Multi-centre Randomised Controlled Trial of Pelvic Floor Muscle Training for Prolapse
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Procedure: Pelvic Floor Muscle Training
- Registration Number
- NCT00476892
- Lead Sponsor
- Glasgow Caledonian University
- Brief Summary
The aim of this study is to determine the effectiveness and cost-effectiveness of pelvic floor muscle training in the management of pelvic organ prolapse in women.
- Detailed Description
Pelvic organ prolapse is a common problem that adversely affects the daily activities and quality of life of many women. Pelvic floor muscle training interventions are commonly used by physiotherapists to manage prolapse. However, a Cochrane review found limited evidence to support the effectiveness of such interventions. Based on the findings of a successful feasibility study, this multi-centre randomised controlled trial will address the paucity of evidence. 556 symptomatic women with diagnosed prolapse will be enrolled in 16 UK centres and 1 New Zealand centre over 16 months and randomised to pelvic floor muscle training plus lifestyle advice, or to receive a lifestyle leaflet only. Principal measures of outcome are: prolapse symptoms, prolapse severity, and subsequent further treatment up to 12 months after trial entry.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 448
- New attendee at outpatient gynaecology clinic
- Any type of prolapse
- Stage 0 or IV prolapse
- Women reporting no symptoms of prolapse
- Previous treatment for prolapse (surgery or formal instruction in Pelvic Floor Muscle Training [PMFT,]unless completed more than 5 years ago, pessary, unless pessary removed more than 12 months ago)
- Unable to comply with PFMT
- women who have urogenital atrophy requiring treatment with local oestrogens (after an 8 week course of local oestrogen such women can be included);
- Pregnant or less than 6 months post-natal
- Unable to give informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Pelvic Floor Muscle Training It consists of five outpatient appointments (weeks 0, 2, 6, 11 and 16) with a local trial physiotherapist at a trial centre. At the first appointment a standardised history is taken from the woman, anatomy and function of the pelvic floor muscles are taught, and types of prolapse described, using diagrams and a model pelvis. Women are taught how to contract the muscles, and also how to contract and hold prior to an event that increases intra-abdominal pressure ("the Knack"). Pelvic floor muscles are assessed by vaginal examination and recorded on a dedicated form at each appointment thus determining the content of a single set of exercises for each woman. At least three sets of exercises daily is recommended. Women use an exercise diary to record compliance. Tailored advice is given on ways of reducing intra-abdominal pressure, e.g. advice on weight loss, chronic cough, heavy lifting and general exercise.
- Primary Outcome Measures
Name Time Method Prolapse symptom score (questions developed in feasibility study and undergoing validation). Primary economic outcome measures are: use of health services, average number of days of prolapse symptoms and further prolapse treatment needed/received 1 year
- Secondary Outcome Measures
Name Time Method Prolapse-related quality of life, prolapse severity, need for further prolapse treatment. Other outcomes include: lifestyle changes, urinary symptoms, bowel symptoms, sexual symptoms, general health status. 1 year
Trial Locations
- Locations (28)
Western Infirmary
🇬🇧Glasgow, United Kingdom
Antrim Area Hospital
🇮🇪Antrim, Ireland
St John's Hospital
🇬🇧Livingston, West Lothian, United Kingdom
Forth Park Hospital
🇬🇧Kirkcaldy, Fife, United Kingdom
St George Hospital
🇦🇺Sydney, Australia
Belfast City Hospital
🇮🇪Belfast, Ireland
Dunedin School of Medicine
🇳🇿Dunedin, New Zealand
Crosshouse Hospital / Ayrshire Maternity Hospital
🇬🇧Kilmarnock, Ayrshire, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Grampian, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, Lothian, United Kingdom
North Hampshire Hospitals NHS Trust
🇬🇧Basingstoke, Hampshire, United Kingdom
Birmingham Women's Hospital
🇬🇧Birmingham, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
St Richard's Hospital
🇬🇧Chichester, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Chester Hospital
🇬🇧Chester, United Kingdom
Ninewells Hospital
🇬🇧Dundee, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, United Kingdom
Falkirk and District Royal Infirmary
🇬🇧Falkirk, United Kingdom
Victoria Infirmary
🇬🇧Glasgow, United Kingdom
Southern General Hospital
🇬🇧Glasgow, United Kingdom
St Mary's Hospital
🇬🇧Manchester, United Kingdom
Borders General Hospital
🇬🇧Melrose, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
St James's University Hospital
🇬🇧Leeds, United Kingdom
Worcestershire Royal Hospital
🇬🇧Worcester, United Kingdom
York Hospital
🇬🇧York, United Kingdom
Castle Hill Hospital
🇬🇧Hull, United Kingdom