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
A vaginal bowel-control system is a new nonsurgical treatment option for fecal incontinence that demonstrates significant improvement in symptoms and quality of life.
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.
Corresponding author: Holly E. Richter, PhD, MD, University of Alabama at Birmingham, 1700 6th Avenue South, Suite 10382, Birmingham, AL 35233; e-mail: email@example.com.
Supported by an industry-sponsored grant from Pelvalon, Inc.
Presented at the 2014 Joint American Urogynecologic Society and International Urogynecological Association meeting, July 22–26, 2014, Washington, DC.
Financial Disclosure Dr. Richter has been a consultant for Pelvalon and Kimberly Clark. She has received research grants from Pelvalon, the National Institute of Diabetes and Digestive and Kidney Diseases (Urinary Incontinence Treatment Network and K24), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (Pelvic Floor Disorders Network and 3T MRI), National Institute of Allergy and Infectious Diseases/National Institute of Health/Department of Health and Human Services, and the National Institute of Diabetes and Digestive and Kidney Diseases/Yale University. She has received royalties from UpToDate and has served on the Board of Directors for the Society of Gynecologic Surgeons (not compensated). Drs. Takase-Sanchez and Varma have been consultants for Pelvalon. The other authors did not report any potential conflicts of interest.