Patient perspectives in adverse event reporting after vaginal apical prolapse surgery.

BACKGROUND: Many clinical trials use systematic methodology to monitor adverse events and determine grade (severity), expectedness, and relatedness to treatments as determined by clinicians. However, patient perspectives are often not included in this process. OBJECTIVE: This study aimed to compare clinician vs patient grading of adverse event severity in a urogynecologic surgical trial. Secondary objectives were to estimate the association of patient grading of adverse events with decision-making and quality of life outcomes and to determine if patient perspective changes over time. STUDY DESIGN: This was a planned supplementary study (Patient Perspectives in Adverse Event Reporting [PPAR]) to a randomized trial comparing 3 surgical approaches to vaginal apical prolapse. In the parent trial, adverse events experienced by patients were collected per a standardized protocol every 6 months during which clinicians graded adverse event severity (mild, moderate, severe/life-threatening). In this substudy, we obtained additional longitudinal patient perspectives for 19 predetermined "PPAR adverse events." Patients provided their own severity grading (mild, moderate, severe/very severe/life-threatening) at initial assessment and at 12 and 36 months postoperatively. Clinicians and patients were masked to each other's reporting. The primary outcome was the interrater agreement (kappa statistic) for adverse event severity between the initial clinician and patient assessment, combining patient grades of mild and moderate. The association between adverse event severity and the Decision Regret Scale, Satisfaction with Decision Scale, the 12-Item Short-Form Health Survey, and Patient Global Impression of Improvement scores was assessed using the Spearman correlation coefficient (ρ) for continuous scales, the Mantel-Haenszel chi-square test for Patient Global Impression of Improvement, and t tests or chi-square tests comparing the assessments of patients who rated their adverse events or symptoms as severe with those who gave other ratings. To describe patient perspective changes over time, the intraobserver agreement was estimated for adverse event severity grade over time using weighted kappa coefficients. RESULTS: Of the 360 randomly assigned patients, 219 (61%) experienced a total of 527 PPAR adverse events (91% moderate and 9% severe/life-threatening by clinician grading). Mean patient age was 67 years; 87% were White and 12% Hispanic. Among the patients reporting any PPAR event, the most common were urinary tract infection (61%), de novo urgency urinary incontinence (35%), stress urinary incontinence (22%), and fecal incontinence (13%). Overall agreement between clinician and participant grading of severity was poor (kappa=0.24 [95% confidence interval, 0.14-0.34]). Of the 414 adverse events that clinicians graded as moderate, patients graded 120 (29%) as mild and 80 (19%) as severe. Of the 39 adverse events graded as severe by clinicians, patients graded 15 (38%) as mild or moderate. Initial patient grading of the most severe reported adverse event was mildly correlated with worse Decision Regret Scale (ρ=0.2; P=.01), 12-Item Short-Form Health Survey (ρ=-0.24; P<.01), and Patient Global Impression of Improvement (P<.01) scores. There was no association between adverse event severity and Satisfaction with Decision Scale score. Patients with an initial grading of "severe" had more regret, lower quality of life, and poorer global impressions of health than those whose worst severity grade was mild (P<.05). Agreement between the patients' initial severity ratings and their ratings at 12 months (kappa=0.48 [95% confidence interval, 0.39-0.58]) and 36 months (kappa=0.45 [95% confidence interval, 0.37-0.53]) was fair. CONCLUSION: Clinician and patient perceptions of adverse event severity are discordant. Worse severity from the patient perspective was associated with patient-centered outcomes. Including the patient perspective provides additional information for evaluating surgical procedures.

Diet Intake After Diet Modification Intervention in Women With Fecal Incontinence.

