Contact: Will Sansom
Phone: 210-567-2579
E-mail: sansom@uthscsa.edu

The University of Texas Health Science Center at San Antonio, one of nine clinical centers participating in the National Institutes of Health’s Urinary Incontinence Treatment Network (UITN), made major news recently with the publication of results from the UITN’s first multicenter research trial. The results appeared in the New England Journal of Medicine.

Study compared two standard surgical techniques
The Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) compared two long-performed, gold-standard surgical techniques for treating stress urinary incontinence, a costly and embarrassing condition estimated to affect between 15 percent and 50 percent of all American women.

Stress urinary incontinence, the leakage of urine with sneezing, laughing, coughing, running or other forms of exertion, is the most common form of incontinence in women.

SISTEr compared a sling procedure, in which a woman’s own tissue is placed around the urethra to prevent leakage, with a technique called a Burch procedure, in which sutures are attached to a pelvic ligament to support the urethra. The study randomized 655 women to receive a sling or a Burch.

Stephen R. Kraus, M.D., was co-leader of the SISTEr urinary incontinence study involving nine clinical centers.
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Each procedure had value
“The sling was more effective at resolving stress urinary incontinence symptoms at a higher rate of patient satisfaction than the Burch,” said study co-leader Stephen R. Kraus, M.D., associate professor and vice chair of the Health Science Center department of urology. “However, women treated with the Burch procedure reported fewer urinary tract infections and voiding difficulties, and many who received the Burch were either cured or were satisfied with the outcome.”

Sling more successful after two years
Two years after surgery, 66 percent of women in the sling treatment group reported no stress-related leakage, compared to 49 percent of the women in the Burch group.

Dr. Kraus noted that the definition of cure used in SISTEr was much more complex than previous incontinence research trials. “If one criterion in the physical examination, doctor’s observation or patient’s observation was not met, the therapy was deemed a failure in that patient,” Dr. Kraus said.

Cure rates in previous smaller research trials have approached 90 percent, he said.

SISTEr demonstrates that high-quality research in incontinence is possible and can be done on a set timetable. Incontinence research trials traditionally are difficult to complete because of patients’ reluctance to acknowledge the condition and enroll in a study, and because of problems with self-reporting of success or failure and other issues.

Network is first to conduct randomized, controlled incontinence trials
“This group that Dr. Kraus co-leads is the first ever to conduct randomized, controlled clinical trials in incontinence,” said Ian Thompson, M.D., professor and chairman of the department of urology. “It’s an extraordinary advance in urinary incontinence, which affects probably 50 percent of people in their lifetimes.”

UITN also conducted the BE-DRI study
Dr. Kraus and his UITN colleagues also conducted the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study to determine whether the addition of behavioral treatment to drug therapy could enable patients to discontinue their medication and improve or cure their urinary urge incontinence, a different form of incontinence. The results of that research study will be announced in the near future.

Participants now needed for another stress urinary incontinence study
Currently, Dr. Kraus’ team is conducting the third UITN study, the Trial of Mid-Urethral Slings (TOMUS). That research study compares two minimally invasive surgical procedures for the treatment of stress urinary incontinence. “We need women in San Antonio and the surrounding area to call and ask whether they might qualify for this important study,” Dr. Kraus said.

For more information or to volunteer
For more information, contact Caren Prather, R.N., at (210) 567-0548, or Sylvia Escobedo Sluder at (210) 567-0550. Women who live outside San Antonio may call 1-800-614-9431.

Sponsors of Urinary Incontinence Treatment Network
The National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Child Health and Human Development, and the Office of Research on Women’s Health, all within NIH, fund the Urinary Incontinence Treatment Network. The network, which consists of the Health Science Center, eight other clinical centers and a biostatistical center, is charged with conducting rigorous, long-term trials of common incontinence therapies.

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The University of Texas Health Science Center at San Antonio is the leading research institution in South Texas and one of the major health sciences universities in the world. With an operating budget of $536 million, the Health Science Center is the chief catalyst for the $14.3 billion biosciences and health care sector in San Antonio’s economy. The Health Science Center has had an estimated $35 billion impact on the region since inception and has expanded to six campuses in San Antonio, Laredo, Harlingen and Edinburg. More than 22,000 graduates (physicians, dentists, nurses, scientists and allied health professionals) serve in their fields, including many in Texas. Health Science Center faculty are international leaders in cancer, cardiovascular disease, diabetes, aging, stroke prevention, kidney disease, orthopaedics, research imaging, transplant surgery, psychiatry and clinical neurosciences, pain management, genetics, nursing, allied health, dentistry and many other fields.