OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.

Importance: Women with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information. Objective: To assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence. Design, Setting, and Participants: Multicenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence. Interventions: Cystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189). Main Outcomes and Measures: Primary outcome, change from baseline mean number of daily urgency urinary incontinence episodes over 6 months, was measured with monthly 3-day diaries. Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Questionnaire Short Form (SF); range, 0-100, higher scores indicating worse symptoms; Overactive Bladder Satisfaction questionnaire; range, 0-100; includes 5 subscales, higher scores indicating better satisfaction; and adverse events. Results: Of the 364 women (mean [SD] age, 63.0 [11.6] years) in the intention-to-treat population, 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group (-3.9 vs -3.3 episodes per day; mean difference, 0.63; 95% CI, 0.13 to 1.14; P = .01). Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Questionnaire SF for symptom bother (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0 to 13.3; P = .002); treatment satisfaction (67.7 vs 59.8; mean difference, 7.8; 95% CI, 1.6 to 14.1; P = .01) and treatment endorsement (78.1 vs 67.6; mean difference; 10.4, 95% CI, 4.3 to 16.5; P < .001) than treatment with sacral neuromodulation. There were no differences in convenience (67.6 vs 70.2; mean difference, -2.5; 95% CI, -8.1 to 3.0; P = .36), adverse effects (88.4 vs 85.1; mean difference, 3.3; 95% CI, -1.9 to 8.5; P = .22), and treatment preference (92.% vs 89%; risk difference, -3%; 95% CI, -16% to 10%; P = .49). Urinary tract infections were more frequent in the onabotulinumtoxinA group (35% vs 11%; risk difference, -23%; 95% CI, -33% to -13%; P < .001). The need for self-catheterization was 8% and 2% at 1 and 6 months in the onabotulinumtoxinA group. Neuromodulation device revisions and removals occurred in 3%. Conclusions and Relevance: Among women with refractory urgency urinary incontinence, treatment with onabotulinumtoxinA compared with sacral neuromodulation resulted in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance. In addition, it resulted in a higher risk of urinary tract infections and need for transient self-catheterizations.

Female mixed urinary incontinence: a clinical review.

IMPORTANCE: Mixed urinary incontinence, a condition of both stress and urge urinary incontinence, is prevalent in 20% to 36% of women and is challenging to diagnosis and treat because urinary symptoms are variable and guidelines for treatment are not clear. OBJECTIVE: To review the diagnosis and management of mixed urinary incontinence in women, with a focus on current available evidence. EVIDENCE REVIEW: MEDLINE was searched from January 1, 1992, to December 31, 2013. Additional citations were obtained from references of the selected articles and reviews. Articles that discussed the prevalence, diagnosis, results, and treatment of mixed urinary incontinence were selected for review. Evidence was graded using Oxford Centre for Evidence-Based Medicine levels of evidence for treatment recommendations. FINDINGS: The MEDLINE search resulted in 785 articles. After selection and obtainment of additional citations, a total of 73 articles were reviewed. There is high-quality (level 1) evidence for treating urinary incontinence with weight loss, for treating stress urinary incontinence by performing anti-incontinence procedures of both traditional and mid-urethral slings and retropubic urethropexies, and for managing urge urinary incontinence with anticholinergic medications. However, direct high-quality evidence for treatment of women with mixed urinary incontinence is lacking, as are clear diagnostic criteria and management guidelines. CONCLUSION AND RELEVANCE: High-quality, level 1 evidence for urinary incontinence therapy can guide clinicians in the treatment of the components of mixed urinary incontinence. Because high-quality evidence is lacking regarding the treatment of mixed urinary incontinence, treatment generally begins with conservative management emphasizing the most bothersome component. Randomized trials in women with mixed urinary incontinence populations are needed.

Chatbot responses suggest that hypothetical biology questions are harder than realistic ones.

