Results from analyses of urodynamics data collected in the Trial of Mid-urethral Slings show some parameters change significantly after surgery.
"It was surprising to find no associations between the UDS changes and the primary efficacy outcomes, in part because in the previously conducted Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr), certain UDS changes after the Burch and autologous fascia sling procedures were found to correspond with surgical success," said Dr. Kraus, head of female urology, neuro-urology, and voiding dysfunction, and professor and vice chairman of urology at the University of Texas Health Science Center, San Antonio.
"However, the lack of change in MUCP after the MUS [mid-urethral sling] procedures was perhaps the most surprising result. Although preoperative MUCP is a marker of incontinence severity and was shown in other analyses to predict outcome after these MUS procedures, the lack of a meaningful change suggests MUCP is not a measure for the underlying mechanism of action of these procedures."
"All of the UDS testing was done in a standardized fashion across the nine participating sites, and that is a strength of the TOMUS," Dr. Kraus noted.
Analysis of the primary efficacy endpoint of treatment success was based on objective (negative stress test, negative pad test, and no SUI retreatment) and subjective (no leakage on 3-day voiding diary, no symptoms on MESA questionnaire, and no retreatment for SUI) criteria. These previously published results showed the procedures were equivalent in terms of the objective measures; subjective-assessed success rates were similar but did not meet the criteria for equivalence (N Engl J Med 2010; 362:2066-76).