By performing two surgical procedures during the same operation, researchers in an NIH network reduced by half the incidence of urinary incontinence in women with a condition known as pelvic organ prolapse. .
Ordinarily, a single surgery is performed to correct pelvic organ prolapse, and a second surgery is performed only if incontinence develops.
"This is an important advance in treatment for a large number of women," said Duane Alexander, M.D., Director of NIH's National Institute of Child Health and Human Development. "More than 200,000 women have prolapse surgery every year, and these research findings could prevent incontinence in many of them."
These findings, reported by NICHD's Pelvic Floor Disorders Research Network, appear in the April 13 issue of the New England Journal of Medicine.
The first author of the study was Linda Brubaker, M.D., of Loyola University Medical Center, in Maywood, Ill.
Pelvic organ prolapse occurs when the pelvic muscles and connective tissue within the pelvic cavity weaken or are injured, explained the NICHD author and program officer of the study, Anne Weber, M.D., of the Institute's Contraception and Reproductive Health Branch. The tissue ordinarily supports the vagina and holds it in place within the pelvis. Without normal support, however, the uterus, bladder, and bowel press down on the vagina, causing it to invert and, in some women, these organs eventually protrude through the vaginal opening.
With advanced pelvic organ prolapse, the vaginal protrusion may cause a kinking of the urethra, blocking the flow of urine and preventing the bladder from emptying completely (called partial retention). This retention, in turn, may lead to frequent or persistent urinary tract infections. In other cases, depending on the individual, pelvic organ prolapse may occur along with stress incontinence- urine leakage from the bladder during a cough or a sneeze.
To treat pelvic organ prolapse, gynecologists may recommend that patients have a surgical procedure known as sacrocolpopexy, Dr. Weber added. In this procedure, surgical mesh and sutures are used to anchor the vagina to the sacrum.
However, after sacrocolpopexy, many women experience incontinence, which makes them candidates for a second surgical procedure, the Burch colposuspension. With Burch colposuspension, Dr. Weber said, additional sutures are sewn through the wall of the vagina and anchored to ligaments inside the pelvic cavity, near the pubic bone.
The Network investigators undertook the current study to determine if proactively performing the Burch colposuspension at the same time as sacrocolpopexy might prove effective at preventing incontinence in women with prolapse who did not have symptoms of stress incontinence before surgery.
For their study, with the women's consent, the researchers randomly assigned women who were undergoing sacrocolpopexy to receive either Burch colposuspension or no additional surgery. Of 322 women, 157 received Burch colposuspension and sacrocolpopexy, and 165 received only sacrocolpopexy.
Three months after their surgery, the women were evaluated according to standardized criteria for urinary stress incontinence. These criteria measured incontinence that occurred in response to such activities as coughing, sneezing, laughing, physical exercise, lifting, or bending over. Of the Burch group, 23.8 percent met one or more criteria for stress incontinence. In comparison, of the group that underwent sacrocolpopexy alone, 44.1 percent met one or more criteria for stress incontinence.
The women also responded to a questionnaire asking whether they were bothered by their symptoms of incontinence. The questionnaire was designed to distinguish between minor leakage and incontinence severe enough to be considered a bother by the women. Three months after the surgery, 24.5 percent of the women in the control group reported bothersome symptoms of incontinence, compared to 6.1 percent of women in the Burch colposuspension group.
"In women without stress incontinence who are undergoing abdominal sacrocolpopexy for prolapse, Burch colposuspension significantly reduced postoperative symptoms of stress incontinence without increasing other urinary tract symptoms," the study authors wrote.
In addition to the NICHD, other member institutions of the Pelvic Floor Disorders Research Network that participated in this study were the Loyola University Medical Center in Maywood, Illinois; the Johns Hopkins University in Baltimore; Baylor College of Medicine in Houston, Texas; the University of Iowa in Iowa City; the University of Alabama at Birmingham; the University of North Carolina at Chapel Hill; the University of Pittsburgh; and the University of Michigan, Ann Arbor.
The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Web site at http://www.nichd.nih.gov/.
The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.