To develop a patient-centered text message-based platform that promotes self-management of symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: Adult women with IC/BPS interested in initiating a first- or second-line treatments per American Urological Association guidelines (recategorized as "behavioral/non-pharmacologic treatments" and "oral medicines" in the 2022 version) participated in rapid cycle innovation consisting of iterative cycles of contextual inquiry, prototype design and development. We delivered treatment modules and supportive messages using an algorithm-driven interactive messaging prototype through a HIPAA-compliant texting platform. Patients provided feedback through narrative text messages and an exit interview. Feedback was analyzed qualitatively and used to iteratively revise the platform until engagement ≥ 85% and accuracy ≥ 80% were achieved. The final version consisted of four treatment module categories (patient education and behavioral modification, cognitive behavioral therapy, pelvic floor physical therapy, and guided mindfulness practices) and supportive messages delivered through an automated algorithm over 6 weeks. RESULTS: Thirty IC/BPS patients with moderate symptom bother (median IC Problem Index score 9, range 6-12) participated in five cycles of contextual inquiry. Qualitative analysis identified three overarching concepts that informed the development of the platform: preference for patient centered terms, desire to gain self-efficacy in managing symptoms, and need for provider support. Patients preferred the term "interstitial cystitis" to "bladder pain syndrome" which carried the stigma of chronic pain. Patients reported greater self-efficacy in managing symptoms through improved access to mind-body and behavioral treatment modules that helped them to gain insight into their motivations and behaviors. The concept of provider support was informed by shared decision making (patients could choose preferred treatment modules) and reduced sense of isolation (weekly check in messages to check on symptom bother). CONCLUSION: A patient centered text message-based platform may be clinically useful in the self-management of IC/BPS symptoms.

Is the volume of Burch urethropexy sufficient for urogynecology fellows to meet the ACGME requirement?

INTRODUCTION AND HYPOTHESIS: Urogynecology fellows report low exposure to nonsling retropubic anti-incontinence procedures such as Burch urethropexy and thus may have difficulty meeting the required minimum case numbers, but there has been an even more objective exploration of this observation. Thus, our objective was to assess the feasibility of meeting the Accreditation Council for Graduate Medical Education (ACGME) requirement for each urogynecology fellow to perform five nonsling retropubic anti-incontinence procedures during fellowship. METHODS: Cross-sectional study using the National Surgical Quality Improvement Program (NSQIP) and National Resident Matching Program (NRMP) databases from 2009 to 2019. From NSQIP, the number of nonsling retropubic anti-incontinence procedures (open and laparoscopic Burch urethropexy and bladder neck needle suspension) and midurethral sling procedures was extracted using CPT codes. The number of fellows was extracted from the NRMP database. Trends in the number of anti-incontinence procedures were compared with the trend in the number of fellows using linear regression. RESULTS: From 2009 to 2019 the number of fellows doubled from 81 to 176. An average of 97 nonsling retropubic anti-incontinence and 6,372 sling procedures were performed annually. Linear regression showed an increase of 10.7 fellows per year (95% CI 9.3-12.1) versus an increase of 5.8 nonsling retropubic anti-incontinence procedures per year (95% CI -0.4 to 12.1). This contrasts with an increase of 690.9 slings per year (95% CI 509.9-872.0). CONCLUSIONS: The increase in the number of nonsling retropubic anti-incontinence procedures does not appear to match the increase in the number of urogynecology fellows. Supplementary educational approaches such as simulation may be prudent.

Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial.

INTRODUCTION: To determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments. METHODS: Women aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model. RESULTS: Of 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group. DISCUSSION: Although symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.

Pilot randomized controlled trial of a hypnosis intervention for women with bladder pain syndrome.

AIMS: To evaluate the feasibility and acceptability of a randomized controlled trial of a hypnosis intervention for the treatment of bladder pain syndrome/interstitial cystitis (BPS/IC) in women. METHODS: We conducted a parallel arm, non-blinded, pilot randomized controlled trial of standardized hypnosis sessions including a hypnosis web tool versus usual care in adult women with BPS/IC. Pilot study outcomes included feasibility domains: process, resources and management, safety, and acceptability. Clinical outcomes of lower urinary tract symptoms and quality of life were measured using validated questionnaires at baseline and at the end of the 4-week intervention. RESULTS: We randomized 29 out of 30 (96.7%) eligible women. In the hypnosis group, 12 of 15 (80.0%) subjects completed the 4-week intervention and follow up, and 13 of 14 (92.9%) in the usual care group. In the hypnosis group, adherence to the standardized sessions was 80% and participants used the web-based tool for an average of 5.6 ± 2.7 times per week. Scores for emotional distress, relaxation, pain severity and expected bladder symptoms significantly improved during the first two of three planned hypnosis sessions (all p < 0.05). Improvement in quality of life scores was greater in the hypnosis group than the usual care group (-2.6 ± 2.3 vs. -0.9 ± 1.1, p = 0.04). There were no significant between-group differences in urinary symptoms or bladder pain. No adverse events were reported. CONCLUSIONS: A hypnosis intervention for the treatment of bladder pain syndrome/interstitial cystitis is feasible, acceptable, safe, and may improve quality of life.

