Renessa® Treatment For Stress Incontinence, Three Year Clinical Results Presented
Novasys Medical, Inc., a developer of innovative therapies in women’s health, announced today that a poster describing results from a prospective three year clinical trial of its non-surgical Renessa® treatment for stress urinary incontinence (SUI) in women was presented at two professional society meetings in September 2011: the annual national Scientific Meeting of the American Urogynecologic Society (AUGS) and the South Central Section of the American Urological Association.
The poster, authored by Harvey A. Winkler, MD, co-chief of Urogynecology at North Shore-LIJ University in Manhasset, New York, showed that an estimated 71% of patients experienced an improvement in quality of life at 36 months post-treatment. “These results confirm that the majority of patients treated with the non-surgical Renessa procedure experience lasting improvements in symptoms and quality of life,” said Dr. Winkler. “The procedure also appears to be very safe, as no serious adverse events were reported at any time during the follow-up period,” he added.
Surgical procedures for SUI often involve permanent implantation of a strip of synthetic mesh to provide additional support to the urethra. In July 2011 the U.S. Food and Drug Administration (FDA) issued its second Safety Communication regarding serious complications reported with mesh placed transvaginally in pelvic organ prolapse (POP) surgical procedures and is continuing to monitor adverse events associated with mesh used to repair both POP and SUI. The most common serious complications reported for mesh procedures for SUI include pelvic pain, mesh erosion through vaginal tissue, and groin injury and pain [source: FDA Perspective on Surgical Mesh for Stress Urinary Incontinences (SUI), presentation at FDA Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee, September 9, 2011.
“Many studies have shown that SUI has a significant negative impact on the lives of millions of women,” said Scott Cramer, Novasys Medical President and Chief Executive Officer. “Given concerns about the risks of mesh used in prolapse and incontinence surgery, it is more important than ever for women and their physicians to have safe, effective, less invasive treatment options. When conservative therapies for SUI such as Kegel exercises fail, Renessa is the logical next step in the treatment pathway before proceeding to a more invasive surgical procedure.”
Female Stress Urinary Incontinence (SUI)
SUI is the involuntary leakage of urine associated with coughing, sneezing, laughing and recreational activities. Caused by a variety of factors — most commonly childbirth — SUI often restricts the social, professional, and personal lives of an estimated 15 million women in the U.S. With currently available SUI therapies, many patients and physicians have concerns about safety, recovery, compliance and/or effectiveness. Experts estimate 80-90% of women with SUI do not pursue treatment of any kind.