A previous proof of efficacy and safety study showed short-term benefit for a vaginal bowel control device for fecal incontinence (FI). This study evaluated the longer-term clinical effectiveness and impact on quality of life for women with FI.

Women with > 4 fecal incontinence episodes over 2 weeks were fit with the intra-vaginal device. In this responder analysis, subjects achieving a 50% reduction in FI episodes over a 2-week testing period were included in this trial. Treatment success was defined as achieving a >50% reduction of incontinent episodes, and was assessed at the primary endpoint of 3 months, and 6 and 12 months. The sample size for the study was selected to provide >90% power to detect a response rate of >40% of subjects achieving treatment success, and an exact binomial test was used to determine if this response rate was met at the 3, 6 and 12 month time points. Secondary outcomes included symptom impact measured by the Fecal Incontinence Quality of Life, symptom distress using the St Mark’s (Vaizey) questionnaire, Patient Global Impression of Improvement (PGI-I) and device satisfaction. Adverse events were collected. Intention-to-treat analysis included subjects who were successfully fit, responded to initial testing and entered treatment. Per protocol analysis included subjects with valid treatment diaries, no major protocol deviations and completion of the 3-month visit.

73 subjects from eleven clinical sites were successfully fit and entered treatment. At 3 months, intention-to-treat success was, 72.6% (53/73, p<.0001) and per protocol success, 84.1% (53/63, p<.0001) (Table). Per-protocol success rate at 6 and 12 months was 89.5% (51/57), (95% CI, 78.5 – 96.0%) and 94.4% (51/54), (95% CI, 84.6 – 98.8%), respectively (Table).  ITT success rate at 6 and 12 months was 71.2% (52/73) (95% CI, 59.4 – 81.2%) and 69.9% (51/73) (95% CI, 58.0 – 80.1%), respectively.  Subjects counted in the ITT, but not in the PP, include those lost to follow-up, early study exits, and an incomplete study diary.  Among study completers, the average reduction in FI episodes improved over time from 77.3%, to 82.6%, to 85.4% at 3, 6, and 12 months, respectively. There was significant improvement in all Fecal Incontinence Quality of Life ( p<.0001) subscales (Figure). There was significant improvement of all time-points from baseline in the St Mark’s questionnaire (Table). Satisfaction was noted to be 90.3% (56/62), 89.3% (50/56) and 94.4% (51/54) at the 3, 6 and 12-month time-points, respectively; and 77.4% (48/62) vs 77.6% (45/58) vs 79.6% (43/54) of subjects were very much or much better on the PGI-I at 3, 6 and 12 months, respectively. There were no serious adverse events; the most common study-wide device-related adverse event including all enrolled subjects was vaginal abrasion (26/137 subjects, 19%), the majority of events (19/26, 63%) occurring during the fitting period.

For women with FI, the use of a transvaginal device with adjustable balloon resulted in a significant reduction in FI episodes and high treatment efficacy at 3 months, sustained to 12 months. Satisfaction with the device use was high and global impression of improvement of incontinence was found to be better or very much better in the majority of women. Adverse events are low and mainly noted in the fitting period.

A successfully fit vaginal bowel control device is an effective non-surgical treatment option for FI with effectiveness at 3, 6 and 12 months by objective and subjective measures.