Scores on the Fecal Incontinence Quality of Life survey and the Modified Manchester Health Questionnaire improved significantly across all subscales. At 1 month, 86% reported their fecal incontinence to be "very much better" (57%) or "much better" (29%). Almost all – 96% – reported their insert to be comfortable, and half said they could not feel it.
To qualify for the six-center study, women had to have a history of fecal incontinence of at least 6 months, with 4 or more incontinence episodes recorded during a 2-week baseline bowel diary.
Study participants had a mean age of 61 years and a mean of 5.9 weekly fecal incontinence episodes (or 12 in their diaries).Thirty percent were obese. Nearly 50% had prior hysterectomy, 8% had prior pelvic prolapse surgery, and 15% had prior urinary incontinence surgery.
There were no device-related serious adverse events. The most common complaint was cramping or discomfort, which most often occurred during the fitting period. There were approximately a half-dozen reported changes in urinary incontinence or overactive bladder symptoms.
Courtesy Pelvalon Inc.
A diagram of the inflated balloon deflecting the rectovaginal septum.
"We believe that the Vaginal Bowel Control System can be tried early in the algorithm of treatment for fecal incontinence," Dr. Richter said.
It won’t be a good option for everyone, however. After being fitted with the device (it is made with three base sizes and two balloon sizes), women in the study were instructed to try it for a week before entering the 1-month treatment period. Approximately 40 women who were screened and fitted did not continue. This rate of discomfort or nonacceptance is similar to that associated with pessaries, Dr. Richter noted.
The initial fitting procedure for the new bowel control device "requires a little more provider and patient training, beyond [what is needed] for use of a traditional vaginal pessary," she said.
"Patients in the study could put the device in and take it out as they wished. Most patients used it all day long, and some took it out at night," she said. Patients were instructed to "take it out once or twice a week to wash it."
Dr. Richter is a paid consultant for Pelvalon. Her coinvestigators reported consulting for Pelvalon and other companies.