An over-the-counter device to treat stress urinary incontinence (SUI) in women has been made available by Rinovum Women’s Health.
The FDA-approved Revive device is designed to be inserted into the vaginal tract using a tampon-like applicator. By supporting the urethra and surrounding muscles, the device helps to temporarily reduce leaks associated with SUI. A looped retrieval string is used to remove the device; the string must be discarded and replaced with a new string with each use.
Approval of the device was based on data from a single arm, clinical trial conducted in 73 female patients. Results showed that use of the device led to a clinically significant reduction in SUI symptoms in 71% of women; SUI episodes were reduced to <1 per day. In addition, 79% of patients reported no discomfort while wearing the device.
Revive can be worn up to 12 hours per day and can be reused for up to 31 days. The device is not intended for use in patients with urge incontinence.
“Revive is another important milestone for Rinovum. With its tampon-like applicator and removal string, Revive allows women to go about their day worry-free and return to an active lifestyle,” said Stephen Bollinger, CEO of Rinovum.
The suggested retail price of Revive for a 1 month supply is $34.99.
For more information visit userevive.com.