Defining the relationship between vaginal and urinary microbiomes.

BACKGROUND: Although the vaginal and urinary microbiomes have been increasingly well-characterized in health and disease, few have described the relationship between these neighboring environments. Elucidating this relationship has implications for understanding how manipulation of the vaginal microbiome may affect the urinary microbiome and treatment of common urinary conditions. OBJECTIVE: To describe the relationship between urinary and vaginal microbiomes using 16S rRNA gene sequencing. We hypothesized that the composition of the urinary and vaginal microbiomes would be significantly associated, with similarities in predominant taxa. STUDY DESIGN: This multicenter study collected vaginal swabs and catheterized urine samples from 186 women with mixed urinary incontinence enrolled in a parent study and 84 similarly aged controls. Investigators decided a priori that if vaginal and/or urinary microbiomes differed between continent and incontinent women, the groups would be analyzed separately; if similar, samples from continent and incontinent women would be pooled and analyzed together. A central laboratory sequenced variable regions 1-3 (v1-3) and characterized bacteria to the genus level. Operational taxonomic unit abundance was described for paired vaginal and urine samples. Pearson's correlation characterized the relationship between individual operational taxonomic units of paired samples. Canonical correlation analysis evaluated the association between clinical variables (including mixed urinary incontinence and control status) and vaginal and urinary operational taxonomic units, using the Canonical correlation analysis function in the Vegan package (R version 3.5). Linear discriminant analysis effect size was used to find taxa that discriminated between vaginal and urinary samples. RESULTS: Urinary and vaginal samples were collected from 212 women (mean age 53±11 years) and results from 197 paired samples were available for analysis. As operational taxonomic units in mixed urinary incontinence and control samples were related in canonical correlation analysis and since taxa did not discriminate between mixed urinary incontinence or controls in either vagina or urine, mixed urinary incontinence and control samples were pooled for further analysis. Canonical correlation analysis of vaginal and urinary samples indicated that that 60 of the 100 most abundant operational taxonomic units in the samples largely overlapped. Lactobacillus was the most abundant genus in both urine and vagina (contributing on average 53% to an individual's urine sample and 64% to an individual's vaginal sample) (Pearson correlation r=0.53). Although less abundant than Lactobacillus, other bacteria with high Pearson correlation coefficients also commonly found in vagina and urine included: Gardnerella (r=0.70), Prevotella (r=0.64), and Ureaplasma (r=0.50). Linear discriminant analysis effect size analysis identified Tepidimonas and Flavobacterium as bacteria that distinguished the urinary environment for both mixed urinary incontinence and controls as these bacteria were absent in the vagina (Tepidimonas effect size 2.38, P<.001, Flavobacterium effect size 2.15, P<.001). Although Lactobacillus was the most abundant bacteria in both urine and vagina, it was more abundant in the vagina (linear discriminant analysis effect size effect size 2.72, P<.001). CONCLUSION: Significant associations between vaginal and urinary microbiomes were demonstrated, with Lactobacillus being predominant in both urine and vagina. Abundance of other bacteria also correlated highly between the vagina and urine. This inter-relatedness has implications for studying manipulation of the urogenital microbiome in treating conditions such as urgency urinary incontinence and urinary tract infections.

Accidental Bowel Leakage Evaluation: A New Patient-Centered Validated Measure of Accidental Bowel Leakage Symptoms in Women.

