NCT00476892

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 448 (actual)
• Sponsor: Glasgow Caledonian University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	Pelvic 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.

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-07-01
• Completion: 2011-03-01
• First posted: 2007-05-22
• Last updated: 2011-03-23

Locations

28 sites across 4 countries: Australia, Ireland, New Zealand, United Kingdom