Multi-Centre Randomised Controlled Trial of Pelvic Floor Muscle Training for Prolapse - Full Text View

Sponsors and Collaborators:	Glasgow Caledonian University Chief Scientist Office South Glasgow University Hospitals NHS Trust University of Aberdeen University of Otago
Information provided by:	Glasgow Caledonian University
ClinicalTrials.gov Identifier:	NCT00476892

Purpose

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.

Condition	Intervention
Pelvic Organ Prolapse	Procedure: Pelvic Floor Muscle Training

MedlinePlus related topics: Pelvic Support Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Multi-Centre Randomised Controlled Trial of a Pelvic Floor Muscle Training Intervention for Women With Pelvic Organ Prolapse

Further study details as provided by Glasgow Caledonian University:

Primary Outcome Measures:

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	520
Study Start Date:	June 2007
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Procedure: 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: 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.

Arms

Assigned Interventions

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.

Procedure: 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: 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.

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

New attendee at outpatient gynaecology clinic
Any type of prolapse

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476892

Contacts

Contact: Suzanne Hagen

0141 331 8104

S.Hagen@gcal.ac.uk

Locations

Australia
St George Hospital	Recruiting
Sydney, Australia
Ireland
Belfast City Hospital	Not yet recruiting
Belfast, Ireland, BT9 7AB
New Zealand
Dunedin School of Medicine	Recruiting
Dunedin, New Zealand, P O Box 913
United Kingdom
Borders General Hospital	Recruiting
Melrose, United Kingdom, TD6 9BS
Royal Blackburn Hospital / Burnley General Hospital	Withdrawn
Blackburn, United Kingdom, BB2 3HH
Falkirk and District Royal Infirmary	Recruiting
Falkirk, United Kingdom, FK1 5QE
Ninewells Hospital	Recruiting
Dundee, United Kingdom, DD1 9SY
Southern General Hospital	Recruiting
Glasgow, United Kingdom, G51 4TF
St Mary's Hospital	Recruiting
Manchester, United Kingdom, M13 OJH
Victoria Infirmary	Recruiting
Glasgow, United Kingdom, G42 9TY
Western Infirmary	Not yet recruiting
Glasgow, United Kingdom, G11 6NT
Glasgow Royal Infirmary	Recruiting
Glasgow, United Kingdom, G4 0SF
Birmingham Women's Hospital	Not yet recruiting
Birmingham, United Kingdom, B15 2TG
Bradford Royal Infirmary	Not yet recruiting
Bradford, United Kingdom, BD9 6RJ
St James's University Hospital	Not yet recruiting
Leeds, United Kingdom
Worcestershire Royal Hospital	Not yet recruiting
Worcester, United Kingdom, WR5 1DD
Addenbrooke's Hospital	Not yet recruiting
Cambridge, United Kingdom, CB2 8AF
Chester Hospital	Not yet recruiting
Chester, United Kingdom, CH2 1UL
United Kingdom, Ayrshire
Crosshouse Hospital / Ayrshire Maternity Hospital	Recruiting
Kilmarnock, Ayrshire, United Kingdom, KA2 0BE
United Kingdom, Fife
Forth Park Hospital	Recruiting
Kirkcaldy, Fife, United Kingdom, KY2 5RA
United Kingdom, Grampian
Aberdeen Royal Infirmary	Recruiting
Aberdeen, Grampian, United Kingdom, AB25 2ZN
United Kingdom, Hampshire
North Hampshire Hospitals NHS Trust	Not yet recruiting
Basingstoke, Hampshire, United Kingdom, RG24 9NA
United Kingdom, Lothian
Royal Infirmary of Edinburgh	Recruiting
Edinburgh, Lothian, United Kingdom, EH16 4SA
United Kingdom, West Lothian
St John's Hospital	Recruiting
Livingston, West Lothian, United Kingdom, EH54 6PP

Sponsors and Collaborators

Glasgow Caledonian University

Chief Scientist Office

South Glasgow University Hospitals NHS Trust

University of Aberdeen

University of Otago

Investigators

Principal Investigator:

Suzanne Hagen

NMAHP Research Unit, Glasgow Caledonian University

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	NMAHP Research Unit, Glasgow Caledonian University ( Dr Suzanne Hagen )
Study ID Numbers:	CZH/4/377, ISRCTN35911035
Study First Received:	May 18, 2007
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00476892
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Glasgow Caledonian University:

Pelvic organ prolapse
Pelvic floor muscle training
Prolapse symptoms

Urinary symptoms
Sexual function
randomised controlled trial

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

Rectal Diseases
Prolapse
Rectal Prolapse

ClinicalTrials.gov processed this record on January 16, 2009