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
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