Algorithm-Based Mobile Texting Platform for the Self-Management of Interstitial Cystitis/Bladder Pain Syndrome: Pilot Study Evaluating Feasibility, Usability, and Potential Utility.

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.

Validation of Lower Urinary Tract Symptom Questionnaire in the Transmasculine Population.

INTRODUCTION AND HYPOTHESIS: 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. METHODS: 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. RESULTS: A total of 131 respondents were included in the analysis. Only two individuals (1.5%) reported prior vaginectomy and/or phalloplasty. Concurrent validity was demonstrated by a significant association between ICIQ-LUTS subscales and PPBC (filling p < 0.001, voiding p < 0.001, incontinence p < 0.001). Construct validity was demonstrated by a significant correlation between ICIQ-LUTS and UDI-6 (filling ρ = 0.76, p < 0.001; voiding ρ = 0.48, p < 0.001; incontinence ρ = 0.61, p < 0.001). For discriminant validity, those with at least one self-reported LUTS had significantly higher (worse) ICIQ-LUTS subscale scores than those without self-reported LUTS. CONCLUSIONS: The ICIQ-LUTS is valid for measurement of LUTS severity in transmasculine individuals. This will be an important tool to use in future research to learn more about LUTS in this population.

Spending Analysis of Machine Learning-Based Communication Nudges in Oncology.

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.).

Dual Incontinence and Risk of Fall: A Retrospective Cohort Study.

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.

Trial Design for Mixed Urinary Incontinence: Midurethral Sling Versus Botulinum Toxin A.

IMPORTANCE: Mixed urinary incontinence (MUI) is common and can be challenging to manage. OBJECTIVES: We present the protocol design and rationale of a trial comparing the efficacy of 2 procedures for the treatment of women with MUI refractory to oral treatment. The Midurethral sling versus Botulinum toxin A ( MUSA) trial compares the efficacy of intradetrusor injection of 100 U of onabotulinimtoxinA (an office-based procedure directed at the urgency component) versus midurethral sling (MUS) placement (a surgical procedure directed at the stress component). STUDY DESIGN: The MUSA is a multicenter, randomized trial of women with MUI electing to undergo procedural treatment for MUI at 7 clinical centers in the NICHD Pelvic Floor Disorders Network. Participants are randomized to either onabotulinumtoxinA 100 U or MUS. OnabotulinimtoxinA recipients may receive an additional injection between 3 and 6 months. Participants may receive additional treatment (including crossover to the alternative study intervention) between 6 and 12 months. The primary outcome is change from baseline in Urogenital Distress Inventory (UDI) at 6 months. Secondary outcomes include change in UDI at 3 and 12 months, irritative and stress subscores of the UDI, urinary incontinence episodes, predictors of poor treatment response, quality of life and global impression outcomes, adverse events, use of additional treatments, and cost effectiveness. RESULTS: Recruitment and randomization of 150 participants is complete and participants are currently in the follow-up phase. CONCLUSIONS: This trial will provide information to guide care for women with MUI refractory to oral treatment who seek surgical treatment with either onabotulinumtoxinA or MUS.

Patient perspectives on treatment and prevention of recurrent urinary tract infections: a focus group study.

INTRODUCTION AND HYPOTHESIS: We sought to understand factors that are important to patients for the management of recurrent urinary tract infections (UTI) during both an acute episode and for the prevention of future episodes. METHODS: This was a qualitative study with focus groups in women with recurrent UTIs. Participants filled out information about prior recurrent UTI treatment and the Belief about Medicines Questionnaire (BMQ). Each 90-minute focus group was moderated by a nonphysician psychologist. Line-by-line coding of each transcript by three independent physicians was used to develop emergent concepts and themes using Grounded Theory methodology. RESULTS: Twenty-six women participated in six focus groups. The average age of participants was 62 years and 77% were post-menopausal. All women had already tried multiple prevention strategies for their recurrent UTIs. The average BMQ-specific scores indicated a net positive attitude toward medicines specifically prescribed for recurrent UTI prevention. Several themes emerged from the focus groups. First, patients wanted providers to acknowledge the high burden imposed by frequent interactions with the health care system for the management of recurrent UTI. Second, patients wanted earlier access to providers knowledgeable in the management of this condition. Third, patients wanted to self-manage their condition through a structured treatment plan with support from their providers. Finally, patients wanted greater emphasis on education and prevention strategies to reduce their antibiotic intake. CONCLUSIONS: Patients with recurrent UTI want more efficient workflows, a framework that promotes self-management in partnership with their providers, and a greater emphasis on prevention.

