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Trial registered on ANZCTR


Registration number
ACTRN12606000511538
Ethics application status
Not yet submitted
Date submitted
7/12/2006
Date registered
8/12/2006
Date last updated
8/12/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Stroke incontinence study
Scientific title
A randomised controlled trial to evaluate the effects of a continence promotion program including real time ultrasound as biofeedback for pelvic floor muscle rehabilitation, delivered to stroke survivors to reduce urinary incontinence and lower urinary tract symptoms.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary incontinence after stroke 1488 0
Condition category
Condition code
Stroke 1583 1583 0 0
Renal and Urogenital 1584 1584 0 0
Other renal and urogenital disorders
Physical Medicine / Rehabilitation 1585 1585 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group will receive daily physiotherapy stroke rehabilitation. As well as this, they will receive specifically designed:
Continence promotion intervention that will be tailored to patient's requirements and might include:
Bladder training,
Pelvic floor muscle exercises,
Real Time Ultrasound Biofeedback for pelvic floor and transversus abdominis muscles.
Pelvic floor muscle exercises will be encouraged at each physiotherapy intervention. Bladder training protocols will need to be repeated daily since stroke patients often have problems with short term memory deficits.
Real time ultrasound provides images of muscles as they actually contract. Biofeedback using real time ultrasound will be used to teach patients how to contract pelvic floor muscles and abdominal muscles. It will be used daily until patients are aware of the muscle contraction and no longer require biofeedback. This will differ between patients
Information booklet based on succesfully developed continence promotion booklets previously produced by Dr Chiarelli aimed at different clinical groups e.g postpartum women, older people following surgery for fractured hip.
The "Waterworks after Stroke" information booklet will be designed using health promotion principles and with the assistance of speech pathologists who have special expertise in management of stroke patients. Booklet will be given to patients and their carers. Acceptability, understandability and relevance of the contents of the booklet will be tested in both patient and carer groups
Intervention progressed as required for the duration of patient's stay in Rehabiliation Unit
Intervention code [1] 1491 0
Rehabilitation
Comparator / control treatment
Control group to receive usual care consisting of routine physiotherapy post stroke rehabiliation tailored to individual patient needs.
Control group
Active

Outcomes
Primary outcome [1] 2187 0
Urinary incontinence, will be measured using:
24 hour pad test
Timepoint [1] 2187 0
On admission to the rehabilitation unit and immediately prior to discharge
Primary outcome [2] 2188 0
Urinary incontinence, will be measured using:
Validated questionnaire
Timepoint [2] 2188 0
On admission to the rehabilitation unit and immediately prior to discharge
Primary outcome [3] 2189 0
Urinary incontinence, will be measured using :
Ultrasound assessment of pelvic floor and abdominal muscle function.
Timepoint [3] 2189 0
On admission to the rehabilitation unit and immediately prior to discharge
Secondary outcome [1] 3816 0
Functional Independence measure
Timepoint [1] 3816 0
Time points on admission to unit and immediately prior to discharge
Secondary outcome [2] 3817 0
Trunk control test.
Timepoint [2] 3817 0
Time points on admission to unit and immediately prior to discharge

Eligibility
Key inclusion criteria
Admitted to stroke rehabilitation unit.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Unaware of loss of bladder controlIndwelling urethral catheter in situdocumentation of pelvic organ prolapse, suffering chronic obstructive pulmonary disease, psychological problems, other neurological conditions, not understanding English, severely hearing impaired, severely sight impaired.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessors at final assessment at time of discharge from the unit will be blinded to patient's group allocation
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1729 0
University
Name [1] 1729 0
University of Newcastle Faculty of Health
Country [1] 1729 0
Australia
Primary sponsor type
Individual
Name
Dr Pauline Chiarelli
Address
Country
Secondary sponsor category [1] 1524 0
University
Name [1] 1524 0
Centre for Research in Gender Health and Aging
Address [1] 1524 0
Country [1] 1524 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3195 0
Rankin Park Hospital Stroke Rehabilitation Unit
Ethics committee address [1] 3195 0
Ethics committee country [1] 3195 0
Australia
Date submitted for ethics approval [1] 3195 0
Approval date [1] 3195 0
Ethics approval number [1] 3195 0
Ethics committee name [2] 3196 0
Belmont District Hospital Stroke Rehabilitation Unit
Ethics committee address [2] 3196 0
Ethics committee country [2] 3196 0
Australia
Date submitted for ethics approval [2] 3196 0
Approval date [2] 3196 0
Ethics approval number [2] 3196 0
Ethics committee name [3] 3197 0
Maitland Hospital Stroke Rehabilitation Unit
Ethics committee address [3] 3197 0
Ethics committee country [3] 3197 0
Australia
Date submitted for ethics approval [3] 3197 0
Approval date [3] 3197 0
Ethics approval number [3] 3197 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27425 0
Address 27425 0
Country 27425 0
Phone 27425 0
Fax 27425 0
Email 27425 0
Contact person for public queries
Name 10680 0
Dr Pauline Chiarelli
Address 10680 0
Box 24 Hunter Building, University of Newcastle, Callaghan 2308 NSW
Country 10680 0
Australia
Phone 10680 0
61 2 49216046
Fax 10680 0
61 2 497902
Email 10680 0
Pauline.Chiarelli@newcastle.edu.au
Contact person for scientific queries
Name 1608 0
Professor Julie Byles
Address 1608 0
Director, Research Centre for Gender, Health and Ageing

Level 2, David Madison Sciences Block
Cnr King and Watt Sts
Newcastle NSW 2300
Country 1608 0
Australia
Phone 1608 0
61 2 4923 6643
Fax 1608 0
61 2 492 36321
Email 1608 0
julie.byles@newcastle.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.