BACKGROUND: Questionnaires assessing accidental bowel leakage lack important patient-centered symptoms. OBJECTIVE: We aimed to create a valid measure of accidental bowel leakage symptoms. DESIGN: We previously created a conceptual framework capturing patient-centered accidental bowel leakage symptoms. The framework included bowel leakage type, severity and bother, and ancillary bowel symptoms, including predictability, awareness, leakage control, emptying disorders, and discomfort. SETTINGS: The study was conducted in outpatient clinics. PATIENTS: Women with at least monthly accidental bowel leakage were included. INTERVENTIONS: Participants completed the Accidental Bowel Leakage Evaluation at baseline and 12 and 24 weeks, as well as bowel diaries and other validated pelvic floor questionnaires. A subset completed items twice before treatment. Final item selection was based on psychometric properties and clinical importance. MAIN OUTCOME MEASURES: Psychometric analyses included Cronbach α, confirmatory factor, and item response theory analyses. Construct validity was based on correlations with measures of similar constructs. RESULTS: A total of 296 women completed baseline items, and 70 provided test-retest data. The cohort was predominately white (79%) and middle aged (64 ± 11 y). Confirmatory factor analyses supported the conceptual framework. The final 18-item scale demonstrated good internal consistency (Cronbach α = 0.77-0.90) and test-retest reliability (intraclass correlation = 0.80). Construct validity was demonstrated with baseline and 12- and 24-week scale scores, which correlated with the Vaizey (r = 0.52, 0.68, and 0.69), Colorectal Anal Distress Inventory (r = 0.54, 0.65, 0.71), Colorectal Anal Impact Questionnaire (r = 0.48, 0.53, 0.53), and hygiene (r = 0.39, 0.43, 0.49) and avoidance subscales scores of the adaptive index (r = 0.45, 0.44, 0.43) and average number of pad changes per day on bowel diaries (r = 0.35, 0.38, 0.31; all p < 0.001). LIMITATIONS: The study was limited by nature of involving validation in a care-seeking population. CONCLUSIONS: The Accidental Bowel Leakage Evaluation instrument is a reliable, patient-centered measure with good validity properties. This instrument improves on currently available measures by adding patient-important domains of predictability, awareness, control, emptying, and discomfort. See Video Abstract at http://links.lww.com/DCR/B172. EVALUACIóN DE FUGA INTESTINAL ACCIDENTAL: UNA NUEVA MEDIDA VALIDADA Y CENTRADA EN PACIENTES FEMENINOS CON SíNTOMAS DE FUGA INTESTINAL ACCIDENTAL: Los cuestionarios que evalúan la fuga intestinal accidental, carecen de síntomas centrados en el paciente.Nuestro objetivo fue crear una medida válida de síntomas de fuga intestinal accidental.Previamente creamos un marco conceptual centrado en el paciente, para capturar síntomas de fuga intestinal accidental. El marco incluía tipo de fuga intestinal, gravedad, molestia, y síntomas intestinales auxiliares, incluyendo previsibilidad, conciencia, control de fugas, trastornos de vaciado e incomodidad.Clínicas de pacientes externos.Mujeres con al menos una fuga intestinal accidental mensual.Las participantes completaron la Evaluación de Fuga Intestinal Accidental al inicio del estudio y a las 12 y 24 semanas, así como diarios intestinales y otros cuestionarios validados del piso pélvico. Un subconjunto completó los elementos dos veces antes del tratamiento. La selección final del elemento se basó en las propiedades psicométricas y la importancia clínica.Los análisis psicométricos incluyeron el Alfa de Cronbach, factor confirmatorio y análisis de la teoría de respuesta al elemento. La validez de constructo se basó en correlaciones con medidas de constructos similares.Un total de 296 mujeres completaron los elementos de referencia y 70 proporcionaron datos de test-retest. La cohorte fue predominantemente blanca (79%) y de mediana edad (64 +/- 11 años). Análisis factorial confirmatorio respaldó el marco conceptual. La escala final de 18 elementos, demostró una buena consistencia interna (Alfa de Cronbach = 0,77-0,90) y fiabilidad test-retest (correlación intraclase = 0,80). La validez de constructo se demostró con puntajes de escala de referencia de 12 y 24 semanas que se correlacionaron con Vaizey (r = 0,52, 0,68 y 0,69), Inventario de Ansiedad colorecto anal (r = 0,54, 0,65, 0,71), Cuestionarios de Impacto colorecto anal (r = 0,48, 0,53, 0,53) e higiene (r = 0,39, 0,43, 0,49), puntuaciones de subescalas de evitación del índice adaptativo (r = 0,45, 0,44, 0,43), número promedio de cambios de almohadilla por día, de los diarios intestinales (r = 0.35, 0.38, 0.31), todos p <.001.Validación de una población en busca de atención.El instrumento de Evaluación de Fuga Intestinal Accidental es una medida confiable, centrada en el paciente y con buenas propiedades de validez. Este instrumento mejora las medidas actualmente disponibles, al agregar dominios importantes para el paciente de previsibilidad, conciencia, control, vaciado e incomodidad. Consulte Video Resumen en http://links.lww.com/DCR/B172. (Traducción-Dr. Fidel Ruiz Healy).