Effect of Second-Stage Pushing Timing on Postpartum Pelvic Floor Morbidity: A Randomized Controlled Trial.

OBJECTIVE: To assess whether immediate or delayed pushing in the second-stage results in higher risk of pelvic floor morbidity. METHODS: This study was a planned secondary aim of a multicenter randomized clinical trial that included nulliparous patients at 37 weeks of gestation or greater in labor with neuraxial analgesia. Participants were randomized in the second stage to initiate pushing immediately or wait 60 minutes before pushing. Participants had pelvic floor assessments at 1-5 days postpartum, 6 weeks postpartum, and 6 months postpartum. Rates of perineal lacerations, pelvic organ prolapse quantification (POP-Q) measures, and scores on validated symptom-specific distress and quality-of-life questionnaires (PFDI-20 [Pelvic Floor Distress Inventory], PFIQ [Pelvic Floor Impact Questionnaire], FISI [Fecal Incontinence Severity Index], and MMHQ [Modified Manchester Health Questionnaire]) were compared. It was estimated that 630 participants would provide more than 80% power to detect a 40% difference in second-degree or greater perineal lacerations and approximately 80% power to detect a 40% difference in stage 2 or greater pelvic organ prolapse (POP). RESULTS: Among 2,414 participants in the primary trial conducted between May 19, 2014, and December 16, 2017, 941 (39%) had pelvic floor assessments: 452 immediate pushing and 489 delayed pushing. The mean age was 24.8 years, and 93.4% had vaginal delivery. There were no significant differences in perineal lacerations at delivery and POP at 6 weeks and 6 months postpartum. Changes from baseline in total and subscale scores for the PFDI-20, the PFIQ, and the MMHQ were not significantly different at 6 weeks postpartum and 6 months postpartum. The change in FISI score was higher in the immediate pushing group at 6 months (2.9±5.7 vs 2.0±4.5, difference 0.9, P =.01), but less than the minimum important difference of 4. CONCLUSION: Among nulliparous patients in the second stage with neuraxial analgesia, immediate pushing, compared with delayed pushing, did not increase perineal lacerations, POP-Q measures, or patient-reported pelvic floor symptoms at 6 weeks and 6 months postpartum. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02137200.

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.

Reducing Falls in Older Women with Urinary Incontinence.

Urinary incontinence is common in older women and doubles the risk of falls in this population. The association between urinary incontinence, especially urgency urinary incontinence, and falls is multifactorial and likely the result of a complex interaction between physical, mental, social, and environmental factors. As a result of this multifactorial etiology and based on existing evidence, the integration of different fall prevention strategies including strength and resistance exercises, bladder training, and home hazard reduction have the potential to decrease the risk of falls in older women with urinary incontinence. Given the prevalence of urinary incontinence and the significant morbidity associated with falls, effective interventions to reduce fall risk in older women with urinary incontinence is of high public health significance.

Relationship Between Opioid Prescriptions and Number of Chronic Pain Conditions in Women With Interstitial Cystitis.

