Condition category
Urological and Genital Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
07/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Libby Whelpton

ORCID ID

Contact details

Willesden Community Hospital
Harlesden Road
London
NW10 3RY
United Kingdom
+44 (0)20 8451 8281 (ans)
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

M0001127331

Study information

Scientific title

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

Acronym

Study hypothesis

One 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Urological and Genital Diseases: Urinary incontinence

Intervention

Participants 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The 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 measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

01/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Women between the ages of 30 and 65 with USI

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/01/2003

Recruitment end date

01/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Willesden Community Hospital
London
NW10 3RY
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Research organisation

Funder name

The West London Research Network (WeLReN) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes