Management of fecal incontinence – focus on a vaginal insert for bowel control

Figures & data

Figure 1 The vaginal bowel control (VBC) insert.

Note: The VBC insert consists of a silicone-coated stainless steel base and posterior-directed, dual-layer balloon that connects to a user-controlled, pressure-regulated pump. Printed with permission from © Julia Stack.

Figure 2 The vaginal bowel control insert deflated (A) and inflated (B).

Notes: Upon inflation, the dual-layer balloon provides reversible occlusion of the rectum, enabling the user to regain control of her bowel function. The insert, which is available in a range of base and balloon sizes, does not need to be removed for defecation, but can simply be deflated (courtesy of Pelvalon).

Figure 3 Folding the vaginal bowel control insert for placement.

Note: Printed with permission from © Julia Stack.

Figure 4 Treatment options for accidental bowel leakage.

Note: Data from Whitehead et al.²⁰

Figure 5 Updated vaginal bowel control system that enhances fit, stability, comfort, and appearance based on the feasibility studies (courtesy of Pelvalon).

Figure 6 Within-subject efficacy of vaginal bowel control system wear on accidental bowel leakage (ABL) episodes.

Notes: Data points represent mean ± standard deviation. Data from Richter et al.²³

Table 1 Overview of a clinical evaluation of a VBC system for the treatment of fecal incontinence in women (LIFE Study, NCT01655498)

Study type	Multicenter, prospective, open-label
Device	A vaginal bowel control (VBC) system that consists of a vaginal insert and user-controlled, pressure-regulated pump. The vaginal insert consists of a silicone-coated stainless steel base and posterior-directed balloon that provides reversible occlusion of the rectum as controlled by the patient
Eligibility	Women between the ages of 19 and 75 years with:
	A history of fecal incontinence for at least 6 months
	A minimum of four incontinence episodes during the 2-week baseline period (assessed by patient diary)
	Willingness and ability to give written informed consent, undergo a successful device fitting, and have the ability to self-manage insertion and removal of the vaginal insert, to participate in the study
Enrolled	Sixty-one women achieved successful fitting and entered treatment
Protocol	One month of VBC system use and documentation of ABL symptoms in treatment bowel diary during the final 2 weeks of the wear period
	Optional 2-month extension of VBC system use with additional bowel diary entry during the final 2 weeks of wear (n=44 subjects)
Key findings	Eighty-six percent of per protocol participants met treatment success as reported by ≥50% improvement in ABL episodes
	No serious adverse events during treatment. Reported adverse events were mild to moderate and resolved quickly
	Participants reported higher quality-of-life ratings following VBC treatment
	Women with ABL reported fewer liquid stools, less urgency with bowel movements, and improved evacuation
	Women with high frequency of bowel movements at baseline (>2 per day) noted a significant decrease in bowel movements following 1-month VBC treatment
	Women with previous prolapse surgery and shorter vaginal length had greater difficulty in finding successful VBC fit

Abbreviation: ABL, accidental bowel leakage.

WhiteheadWERaoSSLowryATreatment of fecal incontinence: state of the science summary for the National Institute of Diabetes and Digestive and Kidney Diseases workshopAm J Gastroenterol201511013814625331348

 PubMed Web of Science ®Google Scholar

RichterHEMatthewsCAMuirTA vaginal bowel-control system for the treatment of fecal incontinenceObstet Gynecol201512554054725730213

 PubMed Web of Science ®Google Scholar