OBJECTIVES: The aim of this study was to determine the relationship between opioid prescriptions and number of chronic pain conditions in women with interstitial cystitis (IC). METHODS: This was a cross-sectional study. Women diagnosed with IC based on International Classification of Diseases, Ninth Revision/Tenth Revision codes over an 11-year period (2010-2020) were identified from electronic medical records. Data on comorbidities and ambulatory opioid prescriptions were also extracted. Univariable and multivariable logistic regressions were used to assess the relationship between opioid prescriptions and the number and type of coexisting chronic pain conditions. RESULTS: Of the 1,219 women with IC, 207 (17%) had received at least 1 opioid prescription. The proportions of women with opioid prescriptions for no, 1, 2, and 3 or more coexisting chronic pain conditions were 13%, 20%, 28%, and 32%, respectively. On univariable analysis, factors significantly associated with opioid use were higher body mass index ( P < 0.001), depression ( P < 0.001), sleep disorder ( P < 0.001), endometriosis ( P < 0.05), chronic pelvic pain ( P < 0.001), fibromyalgia ( P < 0.05), joint pain ( P < 0.001), and number of coexisting chronic pain diagnoses ( P < 0.001). On multivariable analysis, opioid prescriptions remained significantly associated with the number of coexisting chronic pain diagnoses: 1 diagnosis (adjusted odds ratio [aOR], 1.8; 95% confidence interval [CI], 1.3-2.7), 2 diagnoses (aOR, 2.6; 95% CI, 1.6-4.3), 3 or more diagnoses (aOR, 2.5; 95% CI, 1.1-5.5), diagnosis of chronic pelvic pain (aOR, 2.1; 95% CI, 1.3-3.5), endometriosis (aOR, 2.4; 95% CI, 1.4-4.3), chronic joint pain (aOR, 1.8; 95% CI, 1.1-2.9), and sleep disorders (aOR, 2.4; 95% CI, 1.6-3.6). CONCLUSION: The likelihood of opioid prescriptions in women with IC increases with the number and type of coexisting chronic pain conditions and sleep disorders.

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.

How do women with interstitial cystitis/bladder pain syndrome make treatment choices?

INTRODUCTION AND HYPOTHESIS: There is a relative lack of data regarding how patients weigh various factors when choosing a treatment strategy for interstitial cystitis/bladder pain syndrome (IC/BPS). Our aim is to describe patient experience with their current and prior treatments and discuss factors they consider when choosing a treatment. METHODS: Twenty-one women with IC/BPS participated in five focus groups moderated by a psychologist. Focus groups were conducted until thematic saturation was reached. Group discussions were transcribed and independently coded by two reviewers. Emergent themes and concepts were identified using grounded theory methodology. Data on symptoms and beliefs regarding medications were collected using validated questionnaires: Interstitial Cystitis Symptom and Problem Index (ICSI and ICPI) and Beliefs in Medications Questionnaire-Specific (BMQ-S). RESULTS: The median age of participants was 42 years, and all had some college education. Median score (range) for the ICSI was 12 (4, 20) and for the ICPI was 10 (3, 16), indicating moderate symptom burden. Most patients had tried only first- or second-line treatments. The median BMQ-S score was 2, indicating a neutral attitude toward medication. Several themes were identified. Patients expressed interest in self-management of symptoms using a structured care plan that incorporates guided self-care practices and care that can be delivered virtually. Patients desired to minimize treatment side effects by reducing prescription medications and avoiding surgical procedures. Finally, patients had considerable interest in alternative treatments; however, they wanted these treatments to be evidence-based. CONCLUSIONS: Women with IC/BPS have a strong interest in guided programs that teach self-care practices and deliver alternative treatments through remote platforms.

Association between the urogenital microbiome and surgical treatment response in women undergoing midurethral sling operation for mixed urinary incontinence.

