VUE: Two UK based Multicentre Parallel Randomised Controlled Surgical Trials for Uterine and Vault Prolapse

Hemming C1, Constable L2, Boyers D2, Breeman S2, Goulao B2, Cooper K3, Freeman R4, Smith A5, Elders A2, Hagen S6, Glazener C2

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 405
Open Discussion ePosters
Scientific Open Discussion Session 21
Thursday 30th August 2018
13:15 - 13:20 (ePoster Station 10)
Exhibition Hall
Surgery Pelvic Organ Prolapse Prolapse Symptoms Clinical Trial
1. NHS Grampin, 2. University of Aberdeen, 3. NHS GRampian, 4. NHS, 5. NHS Manchester, 6. Universiy of Glasgow
Presenter
Links

Poster

Abstract

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.
Results
Uterine Trial: adjusting for baseline and minimisation covariates, mean POP-SS at 12 months after randomisation for uterine preservation vs. vaginal hysterectomy will be presented in addition to serious adverse event rates and healthcare cost analysis between uterine preservation and vaginal hysterectomy.  
Vault Trial: adjusting for baseline and minimisation covariates, mean POP-SS at 12 months after randomisation for an abdominal procedure vs. vaginal procedure will be presented in addition to serious adverse event rates and healthcare cost analysis between the groups.
Interpretation of results
Only short term outcomes for both trials are available.
Concluding message
Although some differences have been identified in the short term, continuing long term follow up is required to identify if further differences become evident over the long term for women in both RCTs for uterine and vault prolapse.
Disclosures
Funding UK Health Technology Assssment Clinical Trial Yes Registration Number VUE RCT Yes Subjects Human Ethics Committee Grampian Helsinki Yes Informed Consent Yes
20/11/2024 14:43:19