IMPORTANCE: Older women with fecal incontinence (FI) who underwent diet modification intervention (DMI) showed significant improvement in FI symptoms. It is unclear whether improvement in symptoms was associated with objective changes in dietary intake quality. OBJECTIVES: The primary aim was to determine if improvement in overall dietary intake quality was associated with improvement in FI symptoms. Our secondary aim was to evaluate whether individual food group consumption changes were associated with changes in FI symptoms. STUDY DESIGN: This was an ancillary analysis of a prospective cohort study of women aged 65 years and older with FI who underwent DMI. Seven-day diet-and-bowel diaries at baseline and 6 weeks after DMI were examined for how frequently participants consumed food categories and FI triggers. Adherence to recommended dietary guidelines was assessed between 2 and 4 weeks using a 24-hour diet recall. Baseline and postintervention consumption were compared using the Wilcoxon signed rank test. Spearman correlation was used to compare dietary intake changes with FI symptom changes. RESULTS: Twenty-four women completed the 24-hour diet recalls, and 17 women completed the 7-day diet-and-bowel diaries at baseline and 6 weeks. More participants who were adherent had clinically significant improvement in symptoms compared with those who were not adherent (70% vs 30%, P=0.57). Decreased consumption of saturated fats (P=0.01) and fried foods (P<0.001) was associated with improvement in FI symptoms. CONCLUSIONS: In this small population, overall dietary intake quality was not associated with change in FI symptom improvement. Decreased intake of saturated fat and fried food was associated with FI symptom improvement.

Dietary Intake and Symptom Severity in Women with Fecal Incontinence.

INTRODUCTION AND HYPOTHESIS: The goal of this study was to determine whether dietary fat/fiber intake was associated with fecal incontinence (FI) severity. METHODS: Planned supplemental analysis of a randomized clinical trial evaluating the impact of 12-week treatment with percutaneous tibial nerve stimulation versus sham in reducing FI severity in women. All subjects completed a food screener questionnaire at baseline. FI severity was measured using the seven-item validated St. Mark's (Vaizey) FI severity scale. Participants also completed a 7-day bowel diary capturing the number of FI-free days, FI events, and bowel movements per week. Spearman's correlations were calculated between dietary, St. Mark's score, and bowel diary measures. RESULTS: One hundred and eighty-six women were included in this analysis. Mean calories from fats were 32% (interquartile range [IQR] 30-35%). Mean dietary fiber intake was 13.9 ± 4.3 g. The percentage of calories from fats was at the higher end of recommended values, whereas fiber intake was lower than recommended for adult women (recommended values: calories from fat 20-35% and 22-28 g of fiber/day). There was no correlation between St. Mark's score and fat intake (r = 0.11, p = 0.14) or dietary fiber intake (r = -0.01, p = 0.90). There was a weak negative correlation between the number of FI-free days and total fat intake (r = -0.20, p = 0.008). Other correlations between dietary fat/fiber intake and bowel diary measures were negligible or nonsignificant. CONCLUSION: Overall, in women with moderate to severe FI, there was no association between FI severity and dietary fat/fiber intake. Weak associations between FI frequency and fat intake may suggest a role for dietary assessment in the evaluation of women with FI.

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.

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.

Twelve Month Outcomes of Pelvic Organ Prolapse Surgery in Patients With Uterovaginal or Posthysterectomy Vaginal Prolapse Enrolled in the Multicenter Pelvic Floor Disorders Registry.

OBJECTIVE: The aim of the study was to compare 12-month subjective and objective outcomes between 3 approaches to apical pelvic organ prolapse (POP) surgery in patients presenting with uterovaginal or posthysterectomy vaginal prolapse enrolled in the Pelvic Floor Disorders Registry for Research. STUDY DESIGN: This was an analysis of a multicenter, prospective registry that collected both patient- and physician-reported data for up to 3 years after conservative (pessary) and surgical treatment for POP. Twelve-month subjective and anatomic outcomes for patients who underwent surgical treatment were extracted from the registry for analysis. Pelvic organ prolapse recurrence was defined as a composite outcome and compared between the 3 apical surgery groups (native tissue repair, sacrocolpopexy, colpocleisis) as well as the 2 reconstructive surgery groups (native tissue repair and sacrocolpopexy). RESULTS: A total of 1,153 women were enrolled in the registry and 777 (67%) opted for surgical treatment, of whom 641 underwent apical repair and were included in this analysis (404 native tissue repair, 187 sacrocolpopexy, and 50 colpocleisis). The overall incidence of recurrence was as follows: subjective 6.5%, anatomic 4.7%, retreatment 7.2%, and composite 13.6%. The incidence of recurrence was not different between the 3 surgical groups. When baseline patient characteristics were controlled for, composite POP recurrence between the native tissue and sacrocolpopexy groups remained statistically nonsignificant. Concurrent perineorrhaphy with any type of apical POP surgery was associated with a lower risk of recurrence (adjusted odds ratio, 0.43; 95% confidence interval, 0.25-0.74; P = 0.002) and prior hysterectomy was associated with a higher risk (adjusted odds ratio, 1.77, 95% confidence interval, 1.04-3.03; P = 0.036). CONCLUSION: Pelvic Floor Disorders Registry for Research participants undergoing native tissue apical POP repair, sacrocolpopexy, and colpocleisis surgery had similar rates of POP recurrence 12 months after surgery.

