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

Pelvic Organ Prolapse Clinical Trial

— POPPY  

Official title:

A Multi-centre Randomised Controlled Trial of a Pelvic Floor Muscle Training Intervention for Women With Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476892
• Other study ID #: CZH/4/377
• Secondary ID: ISRCTN35911035
• Status: Completed
• Phase: N/A
• First received: May 18, 2007
• Last updated: March 22, 2011
• Start date: June 2007
• Est. completion date: March 2011

Study information

• Verified date: February 2010
• Source: Glasgow Caledonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: March 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.

Locations

Country	Name	City	State
Australia	St George Hospital	Sydney
Ireland	Antrim Area Hospital	Antrim
Ireland	Belfast City Hospital	Belfast
New Zealand	Dunedin School of Medicine	Dunedin
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Grampian
United Kingdom	North Hampshire Hospitals NHS Trust	Basingstoke	Hampshire
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	Royal Infirmary of Edinburgh	Edinburgh	Lothian
United Kingdom	Falkirk and District Royal Infirmary	Falkirk
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Southern General Hospital	Glasgow
United Kingdom	Victoria Infirmary	Glasgow
United Kingdom	Western Infirmary	Glasgow
United Kingdom	Castle Hill Hospital	Hull
United Kingdom	Crosshouse Hospital / Ayrshire Maternity Hospital	Kilmarnock	Ayrshire
United Kingdom	Forth Park Hospital	Kirkcaldy	Fife
United Kingdom	St James's University Hospital	Leeds
United Kingdom	St John's Hospital	Livingston	West Lothian
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

Sponsors (5)

Lead Sponsor	Collaborator
Glasgow Caledonian University	Chief Scientist Office of the Scottish Government, South Glasgow University Hospitals NHS Trust, University of Aberdeen, University of Otago

Countries where clinical trial is conducted

Australia,  Ireland,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No