Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Glasgow Caledonian University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Wellbeing of Women
University of Birmingham
Birmingham Women's Hospital
University of Aberdeen
Aberdeen Royal Infirmary
Dunedin School of Medicine
Information provided by (Responsible Party):
Ms Suzanne Hagen, Glasgow Caledonian University
ClinicalTrials.gov Identifier:
NCT01171846
First received: July 6, 2010
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Pelvic Organ Prolapse
Other: Pelvic Floor Muscle training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training to Prevent Pelvic Organ Prolapse in Women

Resource links provided by NLM:


Further study details as provided by Glasgow Caledonian University:

Primary Outcome Measures:
  • Pelvic organ prolapse symptom score (POP-SS) [ Time Frame: Baseline (prior to randomisation) ] [ Designated as safety issue: No ]
    A summation of responses to seven prolapse symptom questions (range 0-28)

  • Pelvic organ prolapse symptom score (POP-SS) [ Time Frame: 1 Year post randomisation ] [ Designated as safety issue: No ]
    A summation of responses to seven prolapse symptom questions (range 0-28)

  • Pelvic organ prolapse symptom score (POP-SS) [ Time Frame: 2 years post randomisation ] [ Designated as safety issue: No ]
    A summation of responses to seven prolapse symptom questions (range 0-28)

  • Pelvic organ prolapse symptom score (POP-SS) [ Time Frame: 3 years post randomisation ] [ Designated as safety issue: No ]
    A summation of responses to seven prolapse symptom questions (range 0-28)

  • Pelvic organ prolapse symptom score (POP-SS) [ Time Frame: 4 years post randomisation ] [ Designated as safety issue: No ]
    A summation of responses to seven prolapse symptom questions (range 0-28)


Secondary Outcome Measures:
  • Prolapse-related quality of life [ Time Frame: Baseline (prior to randomisation) ] [ Designated as safety issue: No ]
    Single item scored 0 to 10

  • Prolapse severity [ Time Frame: Four years post randomisation ] [ Designated as safety issue: No ]
    Pelvic Organ Prolapse Quantification assessment

  • Lifestyle changes [ Time Frame: 1 year post randomisation ] [ Designated as safety issue: No ]
  • Urinary symptoms [ Time Frame: Baseline (prior to randomisation) ] [ Designated as safety issue: No ]
    ICIQ urinary incontinence short-form

  • Bowel symptoms [ Time Frame: Baseline (prior to randomisation) ] [ Designated as safety issue: No ]
    ICIQ bowel symptoms module

  • Sexual symptoms [ Time Frame: Baseline (prior to randomisation) ] [ Designated as safety issue: No ]
    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  • General health status [ Time Frame: Baseline (prior to randomisation) ] [ Designated as safety issue: No ]
    SF-12

  • Need for prolapse treatment [ Time Frame: 1 year post randomisation ] [ Designated as safety issue: No ]
  • The average number of days of prolapse symptoms [ Time Frame: Baseline (prior to randomisation) ] [ Designated as safety issue: No ]
  • Prolapse-related quality of life [ Time Frame: 1 year post randomisation ] [ Designated as safety issue: No ]
    Single item scored 0 to 10

  • Prolapse-related quality of life [ Time Frame: 2 years post randomisation ] [ Designated as safety issue: No ]
    Single item scored 0 to 10

  • Prolapse-related quality of life [ Time Frame: 3 years post randomisation ] [ Designated as safety issue: No ]
    Single item scored 0 to 10

  • Prolapse-related quality of life [ Time Frame: 4 years post of randomisation ] [ Designated as safety issue: No ]
    Single item scored 0 to 10

  • Lifestyle changes [ Time Frame: 2 years post randomisation ] [ Designated as safety issue: No ]
  • Lifestyle changes [ Time Frame: 3 years post randomisation ] [ Designated as safety issue: No ]
  • Lifestyle changes [ Time Frame: 4 years post randomisation ] [ Designated as safety issue: No ]
  • Urinary symptoms [ Time Frame: 1 year post randomisation ] [ Designated as safety issue: No ]
    ICIQ urinary incontinence short-form