The biology education literature includes compelling assertions that unfamiliar problems are especially useful for revealing students' true understanding of biology. However, there is only limited evidence that such novel problems have different cognitive requirements than more familiar problems. Here, we sought additional evidence by using chatbots based on large language models as models of biology students. For human physiology and cell biology, we developed sets of realistic and hypothetical problems matched to the same lesson learning objectives (LLOs). Problems were considered hypothetical if (i) known biological entities (molecules and organs) were given atypical or counterfactual properties (redefinition) or (ii) fictitious biological entities were introduced (invention). Several chatbots scored significantly worse on hypothetical problems than on realistic problems, with scores declining by an average of 13%. Among hypothetical questions, redefinition questions appeared especially difficult, with many chatbots scoring as if guessing randomly. These results suggest that, for a given LLO, hypothetical problems may have different cognitive demands than realistic problems and may more accurately reveal students' ability to apply biology core concepts to diverse contexts. The Test Question Templates (TQT) framework, which explicitly connects LLOs with examples of assessment questions, can help educators generate problems that are challenging (due to their novelty), yet fair (due to their alignment with pre-specified LLOs). Finally, ChatGPT's rapid improvement toward expert-level answers suggests that future educators cannot reasonably expect to ignore or outwit chatbots but must do what we can to make assessments fair and equitable.

Changes in bowel symptoms 1 year after rectocele repair.

OBJECTIVE: We sought to evaluate changes in bowel symptoms after rectocele repair and identify risk factors for persistent symptoms. STUDY DESIGN: We conducted ancillary analysis of a randomized surgical trial for rectocele repair. Subjects underwent examinations and completed questionnaires for bowel symptoms at baseline and 12 months postoperatively. Outcomes included resolution, persistence, or de novo bowel symptoms. We used multiple logistic regression to identify risk factors for bowel symptom persistence. RESULTS: A total of 160 women enrolled: 139 had baseline bowel symptoms and 85% had 12-month data. The prevalence of bowel symptoms decreased after rectocele repair (56% vs 23% splinting, 74% vs 37% straining, 85% vs 19% incomplete evacuation, 66% vs 14% obstructive defecation; P < .001 for all). On multiple logistic regression, a longer history of splinting was a risk factor for persistent postoperative splinting (adjusted odds ratio, 2.25; 95% confidence interval, 1.02-4.93). CONCLUSION: Bowel symptoms may improve after rectocele repair, but almost half of women will have persistent symptoms.

Pharmacologic treatment for urgency-predominant urinary incontinence in women diagnosed using a simplified algorithm: a randomized trial.

OBJECTIVE: The purpose of this study was to evaluate clinical outcomes associated with the initiation of treatment for urgency-predominant incontinence in women diagnosed by a simple 3-item questionnaire. STUDY DESIGN: We conducted a multicenter, double-blinded, 12-week randomized trial of pharmacologic therapy for urgency-predominant incontinence in ambulatory women diagnosed by the simple 3-item questionnaire. Participants (N = 645) were assigned randomly to fesoterodine therapy (4-8 mg daily) or placebo. Urinary incontinence was assessed with the use of voiding diaries; postvoid residual volume was measured after treatment. RESULTS: After 12 weeks, women who had been assigned randomly to fesoterodine therapy reported 0.9 fewer urgency and 1.0 fewer total incontinence episodes/day, compared with placebo (P ≤ .001). Four serious adverse events occurred in each group, none of which was related to treatment. No participant had postvoid residual volume of ≥ 250 mL after treatment. CONCLUSION: Among ambulatory women with urgency-predominant incontinence diagnosed with a simple 3-item questionnaire, pharmacologic therapy resulted in a moderate decrease in incontinence frequency without increasing significant urinary retention or serious adverse events, which provides support for a streamlined algorithm for diagnosis and treatment of female urgency-predominant incontinence.

Content validation of the patient-reported outcomes measurement information system (PROMIS) framework in women with urinary incontinence.

AIMS: To assess whether the existing National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) conceptual framework and item banks sufficiently capture the concerns of women with urinary incontinence (UI). METHODS: Thirty-five women with UI were recruited between February-April 2009 for 4 structured focus groups to develop and assess the content validity of a conceptual framework for the impact of UI. This framework included domains from the NIH PROMIS framework and item banks including broad domains of physical and social function and mental health. All sessions were transcribed, coded, and qualitatively and quantitatively analyzed using analytic induction and deductive analysis to identify new themes and domains relevant to women with UI. RESULTS: The focus groups provided information that confirmed the relevance of existing PROMIS domains and identified new outcome domains that are important to this patient population. The groups confirmed the relevance of the physical and social functioning, and mental health domains. Additional themes that emerged included the distinction between ability versus participation and satisfaction, role functioning, external mediators, re-calibration/coping, cognitive function and new possibilities. Participants also felt strongly that not all domains and items apply to all women with UI and an option to tailor questionnaires and skip non-relevant items was important. CONCLUSIONS: The PROMIS framework domains are relevant to women with UI, but additional patient-important themes are identified that may improve the comprehensiveness of this assessment framework for measuring outcomes important to women with UI. These results will inform future item content development for UI.

