Clinical trial NCT00476892: Multi-centre Randomised Controlled Trial of Pelvic Floor Muscle Training for Prolapse
Official title: A Multi-centre Randomised Controlled Trial of a Pelvic Floor Muscle Training Intervention for Women With Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic organ prolapse
Pelvic floor muscle training
Prolapse symptoms
Urinary symptoms
Sexual function
randomised controlled trial
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: Chief Scientist Office of the Scottish Government
name: South Glasgow University Hospitals NHS Trust
name: University of Aberdeen
name: University of Otago
First posted: 2007-05-22
Enrollment: 448
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St George Hospital
city: Antrim
country: Ireland
facility: Antrim Area Hospital
city: Belfast
country: Ireland
facility: Belfast City Hospital
city: Dunedin
country: New Zealand
facility: Dunedin School of Medicine
city: Kilmarnock
country: United Kingdom
facility: Crosshouse Hospital / Ayrshire Maternity Hospital
state: Ayrshire
city: Kirkcaldy
country: United Kingdom
facility: Forth Park Hospital
state: Fife
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Grampian
city: Basingstoke
country: United Kingdom
facility: North Hampshire Hospitals NHS Trust
state: Hampshire
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Lothian
city: Livingston
country: United Kingdom
facility: St John's Hospital
state: West Lothian
city: Birmingham
country: United Kingdom
facility: Birmingham Women's Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Chester
country: United Kingdom
facility: Chester Hospital
city: Chichester
country: United Kingdom
facility: St Richard's Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Falkirk
country: United Kingdom
facility: Falkirk and District Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Western Infirmary
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Victoria Infirmary
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
city: Hull
country: United Kingdom
facility: Castle Hill Hospital
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Manchester
country: United Kingdom
facility: St Mary's Hospital
city: Melrose
country: United Kingdom
facility: Borders General Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Worcester
country: United Kingdom
facility: Worcestershire Royal Hospital
city: York
country: United Kingdom
facility: York Hospital
Study officials:
affiliation: NMAHP Research Unit, Glasgow Caledonian University
name: Suzanne Hagen
role: PRINCIPAL_INVESTIGATOR
References: