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.

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.

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.

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.

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.

"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.

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.

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.

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.

Generic Health-Related Quality of Life in Patients Seeking Care for Pelvic Organ Prolapse.

OBJECTIVE: Using the American Urogynecologic Society multicenter Pelvic Floor Disorder Registry for Research, we (1) compared generic quality of life (QOL) in women planning pelvic organ prolapse (POP) treatment (surgery vs pessary), (2) correlated generic and condition-specific QOL scores, and (3) identified associations between generic QOL and other factors. METHODS: This cross-sectional analysis assessed generic physical and mental QOL using the Patient-Reported Outcomes Measurement Information System Global Health Scale at baseline. Global Physical and Mental T-scores center on a representative US population sample (mean [SD], 50 [10]; higher scores, better health). Condition-specific QOL was assessed with Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and POP/Urinary Incontinence Sexual Function Questionnaire. Linear regression models identified associations between clinical factors and Global Physical/Mental scores. RESULTS: Five hundred sixty-eight women (419 surgery, 149 pessary) were included. Surgery patients were younger, heavier, and more often sexually active (all P's ≤ 0.01). Global Physical scores were lower in the surgery versus pessary group, but not likely clinically meaningful (mean [SD], 48.8 [8.1] vs 50.4 [8.5]; P = 0.035); Global Mental scores were similar (51.4 [8.4] vs 51.9 [9.5], P = 0.56). Global Health scores correlated with Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and POP/Urinary Incontinence Sexual Function Questionnaire scores (all P's < 0.0001). In multivariable models, menopause was associated with better physical QOL, and constipation, coronary artery disease, pelvic pain, and increased body mass index with worse physical QOL. Age was associated with better mental QOL, and constipation, fecal incontinence, pelvic pain, and coronary artery disease with worse mental QOL. CONCLUSIONS: Women choosing POP surgery versus pessary had similar physical and mental generic QOL.

Baseline Characteristics, Evaluation, and Management of Women With Complaints of Recurrent Urinary Tract Infections.

OBJECTIVE: The aims of this study were to determine the proportion of women presenting for recurrent urinary tract infections (UTIs) who met the diagnostic criteria (culture-proven UTI ≥3 in 1 year or ≥2 in 6 months) and to assess advanced testing utilization, preventive therapy use, and risk factors. METHODS: This is a retrospective chart review of women seen as new urogynecology consults for recurrent UTI (rUTI) between April 1, 2017, and April 1, 2018, followed through April 1, 2019. Exclusion criteria included catheter use, cancer treatment within 2 years, and prior organ transplant, urinary diversion, conduit, or bladder augmentation. RESULTS: Of 600 women, 71% had follow-up with a median of 179 days. Urinary tract infection symptoms included frequency (50%), dysuria (46%), urgency (43%), and malodorous urine (7%). One third met the rUTI diagnostic criteria. Two hundred thirty-four (39%) underwent advanced testing, and 9% (21/234) of women who underwent advanced testing had a change in clinical care. Preventive therapy use increased after consultation (P < 0.001), with vaginal estrogen (47%) being most common. Compared with women not meeting the rUTI criteria, women meeting the rUTI criteria were more likely to be older (adjusted odds ratio [aOR], 1.03/year; 95% confidence interval [CI], 1.02-1.04), have a prior history of gynecologic cancer (aOR, 4.07; 95% CI, 1.02-16.25), or report UTI symptoms of dysuria (aOR, 2.27; 95% CI, 1.57-3.27), or malodorous urine (aOR, 2.96; 95% CI, 1.47-5.94) and, while equally likely to be receiving preventive treatment prior to consultation, were more likely after consultation (OR, 3.06; 95% CI, 2.05-4.55). DISCUSSION: Thirty-seven percent of women seen for rUTI met the diagnostic criteria. Advanced imaging rarely changed care. Education about diagnostic criteria and preventive therapy is warranted.

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.

Review of Malpractice Litigations Involving Vesicovaginal and Rectovaginal Fistulas Following Elective Hysterectomy for Benign Indications in the United States From 1970 to 2020.

