Trial Of Mid-Urethral Slings

Urinary incontinence affects up to 50% of women, resulting in substantial medical, social, and economic burdens. Among U.S. women with urinary incontinence, 15 to 80% have a component of stress incontinence, which results in leakage of urine during physical exertion, sneezing, and coughing. Of these women, 4 to 10% undergo surgery.

TOMUS is a 2-arm, unmasked, multi-center randomized controlled trial that compared two types of mid-urethral slings used for treatment of stress incontinence: the retropubic mid-urethral mesh sling (RMUS) and the transobturator mid-urethral sling (TMUS). RMUS procedures are less invasive than the fascial sling procedures that were reference standards at the start of the study. Specifically, a synthetic tape is passed transvaginally at the midurethral level through the retropubic space. TMUS procedures were developed to minimize the potential for bladder and bowel injuries associated with the retropubic sling, since the sling is passed through the obturator canal, avoiding the pelvic organs in the retropubic space.

Eligible women 21 years of age or older who were planning to undergo surgery for the treatment of stress incontinence were invited to participate in TOMUS. Randomization was performed after anesthesia was administered. Women were randomly assigned with the use of a permuted-block randomization schedule, with stratification according to clinical site. After the surgery, information regarding the treatment assignment was not kept from the patient. Subjects were followed up at 12 and 24 months after the surgery.

ETOMUS: Women completing 2-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a 5-year observational cohort.