Regions of the brain activated in bladder filling vs rectal distention in healthy adults: A meta-analysis of neuroimaging studies.

AIMS: Adults with pelvic floor disorders commonly present with overlapping bladder and bowel symptoms; however, the relationship between urinary and defecatory dysfunction is not well understood. Our aim was to compare and determine if overlapping brain regions are activated during bladder filling and rectal distention in healthy adults. METHODS: We conducted separate Pubmed searches for neuroimaging studies investigating the effects of rectal distention and bladder filling on brain activation in healthy subjects. Coordinates of activated regions were extracted with cluster-level threshold P < .05 and compared using the activation likelihood estimate approach. Results from the various studies were pooled and a contrast analysis was performed to identify any common areas of activation between bladder filling and rectal distension. RESULTS: We identified 96 foci of activation from 14 neuroimaging studies on bladder filling and 182 foci from 17 studies on rectal distension in healthy adults. Regions activated during bladder filling included right insula, right and left thalamus, and right periaqueductal grey. Regions activated during rectal distention included right and left insula, right and left thalamus, left postcentral gyrus, and right inferior parietal lobule. Contrast analysis revealed common activation of the right insula with both rectal distention and bladder filling. CONCLUSION: Bladder filling and rectal distention activate several separate areas of the brain involved in sensory processing in healthy adults. The common activation of the insula, the region responsible for interoception, in these two conditions may offer an explanation for the coexistence of bladder and defecatory symptoms in pelvic floor disorders.

Performance, acceptability, and validation of a phone application bowel diary.

AIMS: To assess performance, acceptability, external validity, and reliability of a phone application electronic bowel diary (PFDN Bowel eDiary). METHODS: Women reporting refractory accidental bowel leakage (ABL) were enrolled in a randomized, crossover trial evaluating paper versus eDiary documentation of bowel movements (BM) and fecal incontinence episodes (FIE). Events were characterized by the presence or absence of urgency and Bristol stool scale consistency. The eDiary entries were date/time stamped and prompted by twice-daily phone notifications. Women were randomized to complete up to three consecutive 14-day diaries in two sequences. Diary events were compared between formats using the Pearson correlation. System usability scale (SUS) assessed eDiary usability. The eDiary test-retest reliability was assessed with intraclass correlations (ICCs). RESULTS: Paired diary data were available from 60/69 (87%) women 63.8 ± 9.8 years old with mean 13.2 BM per week and 6.5 FIE per week (nearly half with urgency). Among those providing diaries, adherence did not differ by paper or eDiary (93.3% vs. 95.0%). Notifications prompted 29.6% of eDiary entries, improving adherence from 70% to 95%. Paper and eDiaries were moderate to-strongly correlated for BMs per week (r = .61), urgency BMs per week (r = .76), FIE per week (r = .66), urgency FIE per week (r = .72). Test-retest reliability was good (ICC = .81 BMs per week, .79 urgency BMs per week, .74 FIE per week, and .62 urgency FIE per week). The mean SUS score was high, 82.3 ± 17.5 (range, 0-100) with 91.4% rating it easy to use, and 75.9% preferring the eDiary over paper. CONCLUSION: The PFDN Bowel eDiary correlated well with paper diary was considered easy to use, preferred to paper diaries, had high rates of confirmed real-time diary completion that obviated staff data entry.

Perioperative adverse events in women over age 65 undergoing robot-assisted sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: Pelvic floor disorders are common among and disproportionately affect older women. There are limited data regarding perioperative adverse events in older women undergoing robot-assisted sacrocolpopexy (RASC) specifically. The aim of this study was to compare the rate of perioperative adverse events in younger (age <65 years) versus older (age >65 years) women who underwent RASC. METHODS: We conducted a retrospective cohort study of women who underwent RASC between 2013 and 2018. Postoperative adverse events were categorized according to the Clavien-Dindo classification. Our primary outcome was the rate of intraoperative adverse events and postoperative adverse events with Clavien-Dindo grade II or greater. Outcomes were compared using univariate and multivariate analysis. RESULTS: Of the 327 patients included in the study, 227 were <65 years of age and 100 were ≥65 years of age. Women ≥65 years of age had higher rates of hypertension, higher American Society of Anesthesiologist (ASA) class, and higher Charlson Comorbidity Index (CCI) scores compared with women <65 years of age; these were not associated with increased likelihood of adverse events. The overall rate of any perioperative adverse event was 18.3%. There was no statistically significant difference in the overall rate of perioperative adverse events between younger and older women (18.5% vs 18.0%, p = 0.91). CONCLUSIONS: There is no difference in rate of adverse events between women ≥65 years of age undergoing RASC and their younger counterparts.

