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

KRAUS
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San Antonio (Jan. 24, 2007) – Fifty San Antonio and area women are wanted for a research study comparing two ways to treat stress urinary incontinence, a condition that forces many sufferers into embarrassed silence and fear. The study is conducted by physicians and nurses in the department of urology at The University of Texas Health Science Center at San Antonio.

The study is for women who are bothered by urine leakage during daily activities such as coughing, laughing, walking and lifting. This is stress urinary incontinence.

“In this clinical trial, we compare the effectiveness of two procedures to insert a mid-urethral sling – a synthetic mesh sling or ‘hammock’ to support the bladder neck so urine does not leak,” said study principal investigator Stephen R. Kraus, M.D., associate professor of urology at the Health Science Center. “Both procedures are safe and successful in treating stress urinary incontinence, but they differ in where we make the incisions to insert the sling. Our goal is to learn if one is better, and if so, which one.”

In a sling procedure used for decades, a piece of tissue harvested from the belly wall was routed underneath the bladder neck to give support to prevent leakage. This procedure was very successful but required a two-or three-day hospital stay and left a 5- to 6-inch scar.

“The two newer techniques achieve the same result, but instead of the patient’s own tissue we use synthetic mesh,” Dr. Kraus said. “These are outpatient procedures, leave no abdominal scar and greatly minimize recovery time. Many people return to work or daily activities in a day or so.”

He said patients should know these are not experimental procedures, but rather are the standard of care in urologic practice and are approved by the U.S. Food and Drug Administration. “They both are effective, but the question is, do patients do better with one procedure than the other?” Dr. Kraus said.

The two sling techniques are called the Trans-Obturator Tape (TOT) procedure and the Trans-Vaginal Tape (TVT) procedure. Both involve a small incision in the vagina under the urethra, the tube through which urine passes from the body. Both also involve two puncture incisions that are about the size of bee bites, Dr. Kraus said. The sling is pulled to its correct position through these puncture incisions.

In the TOT procedure, surgeons make the two puncture incisions in the groin. In the TVT procedure, the puncture incisions are made on top of the pubic bone.

Women will be considered for study eligibility if they are at least 21 years old, not pregnant and never intend to get pregnant. Compensation is available for completion of the study, but participants must have either medical insurance or CareLink. Participants will be seen at University Hospital, CHRISTUS Santa Rosa-Medical Center Hospital, or the Audie Murphy Division, South Texas Veterans Health Care System.

Women will first be evaluated for study eligibility. After surgery, participants will be asked to make three more visits to the doctor than normally required. These will occur at six months, 12 months and 24 months after surgery.

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.

The Trial of Mid-Urethral Slings study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The study involves nine clinical centers nationwide, including the Health Science Center. This clinical trial is a research activity of the National Center of Excellence in Women’s Health.
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