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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN35911035 |
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| Name | Class |
|---|---|
| Chief Scientist Office of the Scottish Government | OTHER_GOV |
| South Glasgow University Hospitals NHS Trust | OTHER |
| University of Aberdeen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | 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. |
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| 2 | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic Floor Muscle Training | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Hagen | NMAHP Research Unit, Glasgow Caledonian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St George Hospital | Sydney | Australia | ||||
| Antrim Area Hospital |
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| University of Otago |
| OTHER |
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|
| Antrim |
| Ireland |
| Belfast City Hospital | Belfast | BT9 7AB | Ireland |
| Dunedin School of Medicine | Dunedin | P O Box 913 | New Zealand |
| Crosshouse Hospital / Ayrshire Maternity Hospital | Kilmarnock | Ayrshire | KA2 0BE | United Kingdom |
| Forth Park Hospital | Kirkcaldy | Fife | KY2 5RA | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | Grampian | AB25 2ZN | United Kingdom |
| North Hampshire Hospitals NHS Trust | Basingstoke | Hampshire | RG24 9NA | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | Lothian | EH16 4SA | United Kingdom |
| St John's Hospital | Livingston | West Lothian | EH54 6PP | United Kingdom |
| Birmingham Women's Hospital | Birmingham | B15 2TG | United Kingdom |
| Bradford Royal Infirmary | Bradford | BD9 6RJ | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 8AF | United Kingdom |
| Chester Hospital | Chester | CH2 1UL | United Kingdom |
| St Richard's Hospital | Chichester | United Kingdom |
| Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| Falkirk and District Royal Infirmary | Falkirk | FK1 5QE | United Kingdom |
| Western Infirmary | Glasgow | G11 6NT | United Kingdom |
| Glasgow Royal Infirmary | Glasgow | G4 0SF | United Kingdom |
| Victoria Infirmary | Glasgow | G42 9TY | United Kingdom |
| Southern General Hospital | Glasgow | G51 4TF | United Kingdom |
| Castle Hill Hospital | Hull | United Kingdom |
| St James's University Hospital | Leeds | United Kingdom |
| St Mary's Hospital | Manchester | M13 OJH | United Kingdom |
| Borders General Hospital | Melrose | TD6 9BS | United Kingdom |
| James Cook University Hospital | Middlesbrough | United Kingdom |
| Worcestershire Royal Hospital | Worcester | WR5 1DD | United Kingdom |
| York Hospital | York | United Kingdom |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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