OBJECTIVE: The aims of this study were to review malpractice litigations involving vesicovaginal and rectovaginal fistulas after elective hysterectomy for benign indications in the United States and identify the most common themes in allegations by the plaintiffs and defenses by the defendants. METHODS: Using the Lexis Nexis legal database, we searched for and reviewed all U.S. malpractice litigations pertinent to this question between 1970 and 2020. RESULTS: Out of 82 cases that were identified and reviewed, 17 cases met our inclusion and exclusion criteria. These cases were decided between 1973 and 2019. Nine cases involved total abdominal hysterectomies, 1 involved total laparoscopic hysterectomy (TLH), 1 involved total vaginal hysterectomy (TVH), and the rest were not specified. Fifteen cases involved vesicovaginal fistulas and 2 involved rectovaginal fistulas. Three cases were ruled in favor of the plaintiffs, with monetary compensation ranging from $250,000 to $753,722 (approximately $364,120 to $1.8 million when adjusted for inflation), whereas 14 cases were ruled in favor of the defending surgeons. Common allegations were negligence in 15 cases and lack of informed consent in 2 cases. Factors that strengthened the defendants' arguments were thorough documentation, informed consent, and prompt referral to specialists. Intraoperative cystoscopy may have benefited in some cases. CONCLUSIONS: Thorough documentation, informed consent, and prompt referral to specialists strengthened the defendants' legal arguments. Intraoperative cystoscopy may also be beneficial.

A Mobile Application Patient Decision Aid for Treatment of Overactive Bladder.

OBJECTIVE: The aim of this study was to develop and validate a mobile application patient decision aid (mPDA) for providing treatment options to women with overactive bladder (OAB). METHODS: We performed a mixed methods study. We conducted cognitive interviews to gain insight about treatment decisions for OAB. We then developed an evidence-based mPDA and conducted a prospective cohort study to validate it. Women completed the validated Decisional Conflict Scale. Construct validity was determined by comparing Decisional Conflict Scale scores before and after use of the decision aid. Concurrent validity was assessed by determining the relationship between change in Decision Conflict Scale score and a validated Patient Satisfaction Questionnaire. Discriminant validity was assessed by comparing the change in Decision Conflict Scale score in women who had failed 2 or less versus 3 or more prior treatments. RESULTS: Fifteen women participated in cognitive interviews. Thematic analysis revealed that women want information about adverse events, personalization of treatment options, and supplemental interactive sources. Sixty-five women participated in the validation study. Decision Conflict Scale scores improved significantly after use of the decision aid (60.2 ± 22.3 vs 18.7 ± 19.5, P < 0.001). Change in Decision Conflict Scale score correlated moderately with Patient Satisfaction Questionnaire score (r = 0.437, P = 0.003). Women with 3 or more prior treatment failures had greater improvement in Decision Conflict Scale score than women with 2 or less prior treatment failures (P < 0.001). CONCLUSIONS: The mPDA is a valuable adjunct to physician counseling for treatment options in women with OAB.

Impact of Surgical Wait Time to Hysterectomy for Benign Gynecologic Disease.

STUDY OBJECTIVE: To determine the impact of surgical wait time on healthcare use and surgical outcomes for patients undergoing hysterectomy for benign gynecologic indications. DESIGN: Retrospective cohort study. SETTING: Urban, academic tertiary care center. PATIENTS: Patients who underwent hysterectomy for benign disease between 2012 and 2018. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Patients were categorized into 2 groups, dichotomized by surgical wait times >30 days or ≤30 days. Healthcare use was measured by the number of discrete patient interactions with the healthcare system through phone calls, secure electronic messaging, and office and emergency room visits. Univariate and multivariable logistic regression models were performed to assess the association between surgical wait time and healthcare use and perioperative outcomes while controlling for confounders. A total of 277 patients were included in our analysis: 106 (38.3%) had surgical wait times >30 days (median 47 days, range 24-68 days), and 171 (67.1%) had surgical wait times ≤30 days (median 19 days; range 12-26 days). The groups did not differ by age, insurance status, substance use, or comorbid conditions. Patients in the group with surgical wait times >30 days were more likely to have increased healthcare use (69 of 106, 65% vs 43 of 171, 25%; odds ratio 5.55; 95% confidence interval, 3.27-9.41). There were no differences in intraoperative complications (9 of 106, 8% vs 19 of 171, 11%; p = .482) or postoperative complications (28 of 106, 26% vs 32 of 171, 19%; p = .13) between the groups; however, after controlling for potential confounders, patients with surgical wait times >30 days were 3.22 times more likely to be readmitted than patients with surgical wait times ≤30 days (95% confidence interval, 1.27-8.19). CONCLUSION: A surgical wait time >30 days in patients undergoing a hysterectomy for benign disease is associated with increased healthcare use in the interim. Although patients who experience longer surgical wait times do not experience worse surgical outcomes, they may be at higher risk for readmission after surgery. Targeted interventions to optimize perioperative coordination of care for patients undergoing a hysterectomy for benign disease, especially those within vulnerable populations, are needed to improve quality of care, decrease any redundant or inefficient healthcare use, and reduce any unnecessary delays.

