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

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pelvic Floor Muscle Training
Sponsored by
Glasgow Caledonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, Pelvic floor muscle training, Prolapse symptoms, Urinary symptoms, Sexual function, randomised controlled trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • St George Hospital
  • Antrim Area Hospital
  • Belfast City Hospital
  • Dunedin School of Medicine
  • Crosshouse Hospital / Ayrshire Maternity Hospital
  • Forth Park Hospital
  • Aberdeen Royal Infirmary
  • North Hampshire Hospitals NHS Trust
  • Royal Infirmary of Edinburgh
  • St John's Hospital
  • Birmingham Women's Hospital
  • Bradford Royal Infirmary
  • Addenbrooke's Hospital
  • Chester Hospital
  • St Richard's Hospital
  • Ninewells Hospital
  • Falkirk and District Royal Infirmary
  • Western Infirmary
  • Glasgow Royal Infirmary
  • Victoria Infirmary
  • Southern General Hospital
  • Castle Hill Hospital
  • St James's University Hospital
  • St Mary's Hospital
  • Borders General Hospital
  • James Cook University Hospital
  • Worcestershire Royal Hospital
  • York Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

1

2

Arm Description

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.

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.

Outcomes

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

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.

Full Information

First Posted
May 18, 2007
Last Updated
March 22, 2011
Sponsor
Glasgow Caledonian University
Collaborators
Chief Scientist Office of the Scottish Government, South Glasgow University Hospitals NHS Trust, University of Aberdeen, University of Otago
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1. Study Identification

Unique Protocol Identification Number
NCT00476892
Brief Title
Multi-centre Randomised Controlled Trial of Pelvic Floor Muscle Training for Prolapse
Acronym
POPPY
Official Title
A Multi-centre Randomised Controlled Trial of a Pelvic Floor Muscle Training Intervention for Women With Pelvic Organ Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Pelvic organ prolapse, Pelvic floor muscle training, Prolapse symptoms, Urinary symptoms, Sexual function, randomised controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
448 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
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.
Arm Title
2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pelvic Floor Muscle Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Hagen
Organizational Affiliation
NMAHP Research Unit, Glasgow Caledonian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St George Hospital
City
Sydney
Country
Australia
Facility Name
Antrim Area Hospital
City
Antrim
Country
Ireland
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
Ireland
Facility Name
Dunedin School of Medicine
City
Dunedin
ZIP/Postal Code
P O Box 913
Country
New Zealand
Facility Name
Crosshouse Hospital / Ayrshire Maternity Hospital
City
Kilmarnock
State/Province
Ayrshire
ZIP/Postal Code
KA2 0BE
Country
United Kingdom
Facility Name
Forth Park Hospital
City
Kirkcaldy
State/Province
Fife
ZIP/Postal Code
KY2 5RA
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Grampian
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
North Hampshire Hospitals NHS Trust
City
Basingstoke
State/Province
Hampshire
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Lothian
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
St John's Hospital
City
Livingston
State/Province
West Lothian
ZIP/Postal Code
EH54 6PP
Country
United Kingdom
Facility Name
Birmingham Women's Hospital
City
Birmingham
ZIP/Postal Code
B15 2TG
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 8AF
Country
United Kingdom
Facility Name
Chester Hospital
City
Chester
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
St Richard's Hospital
City
Chichester
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Falkirk and District Royal Infirmary
City
Falkirk
ZIP/Postal Code
FK1 5QE
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Victoria Infirmary
City
Glasgow
ZIP/Postal Code
G42 9TY
Country
United Kingdom
Facility Name
Southern General Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Hull
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
Country
United Kingdom
Facility Name
St Mary's Hospital
City
Manchester
ZIP/Postal Code
M13 OJH
Country
United Kingdom
Facility Name
Borders General Hospital
City
Melrose
ZIP/Postal Code
TD6 9BS
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
Country
United Kingdom
Facility Name
Worcestershire Royal Hospital
City
Worcester
ZIP/Postal Code
WR5 1DD
Country
United Kingdom
Facility Name
York Hospital
City
York
Country
United Kingdom

12. IPD Sharing Statement

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

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