Multi-centre Randomised Controlled Trial of Pelvic Floor Muscle Training for Prolapse
NCT ID: NCT00476892
Last Updated: 2011-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
448 participants
INTERVENTIONAL
2007-06-30
2011-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Does Doing Pelvic Floor Exercise Ease Symptoms for Women Living With Prolapse?
NCT00158626
A Study of the Effects of Physiotherapy to Prevent Pelvic Organ Prolapse
NCT01171846
PEssary Plus Physiotherapy for Pelvic Organ Prolapse (PEPPY)
NCT01136889
Can Pelvic Floor Muscle Training Reduce my Prolapse
NCT01612637
Pelvic Floor Muscle Training and Hypopressive Exercises for Pelvic Organ Prolapse
NCT01196598
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
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.
Pelvic Floor Muscle Training
Women in the intervention group attend 5 physiotherapy sessions. At each appointment a clinical history is taken, pelvic floor muscle assessment carried out, exercises taught and prescribed, and appropriate lifestyle advice given. At the first of these appointments a detailed explanation of the pelvic anatomy and different types of prolapse is given.
2
Women allocated to the control group will be sent a lifestyle advice leaflet only, and will have no planned contact with the centre until their consultant review appointment at six months. The leaflet gives instructions on seeking advice where appropriate about weight loss, constipation, and avoidance of heavy lifting, coughing and high impact exercise, with a view to minimising increases in intra-abdominal pressure which may cause prolapse to worsen.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pelvic Floor Muscle Training
Women in the intervention group attend 5 physiotherapy sessions. At each appointment a clinical history is taken, pelvic floor muscle assessment carried out, exercises taught and prescribed, and appropriate lifestyle advice given. At the first of these appointments a detailed explanation of the pelvic anatomy and different types of prolapse is given.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Any type of prolapse
Exclusion Criteria
* 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
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chief Scientist Office of the Scottish Government
OTHER_GOV
South Glasgow University Hospitals NHS Trust
OTHER
University of Aberdeen
OTHER
University of Otago
OTHER
Glasgow Caledonian University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
NMAHP Research Unit, Glasgow Caledonian University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Suzanne Hagen
Role: PRINCIPAL_INVESTIGATOR
NMAHP Research Unit, Glasgow Caledonian University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St George Hospital
Sydney, , Australia
Antrim Area Hospital
Antrim, , Ireland
Belfast City Hospital
Belfast, , Ireland
Dunedin School of Medicine
Dunedin, , New Zealand
Crosshouse Hospital / Ayrshire Maternity Hospital
Kilmarnock, Ayrshire, United Kingdom
Forth Park Hospital
Kirkcaldy, Fife, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Grampian, United Kingdom
North Hampshire Hospitals NHS Trust
Basingstoke, Hampshire, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom
St John's Hospital
Livingston, West Lothian, United Kingdom
Birmingham Women's Hospital
Birmingham, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Chester Hospital
Chester, , United Kingdom
St Richard's Hospital
Chichester, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Falkirk and District Royal Infirmary
Falkirk, , United Kingdom
Western Infirmary
Glasgow, , United Kingdom
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Victoria Infirmary
Glasgow, , United Kingdom
Southern General Hospital
Glasgow, , United Kingdom
Castle Hill Hospital
Hull, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
St Mary's Hospital
Manchester, , United Kingdom
Borders General Hospital
Melrose, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Worcestershire Royal Hospital
Worcester, , United Kingdom
York Hospital
York, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISRCTN35911035
Identifier Type: -
Identifier Source: secondary_id
CZH/4/377
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.