Video Virtual Clinical Encounters Versus Office Visits for Postoperative Care After Pelvic Organ Prolapse Surgery: A Randomized Clinical Trial.

OBJECTIVES: To determine if patient satisfaction of virtual clinical encounters is noninferior to traditional in-office clinical encounters for postoperative follow-up after reconstructive surgery for pelvic organ prolapse. METHODS: This was a randomized controlled noninferiority trial of women undergoing surgery for pelvic organ prolapse. Women were recruited and randomized during their preoperative counseling visit to virtual clinical encounters via video conference technology or in-office clinical encounters for their 30-day postoperative follow-up visits. The primary outcome was patient satisfaction measured by the validated Patient Satisfaction Questionnaire-18 (score range, 18-90, with higher scores indicating greater satisfaction) administered by telephone following the 30-day visit. Additional information regarding demographics, postoperative health care utilization, and complications was collected via chart review and compared between groups. RESULTS: A total of 52 women were randomly assigned to virtual clinical encounters via videoconference technology or traditional in-office clinical encounters (26 per group). The mean patient satisfaction score was 80.7 ± 2.6 in the virtual group and 81.2 ± 2.8 in the office group (difference, -0.46 points; 95% confidence interval, -1.95 to 1.03), which was consistent with noninferiority. Postoperative complication rates were 31% in the virtual group and 46% in the office group (P = 0.3). There were no significant between-group differences in secondary measures of unscheduled telephone calls (88% versus 77%, P = 0.5) and office visits (35% versus 38%, P = 0.8), emergency room visits (15% versus 19%, P = 1.0), and hospital readmissions (4% versus 12%, P = 0.6) within 90 days of surgery. CONCLUSIONS: For patients with pelvic organ prolapse undergoing reconstructive surgery, postoperative virtual clinical encounters via video conference technology are noninferior to traditional in-office clinical encounters with high levels of short-term patient satisfaction and no differences in postoperative health care utilization and complications rates.

Is Fluid Intake Associated With Fecal Incontinence in Women?

OBJECTIVE: The primary aim of this study was to determine if fecal incontinence (FI) is associated with self-reported fluid intake in women seeking care for pelvic floor disorders. The secondary aim was to determine the association between bowel symptoms and fluids associated with FI. METHODS: We conducted a retrospective cross-sectional study of women presenting for evaluation of pelvic floor disorders from 2009 to 2015. The presence of FI was defined as an affirmative response of any frequency to the question, "During the last 4 weeks, how often have you leaked or soiled yourself with stool?" Data on fluid intake and bowel symptoms were collected using the Questionnaire-based Voiding Diary and Colorectal-Anal Distress Inventory short form, respectively. The relationship between FI and quartiles of fluid intake, as well as the relationship between bowel symptoms and fluids associated with FI, was analyzed. RESULTS: Nine hundred twenty-four women were included: 379 (41%) with and 545 (59%) without FI. There was an association between FI and increasing total carbonated fluid intake (P = 0.009) and decreasing water intake (P = 0.009). The associations between FI and carbonated fluid intake and FI and water intake remained significant after controlling for patient characteristics (P < 0.05). There was a significant association between the symptom of straining to defecate and carbonated beverage intake (P = 0.046), which remained significant after controlling for patient characteristics (P < 0.001). CONCLUSIONS: Consumption of carbonated beverages is associated with FI in women. Intake of carbonated fluids is associated with bowel symptoms that may exacerbate FI symptoms.