Use of a motion-based digital therapeutic in women with fecal incontinence: A pilot study

There is limited data addressing the value of vaginal biofeedback (VBF) on fecal incontinence (FI) symptoms. The objective of this pilot study was to evaluate whether use of a motion-based VBF device and app was effective for at-home treatment of women with FI. We hypothesized that VBF would result in improvement in FI symptoms.

A single-arm 10-week prospective pilot trial in women with FI was conducted using the VBF device. The primary outcome was change in St. Mark's score from baseline to week 10. Secondary outcomes included change in 2-week bowel diary and FI quality of life (FIQoL). Statistical analysis included paired t test and Wilcoxon's signed-rank test.

Of 29 enrolled women, 27 had data available for analysis. Mean (±SD) age was 60.9 (±14.4). 63% (17) subjects were White, 33% (9) were Black. Mean St. Mark's score was 14.6 (±4.4) at baseline and 11.6 (±5.1) at 10-weeks (p = 0.005). Changes in the total FIQol, and three of four subsets of the FIQoL scores were also significantly improved (p < 0.001). Bowel diary showed decrease in FI episodes, baseline 8.4 (±8.73) to 10 weeks 4.8 (±3.79), (p = 0.052).

In this pilot study, there was significant improvement in FI symptom-specific severity and quality of life using a vaginal, motion-based device for biofeedback. A larger study is needed to better understand the value of this device, which may be useful for women who prefer a vaginal device, which can be utilized at home compared with standard anal biofeedback for treatment of FI in the clinical setting.