Re-education of the pelvic floor in women with urinary stress incontinence

ISRCTN ISRCTN59388318
DOI https://doi.org/10.1186/ISRCTN59388318
Secondary identifying numbers M0001127331
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
07/09/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Libby Whelpton
Scientific

Willesden Community Hospital
Harlesden Road
London
NW10 3RY
United Kingdom

Phone +44 (0)20 8451 8281 (ans)
Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRe-education of the pelvic floor in women with urinary stress incontinence
Study objectivesOne in four women suffer from Urinary Stress Incontinence (USI). The literature search suggests there is evidence from clinical experience and from research into the management of low back pain that retraining of the transversus abdominis muscle using real time ultrasound can facilitate correct tonic activity of the pelvic floor muscles (Richardson et al, 1999 and Critchely et al 2002). Studies so far of facilitation of the pelvic floor using RTUS have so far only been tested in healthy adult females (Sapsford, 2001).

The aim of this study is to evaluate if by using Real Time Ultra Sound biofeedback (RTUS), a non-invasive technique, patients with urinary stress incontinence can learn more quickly how to co-contract the Transversus Abdominis muscle (TrA) and Pelvic Floor Muscles (PFM) in order to rehabilitate the pelvic floor and thereby reduce or eradicate the distressful symptoms of leakage. If RTUS can shorten the number of sessions required for patients to learn correctly how to co-contract the pelvic floor muscles this would enable physiotherapists to see a greater number of patients.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUrological and Genital Diseases: Urinary incontinence
InterventionParticipants will be randomised into two groups, one with RTUS over the abdominal muscles to facilitate instructions to activate co-contraction of the pelvic floor muscles, and the other without real time ultra sound biofeedback. Assessment parameters include a leakage diary, a one hour pad test, and subjective evaluation of life impact questionnaire (Kings Health Questionnaire). Each group will be assessed after 12 weeks training.
Intervention typeOther
Primary outcome measureThe study is to evaluate if by using RTUS, patients with urinary stress incontinence can learn more quickly how to co-contract the Transversus Abdominis muscle (TrA) and Pelvic Floor Muscles (PFM) in order to rehabilitate the pelvic floor and thereby reduce or eradicate the distressful symptoms of leakage. If RTUS can shorten the number of sessions required for patients to learn correctly how to co-contract the pelvic floor muscles this would enable physiotherapists to see a greater number of patients .
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2003
Completion date01/03/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants40
Key inclusion criteriaWomen between the ages of 30 and 65 with USI
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/01/2003
Date of final enrolment01/03/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Willesden Community Hospital
London
NW10 3RY
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Research organisation

The West London Research Network (WeLReN) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan