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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00476892
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : March 23, 2011
Chief Scientist Office of the Scottish Government
South Glasgow University Hospitals NHS Trust
University of Aberdeen
University of Otago
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Procedure: Pelvic Floor Muscle Training Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre Randomised Controlled Trial of a Pelvic Floor Muscle Training Intervention for Women With Pelvic Organ Prolapse
Study Start Date : June 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : March 2011

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U.S. FDA Resources

Arm Intervention/treatment
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.
No Intervention: 2
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.

Primary Outcome Measures :
  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 [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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. [ Time Frame: 1 year ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00476892

St George Hospital
Sydney, Australia
Antrim Area Hospital
Antrim, Ireland
Belfast City Hospital
Belfast, Ireland, BT9 7AB
New Zealand
Dunedin School of Medicine
Dunedin, New Zealand, P O Box 913
United Kingdom
Crosshouse Hospital / Ayrshire Maternity Hospital
Kilmarnock, Ayrshire, United Kingdom, KA2 0BE
Forth Park Hospital
Kirkcaldy, Fife, United Kingdom, KY2 5RA
Aberdeen Royal Infirmary
Aberdeen, Grampian, United Kingdom, AB25 2ZN
North Hampshire Hospitals NHS Trust
Basingstoke, Hampshire, United Kingdom, RG24 9NA
Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom, EH16 4SA
St John's Hospital
Livingston, West Lothian, United Kingdom, EH54 6PP
Birmingham Women's Hospital
Birmingham, United Kingdom, B15 2TG
Bradford Royal Infirmary
Bradford, United Kingdom, BD9 6RJ
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 8AF
Chester Hospital
Chester, United Kingdom, CH2 1UL
St Richard's Hospital
Chichester, United Kingdom
Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
Falkirk and District Royal Infirmary
Falkirk, United Kingdom, FK1 5QE
Western Infirmary
Glasgow, United Kingdom, G11 6NT
Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Victoria Infirmary
Glasgow, United Kingdom, G42 9TY
Southern General Hospital
Glasgow, United Kingdom, G51 4TF
Castle Hill Hospital
Hull, United Kingdom
St James's University Hospital
Leeds, United Kingdom
St Mary's Hospital
Manchester, United Kingdom, M13 OJH
Borders General Hospital
Melrose, United Kingdom, TD6 9BS
James Cook University Hospital
Middlesbrough, United Kingdom
Worcestershire Royal Hospital
Worcester, United Kingdom, WR5 1DD
York Hospital
York, United Kingdom
Sponsors and Collaborators
Glasgow Caledonian University
Chief Scientist Office of the Scottish Government
South Glasgow University Hospitals NHS Trust
University of Aberdeen
University of Otago
Principal Investigator: Suzanne Hagen NMAHP Research Unit, Glasgow Caledonian University

Responsible Party: Dr Suzanne Hagen, NMAHP Research Unit, Glasgow Caledonian University Identifier: NCT00476892     History of Changes
Other Study ID Numbers: CZH/4/377
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: February 2010

Keywords provided by Glasgow Caledonian University:
Pelvic organ prolapse
Pelvic floor muscle training
Prolapse symptoms
Urinary symptoms
Sexual function
randomised controlled trial

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Pathological Conditions, Anatomical