Study in New England Journal of Medicine finds greater success with sling procedure
Different surgical procedures have been available for decades to relieve urinary stress incontinence, a distressing problem that affects more than three million women in the United States. But until now, the two main techniques—the “sling” and the Burch—had never been compared in a scientific study to see which was more effective.
In a randomized clinical trial at nine medical centers, including the University of Maryland Medical Center in Baltimore, doctors found that the “sling” procedure worked better than another surgical treatment, called the Burch procedure, to treat urinary stress incontinence in women. The results of the NIH-funded study are reported in the New England Journal of Medicine (NEJM) and are being released early to coincide with a presentation at the annual meeting of the American Urological Association on May 21, 2007. Results will appear in the May 24 print edition of NEJM.
Stress incontinence is, by far, the most common type of incontinence. It often results from inadequate bladder support from the pelvic muscles, or a weak or damaged urethra. Anything that strains or stresses the abdomen, such as coughing, sneezing, laughing, or even walking, may cause urine to leak.
“We found that the sling was successful at treating the stress incontinence in 66 percent of the women in our study, versus a 49 percent success rate for those who had the Burch, and this difference was statistically significant,” says Toby C. Chai, M.D., a urologist at the University of Maryland Medical Center, and associate professor of surgery at the University of Maryland School of Medicine. He was the principal investigator in the study from the University of Maryland Medical Center site.
The study, which began in 2002, randomly assigned 655 women with the average age of 52 to one of two groups—326 had what is known as the autologous fascial sling procedure and 329 had the Burch colposuspension procedure. All of the women were followed for a minimum 24 months after their surgeries. The sling technique has traditionally been performed by urologists, while gynecologists favored the Burch. The study was conducted by both urologists and gynecologists who were trained in the two procedures.
Regardless of the outcome, says Dr. Chai, “The vast majority of patients in both groups reported satisfaction with the treatment they had received.” Two years following their surgery, 86 percent of those who had the sling procedure reported that they were satisfied with the treatment, compared to 78 percent of those who had the Burch technique. However, the one advantage of the Burch over the sling was that there was a higher rate of side effects, such as urinary tract infections, following the sling. The reasons were not clear.
“The important take-home message for women is that successful treatments are available for incontinence, and the tools and techniques are improving all the time,” says Harry W. Johnson, Jr., M.D., a urogynecologist at the University of Maryland Medical Center and associate professor of obstetrics, gynecology and reproductive sciences at the University of Maryland School of Medicine.
“There is also now an array of new minimally invasive techniques that we can offer so that our patients do not have to suffer from the embarrassment and inconvenience of incontinence. The new treatments are replacing the traditional sling and Burch surgeries,” says Dr. Johnson, who is a co-investigator in the study.
Dr. Johnson and Dr. Chai are participating in a new, multi-center study comparing two types of minimally invasive treatments that require only two small holes—either in the abdomen or in the upper thigh—to help position a mesh material to support the urethra. Because they do not require an incision of 3-4 inches, the recovery time for these procedures is only about two weeks, compared to 4-6 weeks for the older sling or Burch operations.
These new techniques are based on the “sling” approach. “Our study results support the validity of these new, less invasive treatment kits. We believe our latest study, comparing two different minimally invasive products, will provide additional guidance on the most effective way to help patients with urinary stress incontinence,” says Dr. Chai.
An estimated 11 million American women and five million men suffer from one or more forms of urinary incontinence, the involuntary loss of urine. It affects older women more often than younger women, but Dr. Johnson estimates that more than 20 percent of women between the ages of 20 and 65 are also affected. Pregnancy and childbirth, menopause and the structure of the female urinary tract may contribute to urinary incontinence in women. The condition is believed to be under-reported. Some patients are too embarrassed to seek help, while others suffer in silence because they think it is a normal consequence of aging.
People with incontinence may suffer from social isolation, sexual dysfunction and depression, even though the condition can be effectively treated. Recent studies estimate that incontinence costs more than $20 billion annually in the United States, the bulk spent on management measures, such as pads and diapers, not medical treatment.
There are several types of incontinence, ranging from the most common, stress incontinence, to urge incontinence and overflow incontinence. One of the main goals of the Urinary Incontinence Treatment Network or UITN, the group of nine centers that participated in this latest study, is to assess which therapies work best for each type of incontinence.
In addition to the University of Maryland Medical Center, other incontinence treatment centers in the UITN that participated in the study include the University of Alabama, University of California at San Diego, University of Pittsburgh, University of Texas at Dallas and San Antonio, University of Utah, Beaumont Hospital in Royal Oak, Michigan, and Loyola University in Chicago.
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