Long-term effectiveness of Sacrospinous Ligament Fixation (SSLF) versus Uterosacral ligament Suspension (ULS) with and without perioperative Behavioral Therapy/ Pelvic muscle Training: The Extended operations and pelvic muscle training in the management of apical support loss ( E-OPTIMAL) study
Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit (year 2 in person visit) of the OPTIMAL study. The Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) study is a randomized trial designed to compare Sacrospinous Ligament Fixation (SSLF) to Uterosacral vaginal vault 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 OPTIMAL study includes a two-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures.
E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new study treatment interventions will be given. Rather an enrollment intervention will be investigated with potential E-OPTIMAL participants randomly assigned to watch a standardized video prior to consent or undergo the standard informed consent process. The standardized video will review the rationale for women[Single Quote]s health research, the importance of long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has undergone review by potential subjects, coordinators and physician researchers to ensure that the relevance and importance of issues potentially impacting on long-term participation in studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three additional years. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.
* Completion of the Year 2 OPTIMAL in-person visit