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Impact of a Novel Vaginal Bowel Control System on Bowel Function

Varma, Madhulika G. M.D.1; Matthews, Catherine A. M.D.2; Muir, Tristi M.D.3; Takase-Sanchez, Michelle M. M.D.4; Hale, Douglass S. M.D.5; Van Drie, Douglas M.D.6; Richter, Holly E. Ph.D., M.D.7

doi: 10.1097/DCR.0000000000000517
Original Contributions: Pelvic Floor

BACKGROUND: Bowel dysfunction, including frequency, fecal urgency, stool consistency, and evacuation symptoms, contributes to fecal incontinence.

OBJECTIVE: The purpose of this study was to examine the impact of a vaginal bowel control system on parameters of bowel function, including frequency, urgency, stool consistency, and evacuation.

DESIGN: This was a secondary analysis of a multicenter, prospective clinical trial.

SETTINGS: This study was conducted at 6 sites in the United States, including university hospitals and private practices in urogynecology and colorectal surgery.

PATIENTS: A total of 56 evaluable female subjects aged 19 to 75 years with 4 or more fecal incontinence episodes on a 2-week bowel diary were included.

INTERVENTIONS: The study intervention was composed of the vaginal bowel control system, consisting of a vaginal insert and pressure-regulated pump.

MAIN OUTCOME MEASURES: Subjects completed a 2-week baseline diary of bowel function before and after treatment completed at 1 month. Fecal urgency, consistency of stool (Bristol score), and completeness of evacuation were recorded for all bowel movements.

RESULTS: Use of the insert was associated with an improvement in bowel function across all 4 categories. Two thirds (8/12) of subjects with a high frequency of daily stools (more than 2 per day) shifted to a normal or low frequency of stools. Analysis of Bristol stool scale scores demonstrated a significant reduction in the proportion of all bowel movements reported as liquid (Bristol 6 or 7), from 36% to 21% (p = 0.0001). On average, 54% of stools were associated with urgency at baseline compared with 26% at 1 month (p < 0.0001). Incomplete evacuations with all bowel movements were reduced from 39% to 26% of subjects at 1 month (p = 0.0034).

LIMITATIONS: The study follow-up period was 1 month (with an optional additional 2 months).

CONCLUSIONS: The vaginal bowel control system was associated with an improvement in bowel symptoms and function, including reduced bowel movement frequency, less fecal urgency, increased solid consistency, and improved evacuation in patients with significant fecal incontinence.

1 Section of Colorectal Surgery, Department of Surgery, University of California, San Francisco, San Francisco, California

2 Division of Urogynecology and Reconstructive Surgery, University of North Carolina, Chapel Hill, North Carolina

3 Departments of Obstetrics and Gynecology and Urology, University of Texas Medical Branch, Galveston, Texas

4 Division of Urogynecology, Indiana University Health, Indianapolis, Indiana

5 Female Pelvic Medicine and Reconstructive Surgery, Indiana University Health System, Indiana University Health, Indianapolis, Indiana

6 Female Pelvic Medicine & Urogynecology Institute of Michigan, a division of Grand Rapids Women’s Health, Grand Rapids, Michigan

7 Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama

Financial Disclosure: After completion of this study, Dr Varma was a paid consultant for Pelvalon, Inc. Dr Matthews was a consultant and received grant support from Pelvalon, Inc, and received grant support from Boston Scientific and American Medical Systems. Dr Takase-Sanchez was a paid consultant for Pelvalon. Dr Hale was a reviewer for UpToDate and a researcher for Allergan. Dr Richter was a consultant for Pelvalon, Inc, and Kimberly Clark and received royalties from UpToDate. This study was supported by an industry-sponsored grant from Pelvalon, Inc.

Podium presentation at the meeting of The American Society of Colon and Rectal Surgeons, Boston, MA, May 30 to June 3, 2015.

Correspondence: Madhulika G. Varma, M.D., 550 16th St, 6th Floor, San Francisco, CA 94158. E-mail:

© 2016 The American Society of Colon and Rectal Surgeons