Manchester Procedure Versus Vaginal Hysterectomy for Women With Uterine Prolapse: A Multi-Center Randomized Controlled Study (The Fin-UP Trial)

What this Trial Is About

This research aims to compare two surgical treatments for women with symptomatic uterine prolapse, a condition where pelvic organs descend and affect quality of life. The trial evaluates the Manchester procedure, a uterus-preserving surgery, against vaginal hysterectomy, which removes the uterus and has been the standard treatment. The study focuses on success rates at two years post-operation and includes long-term follow-up to better understand patient outcomes. Participants are randomly assigned to either the Manchester procedure or vaginal hysterectomy group. The Manchester procedure involves modifying and suturing the cervix and surrounding ligaments while preserving the uterus, along with repairing other pelvic areas if needed. Vaginal hysterectomy involves removing the uterus through the vagina, suspending pelvic ligaments, and repairing additional pelvic defects as indicated. Both groups may receive further repairs such as anterior and posterior colporrhaphy and perineorrhaphy. Follow-up visits are scheduled at 2 and 5 years, with questionnaires completed at 1, 2, 5, and 10 years after surgery. During the study, participants will undergo clinical examinations, ultrasound assessments, and complete detailed questionnaires addressing pelvic symptoms, quality of life, sexual function, and satisfaction. Researchers will measure treatment success by the absence of prolapse beyond the hymen, lack of bulge symptoms, and no need for retreatment. Other outcomes include adverse events, surgery details like blood loss and operating time, and long-term complications. The study spans up to 10 years of follow-up, providing valuable data on the effectiveness and safety of both surgical options.

The Finnish Uterine Prolapse Surgery Trial (The Fin-UP Trial)