Pelvic Organ Prolapse
Conditions
Keywords
Pelvic organ prolapse, Pelvic floor muscle training, Prolapse symptoms, Urinary symptoms, Sexual function, randomised controlled trial
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.
Interventions
PROCEDUREPelvic 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.
Sponsors
Chief Scientist Office of the Scottish Government
South Glasgow University Hospitals NHS Trust
University of Aberdeen
University of Otago
Glasgow Caledonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
Countries
Australia, Ireland, New Zealand, United Kingdom
Outcome results
None listed