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

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pelvic Floor Muscle training
Sponsored by
Glasgow Caledonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pelvic Organ Prolapse focused on measuring prevention, pelvic floor muscle training, prolapse symptoms, urinary symptoms, sexual function, randomised controlled trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dunedin School of Medicine
  • Aberdeen Royal Infirmary
  • Birmingham Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Physiotherapy

Control

Arm Description

Women allocated to the Control group will only receive, by post, the same Lifestyle Advice Sheet as the intervention group.

Outcomes

Primary Outcome Measures

Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)

Secondary Outcome Measures

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

Full Information

First Posted
July 6, 2010
Last Updated
March 16, 2015
Sponsor
Glasgow Caledonian University
Collaborators
University of Birmingham, Birmingham Women's NHS Foundation Trust, University of Aberdeen, Aberdeen Royal Infirmary, University of Otago
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1. Study Identification

Unique Protocol Identification Number
NCT01171846
Brief Title
A Study of the Effects of Physiotherapy to Prevent Pelvic Organ Prolapse
Acronym
PREVPROL
Official Title
A Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training to Prevent Pelvic Organ Prolapse in Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glasgow Caledonian University
Collaborators
University of Birmingham, Birmingham Women's NHS Foundation Trust, University of Aberdeen, Aberdeen Royal Infirmary, University of Otago

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
prevention, pelvic floor muscle training, prolapse symptoms, urinary symptoms, sexual function, randomised controlled trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
337 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Arm Description
Women allocated to the Control group will only receive, by post, the same Lifestyle Advice Sheet as the intervention group.
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Muscle training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pelvic organ prolapse symptom score (POP-SS)
Description
A summation of responses to seven prolapse symptom questions (range 0-28)
Time Frame
Baseline (prior to randomisation)
Title
Pelvic organ prolapse symptom score (POP-SS)
Description
A summation of responses to seven prolapse symptom questions (range 0-28)
Time Frame
1 Year post randomisation
Title
Pelvic organ prolapse symptom score (POP-SS)
Description
A summation of responses to seven prolapse symptom questions (range 0-28)
Time Frame
2 years post randomisation
Title
Pelvic organ prolapse symptom score (POP-SS)
Description
A summation of responses to seven prolapse symptom questions (range 0-28)
Time Frame
3 years post randomisation
Title
Pelvic organ prolapse symptom score (POP-SS)
Description
A summation of responses to seven prolapse symptom questions (range 0-28)
Time Frame
4 years post randomisation
Secondary Outcome Measure Information:
Title
Prolapse-related quality of life
Description
Single item scored 0 to 10
Time Frame
Baseline (prior to randomisation)
Title
Prolapse severity
Description
Pelvic Organ Prolapse Quantification assessment
Time Frame
Four years post randomisation
Title
Lifestyle changes
Time Frame
1 year post randomisation
Title
Urinary symptoms
Description
ICIQ urinary incontinence short-form
Time Frame
Baseline (prior to randomisation)
Title
Bowel symptoms
Description
ICIQ bowel symptoms module
Time Frame
Baseline (prior to randomisation)
Title
Sexual symptoms
Description
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time Frame
Baseline (prior to randomisation)
Title
General health status
Description
SF-12
Time Frame
Baseline (prior to randomisation)
Title
Need for prolapse treatment
Time Frame
1 year post randomisation
Title
The average number of days of prolapse symptoms
Time Frame
Baseline (prior to randomisation)
Title
Prolapse-related quality of life
Description
Single item scored 0 to 10
Time Frame
1 year post randomisation
Title
Prolapse-related quality of life
Description
Single item scored 0 to 10
Time Frame
2 years post randomisation
Title
Prolapse-related quality of life
Description
Single item scored 0 to 10
Time Frame
3 years post randomisation
Title
Prolapse-related quality of life
Description
Single item scored 0 to 10
Time Frame
4 years post of randomisation
Title
Lifestyle changes
Time Frame
2 years post randomisation
Title
Lifestyle changes
Time Frame
3 years post randomisation
Title
Lifestyle changes
Time Frame
4 years post randomisation
Title
Urinary symptoms
Description
ICIQ urinary incontinence short-form
Time Frame
1 year post randomisation
Title
Urinary symptoms
Description
ICIQ urinary incontinence short-form
Time Frame
2 years post randomisation
Title
Urinary symptoms
Description
ICIQ urinary incontinence short-form
Time Frame
3 years post randomisation
Title
Urinary symptoms
Description
ICIQ urinary incontinence short-form
Time Frame
4 years post randomisation
Title
Bowel symptoms
Description
ICIQ bowel symptoms module
Time Frame
1 year post randomisation
Title
Bowel symptoms
Description
ICIQ bowel symptoms module
Time Frame
2 years post randomisation
Title
Bowel symptoms
Description
ICIQ bowel symptoms module
Time Frame
3 years post randomisation
Title
Bowel symptoms
Description
ICIQ bowel symptoms module
Time Frame
4 years post randomisation
Title
Sexual symptoms
Description
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time Frame
1 year post randomisation
Title
Sexual symptoms
Description
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time Frame
2 years post randomisation
Title
Sexual symptoms
Description
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time Frame
3 years post randomisation
Title
Sexual symptoms
Description
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time Frame
4 years post randomisation
Title
General health status
Description
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time Frame
1 year post randomisation
Title
General health status
Description
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time Frame
2 years post randomisation
Title
General health status
Description
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time Frame
3 years post randomisation
Title
General health status
Description
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time Frame
4 years post randomisation
Title
Need for prolapse treatment
Time Frame
2 years post randomisation
Title
Need for prolapse treatment
Time Frame
3 years post randomisation
Title
Need for prolapse treatment
Time Frame
4 years post randomisation
Title
The average number of days of prolapse symptoms
Time Frame
1 year post randomisation
Title
The average number of days of prolapse symptoms
Time Frame
2 years post randomisation
Title
The average number of days of prolapse symptoms
Time Frame
3 years post randomisation
Title
The average number of days of prolapse symptoms
Time Frame
4 years post randomisation

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Hagen, PhD MSc BSc CStat CSci
Organizational Affiliation
NMAHP Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dunedin School of Medicine
City
Dunedin
ZIP/Postal Code
9054
Country
New Zealand
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Aberdeenshire
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Birmingham Women's Hospital
City
Edgbaston
State/Province
Birmingham
ZIP/Postal Code
B15 2TG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
Hagen, S., C. Glazener, D. McClurg, C. Macarthur, P. Herbison, D. Wilson, P. Toozs-Hobson et al.
Results Reference
result
PubMed Identifier
28010994
Citation
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.
Results Reference
derived

Learn more about this trial

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

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