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

Introduction Pelvic organ prolapse (POP) is a common condition affecting quality of life. Uterine prolapse, a type of apical prolapse, lacks a universally accepted surgical treatment, though vaginal hysterectomy with apical suspension (VH) has been the standard for years. Uterus-preserving procedures, such as the Manchester procedure (MP), are gaining popularity due to their less invasive nature and women's preference to retain the uterus. Limited evidence suggests MP may have a shorter recovery time and lower short-term recurrence rates compared to VH, but long-term benefits remain unclear. As most current data comes from observational studies, a randomized controlled trial is needed to reliably compare the effectiveness and patient outcomes of MP and VH.

Methods and analysis The Finnish Uterine Prolapse Surgery Trial (Fin-UP) is a randomized, controlled, parallel-group (1:1 ratio) superiority trial with two arms: (1) the MP and (2) VH. Patients with symptomatic POP stage 2 or higher, with uterine descent of at least stage 2, and with POP-Q point D ≤ minus 1 are eligible. The primary outcome is the composite outcome of success defined as the absence of POP beyond the hymen; the absence of bulge symptoms; and the absence of retreatment for POP. Secondary outcomes include anatomical outcomes, pelvic floor symptoms, quality of life, sexual function, satisfaction, perioperative parameters, and adverse events. Follow-up will take place at 1, 2, 5, and 10 years. 426 participants will be recruited, providing 80% power (α=0.05) to detect an 11% difference between groups in the primary outcome, allowing for a 10% loss to follow-up.

Ethics and dissemination Ethical approval for the trial has been obtained from the Ethics Committee of the Wellbeing Services County of Pirkanmaa (ETL-code R25060). The findings will be published in peer-reviewed journals and result in PhD theses. The data will provide important long-term clinical information that will help to unify the very commonly performed prolapse surgery in Finland.