Feasibility and outcomes: Pilot Randomized Controlled Trial of a home-based integrated physical exercise and bladder-training program vs usual care for community-dwelling older women with urinary incontinence.

AIMS: To assess the feasibility of a randomized controlled trial of a home-based integrated physical exercise and bladder-training program vs usual care in community-dwelling women with urinary incontinence (UI). METHODS: We conducted a parallel arm, nonblinded, pilot randomized controlled trial of a home-based integrated physical exercise and bladder training with urge suppression and fall prevention program (ExerciseUP) vs usual care in women aged 65 and older with UI. Outcomes included feasibility (process, resources, management, and acceptability), urinary symptoms, and falls risk using self-administered questionnaires. Objective physical activity was measured using accelerometry. RESULTS: A total of 37 of 38 (97%) eligible women were willing to participate in the study. In the ExerciseUP intervention cohort, 17 of 19 (89%) women completed all 6 weeks of intervention and follow-up, and 16 of 18 (89%) women in the usual group completed follow-up. Ten (53%) women in the ExerciseUP group achieved at least 70% adherence to exercise prescription. The improvement in UI severity scores from baseline was greater in the ExerciseUP intervention group than the usual care group (- 6.2 ± 5.8 vs - 2.4 ± 4.2, P = 0.04). Fall-risk score decreased (improved) in both groups. There were no significant between-group differences in change in physical activity or sedentary behavior. CONCLUSIONS: We determined that it would be feasible to conduct a home-based exercise intervention in older women with UI. Our clinical outcomes were modestly favorable for the ExerciseUP intervention group.

Brain activation during the voiding phase of micturition in healthy adults: A meta-analysis of neuroimaging studies.

Several studies have used a variety of neuroimaging techniques to measure brain activity during the voiding phase of micturition. However, there is a lack of consensus on which regions of the brain are activated during voiding. The aim of this meta-analysis is to identify the brain regions that are consistently activated during voiding in healthy adults across different studies. We searched the literature for neuroimaging studies that reported brain co-ordinates that were activated during voiding. We excluded studies that reported co-ordinates only for bladder filling, during pelvic floor contraction only, and studies that focused on abnormal bladder states such as the neurogenic bladder. We used the activation-likelihood estimation (ALE) approach to create a statistical map of the brain and identify the brain co-ordinates that were activated across different studies. We identified nine studies that reported brain activation during the task of voiding in 91 healthy subjects. Together, these studies reported 117 foci for ALE analysis. Our ALE map yielded six clusters of activation in the pons, cerebellum, insula, anterior cingulate cortex (ACC), thalamus, and the inferior frontal gyrus. Regions of the brain involved in executive control (frontal cortex), interoception (ACC, insula), motor control (cerebellum, thalamus), and brainstem (pons) are involved in micturition. This analysis provides insight into the supraspinal control of voiding in healthy adults and provides a framework to understand dysfunctional voiding. Clin. Anat., 2018. © 2018 Wiley Periodicals, Inc.

Specific Changes in Brain Activity during Urgency in Women with Overactive Bladder after Successful Sacral Neuromodulation: A Functional Magnetic Resonance Imaging Study.

PURPOSE: The mechanism of sacral neuromodulation is poorly understood. We compared brain activity during urgency before and after sacral neuromodulation in women with overactive bladder and according to the response to treatment. MATERIALS AND METHODS: Women with refractory overactive bladder who elected sacral neuromodulation were invited to undergo functional magnetic resonance imaging before and after treatment. During imaging the bladder was filled until urgency was experienced. Regions of interest were identified a priori and brain activity in these regions of interest was compared before and after treatment as well as according to the treatment response. Whole brain exploratory analysis with an uncorrected voxel level threshold of p <0.001 was also performed to identify additional brain regions which changed after sacral neuromodulation. RESULTS: Of the 12 women who underwent a pretreatment functional magnetic resonance imaging examination 7 were successfully treated with sacral neuromodulation and underwent a posttreatment examination. After sacral neuromodulation brain activity decreased in the left anterior cingulate cortex, the bilateral insula, the left dorsolateral prefrontal cortex and the bilateral orbitofrontal cortex (each p <0.05). No new brain regions showed increased activity after sacral neuromodulation. Pretreatment brain activity levels in the bilateral anterior cingulate cortex, the right insula, the bilateral dorsolateral prefrontal cortex, the right orbitofrontal cortex, the right supplementary motor area and the right sensorimotor cortex were higher in women who underwent successful treatment (each p <0.05). CONCLUSIONS: Brain activity during urgency changes after successful sacral neuromodulation. Sacral neuromodulation may be more effective in women with higher levels of pretreatment brain activity during urgency.

