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Multi-centre Randomised Controlled Trial of Pelvic Floor Muscle Training for Prolapse — POPPY  

Pelvic Organ Prolapse Clinical Trial

Official title:
A Multi-centre Randomised Controlled Trial of a Pelvic Floor Muscle Training Intervention for Women With Pelvic Organ Prolapse

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00476892
Study type Interventional
Source Glasgow Caledonian University
Contact
Status Completed
Phase N/A
Start date June 2007
Completion date March 2011
View Details
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