Pelvic Organ ProlapsePREVPROLNCT01171846
A Study of the Effects of Physiotherapy to Prevent Pelvic Organ Prolapse
A study testing Pelvic Floor Muscle training in people with Pelvic Organ Prolapse, run by Glasgow Caledonian University at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Pelvic Floor Muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire, AB25 2ZN
Birmingham Women's Hospital
Edgbaston, Birmingham, B15 2TG
About this study
Official title: 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Pelvic Floor Muscle training
- Keywords
- prevention, pelvic floor muscle training, prolapse symptoms, urinary symptoms, sexual function, randomised controlled trial
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Active comparator | Not described Receives: Other: Pelvic Floor Muscle training |
| Control | No intervention | Women allocated to the Control group will only receive, by post, the same Lifestyle Advice Sheet as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Measured: Baseline (prior to randomisation)
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Measured: 1 Year post randomisation
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Measured: 2 years post randomisation
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Measured: 3 years post randomisation
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Measured: 4 years post randomisation
Secondary outcomes (39)
Prolapse-related quality of life
Single item scored 0 to 10
Measured: Baseline (prior to randomisation)
Prolapse severity
Pelvic Organ Prolapse Quantification assessment
Measured: Four years post randomisation
Lifestyle changes
Measured: 1 year post randomisation
Urinary symptoms
ICIQ urinary incontinence short-form
Measured: Baseline (prior to randomisation)
Bowel symptoms
ICIQ bowel symptoms module
Measured: Baseline (prior to randomisation)
Sexual symptoms
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Measured: Baseline (prior to randomisation)
General health status
SF-12
Measured: Baseline (prior to randomisation)
Need for prolapse treatment
Measured: 1 year post randomisation
The average number of days of prolapse symptoms
Measured: Baseline (prior to randomisation)
Prolapse-related quality of life
Single item scored 0 to 10
Measured: 1 year post randomisation
Prolapse-related quality of life
Single item scored 0 to 10
Measured: 2 years post randomisation
Prolapse-related quality of life
Single item scored 0 to 10
Measured: 3 years post randomisation
Prolapse-related quality of life
Single item scored 0 to 10
Measured: 4 years post of randomisation
Lifestyle changes
Measured: 2 years post randomisation
Lifestyle changes
Measured: 3 years post randomisation
Lifestyle changes
Measured: 4 years post randomisation
Urinary symptoms
ICIQ urinary incontinence short-form
Measured: 1 year post randomisation
Urinary symptoms
ICIQ urinary incontinence short-form
Measured: 2 years post randomisation
Urinary symptoms
ICIQ urinary incontinence short-form
Measured: 3 years post randomisation
Urinary symptoms
ICIQ urinary incontinence short-form
Measured: 4 years post randomisation
Bowel symptoms
ICIQ bowel symptoms module
Measured: 1 year post randomisation
Bowel symptoms
ICIQ bowel symptoms module
Measured: 2 years post randomisation
Bowel symptoms
ICIQ bowel symptoms module
Measured: 3 years post randomisation
Bowel symptoms
ICIQ bowel symptoms module
Measured: 4 years post randomisation
Sexual symptoms
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Measured: 1 year post randomisation
Sexual symptoms
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Measured: 2 years post randomisation
Sexual symptoms
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Measured: 3 years post randomisation
Sexual symptoms
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Measured: 4 years post randomisation
General health status
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Measured: 1 year post randomisation
General health status
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Measured: 2 years post randomisation
General health status
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Measured: 3 years post randomisation
General health status
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Measured: 4 years post randomisation
Need for prolapse treatment
Measured: 2 years post randomisation
Need for prolapse treatment
Measured: 3 years post randomisation
Need for prolapse treatment
Measured: 4 years post randomisation
The average number of days of prolapse symptoms
Measured: 1 year post randomisation
The average number of days of prolapse symptoms
Measured: 2 years post randomisation
The average number of days of prolapse symptoms
Measured: 3 years post randomisation
The average number of days of prolapse symptoms
Measured: 4 years post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, Birmingham Women's NHS Foundation Trust, University of Aberdeen, Aberdeen Royal Infirmary, University of Otago
- Responsible party
- Principal investigator, Ms Suzanne Hagen, Glasgow Caledonian University
- Investigators
- Prof Hagen, PhD MSc BSc CStat CSci, Principal investigator, NMAHP Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171846
- Sponsor's protocol ID
- PREVPROL Study RG1271
- Acronym
- PREVPROL
- Status last verified
- Mar 2015
- First submitted
- 6 Jul 2010
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hagen, S., C. Glazener, D. McClurg, C. Macarthur, P. Herbison, D. Wilson, P. Toozs-Hobson et al.
