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E-OPTIMAL: Extended Follow-up of Patients Enrolled in OPTIMAL


The 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 extends the follow-up of women in the OPTIMAL study up to 5 years from the time of surgery to compare the success and complication rates of the two surgical treatment groups over this extended time period.  It also examines a strategy for improving enrollment and retention in long-term studies of women undergoing surgery for pelvic organ prolapse and stress urinary incontinence (SUI). Participation is offered to all women who have completed the OPTIMAL 24-month Quality of Life (QOL) interview which includes a questionnaire on motivation and barriers for research participation.

The strategy to enhance long-term participation was developed based upon a conceptual framework.  Within this framework, eligible participants consider three broad factors (motivation, barriers and pragmatic issues) at two levels (study level and personal/individual level) when deciding about participating in clinical trials after receiving information on the importance of long-term follow-up in studies of pelvic floor disorders.

The primary outcome of the surgical intervention is the time to surgical failure. The primary outcomes for the PMT intervention is the development of prolapse symptoms and anatomic outcomes assessed up to 5 years after surgery. The primary outcome of the enrollment intervention is the proportion of participants who consent to enroll in E-OPTIMAL, and complete all data collection events in year 3 of E-OPTIMAL (i.e., year 5 from enrollment in OPTIMAL).