154 Short-Term Efficacy of the Vaginal Bowel-Control Device in Improving Fecal Incontinence in Women: A Meta-Analysis of Prospective Studies

Abstract

INTRODUCTION: The vaginal bowel-control system (VBCS) is a novel design consisting of a reversible dynamic vaginal balloon insert that mimics the continence mechanism in the rectum to help control fecal incontinence (FI) in women. We performed a meta-analysis using data from four prospective open-label trials that investigated the efficacy and safety of this novel device at 1- or 3-month intervals. METHODS: PubMed, EMBASE and Cochrane Library databases were searched by two independent investigators using the terms fecal incontinence and vaginal bowel control, vaginal control, vaginal device, or vaginal. Only studies where a VBCS was used and where the response in FI was followed for 1 month or longer were included. Case reports were excluded and there were no case series or randomized controlled trials found. Meta-analysis using the fixed-effect model was performed to illustrate the pooled estimates. RESULTS: Four prospective open-label proof of concept clinical trials were identified. All patients were above 18 years of age and the size of the studies ranged from 5 to 63 patients. Patients were followed for 3 months in three studies and for 1 month in one study (n = 9). A response in FI was defined as a >50% improvement in the number of incontinent episodes compared to baseline in 3 out of the 4 studies, with the fourth study (n = 5) defining clinical improvement as a subjective qualitative improvement experienced by the patients. There was little heterogeneity across the studies. The overall estimated proportion of patients experiencing a response in FI was 85%, with a 95% confidence interval (CI) of 0.77 to 0.90. The overall adverse event rate was 18% with a 95% CI of 0.11 to 0.26. No patients experienced severe adverse events in any of the studies. Patient satisfaction was 89% with a 95% CI of 0.82 to 0.94. CONCLUSION: While recognizing that the number and quality of the studies available on the VBCS to treat FI are limited, the current analysis provides preliminary evidence that the VBCS may be considered a non-invasive, reversible, safe, and efficacious tool to control symptoms of FI in women in the short term, while achieving adequate patient satisfaction. Further validation on the practicality of this device can only be attained through long-term, large controlled studies, preferably randomized controlled trials.