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

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Other: Pelvic Floor Muscle training

• Registration Number: NCT01171846
• Lead Sponsor: Glasgow Caledonian University

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-28
• Study First Posted: 2010-07-29
• Study Start: 2010-08
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 337

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiotherapy	Pelvic Floor Muscle training	-

Primary Outcome Measures

Name	Time	Method
Pelvic organ prolapse symptom score (POP-SS)	4 years post randomisation	A summation of responses to seven prolapse symptom questions (range 0-28)

Secondary Outcome Measures

Name	Time	Method
Prolapse-related quality of life	4 years post of randomisation	Single item scored 0 to 10
Prolapse severity	Four years post randomisation	Pelvic Organ Prolapse Quantification assessment
Lifestyle changes	4 years post randomisation
Urinary symptoms	4 years post randomisation	ICIQ urinary incontinence short-form
Bowel symptoms	4 years post randomisation	ICIQ bowel symptoms module
Sexual symptoms	4 years post randomisation	Prolapse Incontinence Sexual Questionnaire - PISQ 12
General health status	4 years post randomisation	Prolapse Incontinence Sexual Questionnaire - PISQ 12
Need for prolapse treatment	4 years post randomisation
The average number of days of prolapse symptoms	4 years post randomisation

Trial Locations

Locations (3)

Dunedin School of Medicine; 🇳🇿 Dunedin, New Zealand

Birmingham Women's Hospital; 🇬🇧 Edgbaston, Birmingham, United Kingdom

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, Aberdeenshire, United Kingdom