Stephen R. Kraus, M.D., professor and vice chairman of urology in the School of Medicine, co-authored a report of study findings published in the New England Journal of Medicine. <#_ftn1> The clinical research study of 597 women, called the Trial of Mid-Urethral Slings (TOMUS), is the first head-to-head comparison of two types of mid-urethral sling surgery for stress urinary incontinence.
“This is a type of incontinence that millions of women have,” Dr. Kraus said. “It is marked by leakage of urine upon coughing, sneezing, laughing and exercising. Mid-urethral sling surgeries insert a mesh sling or ‘hammock’ to support the bladder neck so urine does not leak.”
Both procedures are approved by the U.S. Food and Drug Administration and have been shown to be safe and successful. Results of the TOMUS trial will help doctors and patients decide which treatment to have.
TOMUS compared the transobturator tape procedure and the transvaginal tape procedure. Both are less invasive than older surgeries that require abdominal incisions. The two procedures differ in where the incisions are made to insert the sling, also called tape. Both involve a small incision in the vagina under the urethra, the tube through which urine passes from the body. Both also involve two small puncture incisions. The sling or tape is pulled to its correct position through these puncture incisions.
In the transobturator tape procedure, surgeons make the two puncture incisions in the groin. In the transvaginal tape procedure, the puncture incisions are made on top of the pubic bone. This technique is also called the “retropubic” procedure.
“It can be safely said the tape procedures have become the most commonly performed surgery for treating stress urinary incontinence,” Dr. Kraus said.
TOMUS results were both objective (a stress test, pad test and retreatment) and subjective (patient’s bladder diary, symptom-specific questionnaires and retreatment). Importantly, there was a high degree of benefit from both mid-urethral sling procedures. However, the overall number of serious adverse events was higher in the transvaginal tape (retropubic) procedure group (14 percent) than in the transobturator procedure group (6 percent). These are summarized as follows:
- The retropubic group experienced more bladder perforations during surgery and more serious voiding problems that required surgical correction.
- The transobturator group experienced more vaginal perforations during surgery and neurological symptoms such as weakness of the upper leg.
- Blood loss during surgery, duration of surgery and likelihood of post-surgery urinary tract infections were modestly higher in the retropublic group.
“The TOMUS study is important because many new procedures for stress urinary incontinence have been introduced without rigorous study of the benefits and risks of such surgeries,” Dr. Kraus said. “These procedures include mesh slings, which are in widespread use. We want to know how to best counsel and treat every woman, and TOMUS gives us evidence-based information.”
 N Engl J Med 2010; 362:2066-2076, Jun 3, 2010; published at www.nejm.org on May 17, 2010 (10.1056/NEJMoa0912658).
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