Changing Practices in the Surgical Management of Adnexal Torsion: An Analysis of the National Surgical Quality Improvement Program Database.

OBJECTIVE: To evaluate trends in the surgical management of adnexal torsion and to evaluate these trends with respect to the updated American College of Obstetricians and Gynecologists (ACOG) guidelines. METHODS: We performed a retrospective cohort study using the National Surgical Quality Improvement Program database. Women who underwent surgery for adnexal torsion between 2008 and 2020 were identified on the basis of International Classification of Diseases codes. Surgeries were grouped as either ovarian conservation or oophorectomy with the use of Current Procedural Terminology codes. Patients were also grouped into year cohorts with respect to the publication of the updated ACOG guidelines (2008-2016 compared with 2017-2020). Multivariable logistic regression, weighted by cases per year, was used to assess differences between groups. RESULTS: Of the 1,791 surgeries performed for adnexal torsion, 542 (30.3%) involved ovarian conservation and 1,249 (69.7%) involved oophorectomy. Older age, higher body mass index, higher American Society of Anesthesiologists classification, anemia, and diagnosis of hypertension were significantly associated with oophorectomy. There was no significant difference in the proportion of oophorectomies performed before 2017 compared with after 2017 (71.9% vs 69.1%, odds ratio [OR] 0.89, 95% CI 0.69-1.16; adjusted OR 0.94, 95% CI 0.71-1.25). A significant decrease in proportion of oophorectomies performed each year was identified over the entire study period (-1.6%/y, P =.02, 95% CI -3.0% to -0.22%); however, the rates did not differ before and after 2017 (interaction P =.16). CONCLUSION: There was a modest decrease in the proportion of oophorectomies for adnexal torsion performed per year over the study period. However, oophorectomy is still commonly performed for adnexal torsion, despite updated guidelines from ACOG recommending ovarian conservation.

U.S.-Based Obstetrician/Gynecologists' Experiences with Delivering Care to Women with Female Genital Cutting.

Background: There has been an increase of women living in the United States who have experienced female genital cutting (FGC). However, limited research exists evaluating the experiences of obstetrician/gynecologists delivering care to this patient population. This study aimed to assess the overall experiences, including barriers and facilitators, of U.S.-based obstetrician/gynecologists (OBGYNs) with delivering care to patients with female genital cutting at a single academic health center in the United States. Materials and Methods: This is a qualitative study of OBGYNs at a large, U.S., urban, academic health center. OBGYNs participated in a one-on-one semistructured interview. Thematic analysis using a grounded theory approach was conducted to identify predominating themes regarding the overall experiences, barriers, and facilitators to delivering care to patients with FGC. Results: Analysis of 15 study interviews revealed 4 main themes impacting the ability of OBGYNs to deliver care to patients with FGC: (1) limited educational training on FGC, (2) challenges with identifying that a patient had FGC and with using the World Health Organization classification system, (3) questions regarding "normative" anatomy and reinfibulation after vaginal procedures, and (4) navigating affective responses of patient and self when FGC is encountered. Conclusion: The above findings have practical implications, showing that the limited educational experience and lack of a clear policy on how to manage the care of women with FGC lead to variation and even limitations in how care is delivered to these women. We encourage OBGYN professional societies to consider creating education and policy to aid clinicians in caring for patients with FGC.

Association Between Enlarged Genital Hiatus and Composite Surgical Failure After Vaginal Hysterectomy With Uterosacral Ligament Suspension.