Weight loss improves fecal incontinence severity in overweight and obese women with urinary incontinence.

INTRODUCTION/HYPOTHESIS: To estimate the effect of weight loss on fecal incontinence (FI) severity among overweight and obese women with urinary incontinence, we analyzed data from women randomized to a weight loss intervention or control condition. METHODS: The modified Fecal Incontinence Severity Index (FISI) was administered at 6, 12, and 18 months in 338 women. Repeated measures analyses identified factors associated with improved FISI scores among women with baseline scores >0. RESULTS: FISI scores improved in 45 (13%) across all time points among the 291 women (87%) completing the trial. Improved scores were associated with a one-point lower urinary tract symptoms (LUTS) score, p < 0.01. Improved liquid stool FI frequency was associated with ≥ 5 kg weight loss (p = 0.001), 10-g increase in fiber intake (p = 0.05), and decreased LUTS (p = 0.003). CONCLUSIONS: FI severity improved with weight loss. Women with liquid stool FI losing at least 5 kg and/or increased dietary fiber intake had improved FI frequency.

Impact of Cystotomy Location on Cystography Results.

OBJECTIVES: This study aimed to determine if the location of a repaired bladder injury (trigone vs dome) impacts the probability of an abnormal cystography result in obstetric/gynecologic surgical patients undergoing repair of an unanticipated cystotomy. METHODS: We conducted a retrospective review of adult obstetric and gynecologic surgical patients who underwent cystographic evaluation of bladder integrity after repair of iatrogenic cystotomy at a single institution between January 2006 and July 2018. We excluded patients who had undergone repair of genitourinary fistula or urethral diverticulum. Patients were dichotomized into 2 groups based on the location of the repaired bladder injury: trigone versus dome. Fisher exact and Student t tests were used to determine the proportion of abnormal cystogram results and factors associated with an abnormal cystography result. RESULTS: Two hundred ten cases met the inclusion criteria: 176 in the dome group and 34 in the trigone group. When comparing the dome and trigone groups, respectively, mean age (45.2 ± 12.5 vs 48.4 ± 11.2 years) and cystotomy size (3.2 ± 3.2 vs 2.2 ± 2.4 cm) were comparable. Duration of postoperative bladder catheterization was longer in the trigone group (13.7 vs 12.1 days, P = 0.03). Despite the additional bladder drainage, there were more abnormal cystogram results in the trigone group versus the dome (8.8% vs 1.1%; odds ratio, 8.4). CONCLUSIONS: A repaired cystotomy at the trigone is associated with increased odds of an abnormal cystography result. An abnormal cystography result after repair at the bladder dome is rare.

Cultivable Bacteria in Urine of Women With Interstitial Cystitis: (Not) What We Expected.

OBJECTIVE: Multiple studies show cultivatable bacteria in urine of most women. The existence of these bacteria challenges interstitial cystitis (IC)/painful bladder syndrome (PBS) diagnosis, which presumes a sterile bladder. The aims of this study were (1) to compare the female bladder microbiomes in women with IC/PBS and unaffected controls and (2) to correlate baseline bladder microbiome composition with symptoms. METHODS: This cross-sectional study enrolled 49 IC/PBS and 40 controls. All provided catheterized urine samples and completed validated questionnaires. A subset of the IC/PBS cohort provided voided and catheterized urine samples. All samples from both cohorts were assessed by the expanded quantitative urine culture (EQUC) protocol; a subset was assessed by 16S rRNA gene sequencing. RESULTS: Of the IC/PBS cohort, 49.0% (24/49) were EQUC positive; in these EQUC-positive samples, the most common urotypes were Lactobacillus (45.8%) and Streptococcus (33.3%). Of the controls, 40.0% were EQUC positive; of these EQUC-positive samples, the most common urotype was Lactobacillus (50.0%). The urotype distribution was significantly different (P < 0.05), as 16% of the IC/PBS cohort, but 0% of controls, were Streptococcus urotype (P < 0.01). Symptom-free IC/PBS participants were less likely to be EQUC positive (12.5%) than IC/PBS participants with moderate or severe symptoms (68.8% and 46.2%) and the control cohort (60%; P < 0.05). CONCLUSION: Lactobacillus was the most common urotype. However, the presence of Lactobacillus did not differ between cohorts, and it did not impact IC/PBS symptom severity. Bacteria were not isolated from most participants with active IC/PBS symptoms. These findings suggest that bacteria may not be an etiology for IC/PBS.

