Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial.
One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events.



VUE is two parallel, pragmatic, UK multicentre, RCTs (Uterine Trial and Vault Trial). Eligible for inclusion are women with vault or uterine prolapse: requiring a surgical procedure, suitable for randomisation and willing to be randomised. Randomisation will be computer-allocated separately for each trial, minimised on: requiring concomitant anterior and/or posterior POP surgery or not, concomitant incontinence surgery or not, age (under 60 years or 60 years and older) and surgeon. Participants will be randomly assigned, with equal probability to intervention or control arms in either the Uterine Trial or the Vault Trial. Uterine Trial participants will receive either a vaginal hysterectomy or a uterine preservation procedure. Vault Trial participants will receive either a vaginal sacrospinous fixation or an abdominal sacrocolpopexy. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomisation) and also reviewed in clinic 12 months post surgery. The primary outcome is the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation.



Demonstrating the efficacy of vault and uterine prolapse surgeries is relevant not only to patients and clinicians but also to health care providers, both in the UK and globally.



Current controlled trials ISRCTN86784244 (assigned 19 October 2012), and the first subject was randomly assigned on 1 May 2013.
Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.
Cathryn
C
Glazener
Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK. l.constable@abdn.ac.uk.|Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Aberdeen, UK. l.constable@abdn.ac.uk.
Lynda
0000-0001-9646-3904
L
Constable
Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.
Christine
C
Hemming
Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Aberdeen, UK.
Suzanne
S
Breeman
Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
Andrew
A
Elders
Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.
Kevin
K
Cooper
Department of Obstetrics and Gynaecology, Plymouth Hospital NHS Trust, Plymouth, UK.
Robert
R
Freeman
Warrell Unit, St Mary's Hospital, Manchester, UK.
Anthony R B
AR
Smith
Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
Suzanne
S
Hagen
Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Aberdeen, UK.
Alison
A
McDonald
Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Aberdeen, UK.
Gladys
G
McPherson
Independent consumer representative, Aberdeen, UK.
Isobel
I
Montgomery
Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.
Mary
M
Kilonzo
Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.
Dwayne
D
Boyers
Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.
Beatriz
B
Goulao
Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Aberdeen, UK.
John
J
Norrie
D002985:Clinical Protocols; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D007045:Hysterectomy, Vaginal / Q000009:adverse effects; D010535:Laparoscopy / Q000009:adverse effects / Q000295:instrumentation; D008875:Middle Aged; D056887:Pelvic Organ Prolapse / Q000175:diagnosis / Q000601:surgery*; D011183:Postoperative Complications / Q000209:etiology; D011788:Quality of Life; D012107:Research Design; D013526:Surgical Mesh; D011795:Surveys and Questionnaires; D013536:Suture Techniques / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D014596:Uterine Prolapse / Q000175:diagnosis / Q000601:surgery*
Hysterectomy; Prolapse; Randomised controlled trial; Suspension; Symptoms; Uterine; Vault