NCT01171846

A Study of the Effects of Physiotherapy to Prevent Pelvic Organ Prolapse

A Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training to Prevent Pelvic Organ Prolapse in Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: Glasgow Caledonian University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
OTHER	Pelvic Floor Muscle training	Women allocated to the intervention group will have five appointments with a specialist women's health physiotherapist (intervention physiotherapist) over 16 weeks who will prescribe a daily exercise programme and provide a Lifestyle Advice Sheet (focusing on weight loss, constipation, avoidance of heavy lifting, coughing and high-impact exercise) and relevant tailored advice (phase 1). Thereafter women in the intervention group will be offered Pilates-based classes, including PFMT, as maintenance (phase 2). Classes will be led by a physiotherapist who has undertaken Pilates training and will take place in six week blocks; each woman will be offered two six week blocks over a year. An exercise DVD will be provided for home use. Each woman will be offered a one-to-one review physiotherapy appointment at one and two years after randomisation.

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-07-29
• Last updated: 2015-03-17

Locations

3 sites across 2 countries: New Zealand, United Kingdom