Comparison of 100 U With 200 U of Intradetrusor OnabotulinumToxinA for Nonneurogenic Urgency Incontinence.

OBJECTIVES: The objective of this study was to compare efficacy and adverse events between 100 U and 200 U of onabotulinumtoxinA for 6 months in women with nonneurogenic urgency incontinence. METHODS: This is a secondary analysis of 2 multicenter randomized controlled trials assessing efficacy of onabotulinumtoxinA in women with nonneurogenic urgency incontinence; one compared 100 U to anticholinergics and the other 200 U to sacral neuromodulation. Of 307 women who received onabotulinumtoxinA injections, 118 received 100 U, and 189 received 200 U. The primary outcome was mean adjusted change in daily urgency incontinence episodes from baseline over 6 months, measured on monthly bladder diaries. Secondary outcomes included perceived improvement, quality of life, and adverse events. The primary outcome was assessed via a multivariate linear mixed model. RESULTS: Women receiving 200 U had a lower mean reduction in urgency incontinence episodes by 6 months compared with 100 U (-3.65 vs -4.28 episodes per day; mean difference, 0.63 episodes per day [95% confidence interval (CI), 0.05-1.20]). Women receiving 200 U had lower perceptions of improvement (adjusted odds ratio, 0.32 [95% CI, 0.14-0.75]) and smaller improvement in severity score (adjusted mean difference, 12.0 [95% CI, 5.63-18.37]). Upon subanalysis of only women who were treated with prior anticholinergic medications, these differences between onabotulinumtoxinA doses were no longer statistically significant. There was no statistically significant difference in adverse events in women receiving 200 U (catheterization, 32% vs 23%; adjusted odds ratio, 1.4 [95% CI, 0.8-2.4]; urinary tract infection, 37% vs 27%; adjusted odds ratio, 1.5 [95% CI, 0.9-2.6]). CONCLUSIONS: A higher dose of onabotulinumtoxinA may not directly result in improved outcomes, but rather baseline disease severity may be a more important prediction of outcomes.

The association between obesity and stage II or greater prolapse.

OBJECTIVE: We sought to evaluate the association between obesity and vaginal prolapse as well as pelvic organ prolapse symptoms. STUDY DESIGN: This was a cross-sectional study of women referred for urogynecologic care. The exposure was obesity and outcome, stage>or=II prolapse. Secondary outcomes were symptom bother and disease-specific quality of life. RESULTS: Our study included 721 women. No difference in stage>or=II prolapse was observed between obese (n/N 58/721 [35.8%]) and nonobese (n/N=463/721 [64.2%]) women (50.8% vs 52.7%; P=.62). Obesity was associated with increased distress on the Pelvic Floor Distress Inventory-20 (100 [+/-57.3] vs 87.4 [+/-53.1]; P=.003) due to higher scores on the Colorectal-Anal Distress Inventory-8 (22.9 [+/-21.5] vs 18.3 [+/-19.7]; P=.003) and the Urinary Distress Inventory-6 (48.8 [+/-27] vs 42.4 [+/-26.1]; P=.002). CONCLUSION: Obesity was not associated with stage>or=II prolapse but was associated with increased pelvic floor symptoms secondary to urinary and anal incontinence subscales.

Treatment decision-making and information-seeking preferences in women with pelvic floor disorders.

