Status:
COMPLETED
A Study of the Effects of Physiotherapy to Prevent Pelvic Organ Prolapse
Lead Sponsor:
Glasgow Caledonian University
Collaborating Sponsors:
University of Birmingham
Birmingham Women's NHS Foundation Trust
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- Women:
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT01171846
Start Date
August 1 2010
End Date
December 1 2013
Last Update
March 17 2015
Active Locations (3)
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1
Dunedin School of Medicine
Dunedin, New Zealand, 9054
2
Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
3
Birmingham Women's Hospital
Edgbaston, Birmingham, United Kingdom, B15 2TG