Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00476892




Registration number
NCT00476892
Ethics application status
Date submitted
18/05/2007
Date registered
22/05/2007
Date last updated
23/03/2011

Titles & IDs
Public title
Multi-centre Randomised Controlled Trial of Pelvic Floor Muscle Training for Prolapse
Scientific title
A Multi-centre Randomised Controlled Trial of a Pelvic Floor Muscle Training Intervention for Women With Pelvic Organ Prolapse
Secondary ID [1] 0 0
ISRCTN35911035
Secondary ID [2] 0 0
CZH/4/377
Universal Trial Number (UTN)
Trial acronym
POPPY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic Organ Prolapse 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Pelvic Floor Muscle Training

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.

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.


Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
- New attendee at outpatient gynaecology clinic

- Any type of prolapse
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
448
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St George Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Ireland
State/province [1] 0 0
Antrim
Country [2] 0 0
Ireland
State/province [2] 0 0
Belfast
Country [3] 0 0
New Zealand
State/province [3] 0 0
Dunedin
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Ayrshire
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Fife
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Grampian
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Hampshire
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Lothian
Country [9] 0 0
United Kingdom
State/province [9] 0 0
West Lothian
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Birmingham
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Bradford
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Cambridge
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Chester
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Chichester
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Dundee
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Falkirk
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Glasgow
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Hull
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Leeds
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Manchester
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Melrose
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Middlesbrough
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Worcester
Country [24] 0 0
United Kingdom
State/province [24] 0 0
York

Funding & Sponsors
Primary sponsor type
Other
Name
Glasgow Caledonian University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Chief Scientist Office of the Scottish Government
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
South Glasgow University Hospitals NHS Trust
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Aberdeen
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Otago
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00476892
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Suzanne Hagen
Address 0 0
NMAHP Research Unit, Glasgow Caledonian University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00476892