Characteristics Associated With Clinically Important Treatment Responses in Women Undergoing Nonsurgical Therapy for Fecal Incontinence.

OBJECTIVE: To identify baseline clinical and demographic characteristics associated with clinically important treatment responses in a randomized trial of nonsurgical therapies for fecal incontinence (FI). METHODS: Women (N = 296) with FI were randomized to loperamide or placebo- and manometry-assisted biofeedback exercises or educational pamphlet in a 2 × 2 factorial design. Treatment response was defined in 3 ways from baseline to 24 weeks: minimal clinically important difference (MID) of -5 points in St. Mark's score, ≥50% reduction in FI episodes, and combined St. Mark's MID and ≥50% reduction FI episodes. Multivariable logistic regression models included baseline characteristics and treatment groups with and without controlling for drug and exercise adherence. RESULTS: Treatment response defined by St. Mark's MID was associated with higher symptom severity (adjusted odds ratio [aOR] 1.20, 95% confidence interval [CI] 1.11-1.28) and being overweight vs normal/underweight (aOR 2.15, 95% CI 1.07-4.34); these predictors remained controlling for adherence. Fifty percent reduction in FI episodes was associated with the combined loperamide/biofeedback group compared with placebo/pamphlet (aOR 4.04, 95% CI 1.36-11.98), St. Mark's score in the placebo/pamphlet group (aOR 1.29, 95% CI 1.01-1.65), FI subtype of urge vs urge plus passive FI (aOR 2.39, 95% CI 1.09-5.25), and passive vs urge plus passive FI (aOR 3.26, 95% CI 1.48-7.17). Controlling for adherence, associations remained, except St. Mark's score. DISCUSSION: Higher severity of FI symptoms, being overweight, drug adherence, FI subtype, and combined biofeedback and medication treatment were associated with clinically important treatment responses. This information may assist in counseling patients, regarding efficacy and expectations of nonsurgical treatments of FI.

Outcome measures to assess anatomy and function of the posterior vaginal compartment.

INTRODUCTION AND HYPOTHESIS: Optimal measures for assessing anatomy and defecatory symptoms related to posterior compartment prolapse are unknown. Our objectives were: (1) to test the inter- and intrarater reliability of commonly used or reported anatomic measures of posterior compartment prolapse performed in the clinic setting and under anesthesia; and (2) to examine the correlation between posterior compartment anatomy and defecatory symptoms prior to surgical intervention. METHODS: A prospective cohort of women with pelvic floor disorders was assessed using a variety of validated questionnaires and standardized examination measures at baseline, at a preoperative visit, and intraoperatively. Inter- and intrarater reliability for anatomic measures were assessed by two separate examiners at the initial visit and repeated by one of the original examiners at a preoperative visit. Reliability was measured using kappa or intraclass correlations according to data type. Symptom and anatomic measure correlations were analyzed using Spearman rank tests. RESULTS: Mean age of the 120 women recruited was 57 ± 15 years, 49 (41 %) had a point Bp ≥ 0; 59 % reported at least moderate bother from at least one obstructed defecation symptom on the Pelvic Floor Distress Inventory (PFDI). At baseline, most anatomic measures showed at least moderate to good inter/intrarater reliability (> 0.5). There were no moderate or better correlations between any symptom and anatomic measure (all r < 0.27). CONCLUSIONS: Most anatomic measures of posterior compartment prolapse are reliable and reproducible; however, they do not correlate well with defecatory symptoms.

Surgical preparation: are patients "ready" for stress urinary incontinence surgery?

INTRODUCTION AND HYPOTHESIS: Patient preparedness for stress urinary incontinence (SUI) surgery is associated with improvements in post-operative satisfaction, symptoms and quality of life (QoL). This planned secondary analysis examined the association of patient preparedness with surgical outcomes, treatment satisfaction and quality of life. METHODS: The ValUE trial compared the effect of pre-operative urodynamic studies with a standardized office evaluation of outcomes of SUI surgery at 1 year. In addition to primary and secondary outcome measures, patient satisfaction with treatment was measured using a five-point Likert scale (very dissatisfied to very satisfied) that queried subjects to rate the treatment's effect on overall incontinence, urge incontinence, SUI, and frequency. Preparedness for surgery was assessed using an 11-question Patient Preparedness Questionnaire (PPQ). RESULTS: Based on PPQ question 11, 4 out of 5 (81 %) of women reported they "agreed" or "strongly agreed" that they were prepared for surgery. Selected demographic and clinical characteristics were similar in unprepared and prepared women. Among SUI severity baseline measures, total UDI score was significantly but weakly associated with preparedness (question 11 of the PPQ; Spearman's r = 0.13, p = 0.001). Although preparedness for surgery was not associated with successful outcomes, it was associated with satisfaction (r s = 0.11, p = 0.02) and larger PGI-S improvement (increase; p = 0.008). CONCLUSIONS: Approximately half (48 %) of women "strongly agreed" that they felt prepared for SUI. Women with higher pre-operative preparedness scores were more satisfied, although surgical outcomes did not differ.