Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial--design and methods.

ABSTRACT:

Background

The 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.

Purpose

To 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.

Methods

The 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 th

SUBMITTER: Wei J 

PROVIDER: S-EPMC2878478 | biostudies-literature | 2009 Apr

REPOSITORIES: biostudies-literature