Does Doing Pelvic Floor Exercise Ease Symptoms for Women Living With Prolapse?
A Feasibility Study for an RCT of a Pelvic Floor Muscle Training Intervention for Pelvic Organ Prolapse
3 other identifiers
interventional
50
1 country
2
Brief Summary
The purpose of this study is to investigate the feasibility of undertaking a multi-centre randomised controlled trial of the effectiveness of a pelvic floor muscle training (PFMT) intervention for women with pelvic organ prolapse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2003
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedMarch 19, 2015
March 1, 2015
1.9 years
September 8, 2005
March 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in prolapse related symptoms and associated quality of life measured by a combination of ICIQ tools, the Prolapse Quality of Life tool and study specific questions at baseline, 20 weeks and 26 weeks.
Secondary Outcomes (1)
Change in prolapse severity using the POP-Q method of quantification at baseline and 20 weeks, days of symptoms at baseline and 26 weeks, and general health status (SF-12) at baseline, 20 weeks and 26 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- women with previously untreated stage I or II pelvic organ prolapse attending gynaecology, urogynaecology and prolapse specific out-patient clinics at South Glasgow University NHS Trust and Grampian University Hospitals NHS Trust
You may not qualify if:
- previous surgical or conservative treatment for prolapse (e.g. pessary management or previous pelvic floor muscle training)
- women considered not suitable for physiotherapy treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Grampian University Hospitals, NHS Grampian
Aberdeen, AB25 2ZB, United Kingdom
South Glasgow University Hospitals Division, NHS Greater Glasgow
Glasgow, G4 0BA, United Kingdom
Related Publications (1)
Hagen S, Stark D, Glazener C, Sinclair L, Ramsay I. A randomized controlled trial of pelvic floor muscle training for stages I and II pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):45-51. doi: 10.1007/s00192-008-0726-4. Epub 2008 Sep 20.
PMID: 18806910BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne Hagen
NMAHP Reserach Unit, Glasgow Caledonian University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
September 1, 2003
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
March 19, 2015
Record last verified: 2015-03