INTRODUCTION AND HYPOTHESIS: The Autonomy Preference Index (API) and Control Preferences Scale (CPS) measure information-seeking and decision-making preferences. Our objective was to validate these scales in women with pelvic floor disorders (PFDs) and identify variables associated with decision-making preferences. METHODS: Women seeking care for PFDs completed the API and the CPS. Psychometric properties were determined. Multivariable analyses were used to identify correlates of information-seeking and decision-making preferences. RESULTS: One hundred ten women were recruited. Both scales demonstrated good psychometric properties (intraclass correlation coefficient = 0.5 to 0.7; Cronbach's alpha = 0.8 for the API, and r = -0.3 between the API and CPS). Based on scores, women had strong preferences to be well informed, but were more neutral in their decision-making preferences. In multivariable analyses, higher education levels were associated with a stronger desire for seeking medical information. CONCLUSIONS: Women seeking care for PFDs vary in their preferences for participating in treatment decisions.

Patient-reported outcomes after combined surgery for pelvic floor disorders in older compared to younger women.

OBJECTIVE: The purpose of this study was to compare patient-reported outcomes after combined surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) between older and younger women. STUDY DESIGN: This was a retrospective cohort study including 122 younger (<65 years) and 70 older women (>/=65 years old) who underwent combined POP and SUI surgery. SUI and POP treatment failure were based on validated measures. Logistic regression was used to calculate adjusted odds ratios and 95% confidence interval [CI]. RESULTS: Mean follow-up was 10 +/- 1.2 months. Women in both age groups reported significant improvement in symptoms and life impact postoperatively. In multivariable analyses, older women had an increased odds of SUI treatment failure (adjusted odds ratio [AOR], 1.10; 95% CI, 1.05-2.5), but not POP treatment failure (AOR, 0.90; 95% CI, 0.29-2.8). CONCLUSION: Women 65 years and older undergoing combined surgery for POP and SUI are at risk for recurrent SUI, but still experience significant improvements in symptoms and life impact.

Ambulatory care related to female pelvic floor disorders in the United States, 1995-2006.

OBJECTIVE: The purpose of this study was to describe trends for pelvic floor disorder (PFD)-related ambulatory visits. STUDY DESIGN: Data were derived from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Care Survey. PFD-related visits were based on ICD-9 codes. We collapsed 12 survey years into 3 study periods (1995-1998, 1999-2002, 2003-2006) to evaluate numbers, rates, and trends for PFD-related visits. RESULTS: The average annual number of PFD-related visits was 3.9 million (95% confidence interval, 3.1-4.7). The annual rate of PFD-related visits per 1000 women was 35.2% in 1995-1998, 40.6% in 1999-2002, and 36.3% in 2003-2006. PFD visits represent 0.9% of all ambulatory visits for adult women in the United States. Women > or =60 years old had higher rates of PFD-related visits compared with women <60 years old. CONCLUSION: The annual number of PFD-related visits is significant and represents 0.9% of all ambulatory visits made by adult women in the United States.

Association between urinary incontinence and depressive symptoms in overweight and obese women.

OBJECTIVE: The objective of the study was to determine the association between urinary incontinence (UI) and depressive symptoms. STUDY DESIGN: The study was a cross-sectional study of 338 incontinent and overweight women at baseline in the Program to Reduce Incontinence by Diet and Exercise trial. Depressive symptoms were defined as a Beck Depression Inventory score of 10 or greater. UI frequency was determined by a 7-day voiding diary. Symptom bother and quality of life were determined using the Urogenital Distress Inventory (UDI) and the Incontinence Impact Questionnaire (IIQ). Multivariable regression was used to estimate the association between UI and depressive symptoms. RESULTS: Women with depressive symptoms (n = 101) reported a higher mean number of UI episodes per week (28 vs 23; P = .005) and higher (worse) mean scores on the UDI (176 vs 162; P = .02) and IIQ (136 vs 97; P < .001) compared with women without depressive symptoms. The risk of having depressive symptoms increased with each 7-episode increase in UI per week (adjusted odds ratio [AOR], 1.10; 95% confidence interval [CI], 1.01-1.21), each 50-point increase in UDI (AOR, 1.27; 95% CI, 1.01-1.60), and each 50-point increase in IIQ (AOR, 1.44; 95% CI, 1.22-1.71). CONCLUSION: Urinary incontinence frequency, symptom bother, and quality of life are independently associated with depressive symptoms in overweight and obese women.

