A Study of the Effects of Physiotherapy to Prevent Pelvic Organ Prolapse (PREVPROL)

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Other: Pelvic Floor Muscle training

• Study Type: Interventional
• Enrollment (Actual): 337
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Dunedin, New Zealand, 9054
    • Dunedin School of Medicine
• United Kingdom
  • Aberdeenshire
    • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
      • Aberdeen Royal Infirmary
  • Birmingham
    • Edgbaston, Birmingham, United Kingdom, B15 2TG
      • Birmingham Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Physiotherapy	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.
NO_INTERVENTION: Control; Women allocated to the Control group will only receive, by post, the same Lifestyle Advice Sheet as the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic organ prolapse symptom score (POP-SS)	A summation of responses to seven prolapse symptom questions (range 0-28)	Baseline (prior to randomisation)
Pelvic organ prolapse symptom score (POP-SS)	A summation of responses to seven prolapse symptom questions (range 0-28)	1 Year post randomisation
Pelvic organ prolapse symptom score (POP-SS)	A summation of responses to seven prolapse symptom questions (range 0-28)	2 years post randomisation
Pelvic organ prolapse symptom score (POP-SS)	A summation of responses to seven prolapse symptom questions (range 0-28)	3 years post randomisation
Pelvic organ prolapse symptom score (POP-SS)	A summation of responses to seven prolapse symptom questions (range 0-28)	4 years post randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolapse-related quality of life	Single item scored 0 to 10	Baseline (prior to randomisation)
Prolapse severity	Pelvic Organ Prolapse Quantification assessment	Four years post randomisation
Lifestyle changes		1 year post randomisation
Urinary symptoms	ICIQ urinary incontinence short-form	Baseline (prior to randomisation)
Bowel symptoms	ICIQ bowel symptoms module	Baseline (prior to randomisation)
Sexual symptoms	Prolapse Incontinence Sexual Questionnaire - PISQ 12	Baseline (prior to randomisation)
General health status	SF-12	Baseline (prior to randomisation)
Need for prolapse treatment		1 year post randomisation
The average number of days of prolapse symptoms		Baseline (prior to randomisation)
Prolapse-related quality of life	Single item scored 0 to 10	1 year post randomisation
Prolapse-related quality of life	Single item scored 0 to 10	2 years post randomisation
Prolapse-related quality of life	Single item scored 0 to 10	3 years post randomisation
Prolapse-related quality of life	Single item scored 0 to 10	4 years post of randomisation
Lifestyle changes		2 years post randomisation
Lifestyle changes		3 years post randomisation
Lifestyle changes		4 years post randomisation
Urinary symptoms	ICIQ urinary incontinence short-form	1 year post randomisation
Urinary symptoms	ICIQ urinary incontinence short-form	2 years post randomisation
Urinary symptoms	ICIQ urinary incontinence short-form	3 years post randomisation
Urinary symptoms	ICIQ urinary incontinence short-form	4 years post randomisation
Bowel symptoms	ICIQ bowel symptoms module	1 year post randomisation
Bowel symptoms	ICIQ bowel symptoms module	2 years post randomisation
Bowel symptoms	ICIQ bowel symptoms module	3 years post randomisation
Bowel symptoms	ICIQ bowel symptoms module	4 years post randomisation
Sexual symptoms	Prolapse Incontinence Sexual Questionnaire - PISQ 12	1 year post randomisation
Sexual symptoms	Prolapse Incontinence Sexual Questionnaire - PISQ 12	2 years post randomisation
Sexual symptoms	Prolapse Incontinence Sexual Questionnaire - PISQ 12	3 years post randomisation
Sexual symptoms	Prolapse Incontinence Sexual Questionnaire - PISQ 12	4 years post randomisation
General health status	Prolapse Incontinence Sexual Questionnaire - PISQ 12	1 year post randomisation
General health status	Prolapse Incontinence Sexual Questionnaire - PISQ 12	2 years post randomisation
General health status	Prolapse Incontinence Sexual Questionnaire - PISQ 12	3 years post randomisation
General health status	Prolapse Incontinence Sexual Questionnaire - PISQ 12	4 years post randomisation
Need for prolapse treatment		2 years post randomisation
Need for prolapse treatment		3 years post randomisation
Need for prolapse treatment		4 years post randomisation
The average number of days of prolapse symptoms		1 year post randomisation
The average number of days of prolapse symptoms		2 years post randomisation
The average number of days of prolapse symptoms		3 years post randomisation
The average number of days of prolapse symptoms		4 years post randomisation

Collaborators and Investigators

• Sponsor: Glasgow Caledonian University
• Collaborators: University of Otago; University of Birmingham; University of Aberdeen; Aberdeen Royal Infirmary; Birmingham Women's NHS Foundation Trust
• Investigators: Principal Investigator: Prof Hagen, PhD MSc BSc CStat CSci, NMAHP Research Unit

Publications and helpful links

General Publications

• Hagen S, Glazener C, McClurg D, Macarthur C, Elders A, Herbison P, Wilson D, Toozs-Hobson P, Hemming C, Hay-Smith J, Collins M, Dickson S, Logan J. Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL): a multicentre randomised controlled trial. Lancet. 2017 Jan 28;389(10067):393-402. doi: 10.1016/S0140-6736(16)32109-2. Epub 2016 Dec 21.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: July 6, 2010
• First Submitted That Met QC Criteria: July 28, 2010
• First Posted (ESTIMATE): July 29, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 16, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: prevention; randomised controlled trial; sexual function; urinary symptoms; pelvic floor muscle training; prolapse symptoms
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: PREVPROL Study RG1271