IMPORTANCE: The impact of a persistently enlarged genital hiatus (GH) after vaginal hysterectomy with uterosacral ligament suspension on prolapse outcomes is currently unclear. OBJECTIVES: This secondary analysis of the Study of Uterine Prolapse Procedures Randomized trial was conducted among participants who underwent vaginal hysterectomy with uterosacral ligament suspension. We hypothesized that women with a persistently enlarged GH size would have a higher proportion of prolapse recurrence. STUDY DESIGN: Women who underwent vaginal hysterectomy with uterosacral ligament suspension as part of the Study of Uterine Prolapse Procedures Randomized trial (NCT01802281) were divided into 3 groups based on change in their preoperative to 4- to 6-week postoperative GH measurements: (1) persistently enlarged GH, 2) improved GH, or (3) stably normal GH. Baseline characteristics and 2-year surgical outcomes were compared across groups. A logistic regression model for composite surgical failure controlling for advanced anterior wall prolapse and GH group was fitted. RESULTS: This secondary analysis included 81 women. The proportion with composite surgical failure was significantly higher among those with a persistently enlarged GH (50%) compared with a stably normal GH (12%) with an unadjusted risk difference of 38% (95% confidence interval, 4%-68%). When adjusted for advanced prolapse in the anterior compartment at baseline, the odds of composite surgical failure was 6 times higher in the persistently enlarged GH group compared with the stably normal group (95% confidence interval, 1.0-37.5; P = 0.06). CONCLUSION: A persistently enlarged GH after vaginal hysterectomy with uterosacral ligament suspension for pelvic organ prolapse may be a risk factor for recurrent prolapse.

Characteristics associated with subjective and objective measures of treatment success in women undergoing percutaneous tibial nerve stimulation vs sham for accidental bowel leakage.

INTRODUCTION AND HYPOTHESIS: In randomized trials both percutaneous tibial nerve stimulation (PTNS) and sham result in clinically significant improvements in accidental bowel leakage (ABL). We aimed to identify subgroups who may preferentially benefit from PTNS in women enrolled in a multicenter randomized trial. METHODS: This planned secondary analysis explored factors associated with success for PTNS vs sham using various definitions: treatment responder using three cutoff points for St. Mark's score (≥3-, ≥4-, and ≥5-point reduction); Patient Global Impression of Improvement (PGI-I) of ≥ much better; and ≥50% reduction in fecal incontinence episodes (FIEs). Backward logistic regression models were generated using elements with significance of p<0.2 for each definition and interaction terms assessed differential effects of PTNS vs sham. RESULTS: Of 166 women randomized, 160 provided data for at least one success definition. Overall, success rates were 65% (102 out of 158), 57% (90 out of 158), and 46% (73 out of 158) for ≥3-, ≥4-, and ≥5-point St Mark's reduction respectively; 43% (68 out of 157) for PGI-I; and 48% (70 out of 145) for ≥50% FIEs. Of those providing data for all definitions of success, 77% (109 out of 142) met one success criterion, 43% (61 out of 142) two, and 29% (41 out of 142) all three success criteria. No reliable or consistent factors were associated with improved outcomes with PTNS over sham regardless of definition. CONCLUSIONS: Despite exploring diverse success outcomes, no subgroups of women with ABL differentially responded to PTNS over sham. Success results varied widely across subjective and objective definitions. Further investigation of ABL treatment success definitions that consistently and accurately capture patient symptom burden and improvement are needed.

Longitudinal urinary microbiome characteristics in women with urgency urinary incontinence undergoing sacral neuromodulation.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the stability of the urinary microbiome communities in women undergoing sacral neuromodulation (SNM) for urgency urinary incontinence (UUI). We hypothesized that clinical response to SNM therapy would be associated with changes in the urinary microbiome. METHODS: Women completed the Overactive Bladder Questionnaire Short-Form, the International Consultation on Incontinence Questionnaire Short Form, and the Female Sexual Function Index at baseline and 3 months post-SNM implantation. Transurethral urinary specimens were obtained for microbiome analysis at baseline and 3 months postoperatively. The V4 region of the 16S rRNA gene (515F-806R) was amplified with region-specific primers, and Amplicon Sequence Variants (ASVs) were identified with a closed-reference approach of taxonomic classification. Alpha-diversity was calculated using the phylogenetic (i.e., Faith's phylogenetic diversity) and nonphylogenetic metrics (i.e., Shannon diversity, and Pielou's evenness) using the QIIME2 plugin. Longitudinal paired volatility analysis was performed using the DEICODE and Gemelli plugin to account for host specificity across both time and space. RESULTS: Nineteen women who underwent SNM and provided both baseline and 3-month urine samples were included in this analysis. Women reported improvement in objective (number of UUI episodes) and subjective (symptom severity and health-related quality of life) measures. Ninety percent of the bacteria were classified as Bacteroidetes, Firmicutes, Proteobacteria, and Actinobacteria. No significant differences were observed in each subject's beta-diversity at 3 months compared with their baseline microbiome. CONCLUSIONS: Our descriptive pilot study of a cohort of women who had achieved objective and subjective improvements in UUI following SNM therapy demonstrates that the urinary microbiome remains relatively stable, despite variability amongst the cohort.

