Renessa Treatment for Stress Urinary Incontinence (SUI)The Renessa treatment uses a small probe which a physician passes through the urethra. The treatment can be performed in the convenience of a physician's office or other outpatient setting. There are no incisions, bandages or dressings required. Recovery is rapid and comfortable, with minimal post-procedure limitations. The Renessa procedure uses radiofrequency energy (RF) to generate controlled heat at low temperatures in tissue targets within the lower urinary tract. The heat denatures collagen in the tissue at multiple small treatment sites. Upon healing, the treated tissue is firmer, increasing resistance to involuntary leakage at times of heightened intra-abdominal pressure, such as laughing, coughing or during exercise, thereby reducing or eliminating SUI episodes.
RF has been routinely used by physicians in the treatment of numerous conditions for many decades. At higher temperatures than those generated by the Renessa System, RF energy can cut and/or ablate tissue for the treatment of upper airway disorders, cardiac arrhythmias, benign prostate hyperplasia, excessive uterine bleeding (menorrhagia) and other conditions. Low temperature RF is used to treat luminal disorders such as gastroesophageal reflux disease, fecal incontinence, and now, female stress urinary incontinence. Benefits of the Renessa® treatment include:
In a U.S. clinical study, the majority of women who underwent the Renessa treatment experienced a significant improvement in quality of life measures such as reduced daily leak episodes and reduced or eliminated pad use. Key 12 month clinical outcomes in Renessa patients are as follows:
The Renessa® Treatment
About Stress Urinary IncontinenceStress urinary incontinence (SUI) is the most common type of urinary incontinence, affecting 15 million women in the United States alone. SUI is the involuntary leakage of urine which occurs during periods of increased intra-abdominal pressure ("stress"). SUI occurs with laughing, sneezing, coughing, exercise, lifting, and other activities. The primary cause of SUI is inadequate support of the bladder, resulting in bladder outlet hypermobility. SUI affects women of all ages, including approximately 25% of women age 30-59 years, particularly those who have delivered at least one baby vaginally. While not a life threatening disorder, SUI diminishes a woman's quality of life, often limiting her professional, social, sexual, and recreational activities. A variety of therapeutic options are available to treat women with SUI. These approaches are broadly divided into non-surgical and surgical treatments, and each category has specific benefits and risks. The SUI Therapeutic Spectrum shown below summarizes where the various non-surgical and surgical treatments currently available fall along a continuum of invasiveness.
|
|||||||||
Once the patient has received the appropriate anesthetic (either local anesthesia or conscious sedation), her physician passes the Renessa probe through the urethral opening and the urethra into the bladder. With the end of the probe positioned within the bladder, a small balloon is inflated to maintain the probe in its proper position during treatment. With the probe in place, radiofrequency energy is delivered from a compact RF generator to four small needles which are deployed from the probe into the tissue of the bladder neck and upper urethra. No visualization of the treatment site is required. RF is delivered for 60 seconds, heating small areas of tissue around the needle tips to a temperature at which collagen undergoes a structural change (denatures). The probe is located and repositioned using a series of simple maneuvers and RF is delivered for 60 seconds a total of nine (9) times, thus denaturing collagen at 36 tissue sites.
