*Women With Stress Incontinence Might Be Better With Sling As Opposed To Burch Colposuspension Surgery, Suggests New Study Women With Stress Incontinence Might Be Better With Sling As Opposed To Burch Colposuspension Surgery, Suggests New Study
22 May 2007
US researchers comparing two types of surgery commonly performed on women with stress incontinence found that the sling procedure was more effective than the Burch procedure at preventing incontinence, but it brought more risk of post operative problems.
The study is published in the online edition of the New England Journal of Medicine (NEJM).
While many different types of surgery are available to treat women with urinary stress incontinence, there have been few randomized trials comparing the different procedures to help specialists recommend the best treatment for their patients.
The research team, led by Dr Michael Albo of the Division of Urology, University of California, San Diego, US, conducted a randomized clinical trial sponsored by the National Institutes of Health (NIH) with female patients with stress incontinence attending a number of different hospitals.
The trial was designed to compare the effectiveness of two common surgical procedures, the pubovaginal sling (commonly known as the sling procedure), and the Burch colposuspension (commonly called the Burch procedure).
The sling procedure involves using a strip of the patient's own muscle or tendon to hold part of the bladder or urine tube in place, while the Burch procedure is where the surgeon ties the tube or part of the bladder to ligaments in the surrounding abdomen with sutures.
The outcome measures were based on a number of surgical success criteria, including for example no urinary incontinence, no self-reported symptoms and no retreatment for the condition. They also analysed the results against a subset of criteria specific to stress incontinence and any adverse side effects.
The participants were 655 women scheduled to have surgery for stress incontinence. They were randomnly assigned such that 326 underwent the sling procedure while 329 underwent the Burch procedure.
The results showed that:
The researchers concluded that:
"The autologous fascial sling results in a higher rate of successful treatment of stress incontinence but also greater morbidity than the Burch colposuspension."
Dr Kris Strohbehn, of the Department of Obstetrics and Gynecology, Dartmouth Medical School, and the Division of Urogynecology and Reconstructive Pelvic Surgery, at Dartmouth-Hitchcock Medical Center, both in Lebanon New Hampshire, made a number of observations on this study in an accompanying editorial.
First he emphasized the need for further, longer term studies to corroborate these findings, citing for example the fact that "Cure rates declined over time in both groups."
Secondly, and this fact has been highlighted by a number of media reports, the success rates in both groups were lower than those commonly reported in other studies. He suggests this is probably explained by the stricter success criteria used in this study compared to many others.
Elaborating further on this point he explains how difficult it is to define success for a procedure where the impact on quality of life and the patient's perception of success, a subjective measure, forms a significant element of the outcome measure. Strohbehn says:
"At present, there is no single outcome that adequately measures success after treatment of urinary incontinence. There are as many "shades of dry" as there are shades of gray."
The third point he makes, is the emergence of new surgical procedures that increase the range of options doctors and surgeons can offer their patients. For example, a new generation of "mesh" slings has come in, which involves less invasive surgery (smaller incisions), less pain, faster recovery, lower cost and fewer complications.
This does not detract from the value of the findings of this study, which he says "greatly advance our ability to counsel patients and effectively compare surgical options for treatment of stress incontinence".
Stress incontinence is an involuntary leakage of urine that can happen during coughing, sneezing, laughing, exercise, or any physical activity that puts pressure on the abdomen.
It is the most common type of urinary incontinence in women. Research suggests that 50 per cent of women have urinary incontinence occasionally, while 10 per cent have it frequently. And one in five women over 75 experience urinary incontinence every day.
It is a condition often seen in menopausal women and women who have had multiple pregnancies and vaginal childbirths, where the bladder, urethra or rectal wall pushes into the vaginal space (as in a pelvic prolapse).
http://www.medilexicon.com/medicalnews.php?newsid=71743∞

*New Trial Of Novasys Medical's Renessa(R) Treatment Studies Women Who Have Failed Previous Surgical Procedures For Stress Urinary Incontinence New Trial Of Novasys Medical's Renessa(R) Treatment Studies Women Who Have Failed Previous Surgical Procedures For Stress Urinary Incontinence
18 May 2007
Novasys Medical, Inc., a developer of innovative therapies in women's health, announced today that the first patients have been treated in a new, prospective, randomized, sham-controlled trial to evaluate the safety and effectiveness of its Renessa(R) treatment for stress urinary incontinence (SUI) in women who have had previous surgical procedures for their incontinence. The study, conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA), will enroll 250 women at 15 sites across the U.S. The Company anticipates using the results of the trial in an application to the FDA for an expanded indication for the Renessa treatment in women who have failed previous surgical intervention for SUI. The Renessa procedure is currently offered to women who have failed conservative therapy and are not candidates for, or who do not desire, a surgical procedure.
Rodney Appell, M.D., Professor of Urology at Baylor College of Medicine, is the Principal Investigator for the trial. According to Dr. Appell, "surgical procedures for SUI such as tension-free vaginal tape (TVT) and transobdurator tape (TOT) slings are very often successful, but as the popularity of these procedures increases, so does the number of women who experience suboptimal results ranging from improvement without cure to postoperative failure." Follow-up surgery can improve residual or recurrent symptoms but generally carries lower success rates and higher complication risks. As a result, many women are reluctant to undergo a second surgical procedure.
In 2006, there were nearly 400,000 women in the U.S. who underwent a surgical procedure for SUI, and this number is expected to continue to grow over the next several years. Studies show that approximately 20% of women continue to experience SUI symptoms after surgery. Over the next five years, an estimated 700,000 women will have had suboptimal results after surgery, representing an incremental $600 million market opportunity for the Renessa treatment.
"Women who continue to experience urine leakage after undergoing a surgical procedure have few options available to them. We are looking forward to the results of this new trial to determine if the Renessa treatment may provide these women with a safe and effective non-surgical option to address their continuing SUI symptoms," said investigator Shawn Menefee, M.D., a urogynecologist with Kaiser Permanente in San Diego, California. Dr. Menefee treated the first patient in the trial.
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. 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.
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.
http://www.medilexicon.com/medicalnews.php?newsid=71321∞