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

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Pelvic Floor Muscle Training

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
• Enrollment (Actual): 448
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Glasgow Caledonian University
• Collaborators: University of Otago; South Glasgow University Hospitals NHS Trust; University of Aberdeen; Chief Scientist Office of the Scottish Government
• Investigators: Principal Investigator: Suzanne Hagen, NMAHP Research Unit, Glasgow Caledonian University

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: May 18, 2007
• First Submitted That Met QC Criteria: May 18, 2007
• First Posted (Estimate): May 22, 2007

Study Record Updates

• Last Update Posted (Estimate): March 23, 2011
• Last Update Submitted That Met QC Criteria: March 22, 2011
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Pelvic floor muscle training; randomised controlled trial; Sexual function; Pelvic organ prolapse; Urinary symptoms; Prolapse symptoms
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: CZH/4/377; ISRCTN35911035