Uterine ProlapsePhase 1/2NCT00158626
Does Doing Pelvic Floor Exercise Ease Symptoms for Women Living With Prolapse?
A Phase 1/2 study testing pelvic floor muscle training in people with Uterine Prolapse, run by Glasgow Caledonian University at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to investigate the feasibility of undertaking a multi-centre randomised controlled trial of the effectiveness of a pelvic floor muscle training (PFMT) intervention for women with pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Prolapse
- What is being tested?
- pelvic floor muscle training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2003to Aug 2005
- Phase
- Phase 1/2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with previously untreated stage I or II pelvic organ prolapse attending gynaecology, urogynaecology and prolapse specific out-patient clinics at South Glasgow University NHS Trust and Grampian University Hospitals NHS Trust
Who cannot join
- previous surgical or conservative treatment for prolapse (e.g. pessary management or previous pelvic floor muscle training)
- women considered not suitable for physiotherapy treatment
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Grampian University Hospitals, NHS Grampian
Aberdeen, AB25 2ZB
South Glasgow University Hospitals Division, NHS Greater Glasgow
Glasgow, G4 0BA
About this study
Official title: A Feasibility Study for an RCT of a Pelvic Floor Muscle Training Intervention for Pelvic Organ Prolapse
The purpose of this study is to investigate the feasibility of undertaking a multi-centre randomised controlled trial of the effectiveness of a pelvic floor muscle training (PFMT) intervention for women with pelvic organ prolapse.
Read the detailed description
Pelvic organ prolapse is a common female condition; it is estimated that 50% of women experience some degree of prolapse and 30% of attendees at gynaecology clinics present with this problem. Vaginal delivery is cited as the main cause of prolapse but menopause, heavy lifting, chronic cough and straining are also important factors. Symptoms associated with prolapse are backache, pelvic heaviness and bladder, bowel and sexual dysfunction. Thus, the condition is debilitating and can greatly affect the sufferer's daily activities and quality of life.
Traditionally, treatment of prolapse consists of surgery or conservative treatment. Surgical procedures to repair the fascia vary and improved techniques are constantly being sought. At present however the recurrence rate of prolapse after surgery is 25%, with 80% re-occurring within two years of surgery. Conservative treatment is often considered if the prolapse is small or the patient is not a good candidate for surgery. There are three types of conservative treatment: 1) Physical interventions that aim to improve pelvic floor muscle function by using pelvic floor muscle assessment and exercises, neuromuscular electrical stimulation, 2) Mechanical interventions that aim to manage the prolapse by supporting the pelvic area (e.g. using vaginal ring pessaries) and, 3) Lifestyle interventions (such as weight loss and reducing exacerbating activities) that seek to avoid exacerbation of the prolapse by decreasing intra-abdominal pressure.
The promotion of pelvic floor exercises (PFEs) for prolapse varies between hospitals with some providing only a patient information leaflet and others giving individual instruction from a physiotherapist. Such a programme is referred to as pelvic floor muscle training (PFMT). An ongoing Cochrane review of the literature has, to date, found no evidence for management of pelvic organ prolapse using PFMT. This proposal addresses a gap in the research evidence by developing a multi-centre randomised controlled trial of a PFMT intervention for women with prolapse. The feasibility of all aspects of such a trial will be assessed, and pilot data will be collected at two Scottish Centres (Glasgow and Aberdeen). Ultimately, a multi-centre trial would aim to establish if PFMT is better than standardised management for reducing prolapse specific symptoms, prolapse severity, the need for surgical prolapse repair and the costs associated with the condition.
50 women attending out-patient clinics who are suitable for the study will be randomised to either the control or intervention arm of the trial. Women in the intervention arm will receive an individualised programme of PFMT delivered by a physiotherapist via 5 sessions of physiotherapy over a 16 week period. This programme will include pelvic muscle assessment, teaching and prescription of pelvic floor exercises, and provision of lifestyle advice. Women in the control arm will only receive, by post, a lifestyle advice leaflet. Type and severity of prolapse will be quantified according to ICS guidelines (POP-Q method). Data on outcome measures relating to improvement in prolapse symptoms and associated quality of life will be obtained via self-completion questionnaires
- Conditions
- Uterine Prolapse
- Being tested
- pelvic floor muscle training
- Keywords
- physical therapy, physiotherapy, pelvic organ prolapse
- Medical subject headings
- Uterine Prolapse, 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 trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in prolapse related symptoms and associated quality of life measured by a combination of ICIQ tools, the Prolapse Quality of Life tool and study specific questions at baseline, 20 weeks and 26 weeks.
Secondary outcomes (1)
Change in prolapse severity using the POP-Q method of quantification at baseline and 20 weeks, days of symptoms at baseline and 26 weeks, and general health status (SF-12) at baseline, 20 weeks and 26 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Investigators
- Suzanne Hagen, Principal investigator, NMAHP Reserach Unit, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158626
- Sponsor's protocol ID
- CZH/4/95
- Other IDs
- NRR N0470119684;, ISRCTN44995705
- Status last verified
- Mar 2015
- First submitted
- 8 Sep 2005
- Last updated
- 19 Mar 2015
- Results posted
- No
Publications
Hagen S, Stark D, Glazener C, Sinclair L, Ramsay I. A randomized controlled trial of pelvic floor muscle training for stages I and II pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):45-51. doi: 10.1007/s00192-008-0726-4. Epub 2008 Sep 20.
