Novasys Medical has developed a non-surgical approach to treat stress urinary incontinence (SUI) due to bladder outlet hypermobility: the Renessa? System. 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:
Non-surgical, in-office procedure
No incisions, bandages, or dressings
Excellent safety profile, well tolerated
Can be performed using local anesthesia + oral sedation
Rapid recovery with minimal limitations
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:
76% of patients reported a reduction in incontinence episodes;
59% of women reduced their daily episodes by at least half;
58% of women eliminated the need for pads;
More than a third of the women treated were completely dry.
The Renessa? Treatment
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.
Following the Renessa procedure, patients can return to most normal daily activities the same or the next day with minimal limitations.
About Stress Urinary Incontinence
Stress 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.
There are several non-surgical approaches to the treatment of SUI; however, these often require multiple and repeated treatments over weeks and months to achieve and maintain effectiveness. Some non-surgical treatments, such as urinary plugs and vaginal pessaries, mechanically block urine leakage. Other therapies, such as Kegel exercises, biofeedback, physical therapy, and pelvic floor electrical stimulation, attempt to strengthen the pelvic floor muscles. These strengthening approaches have limited effectiveness and patient compliance problems. Bulking agents (which are injected into the urethra to partially obstruct the flow of urine) are not approved by the FDA for the treatment of SUI due to hypermobility, but are nonetheless used by some physicians in these patients. Effectiveness is limited, multiple treatments are often required and some agents are associated with a higher incidence of adverse events than other treatment options.
While the various surgical treatments have demonstrated adequate effectiveness, they all pose greater risk to the patient than the non-surgical treatments. The most common type of surgical treatments are referred to as sling procedures because they involve insertion of an implant (known as a ?sling?) to support the bladder and urethra. These treatments range from traditional invasive, open surgical procedures to the more recently introduced, less invasive laparoscopic or percutaneous sling insertion techniques. All can result in post-operative pain, prolonged post-operative recovery, and significant costs. Furthermore, some women who have undergone a surgical treatment report continued leaking. Surveys have shown that many women with SUI are not interested in a surgical therapy.
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