Dataset Information

The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology.

ABSTRACT: OBJECTIVE:Mid-urethral slings (MUS) are increasingly common surgical procedures for the treatment of stress urinary incontinence (SUI) in women. There are currently no adequately powered trials with sufficient length of follow-up comparing the efficacy or safety of the transobturator and retropubic MUS. As a result, no selection criteria are available to guide surgeons or patients. This article describes the methodology and rationale for the Trial Of Mid-Urethral Slings (TOMUS). PATIENTS AND METHODS:The primary aims of this randomized controlled trial is to compare subjective and objective success rates for urinary incontinence (UI) at 12 and 24 months following retropubic and transobturator MUS procedures. Secondary aims are to compare the resolution of overall and stress-specific UI, morbidity, the time to adequate voiding, satisfaction, and quality of life in the two groups. TOMUS will also assess the clinical utility of pre-operative urodynamics in women undergoing MUS procedures. The primary outcome will be obtained at 12 months and 24 months. The definition of treatment success is two-fold. Objective treatment success is defined by a negative stress test, a negative 24-hour pad test and no retreatment for SUI. Subjective treatment success is defined by no self-reported leakage on 3-day diary and no self-reported SUI symptoms. Enrollment began April 2006 and is expected to be complete in 2 years. CONCLUSIONS:The TOMUS trial is designed to provide outcome and safety information to pelvic surgeons and their patients on the two most commonly performed MUS techniques.

SUBMITTER: Urinary Incontinence Treatment Network (UITN)

PROVIDER: S-EPMC3999832 | biostudies-literature | 2008

REPOSITORIES: biostudies-literature

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The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology.

The journal of applied research 20080101 1

<h4>Objective</h4>Mid-urethral slings (MUS) are increasingly common surgical procedures for the treatment of stress urinary incontinence (SUI) in women. There are currently no adequately powered trials with sufficient length of follow-up comparing the efficacy or safety of the transobturator and retropubic MUS. As a result, no selection criteria are available to guide surgeons or patients. This article describes the methodology and rationale for the Trial Of Mid-Urethral Slings (TOMUS).<h4>Patie ...[more]

PMID: 24772006

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Project description:BackgroundThe primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach.PurposeTo present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation.MethodsThe challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network.ResultsThe ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization.LimitationsGiven the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability.ConclusionFindings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information.

Dataset Information

The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology.

Publications

The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology.

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