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Associate Professor, Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Washington University School of Medicine, St. Louis
Dr. Ghetti reports no financial relationships relevant to this field of study.
SYNOPSIS: The vaginal bowel control device provides a safe, effective, and durable treatment option for women with fecal incontinence.
SOURCE: Richter HE, Dunivan G, Brown HW, et al. A 12-month clinical durability of effectiveness and safety evaluation of a vaginal bowel control system for the nonsurgical treatment of fecal incontinence. Female Pelvic Med Reconstr Surg 2019;25:113-119.
Richter et al sought to determine the clinical effectiveness and safety of the vaginal bowel control system (VBC) in women over a 12-month period. This system was designed to offer an effective conservative option for the treatment for fecal incontinence (FI). It consists of an inflatable vaginal insert that deflects the rectovaginal angle posteriorly preventing the undesired passage of stool. The insert is deflated to allow for a voluntary bowel movement (See Richter et al 2015 for images).1
This was a prospective, open-label, 12-month clinical effectiveness trial of a VBC system in women with FI who were successfully fitted with the device. Subjects completed a two-week baseline bowel diary to establish eligibility. Eligible women were age 19 years or older, had a history of FI for a minimum of six months, and had a minimum of four major or minor FI episodes during the two-week diary. Women experiencing fecal staining only were not eligible for the study. There were numerous exclusion criteria, including a history of FI secondary to chronic watery diarrhea, presence of a rectovaginal fistula, vaginal prolapse extending beyond the hymen, history of rectal or pelvic surgery, genitourinary or colorectal cancer, and inflammatory bowel disease.
Subjects who completed a successful fitting with a trial device were enrolled in the run-in phase of the study. Subjects experiencing 50% reduction in FI episodes during this phase were offered continued participation into the 12-month study and were given the more durable VBC system. These subjects formed the intention-to-treat (ITT) population, which is the primary analysis reported. Subjects completed bowel diaries at three, six, and 12 months. Subjects who did not complete three-month treatment or diary were considered failures in this analysis. The authors also performed a per protocol (PP) analysis, including the subjects with at least three-month follow-up and who completed a valid bowel diary at three-, six-, and 12-month treatment periods.
The primary outcome was the proportion of patients experiencing a 50% or greater reduction in FI episodes from baseline at three, six, and 12 months of treatment. Secondary outcomes included physical examination and several self-reported scales as well as adverse events.
A total of 252 women consented to the study, and 137 entered the fitting trial. Of these, 85 (62%) were successfully fitted and entered the run-in phase of the study. Seventy-three (85%) achieved the established 50% reduction in FI episodes required to enter the 12-month trial and comprised the ITT population. Subjects were mainly white and postmenopausal, with a mean age of 61 years. At baseline, subjects reported a mean of 14.1 (± standard deviation, 12.15) FI episodes in a two-week period. Nearly half reported having experienced FI symptoms for five years or more, and the majority (97%) had tried other management strategies. Seventy-three percent of subjects in the ITT population and 84% in the PP population reported 50% or greater reduction in number of FI episodes at three months and. Continued high response to treatment was reported at six and 12 months in both groups. Thirty-seven percent of the PP population achieved complete continence at three months and nearly half at six and 12 months. Of the remaining subjects, the majority (80%) achieved 75% improvement in FI symptoms. No serious adverse events were reported during the study period. Mild to moderate events were reported by 28 (38%) subjects. The majority of these events were mild vaginal wall injuries. The authors concluded that the vaginal bowel control system has durable efficacy at three, six, and 12 months in women who undergo successful fitting and initial treatment.
FI is defined as the involuntary loss of feces.2 Prevalence rates in women vary considerably (range, 9-26%.3,4 It is a debilitating condition and significantly affects quality of life. Despite the effect FI has on quality of life, women continue to hesitate reporting it to providers. More than two-thirds of women with FI do not seek care.3
The evaluation for FI includes a comprehensive history and physical examination. Since many women assume their bowel health experience is “normal,” questions about bowel health ideally focus on specifics, such as frequency of bowel movements, amount, consistency, and associated urgency. These will yield significantly more valuable information than asking: “Are you constipated?” Questions about stool loss include consistency of leakage, timing, duration, frequency, and amount, as well as history of bowel conditions, pelvic health, obstetric history, and existing medical comorbidities.
Several treatment options exist for FI. Pelvic floor physical therapy to address pelvic floor dysfunction is a cornerstone of the conservative treatment options for FI. Other first-line treatment options include bowel regulation such as adding fiber supplementation or other bulking agents, using antidiarrheal agents, and using anal plugs. In 2011, the U.S. Food and Drug Administration approved the use of neuromodulation and the use of injectables for FI. Surgical options are indicated for some patients and include anal sphincter reconstruction or colostomy, but these have variable long-term results.
The VBC system provides an additional and much-needed conservative treatment option to women with FI. The device appears to be safe and effective, with excellent short-term and long-term success. It is well-accepted by patients and functions similarly to a pessary. As with vaginal pessaries, this device has limitations, specifically for women who cannot be successfully fit, have severe vaginal atrophy, or have shortened vaginal length. However, for many women who have been fully evaluated, are up to date with colonoscopy screening, and have failed other conservative options, this can be an additional option to consider.
Treatment options aside, since so few women discuss FI with their providers, screening for FI is important. Ideally, a single screening question regarding FI would be part of standard yearly pelvic floor assessment, alongside questions about urinary incontinence and vaginal bulging.
Financial Disclosure: OB/GYN Clinical Alert’s Editor Jeffrey T. Jensen, MD, MPH, reports that he is a consultant for and receives grant/research support from ObstetRx, Bayer, Merck, and Sebela; he receives grant/research support from Abbvie, Mithra, and Daré Bioscience; and he is a consultant for CooperSurgical and the Population Council. Peer Reviewer Catherine Leclair, MD; Nurse Planner Andrea O’Donnell, FNP; Editorial Group Manager Leslie Coplin; Editor Jonathan Springston; and Accreditations Manager Amy M. Johnson, MSN, RN, CPN, report no financial relationships relevant to this field of study.