Hypothesis / aims of study
New surgical approaches for apical prolapse have gradually been introduced over time with few prospective randomised controlled data to evaluate their safety and efficacy to traditional methods. This trial aims to compare uterine preservation with vaginal hysterectomy for uterine prolapse and abdominal procedures with vaginal procedures for vault prolapse in terms of clinical effectiveness, adverse effects, quality of life (QoL), costs and cost-effectiveness.
Study design, materials and methods
Two UK based multicentre randomised controlled trials (Uterine and Vault) . Women were eligible for inclusion if a surgical procedure was required for a vault or uterine prolapse, suitable for randomisation and willing to be randomised. Allocation was by a remote web-based randomisation system in a 1 :1 ratio, minimised on need for a concomitant anterior and/or posterior procedure, need for a concomitant incontinence procedure, age and surgeon separately for each trial. Uterine Trial; 563 participants received either a vaginal hysterectomy (control) or a uterine preservation procedure. Vault Trial; 208 participants received either a vaginal sacrospinous fixation (control) or an abdominal sacrocolpopexy. Participants were followed up by postal questionnaires (6 months after surgery and 12 months after randomisation) and reviewed in clinic 12 months after surgery. The primary outcome was the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation with secondary outcomes including POP-Q scores, treatment satisfaction, further treatment and healthcare costs.
Interpretation of results
Only short term outcomes for both trials are available.