PubMed 18806910
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for an RCT of a Pelvic Floor Muscle Training Intervention for Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT00158626
- Acronym / sponsor ID
- CZH/4/95
- Conditions
- Uterine Prolapse
- Keywords
- physical therapy, physiotherapy, pelvic organ prolapse
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Study start
- Sep 2003
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 12 Sep 2005 (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.
The purpose of this study is to investigate the feasibility of undertaking a multi-centre randomised controlled trial of the effectiveness of a pelvic floor muscle training (PFMT) intervention for women with pelvic organ prolapse.
Detailed description
Pelvic organ prolapse is a common female condition; it is estimated that 50% of women experience some degree of prolapse and 30% of attendees at gynaecology clinics present with this problem. Vaginal delivery is cited as the main cause of prolapse but menopause, heavy lifting, chronic cough and straining are also important factors. Symptoms associated with prolapse are backache, pelvic heaviness and bladder, bowel and sexual dysfunction. Thus, the condition is debilitating and can greatly affect the sufferer's daily activities and quality of life.
Traditionally, treatment of prolapse consists of surgery or conservative treatment. Surgical procedures to repair the fascia vary and improved techniques are constantly being sought. At present however the recurrence rate of prolapse after surgery is 25%, with 80% re-occurring within two years of surgery. Conservative treatment is often considered if the prolapse is small or the patient is not a good candidate for surgery. There are three types of conservative treatment: 1) Physical interventions that aim to improve pelvic floor muscle function by using pelvic floor muscle assessment and exercises, neuromuscular electrical stimulation, 2) Mechanical interventions that aim to manage the prolapse by supporting the pelvic area (e.g. using vaginal ring pessaries) and, 3) Lifestyle interventions (such as weight loss and reducing exacerbating activities) that seek to avoid exacerbation of the prolapse by decreasing intra-abdominal pressure.
The promotion of pelvic floor exercises (PFEs) for prolapse varies between hospitals with some providing only a patient information leaflet and others giving individual instruction from a physiotherapist. Such a programme is referred to as pelvic floor muscle training (PFMT). An ongoing Cochrane review of the literature has, to date, found no evidence for management of pelvic organ prolapse using PFMT. This proposal addresses a gap in the research evidence by developing a multi-centre randomised controlled trial of a PFMT intervention for women with prolapse. The feasibility of all aspects of such a trial will be assessed, and pilot data will be collected at two Scottish Centres (Glasgow and Aberdeen). Ultimately, a multi-centre trial would aim to establish if PFMT is better than standardised management for reducing prolapse specific symptoms, prolapse severity, the need for surgical prolapse repair and the costs associated with the condition.
50 women attending out-patient clinics who are suitable for the study will be randomised to either the control or intervention arm of the trial. Women in the intervention arm will receive an individualised programme of PFMT delivered by a physiotherapist via 5 sessions of physiotherapy over a 16 week period. This programme will include pelvic muscle assessment, teaching and prescription of pelvic floor exercises, and provision of lifestyle advice. Women in the control arm will only receive, by post, a lifestyle advice leaflet. Type and severity of prolapse will be quantified according to ICS guidelines (POP-Q method). Data on outcome measures relating to improvement in prolapse symptoms and associated quality of life will be obtained via self-completion questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women with previously untreated stage I or II pelvic organ prolapse attending gynaecology, urogynaecology and prolapse specific out-patient clinics at South Glasgow University NHS Trust and Grampian University Hospitals NHS Trust
Key exclusion criteria (2 listed)
- previous surgical or conservative treatment for prolapse (e.g. pessary management or previous pelvic floor muscle training)
- women considered not suitable for physiotherapy 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 training | Behavioural | – |
Primary outcome
Change in prolapse related symptoms and associated quality of life measured by a combination of ICIQ tools, the Prolapse Quality of Life tool and study specific questions at baseline, 20 weeks and 26 weeks.
1 secondary outcome
Change in prolapse severity using the POP-Q method of quantification at baseline and 20 weeks, days of symptoms at baseline and 26 weeks, and general health status (SF-12) at baseline, 20 weeks and 26 weeks.
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 19 Mar 2015.
- Background: PubMed 18806910Hagen S, Stark D, Glazener C, Sinclair L, Ramsay I. A randomized controlled trial of pelvic floor muscle training for stages I and II pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):45-51. doi: 10.1007/s00192-008-0726-4. Epub 2008 Sep 20.
- results paper in IUJLink provided by the sponsor.
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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.
Suzanne Hagen principal investigator
NMAHP Reserach Unit, Glasgow Caledonian University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing pelvic floor muscle training in people with Uterine Prolapse, run by Glasgow Caledonian University at 2 sites in United Kingdom.
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 1 inclusion and 2 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 19 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 2 sites in United Kingdom. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in prolapse related symptoms and associated quality of life measured by a combination of ICIQ tools, the Prolapse Quality of Life tool and study specific questions at baseline, 20 weeks and 26 weeks.. 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 NCT00158626, which also lists 1 linked publication.
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 19 Mar 2015.