Validity of utility measures for women with pelvic organ prolapse.

BACKGROUND: Pelvic organ prolapse is a common condition that frequently coexists with urinary and fecal incontinence. The impact of prolapse on quality of life is typically measured through condition-specific quality-of-life instruments. Utility preference scores are a standardized generic health-related quality-of-life measure that summarizes morbidity on a scale from 0 (death) to 1 (optimum health). Utility preference scores quantify disease severity and burden and are widely used in cost-effectiveness research. The validity of utility preference instruments in women with pelvic organ prolapse has not been established. OBJECTIVE: The objective of this study was to evaluate the construct validity of generic quality-of-life instruments for measuring utility scores in women with pelvic organ prolapse. Our hypothesis was that women with multiple pelvic floor disorders would have worse (lower) utility scores than women with pelvic organ prolapse only and that women with all 3 pelvic floor disorders would have the worst (lowest) utility scores. STUDY DESIGN: This was a prospective observational study of 286 women with pelvic floor disorders from a referral female pelvic medicine and reconstructive surgery practice. All women completed the following general health-related quality-of-life questionnaires: Health Utilities Index Mark 3, EuroQol, and Short Form 6D, as well as a visual analog scale. Pelvic floor symptom severity and condition-specific quality of life were measured using the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire, respectively. We measured the relationship between utility scores and condition-specific quality-of-life scores and compared utility scores among 4 groups of women: (1) pelvic organ prolapse only, (2) pelvic organ prolapse and stress urinary incontinence, (3) pelvic organ prolapse and urgency urinary incontinence, and (4) pelvic organ prolapse, urinary incontinence, and fecal incontinence. RESULTS: Of 286 women enrolled, 191 (67%) had pelvic organ prolapse; mean age was 59 years and 73% were Caucasian. Among women with prolapse, 30 (16%) also had stress urinary incontinence, 39 (20%) had urgency urinary incontinence, and 42 (22%) had fecal incontinence. For the Health Utilities Index Mark 3, EuroQol, and Short Form 6D, the pattern in utility scores was noted to be lowest (worst) in the prolapse + urinary incontinence + fecal incontinence group (0.73-0.76), followed by the prolapse + urgency urinary incontinence group (0.77-0.85) and utility scores were the highest (best) for the prolapse only group (0.80-0.86). Utility scores from all generic instruments except the visual analog scale were significantly correlated with the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire total scores (r values -0.26 to -0.57), and prolapse, bladder, and bowel subscales (r values -0.16 to -0.50). Utility scores from all instruments except the visual analog scale were highly correlated with each other (r = 0.53-0.69, P < .0001). CONCLUSION: The Health Utilities Index Mark 3, EuroQol, and Short Form 6D, but not the visual analog scale, provide valid measurements for utility scores in women with pelvic organ prolapse and associated pelvic floor disorders and could potentially be used for cost-effectiveness research.

Metabolites and microbial composition of stool of women with fecal incontinence: Study design and methods.

AIMS: This paper aims to report the rationale, design, and the specific methodology of an ongoing nested observational study that will determine the association of the metabolite and microbial composition of stool with fecal incontinence (FI). METHODS: Eligible cases are participants with FI enrolled in the Controlling Anal Incontinence in women by Performing Anal Exercises with Biofeedback or Loperamide (CAPABLe) trial, a Pelvic Floor Disorders Network trial across eight clinical centers in the United States. Women of similar age without FI in the last year served as controls. All subject collected stool samples at the baseline and 24-week visit at home using a standardized collection method. Samples were shipped to and stored at centralized laboratories. RESULTS: Specimen collection commenced December 2014 and was completed in May 2016. Fecal water and DNA has been extracted and is currently being analyzed by targeted metabolic profiling for stool metabolites and 16S rRNA gene sequencing for stool microbiota. CONCLUSIONS: This article describes the rationale and design of a study that could provide a paradigm shift for the treatment of FI in women.

The urinary microbiome in women with mixed urinary incontinence compared to similarly aged controls.