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.

"Every minute counts": association between operative time and post-operative complications for patients undergoing minimally invasive sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: Our aim was to assess whether operative time is independently associated with post-operative complications for minimally invasive sacrocolpopexy (MISCP). METHODS: Using the National Surgical Quality Improvement Program (NSQIP) database, patients undergoing MISCP from 2015 to 2020 were identified by CPT code. The following data were extracted: demographics, concomitant procedures (hysterectomies, midurethral sling, and anterior or posterior repair), and post-operative complications. Complications were categorized into minor, major, and composite, modeled after the Clavien-Dindo classification. For analysis, covariates associated with operative time and composite complications were identified using a general linear model and Chi-squared or Fisher's exact test as appropriate. Then, adjusted spline regression was performed as a test of nonlinearity between operative time and composite complications. Adjusted relative risks of complications by 60-min increments were estimated using Poisson regression with robust error variance. RESULTS: A total of 13,239 patients who underwent MISCP were analyzed. Overall, mean operative time (SD) was 189.5 (78.3) min. Post-operative complication rates were 2.6% for minor, 4.7% for major, and 7.3% for composite complications. Age, smoking, and sling were the only covariates associated with both operative time and post-operative complications. Adjusted spline regression demonstrated linearity (p<0.0001). With each 60-min increase in operative time, adjusted relative risks (95% CI) were 1.14 for composite (1.09, 1.19), 1.16 for minor (1.10, 1.21), and 1.11 (1.03, 1.20) for major complications. CONCLUSIONS: Operative time is independently and linearly associated with post-operative complications for patients undergoing MISCP, even when adjusted for demographic variables and concomitant procedures.

Characterization of the GU microbiome in women with self-perceived bladder health over the life course.

BACKGROUND: A variety of factors influence bladder health, including environmental factors, life experiences, biologic foundations, and coexistent medical conditions. A biologically diverse microbial community exists in the urine that is likely influenced by the microbial inhabitants of the vagina. The relationship between the genitourinary (GU) microbiome and self-perceived bladder health is unknown. OBJECTIVE: To longitudinally define the GU microbiome in women with self-percieved bladder health sampled across multiple time points over a year. STUDY DESIGN: Women with no reported lower urinary tract dysfunction or symptoms (LUTS) were recruited from six clinical sites and assessed every 6 weeks for 1 year. Voided urine and vaginal samples were longitudinally collected. Self-perceived bladder health was assessed with select items from the LURN comprehensive assessment of self-reported urinary symptoms (CASUS) tool. We defined four life phases as follows: young (18-34 years, nulliparous), midlife (35-45 years, menstruating), transitional (46-60 years, perimenopausal), mature (>60 years, not using vaginal and/or systemic hormone replacement therapy). DNA was extracted from samples, and the V4 region of the 16S rRNA gene was amplified with region-specific primers. The 16S rRNA sequencing on an Illumina NovaSeq. Microbial beta-diversity was calculated using DEICODE to identify microbial taxa that cluster in the samples. Longitudinal volatility analysis was performed using the gemelli plugin. Log-abundance ratios of microbial features were explored and visualized in Qurro. RESULTS: Fifty-four (N = 16 young, N = 16 midlife, N = 15 transitional, N = 7 mature) women were enrolled and provided baseline data. Most women in each life phase (93%-98%) continued to report self-perceived bladder health throughout the 1-year follow-up as assessed by CASUS items. Temporal-based microbial diversity of urinary and vaginal microbiome remained relatively stable over 1 year in all subjects. The GU microbiomes of mature women were distinct and microbially diverse from that of young, midlife, and transitional women, with genera of Gardnerella, Cupriavidus, and Dialister contributory to the microbial features of the mature microbiome. The mature GU microbiome was statistically different (p < 0.0001) from the midlife, transitional, and young microbiome for the log ratio of Gardnerella and Cupriavidus (in the numerator) and Lactobacillus (in the denominator) for voided samples and Gardnerella and Dialister (in the numerator) and Lactobacillus (in the denominator) for vaginal samples. Differences in the GU microbiome were also demonstrated via longitudinal beta-diversity between women developing urinary frequency as reported by CASUS responses or objectively on bladder diary compared to women without urinary frequency. CONCLUSION: In women with a self-perceived healthy bladder, the GU microbiome remained stable in all age groups over a 1 year period. Differences were seen with respect to life phase, where mature women were distinct from all other groups, and with respect to self-reported LUTS.