Socioeconomic indicators and hysterectomy status in the United States, 2004.

OBJECTIVE: To examine the association between socioeconomic indicators and hysterectomy. STUDY DESIGN: We performed a cross-sectional analysis of the 2004 Behavioral Risk Factor Surveillance Survey database. The effect of multiple socioeconomic exposures (education level, annual income and employment status) on hysterectomy status was evaluated. Logistic regression was used to estimate ORs between the multiple exposures and the outcome of hysterectomy status. RESULTS: Our analytic sample included 180,982 women. Prior hysterectomy was reported by 26.4%. After adjusting for confounders, women who had not graduated from high school had 1.75 times higher odds (95% CI 1.68-1.83) of having a hysterectomy as compared to women who were college graduates, and women with an annual household income of < $15,000 had 1.06 times higher odds (95% CI 1.02 to 1.10) of having a hysterectomy as compared to women who reported an income of > $50,000/year. Women who were unemployed did not have higher odds of having a hysterectomy than women who were employed. CONCLUSION: Socioeconomic indicators of education level and income are associated with hysterectomy status; however, employment status is not.

Uterosacral colpopexy at the time of vaginal hysterectomy: comparison of laparoscopic and vaginal approaches.

OBJECTIVE: To compare the risk of ureteral compromise and of recurrent vault prolapse following vaginal vs. laparoscopic uterosacral vault suspension at the time of vaginal hysterectomy. STUDY DESIGN: In this retrospective, cohort study, uterosacral ligament suspension was performed using either a vaginal or laparoscopic approach. The primary outcome was intraoperative ureteral compromise; secondary outcomes were postoperative anatomic result and recurrent prolapse. The Canadian Task Force Classification was II-2. RESULTS: One hundred eighteen patients were included: 96 patients in the vaginal group and 22 patients in the laparoscopic group. Ureteral compromise was identified intraoperatively in 4 (4.2%) cases in the vaginal group; no ureteral compromise was observed in the laparoscopic group (p = 0.33). Failure at the apex, defined as stage > or = II for point C, was seen in 6.3% of patients in the vaginal group as compared with 0% in the laparoscopic group; this difference did not achieve statistical significance. Similarly, trends toward lower recurrent symptomatic vault prolapse (10% vs. 0%), any symptomatic prolapse recurrence (12.5% vs. 4.6%), and higher postoperative Pelvic Organ Prolapse Quantification point C were observed in the laparoscopic group (p > 0.05 for all). CONCLUSION: Laparoscopic uterosacral vault suspension following vaginal hysterectomy is a safe alternative to the vaginal approach.

Effect of body mass index on the risk of anal incontinence and defecatory dysfunction in women.

OBJECTIVE: The primary objective was to estimate the effect of body mass index on the risk of anal incontinence and defecatory dysfunction in a tertiary referral urogynecologic population. STUDY DESIGN: This was a cross-sectional study, including 519 new patients. Exposure was defined as body mass index. The primary outcome was any reported anal incontinence. The secondary outcome was any defecatory dysfunction. We used multiple logistic regression to estimate odds ratios and 95% confidence intervals for the effect of body mass index on anal incontinence and defecatory dysfunction. RESULTS: After adjusting for confounders, every 5 unit increase in body mass index was associated with a significantly increased odds of anal incontinence (odds ratio 1.25; 95% confidence interval, 1.09 to 1.44) and a trend toward an increased odds of defecatory dysfunction (odds ratio 1.13; 95% confidence interval, 0.98 to 1.31), although this was not statistically significant. CONCLUSION: Increasing body mass index is significantly associated with anal incontinence, but not defecatory dysfunction in women.

Validation of decision-making outcomes for female pelvic floor disorders.

