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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United Kingdom

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

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.

  1. 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)
  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.

  1. First posted12 Sep 2005 (estimated)
  2. Study startSep 2003
  3. Primary completionAug 2005
  4. Study completionAug 2005

Resources

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
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

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.

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