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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
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Scientific title
Conservative treatment for incontinence in elderly women in rest homes: a cost efficacy study
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Secondary ID [1]
283903
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Nil known
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Universal Trial Number (UTN)
Not obtained
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urinary incontinence
290901
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Bowel incontinence
290961
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Condition category
Condition code
Renal and Urogenital
291251
291251
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0
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
288584
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Treatment: Other
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Comparator / control treatment
Before and after intervention study of patient cohort
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Continence levels
Bladder diary for 24 hours, and bowel diary for one week. Pad usage and pad weigh tests, Post void residual urine.
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Assessment method [1]
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Timepoint [1]
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12 weeks
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Primary outcome [2]
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Patient perspectives on quality of life issues
Questionnaires: FIM, EQ5D, ICIQ-SF
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Assessment method [2]
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Timepoint [2]
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12 weeks
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Secondary outcome [1]
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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.
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Assessment method [1]
306340
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Timepoint [1]
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12 weeks
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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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Significant cognitive impairment.
Residents were all residents of rest homes and were elderly, but age was not an inclusion/exclusion criterion
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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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
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
11/06/2012
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Date of last participant enrolment
Anticipated
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Actual
10/06/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
70
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5748
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New Zealand
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State/province [1]
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Canterbury
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Canterbury District Health Board
Planning and Funding Department
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Address [1]
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PO Box 1600
Christchurch 8140
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Country [1]
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New Zealand
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Funding source category [2]
288545
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Charities/Societies/Foundations
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Name [2]
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Urological Research Foundation
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Address [2]
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c/- Mobile Medical Technology
PO Box 39188
Christchurch 8545
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Country [2]
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New Zealand
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Primary sponsor type
Hospital
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Name
Canterbury District Health Board
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Address
Planning and Funding Department
PO Box 1600
Christchurch 8140
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Country
New Zealand
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Secondary sponsor category [1]
287256
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Other Collaborative groups
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Name [1]
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Continence Forum,
Planning and Funding Department
Canterbury District Health Board
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Address [1]
287256
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Department of Health Care of the Elderly
The Princess Margaret Hospital
PO Box 1600
Christchurch 8140
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Country [1]
287256
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New Zealand
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Other collaborator category [1]
277758
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Individual
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Name [1]
277758
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Dr S F English
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Address [1]
277758
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Department of Urology,
Christchurch Hospital
PO Box 1600
Christchurch 8140
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Country [1]
277758
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
290409
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Upper South A Regional Ethics Committee c/- Ministry of Health,
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Ethics committee address [1]
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13 The Terrace,
PO Box 5013
Wellington 6145
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
290409
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Approval date [1]
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18/04/2012
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Ethics approval number [1]
290409
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URA/12/03/010
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Summary
Brief summary
Efficacy of conservative treatments for incontinence in an elderly group of women dwelling in rest homes, and the costs involved in achieving any benefit. Outcome measures include the severity of leakage, and the effect on quality of life.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Edwin Arnold
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Address
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Department of Urology, Christchurch Hospital
190 Cannon Hill Crescent,
Mount Pleasant
Christchurch 8081
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Country
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New Zealand
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Phone
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+64 3 384 3799
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Edwin Arnold
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Address
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Department of Urology
Christchurch Hospital.
190 Cannon Hill Crescent,
Mount Pleasant
Christchurch 8081
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Country
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New Zealand
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Phone
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+64 3 384 3799
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Edwin Arnold
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Address
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Department of Urology
Christchurch Hospital
190 Cannon Hill Crescent,
Mount Pleasant
Christchurch 8081
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Country
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New Zealand
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Phone
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+64 3 384 3799
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Fax
45536
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Email
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[email protected]
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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.
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