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

Pelvic Organ Prolapse Clinical Trial

— PREVPROL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171846
• Other study ID #: PREVPROL Study RG1271
• Status: Completed
• Phase: N/A
• First received: July 6, 2010
• Last updated: March 16, 2015
• Start date: August 2010
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Glasgow Caledonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.

Locations

Country	Name	City	State
New Zealand	Dunedin School of Medicine	Dunedin
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Aberdeenshire
United Kingdom	Birmingham Women's Hospital	Edgbaston	Birmingham

Sponsors (6)

Lead Sponsor	Collaborator
Glasgow Caledonian University	Aberdeen Royal Infirmary, Birmingham Women's NHS Foundation Trust, University of Aberdeen, University of Birmingham, University of Otago

Countries where clinical trial is conducted

New Zealand,  United Kingdom, 

References & Publications (1)

Hagen, S., C. Glazener, D. McClurg, C. Macarthur, P. Herbison, D. Wilson, P. Toozs-Hobson et al.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic organ prolapse symptom score (POP-SS)	A summation of responses to seven prolapse symptom questions (range 0-28)	Baseline (prior to randomisation)	No
Primary	Pelvic organ prolapse symptom score (POP-SS)	A summation of responses to seven prolapse symptom questions (range 0-28)	1 Year post randomisation	No
Primary	Pelvic organ prolapse symptom score (POP-SS)	A summation of responses to seven prolapse symptom questions (range 0-28)	2 years post randomisation	No
Primary	Pelvic organ prolapse symptom score (POP-SS)	A summation of responses to seven prolapse symptom questions (range 0-28)	3 years post randomisation	No
Primary	Pelvic organ prolapse symptom score (POP-SS)	A summation of responses to seven prolapse symptom questions (range 0-28)	4 years post randomisation	No
Secondary	Prolapse-related quality of life	Single item scored 0 to 10	Baseline (prior to randomisation)	No
Secondary	Prolapse severity	Pelvic Organ Prolapse Quantification assessment	Four years post randomisation	No
Secondary	Lifestyle changes		1 year post randomisation	No
Secondary	Urinary symptoms	ICIQ urinary incontinence short-form	Baseline (prior to randomisation)	No
Secondary	Bowel symptoms	ICIQ bowel symptoms module	Baseline (prior to randomisation)	No
Secondary	Sexual symptoms	Prolapse Incontinence Sexual Questionnaire - PISQ 12	Baseline (prior to randomisation)	No
Secondary	General health status	SF-12	Baseline (prior to randomisation)	No
Secondary	Need for prolapse treatment		1 year post randomisation	No
Secondary	The average number of days of prolapse symptoms		Baseline (prior to randomisation)	No
Secondary	Prolapse-related quality of life	Single item scored 0 to 10	1 year post randomisation	No
Secondary	Prolapse-related quality of life	Single item scored 0 to 10	2 years post randomisation	No
Secondary	Prolapse-related quality of life	Single item scored 0 to 10	3 years post randomisation	No
Secondary	Prolapse-related quality of life	Single item scored 0 to 10	4 years post of randomisation	No
Secondary	Lifestyle changes		2 years post randomisation	No
Secondary	Lifestyle changes		3 years post randomisation	No
Secondary	Lifestyle changes		4 years post randomisation	No
Secondary	Urinary symptoms	ICIQ urinary incontinence short-form	1 year post randomisation	No
Secondary	Urinary symptoms	ICIQ urinary incontinence short-form	2 years post randomisation	No
Secondary	Urinary symptoms	ICIQ urinary incontinence short-form	3 years post randomisation	No
Secondary	Urinary symptoms	ICIQ urinary incontinence short-form	4 years post randomisation	No
Secondary	Bowel symptoms	ICIQ bowel symptoms module	1 year post randomisation	No
Secondary	Bowel symptoms	ICIQ bowel symptoms module	2 years post randomisation	No
Secondary	Bowel symptoms	ICIQ bowel symptoms module	3 years post randomisation	No
Secondary	Bowel symptoms	ICIQ bowel symptoms module	4 years post randomisation	No
Secondary	Sexual symptoms	Prolapse Incontinence Sexual Questionnaire - PISQ 12	1 year post randomisation	No
Secondary	Sexual symptoms	Prolapse Incontinence Sexual Questionnaire - PISQ 12	2 years post randomisation	No
Secondary	Sexual symptoms	Prolapse Incontinence Sexual Questionnaire - PISQ 12	3 years post randomisation	No
Secondary	Sexual symptoms	Prolapse Incontinence Sexual Questionnaire - PISQ 12	4 years post randomisation	No
Secondary	General health status	Prolapse Incontinence Sexual Questionnaire - PISQ 12	1 year post randomisation	No
Secondary	General health status	Prolapse Incontinence Sexual Questionnaire - PISQ 12	2 years post randomisation	No
Secondary	General health status	Prolapse Incontinence Sexual Questionnaire - PISQ 12	3 years post randomisation	No
Secondary	General health status	Prolapse Incontinence Sexual Questionnaire - PISQ 12	4 years post randomisation	No
Secondary	Need for prolapse treatment		2 years post randomisation	No
Secondary	Need for prolapse treatment		3 years post randomisation	No
Secondary	Need for prolapse treatment		4 years post randomisation	No
Secondary	The average number of days of prolapse symptoms		1 year post randomisation	No
Secondary	The average number of days of prolapse symptoms		2 years post randomisation	No
Secondary	The average number of days of prolapse symptoms		3 years post randomisation	No
Secondary	The average number of days of prolapse symptoms		4 years post randomisation	No