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.

Outcomes of Pessary Use at 1 Year in Women Treated for Pelvic Organ Prolapse in a Large Multicenter Registry: Developed by the Pelvic Floor Disorders Registry.

IMPORTANCE: There is a lack of high-quality long-term follow-up regarding pessary treatment. Most studies are case series or retrospective with a small sample size and short-term follow-up. OBJECTIVES: This study aimed to evaluate differences in women who continue versus discontinue pessary use and the effectiveness, quality of life, and safety associated with pessary management at 1 year. STUDY DESIGN: This study analyzed a multicenter national registry following women for 3 years with vaginal prolapse treated with a pessary or surgery. The primary outcome of this analysis was to compare the difference in characteristics among those who continue versus discontinue pessary use at 12 months. RESULTS: Among 1,153 participants enrolled, 376 (32.6%) opted for a pessary, and 296 (78.7%) were successfully fitted. Data were available for 240 participants (81%). At 1 year, 62% (n = 148) were still using pessaries, and 38% (n = 92) had stopped with 25% opting for surgery. Most commonly reported de novo adverse effects were urinary leakage (16%), feeling or seeing a bulge (12%), and vaginal discharge (11%). There was no difference in baseline characteristics among women who continued versus discontinued pessary use. At 12 months, subjective symptoms were similar between groups, with similar change in symptoms from baseline on most validated instruments. Those who continued to use a pessary reported worse urinary symptoms due to de novo urinary leakage ( P = 0.01). CONCLUSIONS: At 1 year, most women successfully fitted with a pessary continued pessary use. Although there was a significant improvement in condition-specific quality of life and low rates of complications, approximately 40% of women discontinued pessary use by 12 months. We were unable to identify any baseline characteristics associated with pessary discontinuation.

Cognitive function following surgery for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Older women are at higher risk for cognitive dysfunction following surgery. We hypothesized that for women undergoing pelvic organ prolapse (POP) surgery, memory function would not be significantly different at delayed postoperative assessment compared to baseline. OBJECTIVE: We sought to compare performance on tests of various neurocognitive domains before and after surgery for POP. METHODS: A prospective cohort study was conducted with women, aged 60 years and older who were undergoing surgery for POP. A battery of highly sensitive neurocognitive tests was administered preoperatively (baseline), on postoperative day 1 (postoperative visit 1, POV1), and at the first postoperative clinic visit 4-6 weeks after surgery (postoperative visit 2, POV2). The test battery included the scene-encoding memory task, the n-back task, the Iowa gambling task, the balloon analogue risk task, and the psychomotor vigilance task. These tests assessed the neurocognitive subdomains of episodic memory, working memory, decision-making, risk-taking, and sustained attention. Two score comparisons were made: between baseline and POV1, and between baseline and POV2. RESULTS: In 29 women, performance on the scene-encoding memory task was worse at POV1 than at baseline (2.22 ± 0.4 vs. 2.45 ± 0.6, p < 0.05) but was better than baseline at POV2 (2.7 ± 0.7 vs. 2.45 ± 0.6, p < 0.05). Similarly, performance on the psychomotor vigilance test was worse at POV1 than at baseline (p < 0.01) but there was no difference at POV2. There was no difference in performance on the Iowa gambling test, n-back test, and balloon analogue risk tasks between baseline and any postoperative visit. CONCLUSION: Cognitive test scores did not worsen significantly between baseline and delayed postoperative assessments in older women undergoing surgery for POP.

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.

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.