Does Doing Pelvic Floor Exercise Ease Symptoms for Women Living With Prolapse?

NCT ID: NCT00158626

Last Updated: 2015-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2005-08-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

pelvic floor muscle training

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• previous surgical or conservative treatment for prolapse (e.g. pessary management or previous pelvic floor muscle training)
• women considered not suitable for physiotherapy treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chief Scientist Office of the Scottish Government

OTHER_GOV

Sponsor Role: collaborator

Glasgow Caledonian University

OTHER

Sponsor Role: lead

Principal Investigators

Suzanne Hagen

Role: PRINCIPAL_INVESTIGATOR

NMAHP Reserach Unit, Glasgow Caledonian University

Locations

Grampian University Hospitals, NHS Grampian

Aberdeen, , United Kingdom

South Glasgow University Hospitals Division, NHS Greater Glasgow

Glasgow, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 18806910 (View on PubMed)

Related Links

http://link.springer.com/article/10.1007/s00192-008-0726-4#

results paper in IUJ

Other Identifiers

NRR N0470119684;

Identifier Type: -

Identifier Source: secondary_id

ISRCTN44995705

Identifier Type: -

Identifier Source: secondary_id

CZH/4/95

Identifier Type: -

Identifier Source: org_study_id