Pelvital published a milestone paper in the peer-reviewed Therapeutic Advances in Urology showing the efficacy of its FDA-cleared novel device Flyte to treat stress urinary incontinence and weakened pelvic floor muscles.
EAGAN, Minn., Feb. 21, 2024 /PRNewswire-PRWeb/ —
- The Flyte® device resulted in continence or clinically significant improvement in 2-12 weeks, as evidenced by reduction in 24-hour pad weight.
- Transvaginal mechanotherapy presents a new and beneficial approach to the treatment of SUI in women.
- Subjective improvement in SUI-related symptoms and quality of life maintained over long-term follow up.
Pelvital, the women’s health MedTech company on a mission to transform the standard of care for urinary incontinence, announced today the publication of its landmark paper “Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women” in the peer-reviewed journal Therapeutic Advances in Urology. The paper presents evidence of the efficacy of Pelvital’s novel, FDA-cleared device, Flyte, for the treatment of stress urinary incontinence (SUI) and weakened pelvic floor muscles, with results comparable to surgical intervention.
Flyte delivers mechanotherapy treatment superimposed on the pelvic floor muscles during voluntary pelvic floor muscle contractions and relaxations (Kegels). Mechanotherapy, the clinical application of mechanotransduction, has been shown in clinical research to stimulate cellular tissue regeneration and create both voluntary and involuntary neuromuscular memory.
Pelvital’s clinical trial assessing Flyte is one of the largest trials done examining the clinical benefits of an in-home SUI treatment, with 119 participants in a randomized, controlled, double-blind setting. The trial included women with the highest severity SUI, up to >500 grams of leakage over 24 hours. The results demonstrate Flyte’s ability to effectively treat stress urinary incontinence in all levels of severity, as evidenced by reduction in 24-hour pad weight, which objectively measures leakage over 24-hours. Seventy-one percent of participants became dry or near dry over 2 to 12 weeks, and achieved significant subjective improvements as measured by clinically validated questionnaires assessing SUI symptoms and overall quality of life. The trial examined durability of treatment effect with a long-term follow-up and found that quality of life improvements were maintained or improved in all severity groups two-years post-treatment.
“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.”
The study builds upon a prior clinical study done at the Arctic University of Norway that validated the effectiveness of Flyte as a non-invasive treatment option for SUI. In that study, participants’ average duration of SUI symptoms prior to study was 9.3 years. Using Flyte, 82% of subjects achieved continence in six weeks, and at a two-year follow-up, a remarkable 77% of respondents were still continent. Notably, all participants in the study had been referred for surgery prior to the study, and after using Flyte, none opted for surgical intervention.
“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”.
About the Authors:
- Dr. Nissrine Nakib, MD, Associate Professor, Department of Urology, University of Minnesota
- Dr. Suzette Sutherland, MD, Associate Professor, Department of Urology, University of Washington
- Dr. Kevin Hallman, MD, Metro OBGYN
- Marcus Mianulli, MA, BA, BS, Gnarus Medical Consulting Inc.
- Dr. David Boulware, MD, MPH, Professor, Division of Infectious Diseases and International Medicine, University of Minnesota
About Pelvital
Pelvital USA, Inc. is a women’s health medical device company empowering women and clinicians to restore pelvic health with effective, convenient products backed by strong clinical evidence. Their first product, Flyte®, is an FDA-cleared novel in-home treatment for stress urinary incontinence and weakened pelvic floor muscles. Flyte’s mechanism of action is mechanotherapy, a foundational treatment modality that when paired with an active pelvic floor contraction stimulates tissue regeneration and the creation of neuromuscular memory. Learn more at flytetherapy.com.
