Motion-based digital therapeutic shows potential for women with fecal incontinence

Findings published in Neurourology and Urodynamics suggest that the leva Pelvic Health System may provide an effective, nonsurgical approach to treating fecal incontinence symptoms in women.^1,2

Leva is a small vaginal probe that is implanted and paired with a mobile application. The system is intended to allow women to strengthen their pelvic floor muscles without medication or surgery.

The published data were from a single-arm, 10-week prospective pilot study of women with fecal incontinence. St. Mark's score from baseline to week 10 was the primary outcome measure. Secondary end points included change in 2-week bowel diary and fecal incontinence quality of life (FIQoL).

Overall, there were 27 evaluable patients with a mean age of 60.9 years. About two-thirds of patients were White and about one-third were black.

The mean St. Mark's score decreased from 14.6 at baseline to 11.6 at 10 weeks (P = .005). There was also a significant improvement in the total FIQol, as well as in the scores on 3 of the 4 FIQoL subsets (P <.001).

Bowel diaries available from 21 patients showed that the mean number of fecal incontinence episodes decreased from 8.4 at baseline to 4.8 at 10 weeks (P = .052). Ten (47.6%) of the 21 patients had at least a 50% reduction in the number of episodes.

"While small, our pilot study demonstrated the feasibility of a new treatment option for women with fecal incontinence, which we desperately need," Holly E. Richter, PhD, MD, principal investigator, professor and The Endowed Chair in Obstetrics and Gynecology at the University of Alabama at Birmingham, (UAB) and Associate Director, Gynecologic Research in the UAB Center for Women's Reproductive Health, stated in a news release.

"While additional research involving more women would be valuable to examine intervention effectiveness, these results show that vaginal biofeedback devices like leva can significantly mitigate fecal incontinence symptoms. Considering its established treatment value for urinary incontinence, it could be a uniquely valuable solution for women living with both urinary incontinence and fecal incontinence, an especially impactful situation," added Richter.

In November 2021, the FDA granted a breakthrough device designation to the Ieva Digital Therapeutic System for use as a first-line treatment in women with chronic fecal incontinence. The designation is intended to expedite the development and regulatory review of leva in this setting. The FDA previously approved the Ieva Digital Therapeutic System for the treatment of urinary incontinence and pelvic floor strengthening in women.

"There are multiple barriers that keep fecal incontinence treatment out of reach for women," Samantha Pulliam, MD, chief medical officer for Renovia Inc, the developer of leva, stated in the news release. "The disappointing lack of effective first-line treatment options plays a significant role in delaying treatment for many women. The very few available options are generally clinic-based, require surgery or are undesirable due to their reliance on anal feedback. leva is a nonsurgical option that relies on vaginal biofeedback, which should support patient adherence. Using leva, women can also access first-line therapy at home, on their own schedule, unencumbered by the cost, travel and time associated with in-clinic visits. While its use to treat fecal incontinence requires FDA review and clearance, these early study data show its valuable potential to treat multiple pelvic floor disorders, which could help alleviate existing treatment barriers for women living with urinary incontinence, fecal incontinence, or both."

References

1. Published study supports leva® Pelvic Health System's potential to improve fecal incontinence symptoms. Published online December 21, 2021. Accessed January 3, 2022. https://prn.to/3qHOETL.

2. Weinstein MM, Pulliam SJ, Keyser L, Richter HE. Use of a motion-based digital therapeutic in women with fecal incontinence: A pilot study [published online ahead of print December 11, 2021]. Neurourol Urodyn. doi: 10.1002/nau.24854