A Study of the Effects of Physiotherapy to Prevent Pelvic Organ Prolapse (PREVPROL)
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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 |
- 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)
- 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.
|
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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 |
Principal Investigator: | Prof Hagen, PhD MSc BSc CStat CSci | NMAHP Research Unit |
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:
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on October 17, 2012