Multi-Center Clinical Study Underway to Determine Best Procedure
Researchers at the University of Maryland Medical Center are participating in an NIH-funded national study to evaluate the two most commonly used surgical treatments for urinary incontinence in adult women. The goal is to determine, for the first time, which provides the best result. The three-year study is underway at a consortium of nine treatment centers across the U.S., known collectively as the Urinary Incontinence Treatment Network.
"Dozens of therapies, both surgical and non-surgical, have been used to correct urinary incontinence for years, but outcomes have not been systematically evaluated," says Toby C. Chai, M.D., urologist and principal investigator of the study at the University of Maryland Medical Center. "We really don't know what works best over the long term," says Dr. Chai, who is also an assistant professor of surgery at the University of Maryland School of Medicine.
Harry W. Johnson, Jr., M.D., a urogynecologist at the University of Maryland Medical Center and co-principal investigator in this study says, "Most surgeons do the procedure they're comfortable with. This study is designed to find out which procedure is best for both patients and surgeons." Dr. Johnson is also an associate professor of obstetrics, gynecology and reproductive sciences at the University of Maryland School of Medicine.
An estimated 11 million American women and five million men suffer from urinary incontinence, the involuntary loss of urine. It affects older women more often than younger women, but Dr. Johnson estimates that 20 to 50 percent of women between the ages of 20 and 65 are also affected. The condition remains 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. A study published in the International Urogynecology Journal estimates incontinence costs $26 billion annually, the bulk spent on management measures, such as pads and diapers, not 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 is to assess which therapies work best for each type of incontinence, but women participating in this study must have a predominant diagnosis of stress urinary incontinence.
Pregnancy and childbirth, menopause and the structure of the female urinary tract may contribute to urinary incontinence in women. The body stores urine in the bladder, a balloon-like organ. The bladder connects to the urethra, the tube through which urine leaves the body. Stress urinary incontinence is often the result of 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.
The study will evaluate the effectiveness of two "gold-standard" surgical therapies for stress urinary incontinence -- the Burch colposuspension and the pubovaginal sling. Both have an 80 to 90 percent success rate.
In the Burch procedure, the surgeon secures sutures to thick bands of muscle tissue running along the pubic bones to elevate the urethra and bladder neck to a more normal position.
The sling procedure uses a small strip of the patient's own fascial tissue, which covers the lower abdominal muscle, to compress the urethra back to its original position. The fascia is surgically placed under the urethra and bladder neck like a hammock, then secured with sutures to the lower abdominal wall.
Patients will be randomized for the study, but they won't find out which procedure they received until after the surgery. Surgeons in the study are certified to perform the two procedures in a standardized way, and must be prepared to perform either procedure. The randomized treatment assignment will be determined by a data-coordinating center.
Patients will be followed for a minimum of 24 months after the procedure, using a series of questionnaires, diaries and physical examinations to evaluate the success of the surgery.
Women who would like more information about participating in the study can call the University of Maryland Continence Center at (410) 328-7736.
Each center will be recruiting 146 women with urinary incontinence. Other continence treatment centers in the network include 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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