Departments of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; the University of North Carolina, Chapel Hill, North Carolina; the University of Texas Medical Branch, Galveston, Texas; Indiana University Health, Bloomington, Indianapolis, Indiana; Department of Colorectal Surgery, Grand Rapids Women's Health, Grand Rapids, Michigan; and the University of California, San Francisco, San Francisco, California.
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OBJECTIVE:To evaluate the effectiveness and safety of a vaginal bowel-control device and pump system for fecal incontinence treatment.METHODS:Women with a minimum of four fecal incontinence episodes over 2 weeks were fit with the intravaginal device. Treatment success, defined as a 50% or greater reduction of incontinent episodes, was assessed at 1 month. Participants were invited into an optional extended-wear period of another 2 months. Secondary outcomes included symptom improvement measured by the Fecal Incontinence Quality of Life, Modified Manchester Health Questionnaire, and Patient Global Impression of Improvement. Adverse events were collected. Intention-to-treat analysis included participants who were successfully fit entering treatment. Per protocol, analysis included participants with a valid 1-month treatment diary.RESULTS:Sixty-one of 110 (55.5%) participants from six clinical sites were successfully fit and entered treatment. At 1 month, intention-to-treat success was 78.7% (48/61, P<.001); per protocol success, 85.7% (48/56, P<.001) and 85.7% (48/56) considered bowel symptoms “very much better” or “much better.” There was significant improvement in all Fecal Incontinence Quality of Life (P<.001) and Modified Manchester (P≤.007) subscales. Success rate at 3 months was 86.4% (38/44; 95% confidence interval 73–95%). There were no serious adverse events; the most common study-wide device-related adverse event was pelvic cramping or discomfort (25/110 participants [22.7%]), the majority of events (16/25 [64%]) occurring during the fitting period.CONCLUSION:In women successfully fit with a vaginal bowel-control device for nonsurgical treatment for fecal incontinence, there was significant improvement in fecal incontinence by objective and subjective measures.CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, www.clinicaltrials.gov, NCT01655498.LEVEL OF EVIDENCE:II