FDA okays home-use intravaginal device for urinary incontinence

August 24, 2020 0 By FM

Flyte, a non-invasive, intravaginal home-use device has recently received the U.S FDA approval for the treatment of women with stress urinary incontinence in patients aged ≥21 years, announced Pelvital.

Stress urinary incontinence (SUI) often occurs because pelvic floor muscles and tissues have been weakened, preventing the urethra from closing adequately to hold urine in the bladder. The device uses mechanotherapy to strengthen and treat weakened pelvic floor muscles in women to substantially improve bladder leaks.

” Flyte leverages the natural healing capabilities of skeletal muscle to provide a time-efficient, effective therapy that essentially turbo charges Kegel exercises, the gold standard conservative treatment for SUI. Flyte amplifies the treatment impact of Kegels so women see results much sooner; days to weeks instead of months to years,” said Dale Wahlstrom, Co-Founder and Chief Executive Officer of Pelvital.

Kegel exercise, also known as pelvic floor exercise, involves repeatedly contracting and relaxing the muscles that form part of the pelvic floor.

Women with mild, moderate or severe SUI who want to avoid surgery, or a lengthy regimen of Kegel exercises could use the new option to treat their bladder leaks. The device was originally developed by physicians from the Arctic University of Norway and other experts in gynaecology, muscle rehabilitation and urinary incontinence treatments.

It is recommended to be used as directed for five minutes per day for 6 weeks as the standard treatment time. Two clinical trials studied the safety and effectiveness of Flyte in Norway and the United States. Between the two studies, more than 200 patients were treated using Flyte; most patients were dry or near dry after 2 – 12 weeks of treatment, said the company.