Sling procedures: Consider caveats when reading studies

December 1, 2005

Outcomes must be assessed using validated, patient-driven quality-of-life questionnaires.

With a mean follow-up of just over 1 year, the study showed similar efficacy for tension-free vaginal tape (TVT, Gynecare/Ethicon, Somerville, NJ) and the newer trans-obturator tape (TOT, Mentor Corp., Santa Barbara, CA). About 70% of both TVT and TOT patients reported that they were dry, and urgency symptoms and voiding dysfunction were lower with the TOT procedure in this short-term study. Because the TOT procedure does not involve entry into the retropubic space, it also provides a lower risk of bowel, bladder, or vascular complications.

A number of caveats need to be considered when interpreting these data and those from other studies of sling procedures.

Second, outcomes with sling procedures depend a great deal on the surgeon who is performing the surgery. According to data from a large U.S. database, it appears that the need for subsequent pelvic prolapse surgery in patients whose sling procedure is performed by a urologist is significantly higher than in those whose procedure is performed by a gynecologist.

These data highlight the fact that stress incontinence is only one manifestation of pelvic floor relaxation. Pelvic prolapse surgery, such as cystocele, rectocele, or repair of the vaginal vault, should be performed at the time of the sling for stress incontinence. Urologists not prepared to perform complex pelvic reconstruction should work closely with a gynecologist in pelvic reconstruction cases to repair the concomitant defects.

Third, outcomes must be assessed using validated, patient-driven quality-of-life questionnaires. Treatment success cannot be based strictly on objective measures, such as the amount a patient leaks, as patients' subjective measures of satisfaction can vary widely. Currently, definitions of "cure" and "improvement" tend to vary from study to study. To allow for fair comparisons of the data, studies need to consistently measure outcomes based on patient-derived questionnaires.

In conclusion, minimally invasive procedures have expanded our options for the treatment of women with genuine stress urinary incontinence. It is essential that these techniques must be evaluated with long-term, controlled studies using patient-generated questionnaires.

Dr. Raz, a member of the Urology Times Editorial Council, is professor of surgery/urology, UCLA School of Medicine, Los Angeles.