TOMUS (Trial Of Mid-Urethral Slings) is being conducted by the Urinary Incontinence Treatment Network (UITN), a cooperative network consisting of urologists and urogynecologists at 9 clinical centers and a biostatistical coordinating center.
TOMUS is a 2-arm, unmasked, multicenter RCT (Figure 1) comparing RMUS to TMUS.
TOMUS is designed to isolate one of these variables, the anatomic location (retropubic versus transobturator) through which the trocars are passed during placement of the sling, and to compare the efficacy and morbidity of these approaches in the treatment of SUI.
In selecting which MUS products to include in the TOMUS trial, we chose to use the gold standard MUS as the control and to limit the confounding variables to the location of the trocar passage.
The TOMUS study uses a composite primary outcome measure, with objective and subjective components, similar to the outcome measures utilized in the UITN's recently completed Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) trial (23) comparing the Burch procedure to autologous fascial slings.
The TOMUS protocol standardizes definitions for these conditions, the tools used to measure them, and the timing of assessments across all centers.
The TOMUS trial affords an excellent opportunity to examine the clinical utility of pre-operative UDS by limiting the use of UDS data in the pre- and peri-operative decision-making process.