Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000087651
Ethics application status
Approved
Date submitted
14/01/2014
Date registered
23/01/2014
Date last updated
23/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Outcomes from standard treatment for incontinence in elderly women in residential care
Scientific title
Conservative treatment for incontinence in elderly women in rest homes: a cost efficacy study
Secondary ID [1] 283903 0
Nil known
Universal Trial Number (UTN)
Not obtained
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary incontinence 290901 0
Bowel incontinence 290961 0
Condition category
Condition code
Renal and Urogenital 291251 291251 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:Conservative treatment tailored by the Continence Advisor to each individual. Recording of a bladder diary, of pad usage and volume leaked. The intervention includes pelvic floor muscle training, bladder re-training, life style interventions like increased physical activity, attention to fluid intake type and volume, and diet suggestions, performed by the individual and supervised daily by the carer , and by the Advisor every 2-4 weeks. Treatment was for 12 weeks for each individual and hopefully advice continued via the carer indefinitely. At the end of the 12 weeks further tests were run and costs measured.The study lasted for a year as the dates of recruitment was staggered.
Costs of the intervention were recorded for a cost efficacy analysis
Intervention code [1] 288584 0
Treatment: Other
Comparator / control treatment
Before and after intervention study of patient cohort
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291245 0
Continence levels

Bladder diary for 24 hours, and bowel diary for one week. Pad usage and pad weigh tests, Post void residual urine.
Timepoint [1] 291245 0
12 weeks
Primary outcome [2] 291246 0
Patient perspectives on quality of life issues
Questionnaires: FIM, EQ5D, ICIQ-SF
Timepoint [2] 291246 0
12 weeks
Secondary outcome [1] 306340 0
Total Costs of the intervention include the cost of protective pads, carer time and additional laundry.
Time and mileage costs of the continence Advisor were recorded.
Timepoint [1] 306340 0
12 weeks

Eligibility
Key inclusion criteria
Female
Urinary and/or bowel incontinence requiring at least one pad/day
Reasonable cognitive function and ability to provide informed consent
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant cognitive impairment.
Residents were all residents of rest homes and were elderly, but age was not an inclusion/exclusion criterion

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants were women with incontinence identified by the clinical manager of each rest home. Each was provided with information about the trial. Those deemed possible were given a Minimental status questionnarie to complete. Those with a score of <20/30 were excluded. No other exclusion criteria. Finally a consent form was completed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Each resthome had only a limited number of suitable participants.
To detect a moderate difference of 0.5 SD using a paired t-test with an alpha =0.05 with 90% power needed 44, but as residents were clustered a design effect of 1.2 was allowed bring the numbers to 53. To allow for non-response another 10% was added, and to allow for unforeseen withdrawal on health grounds in this elderly group we aimed for 70. A mixed model was used, and analysed with Stata 13.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/06/2012
Date of last participant enrolment
Anticipated
Actual
10/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 5748 0
New Zealand
State/province [1] 5748 0
Canterbury

Funding & Sponsors
Funding source category [1] 288544 0
Hospital
Name [1] 288544 0
Canterbury District Health Board
Planning and Funding Department
Country [1] 288544 0
New Zealand
Funding source category [2] 288545 0
Charities/Societies/Foundations
Name [2] 288545 0
Urological Research Foundation
Country [2] 288545 0
New Zealand
Primary sponsor type
Hospital
Name
Canterbury District Health Board
Address
Planning and Funding Department
PO Box 1600
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 287256 0
Other Collaborative groups
Name [1] 287256 0
Continence Forum,
Planning and Funding Department
Canterbury District Health Board
Address [1] 287256 0
Department of Health Care of the Elderly
The Princess Margaret Hospital
PO Box 1600
Christchurch 8140
Country [1] 287256 0
New Zealand
Other collaborator category [1] 277758 0
Individual
Name [1] 277758 0
Dr S F English
Address [1] 277758 0
Department of Urology,
Christchurch Hospital
PO Box 1600
Christchurch 8140
Country [1] 277758 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290409 0
Upper South A Regional Ethics Committee c/- Ministry of Health,
Ethics committee address [1] 290409 0
Ethics committee country [1] 290409 0
New Zealand
Date submitted for ethics approval [1] 290409 0
Approval date [1] 290409 0
18/04/2012
Ethics approval number [1] 290409 0
URA/12/03/010

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

Contacts
Principal investigator
Name 45534 0
A/Prof Edwin Arnold
Address 45534 0
Department of Urology, Christchurch Hospital

190 Cannon Hill Crescent,
Mount Pleasant
Christchurch 8081
Country 45534 0
New Zealand
Phone 45534 0
+64 3 384 3799
Fax 45534 0
Email 45534 0
ted.arnold@otago.ac.nz
Contact person for public queries
Name 45535 0
Edwin Arnold
Address 45535 0
Department of Urology
Christchurch Hospital.

190 Cannon Hill Crescent,
Mount Pleasant
Christchurch 8081
Country 45535 0
New Zealand
Phone 45535 0
+64 3 384 3799
Fax 45535 0
Email 45535 0
ted.arnold@otago.ac.nz
Contact person for scientific queries
Name 45536 0
Edwin Arnold
Address 45536 0
Department of Urology
Christchurch Hospital
190 Cannon Hill Crescent,
Mount Pleasant
Christchurch 8081
Country 45536 0
New Zealand
Phone 45536 0
+64 3 384 3799
Fax 45536 0
Email 45536 0
ted.arnold@otago.ac.nz

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.