Form 01E – Eligibility/Randomization - SAS in Extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss

Form 01E – Eligibility/Randomization - SAS
Study Description
This study extends the follow-up of women in the OPTIMAL study, a randomized trial to compare sacrospinous ligament fixation (SSLF) to uterosacral ligament suspension (ULS), and to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence (SUI). The primary aims are to compare SSLF and ULS for the following outcomes up to 5 years after surgery in women with Stage 2-4 prolapse involving the vaginal apex or uterus and SUI: time to surgical failure; the long-term functional and health-related quality of life, adjusted for PMT treatment group; the annual and cumulative incidence, resolution, and persistence of pelvic floor symptoms, adjusted for PMT treatment group; and determine whether exposure to a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process will improve enrollment and/or retention. Women undergoing surgery for pelvic organ prolapse and stress urinary incontinence