Renovia Inc. (“Renovia”), a women-led company that develops digital therapeutics for female pelvic floor disorders, announced that Neurourology and Urodynamics published a pilot study supporting that use of the leva® Pelvic Health System may be effective in treating symptoms of faecal incontinence (FI) in women. Currently cleared for the treatment of female urinary incontinence (UI), leva could offer a treatment option for women with UI, FI or both if cleared by the U.S. Food and Drug Administration (FDA). Renovia received FDA Breakthrough Device Designation for leva as first-line treatment for chronic faecal incontinence in October 2021.
Commonly called accidental bowel leakage, FI refers to the involuntary loss of stool. The isolating, embarrassing condition affects approximately 9% of women, a conservative estimate as fewer than 30% of women seek care. The prospective, single-arm, open label study examined the clinical effectiveness of pelvic floor muscle training (PFMT) assisted by leva on FI symptoms and condition-specific quality of life for 27 women. At the end of the 10-week study, participants reported a “significant improvement in FI symptom–specific severity and quality of life” with approximately half achieving a 50% reduction in FI episodes. Researchers shared initial findings at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meetings on April 30-May 2, 2021.
There are few treatment options for accidental bowel leakage. PFMT is first-line treatment, but existing supportive devices rely on anal feedback (typically electrical stimulation). leva helps women strengthen their pelvic floor using vaginal biofeedback and without electrical stimulation, which can be more tolerable and thus support adherence. Pairing a small, flexible vaginal wand with a smartphone app, leva also offers women the opportunity to strengthen pelvic floor muscles effectively at home with just five minutes of practice per day.
Dr. Samantha Pulliam, Chief Medical Officer for Renovia Inc., commented “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 non-surgical 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 FI 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 UI, FI or both.”