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OPTIMAL: Operations and Pelvic Muscle Training in the Management of Apical Support Loss


The Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial is a dual randomized trial for women who have stage 2 – 4 prolapse involving the vaginal apex or uterus and stress urinary incontinence (SUI).  It compares the effects of sacrospinous ligament fixation (SSLF) versus uterosacral ligament suspension (ULS) with and without perioperative behavioral therapy and pelvic muscle training (PMT).  The goal of this study is to compare the anatomic, functional, sexual, and health-related quality of life (QOL) outcomes of vaginal suspension procedures ((SSLF versus ULS) and to assess the role of perioperative PMT when used 2-4 weeks before and continuing to three months after undergoing these procedures versus standard of care.  All participants received TVT (Tension-free Vaginal Tape) treatment for SUI and were independently randomized to the two interventions.  After the three months, participants were encouraged to continue PMT until the end of study participation. The study is in the follow-up phase.

The primary outcome of the surgical intervention is success or failure of prolapse surgery based on symptoms and the Pelvic Organ Prolapse Quantification system (POPQ). The primary outcomes for the PMT intervention are urinary status at 6 months and prolapse symptom status at 2 years.