BACKGROUND: The urogenital microbiome is associated with urgency and mixed urinary incontinence symptoms and differential treatment responses to pharmacotherapy for urgency urinary incontinence. OBJECTIVE: This study aimed to describe whether the preoperative urinary and vaginal microbiomes were associated with surgical treatment responses at 12 months after a midurethral sling operation in women with mixed urinary incontinence. STUDY DESIGN: This cohort study compared the preoperative microbiome compositions of urine and vaginal samples from a subset of women undergoing a midurethral sling operation in the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence trial (NCT01959347) and compared the microbiota in women who were surgical responders vs surgical nonresponders. Twelve-month objective response was defined as a ≥70% reduction from baseline urinary incontinence episodes on a 3-day diary. Subjective response was defined as a change from baseline in the Urogenital Distress Inventory scores. Bacterial abundance and beta diversity were assessed using 16S ribosomal RNA sequencing. The primary differential abundance analysis described predominant bacterial operational taxonomic units associated with responders vs nonresponders using unadjusted and age-adjusted linear models. RESULTS: Objective nonresponders (n=28) compared with responders (n=72) were older (58.5±10.7 vs 51.6±10.2 years) and more likely postmenopausal without hormone use (odds ratio, 6.4; 95% confidence interval, 1.8-22.6). Vaginal and urinary microbiota beta diversities were associated with age (P<.05) for both responders and nonresponders. Overall, predominant operational taxonomic units (genera) were Lactobacillus, Gardnerella, Tepidimonas, Escherichia, Streptococcus, and Prevotella. Operational taxonomic units from baseline urine samples were not significantly associated (P threshold=.05) with surgical treatment responses. A greater abundance of baseline vaginal Lactobacillus was associated with an objective response (P=.04) and Prevotella with an objective nonresponse (P=.01). Adjusting for age, only a greater abundance of baseline vaginal Prevotella was associated with an objective nonresponse (P=.01). Moreover, less abundant vaginal operational taxonomic units were associated with objective and subjective responses and persistent urinary incontinence symptoms (P<.05). CONCLUSION: Women meeting a 70% reduction of urinary incontinence treatment episodes (objective responders) had greater vaginal Lactobacillus at the time of the surgical procedure; however, controlling for age diminished this association. Women not meeting a 70% reduction of urinary incontinence episodes 1 year after a midurethral sling operation had greater vaginal Prevotella at the time of the midurethral sling operation. Further research is needed to determine whether therapy altering the vaginal microbiome may impact surgical treatment responses in women with mixed urinary incontinence.

Short-Term Effect of Fesoterodine on Physical Function Relevant to Fall Risk in Older Women With Overactive Bladder.

PURPOSE: The aim of this study was to measure the effect of treatment with fesoterodine on physical function relevant to fall risk in older women with overactive bladder. MATERIALS AND METHODS: This was a prospective cohort study of women aged 65 years or older with overactive bladder. Urinary symptoms and physical function were measured at baseline and 8 weeks after treatment with fesoterodine. Physical activity and sedentary behavior were measured subjectively using questionnaires and objectively using an accelerometer. Physical function was measured using the Short Physical Performance Battery test. RESULTS: We enrolled 75 women with a median age of 76 years. At baseline, bothersome urgency urinary incontinence and nocturia were reported by 55% and 81%, respectively. At baseline, participants were highly sedentary with a median of 2,118 steps daily. After treatment, urinary symptom severity and health-related quality of life subscale scores of the Overactive Bladder Questionnaire improved significantly (-22.3±24 and 17.5±19.7, respectively; P < 0.0001). The proportion of participants who self-reported a moderate-to-high level of physical activity increased from 27% to 35% after treatment (P = 0.86). However, daily steps decreased significantly (-420.2±949, P < 0.001), whereas daily sedentary time increased by 36.6±88 minutes (P < 0.001). There was no significant change in the Short Physical Performance Battery score (-0.3±2.3, P = 0.6). CONCLUSIONS: In older women with overactive bladder, short-term treatment with fesoterodine decreased objectively measured physical activity with no significant change in physical function. Treatment with anticholinergics may need to be supplemented with other therapies to address fall risk in older women with overactive bladder.

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.

Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study.

