FDA grants clearance to leva Pelvic Health System for chronic fecal incontinence

The FDA has granted clearance to the leva Pelvic Health System for the frontline treatment of women with chronic fecal incontinence (FI).¹

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.

"I've spent over 20 years studying the causes and treatments for fecal incontinence," Holly E. Richter, PhD, MD, 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 press release. "First-line treatment alternatives have been limited in the past so it's important that clinicians can now consider leva as a new treatment option that is supported by robust clinical data."

"In my clinical practice, accidental bowel leakage is among the conditions that has the most negative effect on patients' emotional well-being," Roger R. Dmochowski, MD, MMHC, professor of Urology and Surgery and associate surgeon-in-chief at Vanderbilt University Medical Center, stated in a press release. "Fewer than 30% of women seek care for FI, suggesting the depth of embarrassment and shame patients experience. My hope is that better first-line treatment options, like leva, will lead more women to seek care. The ability of a single noninvasive therapy to treat both conditions is really very helpful to our patients. Now with FDA approval, patients will have much improved ability to use this efficacious therapy on a long-term basis, which is most beneficial for them.

The clearance for chronic FI follows a prior approved indication for the treatment of women with stress, mixed, and mild-to-moderate urinary incontinence in women.

Clinical results with leva

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.^2,3

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.

References

1. Renovia receives FDA clearance for leva® Pelvic Health System as first-line treatment for chronic fecal incontinence. Published online July 7, 2022. Accessed July 8, 2022. https://prn.to/3NNLM0Z.

2. 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.

3. 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