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.
PubMed 28010994
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training to Prevent Pelvic Organ Prolapse in Women
- ClinicalTrials.gov ID
- NCT01171846
- Acronym / sponsor ID
- PREVPROL / PREVPROL Study RG1271
- Conditions
- Pelvic Organ Prolapse
- Keywords
- prevention, pelvic floor muscle training, prolapse symptoms, urinary symptoms, sexual function, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- University of Birmingham, Birmingham Women's NHS Foundation Trust, University of Aberdeen, Aberdeen Royal Infirmary, University of Otago
- Study start
- Aug 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Active comparator | Other: Pelvic Floor Muscle training |
| Control | No intervention | –Women allocated to the Control group will only receive, by post, the same Lifestyle Advice Sheet as the intervention group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Muscle trainingWomen 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. | Other | Physiotherapy |
Primary outcome
Pelvic organ prolapse symptom score (POP-SS)
Time frame: Baseline (prior to randomisation)
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
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
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
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
A summation of responses to seven prolapse symptom questions (range 0-28)
39 secondary outcomes
Prolapse-related quality of life
Time frame: Baseline (prior to randomisation)
Prolapse severity
Time frame: Four years post randomisation
Lifestyle changes
Time frame: 1 year post randomisation
Urinary symptoms
Time frame: Baseline (prior to randomisation)
Bowel symptoms
Time frame: Baseline (prior to randomisation)
Sexual symptoms
Time frame: Baseline (prior to randomisation)
General health status
Time frame: Baseline (prior to randomisation)
Need for prolapse treatment
Time frame: 1 year post randomisation
The average number of days of prolapse symptoms
Time frame: Baseline (prior to randomisation)
Prolapse-related quality of life
Time frame: 1 year post randomisation
Prolapse-related quality of life
Time frame: 2 years post randomisation
Prolapse-related quality of life
Time frame: 3 years post randomisation
Prolapse-related quality of life
Time frame: 4 years post of randomisation
Lifestyle changes
Time frame: 2 years post randomisation
Lifestyle changes
Time frame: 3 years post randomisation
Lifestyle changes
Time frame: 4 years post randomisation
Urinary symptoms
Time frame: 1 year post randomisation
Urinary symptoms
Time frame: 2 years post randomisation
Urinary symptoms
Time frame: 3 years post randomisation
Urinary symptoms
Time frame: 4 years post randomisation
Bowel symptoms
Time frame: 1 year post randomisation
Bowel symptoms
Time frame: 2 years post randomisation
Bowel symptoms
Time frame: 3 years post randomisation
Bowel symptoms
Time frame: 4 years post randomisation
Sexual symptoms
Time frame: 1 year post randomisation
Sexual symptoms
Time frame: 2 years post randomisation
Sexual symptoms
Time frame: 3 years post randomisation
Sexual symptoms
Time frame: 4 years post randomisation
General health status
Time frame: 1 year post randomisation
General health status
Time frame: 2 years post randomisation
General health status
Time frame: 3 years post randomisation
General health status
Time frame: 4 years post randomisation
Need for prolapse treatment
Time frame: 2 years post randomisation
Need for prolapse treatment
Time frame: 3 years post randomisation
Need for prolapse treatment
Time frame: 4 years post randomisation
The average number of days of prolapse symptoms
Time frame: 1 year post randomisation
The average number of days of prolapse symptoms
Time frame: 2 years post randomisation
The average number of days of prolapse symptoms
Time frame: 3 years post randomisation
The average number of days of prolapse symptoms
Time frame: 4 years post randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Results publicationHagen, S., C. Glazener, D. McClurg, C. Macarthur, P. Herbison, D. Wilson, P. Toozs-Hobson et al.
- Derived from this study: PubMed 28010994Hagen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Hagen, PhD MSc BSc CStat CSci principal investigator
NMAHP Research Unit
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Muscle training in people with Pelvic Organ Prolapse, run by Glasgow Caledonian University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic organ prolapse symptom score (POP-SS) (time frame: Baseline (prior to randomisation)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01171846, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.