Multi-centre Randomised Controlled Trial of Pelvic Floor Muscle Training for Prolapse

NCT00476892 | Completed DMC

• 2 other identifiers: CZH/4/377ISRCTN35911035
• Study Type: interventional
• Target: 448
• Locations: 4 countries
• Sites: 28

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.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse; Pelvic floor muscle training; Prolapse symptoms; Urinary symptoms; Sexual function; randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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.

Procedure: Pelvic Floor Muscle Training

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.

Interventions

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.

1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• New attendee at outpatient gynaecology clinic
• Any type of prolapse

You may not qualify if:

• 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

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• Chief Scientist Office of the Scottish Government: collaborator
• South Glasgow University Hospitals NHS Trust: collaborator
• University of Aberdeen: collaborator
• University of Otago: collaborator

Study Sites (28)

St George Hospital

Sydney, Australia

Location

Antrim Area Hospital

Antrim, Ireland

Location

Belfast City Hospital

Belfast, BT9 7AB, Ireland

Location

Dunedin School of Medicine

Dunedin, P O Box 913, New Zealand

Location

Crosshouse Hospital / Ayrshire Maternity Hospital

Kilmarnock, Ayrshire, KA2 0BE, United Kingdom

Location

Forth Park Hospital

Kirkcaldy, Fife, KY2 5RA, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Grampian, AB25 2ZN, United Kingdom

Location

North Hampshire Hospitals NHS Trust

Basingstoke, Hampshire, RG24 9NA, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

St John's Hospital

Livingston, West Lothian, EH54 6PP, United Kingdom

Location

Birmingham Women's Hospital

Birmingham, B15 2TG, United Kingdom

Location

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB2 8AF, United Kingdom

Location

Chester Hospital

Chester, CH2 1UL, United Kingdom

Location

St Richard's Hospital

Chichester, United Kingdom

Location

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Location

Falkirk and District Royal Infirmary

Falkirk, FK1 5QE, United Kingdom

Location

Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

Victoria Infirmary

Glasgow, G42 9TY, United Kingdom

Location

Southern General Hospital

Glasgow, G51 4TF, United Kingdom

Location

Castle Hill Hospital

Hull, United Kingdom

Location

St James's University Hospital

Leeds, United Kingdom

Location

St Mary's Hospital

Manchester, M13 OJH, United Kingdom

Location

Borders General Hospital

Melrose, TD6 9BS, United Kingdom

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

Worcestershire Royal Hospital

Worcester, WR5 1DD, United Kingdom

Location

York Hospital

York, United Kingdom

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne Hagen

  NMAHP Research Unit, Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 22, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 23, 2011

Record last verified: 2010-02

Locations

GB (24); NZ (1); IE (2); AU (1)