OBJECTIVE: This study was undertaken to modify and validate the Satisfaction with Decision Scale and Decision Regret Scale for women who have undergone surgery for pelvic floor disorders. STUDY DESIGN: We adapted the Satisfaction with Decision Scale and Decision Regret Scale for women with pelvic floor disorders. Forty-five women who underwent surgery for pelvic floor disorders were enrolled postoperatively and completed the Satisfaction with Decision Scale-Pelvic Floor Disorders and Decision Regret Scale-Pelvic Floor Disorders on 2 occasions, 1 week apart. RESULTS: Face and content validity of the Satisfaction with Decision Scale-Pelvic Floor Disorders and Decision Regret Scale-Pelvic Floor Disorders were confirmed by patient interviews and expert panel. The Satisfaction with Decision Scale-Pelvic Floor Disorders and Decision Regret Scale-Pelvic Floor Disorders were internally consistent (Cronbach's alpha: .95 and .88, respectively) and reproducible (intraclass correlations: 0.82 and 0.84, respectively). Larger improvements between preoperative and postoperative Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire-7 scores were positively correlated with the Satisfaction with Decision Scale-Pelvic Floor Disorders (r = 0.42 and 0.49, respectively), and negatively correlated with the Decision Regret Scale-Pelvic Floor Disorders (r = -0.60 and -0.63, respectively). The Satisfaction with Decision Scale-Pelvic Floor Disorders and Decision Regret Scale-Pelvic Floor Disorders were negatively correlated with each other (r = -0.55). CONCLUSION: The Satisfaction with Decision Scale-Pelvic Floor Disorders and Decision Regret Scale-Pelvic Floor Disorders are reliable and valid decision-making outcome measures for women with pelvic floor disorders.

Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial.

BACKGROUND: Urgency urinary incontinence (UUI) is a chronic condition for which sacral neuromodulation (SNM) (InterStim/Medtronic) and onabotulinumtoxinA (BTX) (BotoxA/Allergan) are utilized. These therapies have not been compared over extended time. OBJECTIVE: To compare UUI episodes (UUIE) over 24 mo following SNM or BTX. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, open-label, randomized, extension trial (February 2012-July 2016) at nine US medical centers involving 386 women with ≥6 UUIE over 3 d inadequately managed by medications. Participants were clinical responders to treatment: ≥50% reduction in UUIEs after SNM placement or 1 mo post BTX. INTERVENTION: SNM (n=194) versus 200 U BTX (n=192). SNM reprogrammings occurred throughout the 24 mo. After 6 mo, two additional BTX injections were allowed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome: change in mean daily UUIE over 24 mo. SECONDARY OUTCOMES: no UUIE, ≥75% and ≥50% UUIE reduction; Overactive Bladder Questionnaire Short Form; Urinary Distress Inventory short form; Incontinence Impact Questionnaire; Patient Global Impression of Improvement; Overactive Bladder Satisfaction of Treatment Questionnaire; and adverse events (AEs). Primary analysis used a linear mixed model. RESULTS AND LIMITATIONS: Outcome data were available for 260/298 (87%) clinical responders. No difference in decreased mean UUIE was found over 24 mo (-3.88 vs -3.50 episodes/d,95% confidence interval [CI]=-0.14-0.89; p=0.15), with no differences in UUI resolution, ≥75% or ≥50% UUIE reduction. BTX group maintained higher satisfaction (mean difference=-9.14, 95% CI=-14.38--3.90; p<0.001), treatment endorsement (mean difference=-12.16, 95% CI=-17.7--6.63; p<0.001) through 24 mo. Other secondary measures did not differ. Recurrent urinary tract infections (UTIs) were higher after BTX (24% vs 10%; p<0.01), 6% required intermittent catheterization post second injection. SNM revision and removals occurred in 3% and 9% patients, respectively. CONCLUSIONS: Both treatments offered sustainable UUI improvement, and higher BTX dosing had low clean intermittent catheterization rates, but with UTI risk. SNM revision/removal rates were low due to standardized lead placement with strict treatment response definitions. PATIENT SUMMARY: We compared a large group of US women with severe urgency urinary incontinence (UUI) who received sacral neuromodulation (InterStim) or onabotulinumtoxinA (Botox A) therapy during a 2-yr period. We found that both therapies had similar success in reducing UUI symptoms, and adverse events were low. However, women in the BotoxA group had higher satisfaction and endorsement with their treatment, but with a higher chance of a urinary tract infection. We conclude that both therapies offer sustained reduction in daily incontinence over 2 yr.