A Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training to Prevent Pelvic Organ Prolapse in Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- Glasgow Caledonian University
- Enrollment
- 337
- Locations
- 3
- Primary Endpoint
- Pelvic organ prolapse symptom score (POP-SS)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Pelvic organ prolapse is a problem experienced by women where a bulge comes down in the vagina, and may even drop down outside the vagina. The bulge in the vagina is caused by other organs moving down from their normal position in the pelvis and pushing into the vagina. This is a very common problem and many women who have given birth will have a very mild bulge which does not cause them symptoms. Women can however experience a variety of pelvic, bladder, bowel and sexual symptoms which impact on daily life. No research studies have properly examined whether or not exercises can prevent prolapse. This study aims to explore whether exercises taught by a physiotherapist can prevent women developing a prolapse which requires them to have treatment.
Investigators
Ms Suzanne Hagen
Programme Director
Glasgow Caledonian University
Eligibility Criteria
Inclusion Criteria
- •Women involved in the ProLong study who:
- •have some evidence of vaginal laxity in any compartment (POP-Q stage I, II or III)
- •have had no previous treatment for prolapse (surgery, pessary, PFMT)
- •Women must be willing to participate in the Trial and to comply with their group allocation.
Exclusion Criteria
- •with stage 0 or IV prolapse
- •who have had previous incontinence surgery (except mid-urethral sling operation)
- •who have had previous formal instruction in PFMT for any diagnosis in preceding five years
- •who are pregnant, or delivered a baby within the last six months
- •who are unable to comply with PFMT treatment
- •who are unable to give informed consent
Outcomes
Primary Outcomes
Pelvic organ prolapse symptom score (POP-SS)
Time Frame: 4 years post randomisation
A summation of responses to seven prolapse symptom questions (range 0-28)
Secondary Outcomes
- Prolapse-related quality of life(4 years post of randomisation)
- Prolapse severity(Four years post randomisation)
- Lifestyle changes(4 years post randomisation)
- Urinary symptoms(4 years post randomisation)
- Bowel symptoms(4 years post randomisation)
- Sexual symptoms(4 years post randomisation)
- General health status(4 years post randomisation)
- Need for prolapse treatment(4 years post randomisation)
- The average number of days of prolapse symptoms(4 years post randomisation)