Urinary Incontinence Treatment Network

Magee-Women'S Res Inst And Foundation, Pittsburgh PA

Investigators

Linked publications & trials

Abstract

[unreadable] DESCRIPTION (provided by applicant): This proposal is submitted in response to RFA-DK-06-501 for continuation in the Urinary Incontinence Treatment Network (UITN) as a Clinical Center (CC) at the University of Pittsburgh (UPITT). The investigators propose to conduct the TOMUS trial as well as continue the observational follow-up studies for the SISTEr and BE-DRI studies (i.e. E-SISTEr and E-BE-DRI). The Primary Aims of TOMUS are to compare objective and subjective cure rates for stress incontinence at 12 and 24 months between the retropubic and transobturator midurethral sling (MUS) procedures. The retropubic approach is generally accepted as the gold standard of MUS procedures. The transobturator approach avoids the retropubic space and offers the theoretical advantage of reduced vascular and enteric injury associated with the original retropubic approach. The transobturator technique has been quickly adopted by surgeons despite the absence of data on safety and efficacy. This study will compare the efficacy and safety of the retropubic and transobturator (inside-out and outside-in) procedures in a 2-arm randomized controlled trial (RCT). 588 women with stress urinary incontinence (SUI) will be enrolled; 65 of these women will be from Pittsburgh. The investigators at UPITT also commit to collecting long-term outcome data from 46 local SISTEr trial enrollees consented in the 'Extended SISTEr' study (E-SISTEr), which aims to compare long-term effectiveness and durability (5 years) of the Burch colposuspension and autologous fascial sling for treatment of SUI in a randomized cohort of 655 women. In addition, we will contribute 32 enrolled subjects into the 'Extended BE-DRI (E-BE- DRI) study which will examine long-term durability (26 months) of the addition of behavioral treatment to drug therapy for urge urinary incontinence (UUI) in a randomized cohort of 307 women. For all studies, the CC is responsible for patient enrollment and follow-up, treatment, and data collection and management. The mission and purpose of the UITN is to establish a group of collaborating investigators who will conduct long- term studies, including clinical trials, of the most commonly used surgical, pharmacological and behavioral approaches to the management of urinary incontinence in women. The investigators from UPITT, supported by their experienced research staff, are poised to continue to contribute to these network activities, including protocol development, standing committees and work groups, manuscripts and presentations. [unreadable] [unreadable]