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

Sponsor

Glasgow Caledonian University (Other)

Overall Status

Completed

CT.gov ID

NCT00476892

Collaborator

Chief Scientist Office of the Scottish Government (Other), South Glasgow University Hospitals NHS Trust (Other), University of Aberdeen (Other), University of Otago (Other)

448

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Pelvic Floor Muscle Training	N/A

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 Design

Study Type:

Interventional

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 :

Jun 1, 2007

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

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 [1 year]

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. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

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