Long Term Clinical Data Confirms Safety and Effectiveness of Renessa® Procedure for Female Stress Urinary Incontinence (SUI)

Filed in archive Diagnostics , Studies , Treatment on November 9, 2006

Clinical data of a study on the long term safety and effectiveness of Novasys Medical, Inc.'s Renessa® procedure for the treatment of stress urinary incontinence (SUI) in women was presented by Saad Juma, M.D., of the Incontinence Research Foundation in Encinitas, California at the Global Congress of Minimally Invasive Gynecology sponsored by the American Association of Gynecologic Laparoscopists (AAGL) in Las Vegas, Nevada.

The long term clinical outcomes showed a durable response to the Renessa treatment and confirmed an improvement in quality of life and a reduction in the frequency and severity of incontinence episodes in the majority of women almost 4 years after treatment.

Caused by various factors like (commonly) childbirth, stress urinary incontinence (SUI) is a condition characterized by the involuntary leakage of urine associated with laughing, coughing, sneezing, sexual and recreational activities.

This condition often restricts the social, professional, and personal lives of an estimated 15 million women in the U.S. alone.

In spite of the availability of surgical and non-surgical SUI therapies, many patients and physicians still have concerns about safety, recovery, compliance, and/or effectiveness, while a big population of women with SUI (80%) prefer not to seek any kind of treatment due to concerns over recovery time, possible complications or lack of confidence in the effectiveness of available options.

The USFDA-cleared Renessa® procedure offers women with a new non-surgical approach to the effective treatment of SUI:

The probe heats multiple small treatment sites in the submucosa of the bladder neck and upper urethra, denaturing collagen in the tissue. Upon healing, the treated tissue is less compliant, resulting in increased resistance to involuntary leakage at times of abdominal pressure, such as laughing, coughing or during exercise, thereby reducing or eliminating leaks.

This SUI treatment can be performed in the convenience of a physician's office using local anesthesia: no incisions, no bandages, no dressings.

Recovery is fast and comfortable.

Source: Novasys Medical, Inc. (a pdf file)

[Photo Credit: Novasys Medical, Renessa® probe positioned within the bladder, with balloon inflated ]