INTRODUCTION & HYPOTHESIS: Previous studies have suggested that women with urinary incontinence have an altered urinary microbiome. We hypothesized that the microbiome in women with mixed urinary incontinence (MUI) differed from controls and tested this hypothesis using bacterial gene sequencing techniques. METHODS: This multicenter study compared the urinary microbiome in women with MUI and similarly aged controls. Catheterized urine samples were obtained; v4-6 regions of the 16S rRNA gene were sequenced to identify bacteria. Bacterial predominance (> 50% of an individual's genera) was compared between MUI and controls. Bacterial sequences were categorized into "community types" using Dirichlet multinomial mixture (DMM) methods. Generalized linear mixed models predicted MUI/control status based on clinical characteristics and community type. Post-hoc analyses were performed in women < 51 and ≥ 51 years. Sample size estimates required 200 samples to detect a 20% difference in Lactobacillus predominance with P < 0.05. RESULTS: Of 212 samples, 97.6% were analyzed (123 MUI/84 controls, mean age 53 ± 11 years). Overall Lactobacillus predominance did not differ between MUI and controls (45/123 = 36.6% vs. 36/84 = 42.9%, P = 0.36). DMM analyses revealed six community types; communities differed by age (P = 0.001). A High-Lactobacillus (89.2% Lactobacillus) community had a greater proportion of controls (19/84 = 22.6%, MUI 11/123 = 8.9%). Overall, bacterial community types did not differ in MUI and controls. However, post-hoc analysis of women < 51 years found that bacterial community types distinguished MUI from controls (P = 0.041); Moderate-Lactobacillus (aOR 7.78, CI 1.85-32.62) and Mixed (aOR 7.10, CI 1.32-38.10) community types were associated with MUI. Community types did not differentiate MUI and controls in women ≥ 51 years (P = 0.94). CONCLUSIONS: Women with MUI and controls did not differ in overall Lactobacillus predominance. In younger women, urinary bacterial community types differentiated MUI from controls.

The relationship between fecal incontinence, constipation and defecatory symptoms in women with pelvic floor disorders.

AIMS: To determine if fecal incontinence (FI) is associated with constipation and defecatory symptoms in women with urinary incontinence, fecal incontinence, and pelvic organ prolapse. METHODS: Cross-sectional study of women seeking care for urinary incontinence, fecal incontinence, and pelvic organ prolapse. FI was defined as a positive response to the question, "During the last 4 weeks how often have you leaked or soiled yourself with stool?" Constipation and defecatory symptoms, including straining, sensation of incomplete emptying, and splinting, were measured using the Birmingham Bowel Symptom Questionnaire and the Colorectal Anal Distress Inventory. Prevalence and severity of constipation and defecatory symptoms were compared between women with and without FI. We performed separate multivariable regression analyses for the association of FI and constipation and defecatory symptoms while adjusting for potential confounders. RESULTS: We included 1,015 women: 422 (44%) with and 593 (56%) without FI. Women with FI compared to those without FI were more likely to report constipation (76% vs. 66%) as well as straining (53% vs. 38%), sensation of incomplete emptying (58% vs. 40%) and splinting (30% vs. 20%), all P < 0.001. Women with FI reported greater severity of constipation (4.3 ± 4.3 vs. 3.1 ± 3.6, P < 0.001), straining (2.7 ± 1 vs. 2.5 ± 0.9, P = 0.02) and sense of incomplete emptying (2.6 ± 1 vs. 2.4 ± 0.9, P = 0.02) than women without FI. Even after controlling for potential confounders, the diagnosis of FI was significantly associated with constipation and defecatory symptoms. CONCLUSIONS: In women with urinary incontinence, fecal incontinence, and pelvic organ prolapse, diagnosis of FI is associated with constipation and other defecatory symptoms; which impacts evaluation and management strategies. Neurourol. Urodynam. 36:495-498, 2017. © 2016 Wiley Periodicals, Inc.

The impact of pontine disease on lower urinary tract symptoms in patients with multiple sclerosis.

AIMS: To investigate the relationship between pontine lesion characteristics on MRI and lower urinary tract symptoms (LUTS) in patients with multiple sclerosis (MS). METHODS: We performed a prospective cohort study of patients with MS and LUTS who were undergoing brain/spine MRI. Patients were administered the American Urological Association Symptom Score (AUA-SS), Medical, Epidemiologic, and Social Aspects of Aging questionnaire (MESA), and Urogenital Distress Inventory questionnaire (UDI-6), underwent Kurtzke Expanded Disability Status Scale (EDSS) scoring by a neurologist, and had their MRIs reviewed by a neuroradiologist. The relationships between symptom scores and lesion number, size, and location were analyzed. RESULTS: There were 42 patients that completed the study and 20 (48%) had one or more pontine lesions. Total AUA-SS and UDI-6 were related to multiple Short Form Health Survey (SF-36) scales and not EDSS scoring. Weak urinary stream measured on the AUA-SS (P = 0.028), and urgency incontinence measured on the MESA questionnaire (P = 0.034) were related to pontine lesion diameter. There was no difference in urinary symptoms according to the presence or absence of a pontine lesion, or according to lesion location within the pons. CONCLUSIONS: Pontine lesion size appears to be related to lower urinary tract symptoms (weak stream and urgency incontinence) in patients with MS. Therefore, CNS lesion characteristics may be able to phenotype voiding symptoms in patients with MS. Neurourol. Urodynam. 36:453-456, 2017. © 2016 Wiley Periodicals, Inc.

