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

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse

• 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.

Study Timeline

• Study First Submitted: 2007-05-18
• Study First Submitted QC: 2007-05-18
• Study First Posted: 2007-05-22
• Study Start: 2007-06
• Status Verified: 2010-02
• Primary Completion: 2010-07
• Study Completion: 2011-03
• Last Update Submitted: 2011-03-22
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 448

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

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

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