  • Urinary symptoms [ Time Frame: 2 years post randomisation ] [ Designated as safety issue: No ]
    ICIQ urinary incontinence short-form

  • Urinary symptoms [ Time Frame: 3 years post randomisation ] [ Designated as safety issue: No ]
    ICIQ urinary incontinence short-form

  • Urinary symptoms [ Time Frame: 4 years post randomisation ] [ Designated as safety issue: No ]
    ICIQ urinary incontinence short-form

  • Bowel symptoms [ Time Frame: 1 year post randomisation ] [ Designated as safety issue: No ]
    ICIQ bowel symptoms module

  • Bowel symptoms [ Time Frame: 2 years post randomisation ] [ Designated as safety issue: No ]
    ICIQ bowel symptoms module

  • Bowel symptoms [ Time Frame: 3 years post randomisation ] [ Designated as safety issue: No ]
    ICIQ bowel symptoms module

  • Bowel symptoms [ Time Frame: 4 years post randomisation ] [ Designated as safety issue: No ]
    ICIQ bowel symptoms module

  • Sexual symptoms [ Time Frame: 1 year post randomisation ] [ Designated as safety issue: No ]
    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  • Sexual symptoms [ Time Frame: 2 years post randomisation ] [ Designated as safety issue: No ]
    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  • Sexual symptoms [ Time Frame: 3 years post randomisation ] [ Designated as safety issue: No ]
    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  • Sexual symptoms [ Time Frame: 4 years post randomisation ] [ Designated as safety issue: No ]
    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  • General health status [ Time Frame: 1 year post randomisation ] [ Designated as safety issue: No ]
    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  • General health status [ Time Frame: 2 years post randomisation ] [ Designated as safety issue: No ]
    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  • General health status [ Time Frame: 3 years post randomisation ] [ Designated as safety issue: No ]
    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  • General health status [ Time Frame: 4 years post randomisation ] [ Designated as safety issue: No ]
    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  • Need for prolapse treatment [ Time Frame: 2 years post randomisation ] [ Designated as safety issue: No ]
  • Need for prolapse treatment [ Time Frame: 3 years post randomisation ] [ Designated as safety issue: No ]
  • Need for prolapse treatment [ Time Frame: 4 years post randomisation ] [ Designated as safety issue: No ]
  • The average number of days of prolapse symptoms [ Time Frame: 1 year post randomisation ] [ Designated as safety issue: No ]
  • The average number of days of prolapse symptoms [ Time Frame: 2 years post randomisation ] [ Designated as safety issue: No ]
  • The average number of days of prolapse symptoms [ Time Frame: 3 years post randomisation ] [ Designated as safety issue: No ]
  • The average number of days of prolapse symptoms [ Time Frame: 4 years post randomisation ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171846

Locations
New Zealand
Dunedin School of Medicine
Dunedin, New Zealand, 9054
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
Birmingham Women's Hospital
Edgbaston, Birmingham, United Kingdom, B15 2TG
Sponsors and Collaborators
Glasgow Caledonian University
Wellbeing of Women
University of Birmingham
Birmingham Women's Hospital
University of Aberdeen
Aberdeen Royal Infirmary
Dunedin School of Medicine
Investigators
Principal Investigator: Prof Hagen, PhD MSc BSc CStat CSci NMAHP Research Unit
  More Information

No publications provided

Responsible Party: Ms Suzanne Hagen, Programme Director, Glasgow Caledonian University
ClinicalTrials.gov Identifier: NCT01171846     History of Changes
Other Study ID Numbers: PREVPROL Study RG1271
Study First Received: July 6, 2010
Last Updated: April 4, 2012
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Glasgow Caledonian University:
prevention
pelvic floor muscle training
prolapse symptoms
urinary symptoms
sexual function
randomised controlled trial

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 23, 2014