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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00476892
First received: May 18, 2007
Last updated: March 22, 2011
Last verified: February 2010
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


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 ]

Enrollment: 448
Study Start Date: June 2007
Study Completion Date: March 2011
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.
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia
St George Hospital
Sydney, Australia
Ireland
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
Victoria Infirmary
Glasgow, United Kingdom, G42 9TY
Western Infirmary
Glasgow, United Kingdom, G11 6NT
Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
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
Investigators
Principal Investigator: Suzanne Hagen NMAHP Research Unit, Glasgow Caledonian University
  More Information

No publications provided

Responsible Party: Dr Suzanne Hagen, NMAHP Research Unit, Glasgow Caledonian University
ClinicalTrials.gov Identifier: NCT00476892     History of Changes
Other Study ID Numbers: CZH/4/377, ISRCTN35911035
Study First Received: May 18, 2007
Last Updated: March 22, 2011
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

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

ClinicalTrials.gov processed this record on September 22, 2014