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New Data Presented on the Renessar Treatment for Female Stress Urinary Incontinence
09 / 11 / 2007
6 month results from long term durability study presented at Western Section meeting of the American Urological Association
Novasys Medical, Inc., a developer of innovative therapies in women's health, announced today that six month data from its post-market, prospective open label study to evaluate the long term durability of the Renessar treatment for stress urinary incontinence (SUI) in women was presented at the Western Section meeting of the American Urological Association (AUA). A total of 137 women in the trial have been treated 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 and the principal investigator in the trial, presented the data in Scottsdale, AZ. "The non-surgical Renessa procedure offers women suffering from the isolating effects of SUI a safe, effective alternative between conservative treatments such as Kegel exercises and biofeedback, and more invasive surgical therapies," Dr. Elser said. "Women are looking for an alternative to exercise and surgery. My patients and I have been very pleased with the safety and results of this noninvasive treatment," she continued. The trial results will also be presented during a poster session at the upcoming Global Congress of Minimally Invasive Gynecology in Washington, DC.
Highlights of the six month results include:
"This multi-center three year prospective trial is expected to confirm the outcomes seen in our previous U.S. Pivotal Trial," said Charles S. Carignan, M.D., Chief Medical Officer of Novasys Medical. "The six month results so far not only validate our earlier studies, but outcomes have been better in a slightly more severely affected population of women. And as has been the case in all four previous studies and in our commercial experience, there have been no serious adverse events reported," he states.
The company previously reported long term clinical outcomes from its U.S. Pivotal Trial which 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.
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 physicians office using local anesthesia. There are no incisions, bandages or dressings required. Recovery is rapid and comfortable, with minimal post-procedure limitations.
Novasys Medical, Inc., a developer of innovative therapies in women's health, announced today that six month data from its post-market, prospective open label study to evaluate the long term durability of the Renessar treatment for stress urinary incontinence (SUI) in women was presented at the Western Section meeting of the American Urological Association (AUA). A total of 137 women in the trial have been treated 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 and the principal investigator in the trial, presented the data in Scottsdale, AZ. "The non-surgical Renessa procedure offers women suffering from the isolating effects of SUI a safe, effective alternative between conservative treatments such as Kegel exercises and biofeedback, and more invasive surgical therapies," Dr. Elser said. "Women are looking for an alternative to exercise and surgery. My patients and I have been very pleased with the safety and results of this noninvasive treatment," she continued. The trial results will also be presented during a poster session at the upcoming Global Congress of Minimally Invasive Gynecology in Washington, DC.
Highlights of the six month results include:
- 74% of women showed an improvement in their symptoms with 63% of women reducing their episodes to less than half
- 74% of women reported improvement in their quality of life
"This multi-center three year prospective trial is expected to confirm the outcomes seen in our previous U.S. Pivotal Trial," said Charles S. Carignan, M.D., Chief Medical Officer of Novasys Medical. "The six month results so far not only validate our earlier studies, but outcomes have been better in a slightly more severely affected population of women. And as has been the case in all four previous studies and in our commercial experience, there have been no serious adverse events reported," he states.
The company previously reported long term clinical outcomes from its U.S. Pivotal Trial which 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.
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 physicians office using local anesthesia. There are no incisions, bandages or dressings required. Recovery is rapid and comfortable, with minimal post-procedure limitations.