Methodology for a vaginal and urinary microbiome study in women with mixed urinary incontinence.

INTRODUCTION AND HYPOTHESIS: We describe the rationale and methods of a study designed to compare vaginal and urinary microbiomes in women with mixed urinary incontinence (MUI) and similarly aged, asymptomatic controls. METHODS: This paper delineates the methodology of a supplementary microbiome study nested in an ongoing randomized controlled trial comparing a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone for MUI. Women in the parent study had at least "moderate bother" from urgency and stress urinary incontinence symptoms (SUI) on validated questionnaire and confirmed MUI on bladder diary. Controls had no incontinence symptoms. All participants underwent vaginal and urine collection for DNA analysis and conventional urine culture. Standardized protocols were designed, and a central lab received samples for subsequent polymerase chain reaction (PCR) amplification and sequencing of the bacterial16S ribosomal RNA (rRNA) gene. The composition of bacterial communities will be determined by dual amplicon sequencing of variable regions 1-3 and 4-6 from vaginal and urine specimens to compare the microbiome of patients with controls. Sample-size estimates determined that 126 MUI and 84 control participants were sufficient to detect a 20 % difference in predominant urinary genera, with 80 % power and 0.05 significance level. RESULTS: Specimen collection commenced January 2015 and finished April 2016. DNA was extracted and stored for subsequent evaluation. CONCLUSIONS: Methods papers sharing information regarding development of genitourinary microbiome studies, particularly with control populations, are few. We describe the rigorous methodology developed for a novel urogenital microbiome study in women with MUI.

Clinical anatomy of fecal incontinence in women.

Fecal incontinence is a devastating condition that has a severe impact on quality of life. This condition disproportionately affects women and its incidence is increasing with the aging United States population. Fecal continence is maintained by coordination of a functioning anal sphincter complex, intact sensation of the anorectum, rectal compliance, and the ability to consciously control defecation. Particularly important are the puborectalis sling of the levator ani muscle complex and intact innervation of the central and peripheral nervous systems. An understanding of the intricate anatomy required to maintain continence and regulate defecation will help clinicians to provide appropriate medical and surgical management and diminish the negative impact of fecal incontinence. In this article, we describe the anatomic and neural basis of fecal continence and normal defecation as well as changes that occur with fecal incontinence in women. Clin. Anat. 30:901-911, 2017. © 2017 Wiley Periodicals, Inc.

Impact of Dry Mouth on Fluid Intake and Overactive Bladder Symptoms in Women taking Fesoterodine.

PURPOSE: We investigated the long-term relationships between dry mouth, fluid intake and overactive bladder symptoms in women undergoing treatment with fesoterodine. We hypothesized that women who experienced dry mouth would increase their fluid intake and worsen their urinary symptoms. MATERIALS AND METHODS: We conducted a prospective ancillary study to a 9-month open-label trial of fesoterodine for women with urgency urinary incontinence. Fluid intake was measured and compared according to reported dry mouth. Multivariable analysis was used to study the interaction between dry mouth, fluid intake and urinary symptoms. RESULTS: During the study 407 women without dry mouth significantly reduced their fluid intake (mean decrease 172.1 ml, median 118.3 ml, p = 0.02), while 91 women with dry mouth did not (mean decrease 95.8 ml, median 118.3 ml, p = 0.54). On univariable analysis a greater proportion of women who experienced dry mouth reported improvement in their urinary symptoms compared to women without dry mouth (60.5% vs 47.2%, p = 0.03). On multivariable analysis black women were less likely to report dry mouth (OR 0.4, 95% CI 0.2-0.9, p = 0.03) and older women were less likely to report improvement in urinary symptoms (OR 0.98, 95% CI 0.96-0.99, p = 0.003). Factors not associated with improvement in urinary symptoms on multiple regression were dry mouth, baseline fluid intake volume, change in fluid intake volume and caffeine intake volume. CONCLUSIONS: In women with overactive bladder receiving fesoterodine dry mouth may prevent restriction of fluid intake but does not diminish treatment efficacy.