Pelvital, a medtech company specializing in women’s health, has announced the publication of a pivotal study in the peer-reviewed journal Therapeutic Advances in Urology. The study, titled “Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women,” validates the efficacy of their FDA-cleared Flyte device. The research indicates significant improvements for women suffering from stress urinary incontinence (SUI) and weakened pelvic floor muscles.
Flyte, which utilizes transvaginal mechanotherapy, a method based on mechanotransduction principles that stimulate cellular tissue regeneration, has proven to help women achieve continence or significant improvements within 2-12 weeks. The treatment, which complements voluntary pelvic floor muscle contractions, has shown to be effective across all levels of SUI severity.
The research involved 119 participants in a double-blind, controlled trial, making it one of the largest studies to examine in-home SUI treatment. Remarkably, 71% of the women became dry or nearly dry over the treatment period, with sustained quality of life improvements over two years. This study builds on previous research from the Arctic University of Norway, where Flyte demonstrated a high success rate in treating long-term SUI symptoms, often replacing the need for surgical interventions.
“This study is a true gamechanger for clinicians treating the 62% of women who are struggling with urinary incontinence, of which stress urinary incontinence is the largest segment,” says Dr. Nissrine Nakib, lead author of the study, “Our research proves that Flyte is a first-line, conservative treatment and a viable alternative to surgery by uniquely delivering transvaginal mechanotherapy to the pelvic floor.”
“We are thrilled to share this clinical trial affirming that the Flyte device sets a new standard of care for conservative treatment of stress urinary incontinence,” says Lydia Zeller, CEO of Pelvital. “Pelvital remains committed to prioritizing women’s health by revolutionizing the treatment landscape, providing evidence-based options for clinicians, and empowering women to regain control over their lives”.