OBJECTIVES: High-level evidence for second-line noninvasive treatments for fecal incontinence in women is limited. We present the rationale for and design of the NeuromOdulaTion for Accidental Bowel Leakage trial, a randomized controlled trial of percutaneous tibial nerve stimulation (PTNS) and validated sham stimulation in women with refractory accidental bowel leakage. METHODS: The rationale and goals for a 2-part study with a run-in phase, use of a generic pulse generator for PTNS and sham stimulation, masking, participant inclusion, primary and secondary outcome measures, and adverse event collection are described. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function. RESULTS: Sample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks. CONCLUSIONS: The methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage.

Relationship of Pain Catastrophizing With Urinary Biomarkers in Women With Bladder Pain Syndrome.

OBJECTIVES: Brain-derived neurotrophic factor (BDNF) has been implicated in central neurological processes. We hypothesize that greater pain catastrophizing is associated with higher urinary BDNF levels in women with bladder pain syndrome. METHODS: A secondary analysis of a database of women with urinary urgency was conducted. We identified women who met AUA criteria of bladder pain syndrome. Urinary symptoms, pain catastrophizing, and neuropathic pain were measured using the Female Genitourinary Pain Index, Pain Catastrophizing Scale and painDETECT questionnaires respectively. The relationship of the catastrophizing score with urinary BDNF (primary outcome) and other urinary biomarkers, including nerve growth factor (NGF), vascular endothelial growth factor (VEGF), and osteopontin, was evaluated using univariable and multivariable analyses. RESULTS: In 62 women with bladder pain syndrome, 15 (24%) reported pain catastrophizing symptoms (Pain Catastrophizing Scale score >30). Higher catastrophizing scores were associated with worse urinary symptoms, greater pelvic pain, greater neuropathic pain, and worse quality of life scores (all P < 0.01). On multivariable analysis, after controlling for age, body mass index and urinary symptoms, a higher pain catastrophizing score was associated with lower BDNF (P = 0.04) and lower VEGF levels (P = 0.03). Urinary urgency was associated with a higher NGF level (P = 0.04) while bladder pain was associated with higher levels of NGF (P = 0.03) and VEGF (P = 0.01). CONCLUSIONS: Neuroinflammatory mechanisms contribute to the central processing of pain in women with bladder pain syndrome. Worse urinary symptoms are associated with higher NGF and VEGF levels, but worse pain catastrophizing is associated with lower BDNF and VEGF levels. Urinary BDNF levels may be useful in phenotyping women who have central augmentation of pain processing.

Is Nocturia Associated With Detrusor Underactivity?

OBJECTIVES: Detrusor underactivity (DU) is diagnosed using urodynamic testing. We hypothesized that nocturia is associated with detrusor underactivity. METHODS: We performed a retrospective chart review of all women who underwent urodynamic testing at our institution between 2016 and 2018. Uroflowmetry and pressure-flow study parameters were compared between women with nocturia (≥2 voids/night) and without nocturia (0-1 void/night). Detrusor underactivity was diagnosed using 3 different criteria: (1) bladder voiding efficiency (BVE) of <90%, (2) bladder contractility index of <100, and (3) a composite of three urodynamic measures (Gammie criteria). RESULTS: Of 358 women, 172 (48%) were in the nocturia group and 186 (52%) were in the no nocturia group. On uroflowmetry, median postvoid residual volume was similar (20 mL) in both groups. Median maximum flow rate (15 vs 17 mL/s, P < 0.05) and average flow rate (6 mL/s vs 7 mL/s, P < 0.05) were significantly lower in the nocturia group compared with the no nocturia group. During pressure-flow study, a significantly greater proportion of women with nocturia were unable to void around the catheter (30% vs 27%, P < 0.01). The overall rate of DU varied with the criteria used: BVE (54%), bladder contractility index (41%), and Gammie criteria (7%). The rate of DU using the BVE criteria was significantly higher in the nocturia group (63% vs 48%, P < 0.01), but no significant differences were noted using the other criteria. CONCLUSIONS: Nocturia is associated with reduced voiding efficiency in women. The diagnosis of DU using urodynamics is challenging.