Improving biofeedback for the treatment of fecal incontinence in women: implementation of a standardized multi-site manometric biofeedback protocol.

BACKGROUND: Standardized training and clinical protocols using biofeedback for the treatment of fecal incontinence (FI) are important for clinical care. Our primary aims were to develop, implement, and evaluate adherence to a standardized protocol for manometric biofeedback to treat FI. METHODS: In a Pelvic Floor Disorders Network (PFDN) trial, participants were enrolled from eight PFDN clinical centers across the United States. A team of clinical and equipment experts developed biofeedback software on a novel tablet computer platform for conducting standardized anorectal manometry with separate manometric biofeedback protocols for improving anorectal muscle strength, sensation, and urge resistance. The training protocol also included education on bowel function, anal sphincter exercises, and bowel diary monitoring. Study interventionists completed online training prior to attending a centralized, standardized certification course. For the certification, expert trainers assessed the ability of the interventionists to perform the protocol components for a paid volunteer who acted as a standardized patient. Postcertification, the trainers audited interventionists during trial implementation to improve protocol adherence. KEY RESULTS: Twenty-four interventionists attended the in-person training and certification, including 46% advanced practice registered nurses (11/24), 50% (12/24) physical therapists, and 4% physician assistants (1/24). Trainers performed audio audits for 88% (21/24), representing 84 audited visits. All certified interventionists met or exceeded the prespecified 80% pass rate for the audit process, with an average passing rate of 93%. CONCLUSIONS & INFERENCES: A biofeedback protocol can be successfully imparted to experienced pelvic floor health care providers from various disciplines. Our process promoted high adherence to a standard protocol and is applicable to many clinical settings.

Vitamin D and incident urinary incontinence in older adults.

BACKGROUND/OBJECTIVES: The aim of this study is to determine whether vitamin D status is associated with incident urinary incontinence (UI) among community-dwelling older adults. SUBJECTS/METHODS: The University of Alabama at Birmingham Study of Aging is a prospective cohort study of community-dwelling Medicare enrollees. Standardized assessment of UI was conducted using the validated Incontinence Severity Index. The analysis of 25-hydroxyvitamin D [25(OH)D] levels was performed on stored baseline sera. UI was assessed every 6-12 months for up to 42 months. The analyses included multivariable logistic regression and Cox proportional hazard models. RESULTS: Of 350 participants (175 male, 147 black, mean age 73.6±5.8), 54% (189/350) were vitamin D deficient (25(OH)D <20 ng/ml) and 25% (87/350) were vitamin D insufficient (25(OH)D: 20 ng/ml to <30 ng/ml). Among the 187 subjects with no UI at baseline, 57% (107/187) were vitamin D deficient and 24% (45/187) were vitamin D insufficient. A total of 175 of the 187 subjects had follow-up evaluation for incident UI over 42 months, and incident UI occurred in 37% (65/175). After adjustment, cumulative incident UI at 42 months was associated with baseline vitamin D insufficiency (P=0.03) and demonstrated a trend association with deficiency (P=0.07). There was no association between baseline vitamin D status and the time to incident UI. CONCLUSIONS: These preliminary results support an association between vitamin D and incident UI in community-dwelling older adults. Future studies may target specific at-risk groups, such as men with BPH or women with pelvic floor disorders for evaluation of the impact of vitamin D supplementation on urinary 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.