NEWARK, Calif., Dec. 19 /PRNewswire/ -- Novasys Medical, Inc., a developer of innovative therapies in women's health, announced today that it has completed patient enrollment in a post-market, prospective open label study to evaluate the long term durability of the Renessa(R) treatment for stress urinary incontinence (SUI) in women. A total of 136 women have been enrolled at 13 different sites across the United States. The patients will be followed for three years post-treatment.
Denise Elser, M.D., a urogynecologist practicing in Oak Lawn, Illinois, is one of the clinical investigators. Dr. Elser is treating the last patient in the study, one of 26 enrolled and treated at her site. "The Renessa procedure for SUI provides a non-surgical option for women who may have unacceptably high surgical risk, or whose busy, active lives cannot accommodate the recovery time necessary after a surgical procedure," Dr. Elser said. "My patients and I have been very pleased with the results of the treatment's effectiveness so far, and I look forward to studying its durability over a three year period."
"Since launching the Renessa System commercially in the fall of 2005, our customers have reported clinical outcomes consistent with those seen in our earlier randomized controlled trial. This three year post-market study will enable us to add to the long term effectiveness data available on the treatment," said Debra Reisenthel, President and Chief Executive Officer of Novasys Medical. The previous prospective randomized controlled trial involved over 170 women and followed patients for 12 months post-treatment. Key outcomes for the 110 treated women in that study included:
-- Statistically significant improvement in Valsalva Leak Point Pressure;
-- 76% of women experienced a reduction in daily incontinence episodes;
-- 58% of women no longer used incontinence pads;
-- 67% of women reported an improvement in their quality of life.
The company reported three-year retrospective outcomes data from this previous trial last month.
SUI is the involuntary leakage of urine associated with laughing, coughing, sneezing and recreational activities. The condition is caused by a variety of factors, most commonly childbirth, and often restricts the social, professional, and personal lives of an estimated 15 million women in the U.S. alone. With currently available surgical and non-surgical SUI therapies, many patients and physicians have concerns about safety, recovery, compliance, and/or effectiveness. In fact, it is estimated that approximately 80% of women with SUI do not seek treatment of any kind due to concerns over recovery time, possible complications or lack of confidence in the effectiveness of available options. The Renessa procedure offers women a new non-surgical approach to the effective treatment of SUI.
The FDA-cleared Renessa System includes a small probe which a physician passes through the natural opening of the urethra (transurethral). 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 firmer, resulting in increased resistance to involuntary leakage at times of increased abdominal pressure, such as laughing, coughing or during exercise, thereby reducing or eliminating leaks.
The Renessa treatment can be performed in the convenience of a physician's office using local anesthesia. There are no incisions, bandages or dressings required. Recovery is rapid and comfortable, with minimal post-procedure limitations.
About Novasys Medical
Novasys Medical, Inc. is a privately held, venture-backed company which develops innovative therapies in women's health. The company's initial focus is the development and commercialization of the Renessa System, a proprietary, non-surgical approach to the treatment of female stress urinary incontinence (SUI).
For more information, please visit www.novasysmedical.com or call 510-226-4060.
Novasys Medical, Inc.