Conference Coverage

Vaginal bowel control device shown safe, effective in pivotal trial

Key clinical finding: A controllable vaginal approach to bowel continence may be useful in the future.

Major finding: Almost 80% of 61 patients in an intent-to-treat cohort saw a 50% or greater reduction in fecal incontinence episodes with use of the Vaginal Bowel Control System, a device placed in the vagina to restore bowel control.

Data source: A multicenter, prospective, open-label study of women with fecal incontinence.

Disclosures: Dr. Richter is a paid consultant for Pelvalon. Her coinvestigators reported consulting for Pelvalon and other companies.

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Further studies will reveal the value of this device

Fecal incontinence is one of the most emotionally devastating of all nonfatal medical conditions, and there is a need for new and effective strategies when medical therapy fails. The vaginal bowel control device appears to hold promise for some women with fecal incontinence by mechanically impeding stool passage to the anorectum by means of an inflatable balloon inserted into the vagina. The premise is that it can be used during times when the patient is not near to toileting facilities, can be inserted and removed at will, and is not a safety concern.

It is important to emphasize that this was not a randomized, placebo-controlled trial but rather a proof-of-concept study. The 40% complete continence response is 1) similar to that observed with the sacral nerve stimulation trial that resulted in Food and Drug Administration approval in the absence of a double-blind, controlled trial (Ann. Surg. 2010;1251:441), and 2) superior to the injectable bulking agent (6% complete continence), which was approved on the basis of a randomized, double-blind, sham-controlled trial (Lancet 2011;377:997).

However, complete continence is not necessary to improve quality of life in patients with incontinence. All three of these techniques require future studies to determine which incontinent patients are likely to benefit from each of these modalities. It must be recognized that there are many causes of incontinence, which often require different therapeutic approaches.

I look forward to reading a peer-reviewed paper on this new technique and to future randomized, controlled studies on this innovative approach to a condition with a large unmet need.

Dr. Arnold Wald is professor of medicine at the University of Wisconsin School of Medicine and Public Health, Madison.


 

AT AUGS/IUGA 2014

References

WASHINGTON – Use of a vaginal bowel control device currently under review by the Food and Drug Administration resulted in a significant reduction of fecal incontinence episodes and significant improvement in quality of life, with only mild and transient adverse events, a pivotal study has shown.

The device – the Vaginal Bowel Control (VBC) System made by Pelvalon (Sunnyvale, Calif.) – consists of a silicone base and a posteriorly directed balloon. The patient controls the inflation pump, inflating the balloon to deflect the rectovaginal septum and interrupt stool passage, and deflating it to allow bowel movements.

Courtesy Pelvalon Inc.

The VBC system consists of a silicone base and a posteriorly directed balloon.

"It provides [the patient with] dynamic control of the rectum," said Holly E. Richter, Ph.D., M.D., who served as the national principal investigator of the study. "It’s a new paradigm for treating patients with fecal incontinence."

At the 1-month primary endpoint, 79% of the 61 patients in the study’s intent-to-treat cohort – and 86% of patients in the per-protocol cohort – had experienced treatment success, which was defined as a 50% or greater reduction in fecal incontinence episodes, Dr. Richter reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association.

Mean weekly fecal incontinence episodes were reduced from 5.9 per week at baseline to 1.1 at 1 month.

After the 1-month treatment period, women were given the option of continuing with an additional 2-month study period. The rate of treatment success held steady among the 44 women who continued, with 86% seeing a 50% or greater reduction in fecal incontinence at 3 months, said Dr. Richter, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham.

Total continence was achieved in approximately 40% of women in the 1-month and 3-month per-protocol cohorts, she noted.

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