A new clinical trial at UT Southwestern Medical Center at Dallas seeks to answer a question incontinence specialists have long struggled with -- which of two common, established surgeries for female urinary stress incontinence is better?
Dr. Philippe Zimmern, UT Southwestern professor of urology, is leading the study. He explains that both surgeries work to solve the same problem - stress urinary incontinence, or accidental leakage during certain movements. Doctors have never done a formal clinical trial to find out if one procedure, both of which have cure rates estimated between 60 percent and 90 percent, actually works better in the long term.
"These are not experimental procedures," said Zimmern. "They have been around a long time and are very safe."
The Burch procedure and the sling procedure will be studied in the trial. After being randomly assigned to one procedure, women will be regularly examined for four years after their surgeries. In the sling procedure, urethral sphincter is compressed, preventing leakage of urine. In the Burch procedure, sutures to the pelvic ligaments support the bladder, preventing leakage of urine.
The five-year, nine-center study - called the Urinary Incontinence Treatment Network - is the first National Institutes of Health (NIH)-funded trial aimed at female urinary incontinence, which affects as many as 20 million Americans.
"This is a first for women's health," Zimmern said. "This is good for women and good for science."
Stress incontinence is the accidental leakage of urine during activities such as coughing, laughing, sneezing or lifting heavy objects. Stress incontinence in women is common due to muscle weakening, which can be caused by pregnancy and childbirth, pelvic surgery, aging and even hormonal changes that come with menopause.
UT Southwestern is seeking more than 70 women for this trial.
"Incontinence is embarrassing and extremely bothersome for many people who experience it, but it doesn't have to be," Zimmern said. "There are many effective treatments for incontinence, which can truly bring quality of life back for these patients."
Participants in the trial will be covered by their regular health insurance, and the study is entirely voluntary.
Other physicians participating in the study at UT Southwestern are Drs. Gary Lemack, assistant professor of urology, and Joseph Schaffer, associate professor of obstetrics and gynecology.
For more information on the trial, call 214-648-9158.
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