A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence

摘要

Fecal incontinence (FI) is a common debilitating condition in women that impacts their quality of life. Liability to control bowel movements is embarrassing and can lead to social isolation. Prevalence rates among community-dwelling women range from 12% to 25%. Behavioral therapy is first-line treatment for FI. Other treatment options are limited, and if they are ineffective, surgical procedures may be considered. Effective management appears to require multiple treatment modalities. A novel noninvasive vaginal bowel control (VBC) system provides a low-risk, effective, and easily reversible treatment for FI. The VBC system was approved by the Food and Drug Administration in 2015. The system consists of a vaginal insert with an inflatable balloon that can reversibly deflect the rectovaginal septum and interrupt the passage of stool. In a 2015 study by the same research group, nearly 80% of women in an intention-to-treat (ITT) cohort met success criterion at 1 month, 86% met success criterion in per-protocol analysis, and a similar percentage considered their bowel symptoms "very much" or "much better." There was also significant improvement in all subjective quality-of-life measurements using validated questionnaires, and there were no device-related serious adverse events. The aim of this prospective, multicenter, open-label study was to characterize clinical effectiveness and safety of the VBC system, its impact on quality of life, and durability up to 1 year among women with FI. All participants who successfully fit with the VBC system underwent an initial 2-week trial period and completed a 2-week baseline bowel diary to determine study eligibility based on decreased FI episodes. Subjects meeting a 50% reduction in FI episodes during the 2-week run-in phase were offered continued participation into the long-term treatment period and comprised the ITT population. The primary outcome was success defined as the proportion of patients reporting a 50% or greater reduction in the mean number of FI episodes at 3 months. This outcome was also measured at 6 and 12 months. Secondary outcomes, subjective measures of improvement, were assessed using the following validated questionnaires: Fecal Incontinence Quality of Life scale, symptom severity by the St Mark's (Vaizey) questionnaire, Patient Global Impression of Improvement, and satisfaction. Adverse events and their relationship to the investigational device were assessed throughout the study. Of 137 subjects who had the fitting assessment, 85 (62.0%) achieved a successful fit and underwent the 2-week test diary screening. Among these 85 patients, 73 (85.9%) with baseline mean of 14.1 ± 12.15 FI episodes over 2 weeks entered the 12- month treatment period. At 3 months, the success rate was 72.6% (53/73; P < 0.0001) in the ITT population and 84% (53/63; P < 0.0001) in the per-protocol population. Significant improvement occurred in all Fecal Incontinence Quality of Life subscales and St Mark's questionnaire meeting minimally important differences. More than 90% of participants were satisfied with symptom improvement at 3, 6, and 12 months, and more than 77% reported that their symptoms were very much or much better at each of these time points on the Patient Global Impression of Improvement. No serious device-related adverse events occurred in any portion of the study. Two-thirds of adverse events (90/134 [67%]) were noted during the fitting period; vaginal wall injury was the most common adverse event. These findings show that the VBC device is a safe, highly effective, and durable treatment option for women with FI. Among women with successful fitting and initial treatment response, efficacy at 3, 6, and 12 months was demonstrated by objective and subjective measures. The device can be used early in the FI treatment algorithm concomitantly with other treatment options. Future studies should focus on long-term comparative results.