Plain English Summary
Background and study aims:
One in ten women will need an operation for prolapse. Prolapse occurs when the pelvic organs (such as the bladder, the bowel or the womb) come down into, or out of, the vagina. This is caused either by weakness of the tissues which usually support these organs or by weak pelvic floor muscles. It is most common in women who have had children, although there has been little research into its causes and treatment. Within the next 10 years, an extra 1 million women will reach the age when they are most likely to need prolapse surgery. This study will show which prolapse operations are the safest and most effective for all women. There are many different operations for prolapse: the VUE study only concerns women with a uterine (womb) prolapse or a vault prolapse (top of the vagina, in a woman who has had her womb removed previously). All the types of prolapse surgery in the VUE study are in common use in the NHS. The aim of this study is to answer one main question for each type of prolapse: that is, which of the operations gives the best results and is safest. Therefore, once we have the results of VUE, doctors in the future should be able to choose the prolapse surgery that has the best results with the fewest problems. This will mean fewer repeat operations, better health and quality of life for women, and better use of NHS facilities.
Who can participate?
Women who are going to have prolapse surgery for vault or uterine prolapse.
What does the study involve?
Women having surgery for uterine or vault prolapse will go into one of two trials:
1. Uterine trial: vaginal hysterectomy compared with an operation to suspend the uterus without removing it, and
2. Vault trial: suspending the vault from below (the vaginal route) compared with suspending it via the abdomen (tummy).
Women will not have to undergo any tests or procedures that are not part of routine care for prolapse. Women will have a routine physical examination before surgery and complete a questionnaire before their operation. The women will be examined and reviewed as outpatients at 12 months after surgery.
What are the possible benefits and risks of participating?
There may be no direct benefit to women who take part, but they will be helping with this research enabling doctors to assess which operation is best and safest.
Where is the study run from?
University of Aberdeen in collaboration with NHS Grampian
When is the study starting and how long is it expected to run for?
Recruitment will start in February 2013 and participants will be enrolled for 12 months. The study may extend beyond this as we intend to look at participants health with long term follow up.
Who is funding the study?
NHS National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Health Technology Assessment programme (NETSCC HTA).
Who is the main contact?
Prof. Cathryn Glazener
c.glazener@abdn.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Cathryn Glazener
ORCID ID
Contact details
Professor of Health Services Research
University of Aberdeen
Health Services Research Unit
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 438168
c.glazener@abdn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3/057/12
Study information
Scientific title
Two parallel randomised controlled trials of surgical options for upper compartment (vault or uterine) pelvic organ prolapse
Acronym
VUE
Study hypothesis
The study is investigating which prolapse operations are the safest and most effective and cost-effective for women with vault or uterine pelvic organ prolapse
Ethics approval
1. North of Scotland Research Ethics Service, 13/09/2012, ref: 12/NS/0093
2. Amendments submitted 10/10/2012
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Vaginal wall prolapse
Intervention
Vault Trial
The two broad approaches to vault suspension are vaginal or abdominal.
Participants will be randomised to either
1. Vaginal vault suspension (Vaginal sacrospinous fixation (with sutures or mesh or a mesh kit)) OR
2. Abdominal vault suspension (Abdominal sacrocolpopexy (open abdominal or laparoscopic, with a mesh bridge))
Uterine Trial
The two options for uterine prolapse concern removal or retention of the uterus.
Participants will be randomised to either
1. Vaginal hysterectomy (Vaginal hysterectomy, with a vault suspension technique using sutures or mesh if necessary) OR
2. Uterine preservation (vaginal sacrospinous fixation of uterus with sutures or mesh, OR open abdominal or laparoscopic sacrohysteropexy with a mesh bridge)
At 12 months after surgery, all women will be examined for:
1. Clinical findings (prolapse stage using POP-Q)
2. Complications, e.g. mesh exposure.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
1. The primary clinical outcome is womens prolapse symptoms measured using the Pelvic Organ Prolapse Symptom Scale (POP-SS), at one year after surgery.
2. The primary quality of life outcome is the overall effect of prolapse symptoms on everyday life.
3. The primary economic outcome measure of cost effectiveness is incremental cost per QALY (QALYs based on the EQ-5D data).
All primary and secondary outcomes are measured at 6 and 12 months after surgery, measured in participant-completed questionnaires.
Secondary outcome measures
1. General
1.1. Immediate and late post-operative morbidity
1.2. Other adverse effects or complications
1.3. Operating time
1.4. Blood loss
1.5. Number of nights in hospital
1.6. Number of readmissions to hospital
1.7. Need for further surgery for prolapse or for urinary incontinence
1.8. Time to further surgery
1.9. Recommendation to a friend
1.10. Satisfaction with surgery
2. Prolapse outcomes
2.1. Subjective recurrence of prolapse
2.2. Subjective continuation / recurrence of prolapse symptoms
2.3. Subjective residual prolapse stage (POP-Q) at original site
2.4. Development of new (de novo) prolapse at another site
2.5. Need for other conservative prolapse treatment (e.g. PFMT, mechanical device)
3. Urinary outcomes
3.1. Urinary incontinence (persistent or de novo, and types of incontinence) using the ICI- Questionnaires
3.2. Voiding dysfunction
3.3. Need for alternative management for incontinence or voiding dysfunction (e.g. PFMT, mechanical devices, surgery, drugs, intermittent catheterisation)
4. Bowel outcomes
4.1. Constipation (persistent or de novo)
4.2. Faecal incontinence (persistent or de novo)
5. Sexual function outcomes
5.1. Dyspareunia / apareunia / difficulty with intercourse
5.2. Vaginal symptoms using the ICI-Vaginal Symptoms questionnaire
6. Quality of life outcome measures
6.1. Condition-specific quality of life measures
6.2. General health measures (EQ-5D)
7. Economic outcome measures
7.1. Cost and use of NHS services
7.2. Cost to the women and their families/carers;
7.3. QALYs estimated from the responses to the EQ-5D
7.4. The incremental costs, QALYs and incremental cost per QALY derived by the economic model over a longer term time horizon
All primary and secondary outcomes are measured at 6 and 12 months after surgery, measured in participant-completed questionnaires.
Overall trial start date
01/02/2013
Overall trial end date
31/10/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women with vault or uterine prolapse requiring a surgical procedure
2. Women who are suitable for randomisation (gynaecologists view, i.e. not meeting exclusion criteria)
3. Women who are willing to be randomised (womans view)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
800
Participant exclusion criteria
1. Potential future pregnancies
2. Co-morbidity necessitating particular approach, eg fibroids, previous abdominal surgery (scarring / adhesions)
3. Co-morbidity precluding randomisation (eg poor anaesthetic risk)
4. Obesity precluding abdominal approach (except if two vaginal approaches are feasible)
5. Colpocleisis (vaginal closure operation)
6. Women who are unwilling, unable or unsuitable to be randomized
Recruitment start date
01/02/2013
Recruitment end date
31/10/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Aberdeen
Aberdeen
AB25 2ZD
United Kingdom
Sponsor information
Organisation
University of Aberdeen (UK)
Sponsor details
Research and Innovation
University Office
Kings College
Aberdeen
AB24 3FX
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) - NIHR Health Technology Assessment Programme - HTA (UK) ref: 11/129/183
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27609058