Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000755639
Ethics application status
Approved
Date submitted
15/11/2005
Date registered
18/11/2005
Date last updated
8/09/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of magnets in the control of urinary incontinence
Scientific title
Efficacy of non-invasive magnetic stimulation of the pelvic floor in the control of urinary incontinence
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Incontinence 911 0
Condition category
Condition code
Renal and Urogenital 978 978 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is designed to determine the efficacy of using a non-invasive, easy to use, cost effective system in the control of urinary incontinence in women who are ageing. This project is a double-blind randomised controlled trial (RCT) of magnetic stimulation of the pelvic area. The system is based on the use of non-invasive magnetic stimulation and consists of an undergarment with 15 in-built magnets placed anterior, posterior and inferior to the pelvis. The undergarment is worn over the participant's usual underwear for a period of at least 6 hours during the day and at least 6 hours during the night.

The discs in the treatment garment are magnetic. The trial duration is 12 weeks.
Intervention code [1] 759 0
Treatment: Devices
Comparator / control treatment
Participants in the control group will wear the same designed undergarment as participants in the treatment group, with the same number of in-built discs in the same anatomical positions. However, the metal discs in the placebo garment are inert and have no magnetic properties. The undergarment is worn over the participant's usual underwear for a period of at least 6 hours during the day and at least 6 hours during the night. The trial duration is 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 1300 0
The primary outcome for this study is cessation of episodes of urinary incontinence within a twelve week time period.
Timepoint [1] 1300 0
Measured at baseline, four weeks and twelve weeks using a 24-hour pad test, 48-hour bladder diary and the Bristol Female Lower Urinary Tract Symptoms Scored form questionnaire.
Secondary outcome [1] 2326 0
Reduction in frequency of incontinence episodes and volume of urine lost involuntarily as measured by 24-hour pad test, 48-hour bladder diary and the Bristol Female Lower Urinary Tract Symptoms Scored form questionnaire.
Timepoint [1] 2326 0
Measured at baseline, four weeks and twelve weeks

Eligibility
Key inclusion criteria
Participants were included based on the following criteria: Suffering urinary incontinence; Living independently in the community; English speaking and sufficient reading and writing ability.
Minimum age
60 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
People who met the inclusion criteria were excluded if they: had impaired physical functioning; had cognitive/intellectual impairment; had a cardiac pacemaker, defibrillator, infusion pump or any other implanted electronic equipment; were receiving non-conservative treatment; or suffered symptomatic urinary tract infections and/or a positive MSU.

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)
Sequentially numbered sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation followed a permuted blocks within strata design. Stratification was by recruiting centre as there were multiple recruitment sites. Blocks per centre were used to ensure the allocation to treatment and placebo groups were equal at each recruitment site. The sequence per block was generated by randomly selecting different combinations of treatment allocation sequence from a container.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1075 0
Government body
Name [1] 1075 0
Australian Department of Health & Ageing
Country [1] 1075 0
Australia
Primary sponsor type
University
Name
Research Centre for Clinical Practice Innovation, Griffith University
Address
Griffith University, Gold Coast Campus, QLD 4222
Country
Australia
Secondary sponsor category [1] 936 0
None
Name [1] 936 0
N/A
Address [1] 936 0
N/A
Country [1] 936 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2377 0
Griffith University HREC
Ethics committee address [1] 2377 0
Ethics committee country [1] 2377 0
Australia
Date submitted for ethics approval [1] 2377 0
Approval date [1] 2377 0
Ethics approval number [1] 2377 0
Ethics committee name [2] 2378 0
University of Queensland HREC
Ethics committee address [2] 2378 0
Ethics committee country [2] 2378 0
Australia
Date submitted for ethics approval [2] 2378 0
Approval date [2] 2378 0
Ethics approval number [2] 2378 0
Ethics committee name [3] 2379 0
Royal Brisbane & Women's Hospital HREC
Ethics committee address [3] 2379 0
Ethics committee country [3] 2379 0
Australia
Date submitted for ethics approval [3] 2379 0
Approval date [3] 2379 0
Ethics approval number [3] 2379 0
Ethics committee name [4] 2380 0
The Prince Charles Hospital HREC
Ethics committee address [4] 2380 0
Ethics committee country [4] 2380 0
Australia
Date submitted for ethics approval [4] 2380 0
Approval date [4] 2380 0
Ethics approval number [4] 2380 0
Ethics committee name [5] 2381 0
Gold Coast Hospital HREC
Ethics committee address [5] 2381 0
Ethics committee country [5] 2381 0
Australia
Date submitted for ethics approval [5] 2381 0
Approval date [5] 2381 0
Ethics approval number [5] 2381 0
Ethics committee name [6] 2382 0
Blue Care Research Reference Group
Ethics committee address [6] 2382 0
Ethics committee country [6] 2382 0
Australia
Date submitted for ethics approval [6] 2382 0
Approval date [6] 2382 0
Ethics approval number [6] 2382 0

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

Contacts
Principal investigator
Name 36039 0
Address 36039 0
Country 36039 0
Phone 36039 0
Fax 36039 0
Email 36039 0
Contact person for public queries
Name 9948 0
Professor Marianne Wallis
Address 9948 0
Research Centre for Clinical Practice Innovation Griffith University Gold Coast Campus Post QLD 4222
Country 9948 0
Australia
Phone 9948 0
+61 7 55528759
Fax 9948 0
+61 7 55529144
Email 9948 0
[email protected]
Contact person for scientific queries
Name 876 0
Professor Marianne Wallis
Address 876 0
Research Centre for Clinical Practice Innovation Griffith University Gold Coast Campus Post QLD 4222
Country 876 0
Australia
Phone 876 0
+61 7 55528759
Fax 876 0
+61 7 55529144
Email 876 0
[email protected]

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.