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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01404481




Registration number
NCT01404481
Ethics application status
Date submitted
27/07/2011
Date registered
28/07/2011
Date last updated
24/07/2015

Titles & IDs
Public title
Clean Intermittant Self Catheterisation: A Trial Comparing Single Use vs Reuse of Nelaton Catheters
Scientific title
Clean Intermittant Self Catheterisation: A Randomised Control Trial Comparing Single Use vs Reuse of Nelaton Catheters
Secondary ID [1] 0 0
09/STG/176
Universal Trial Number (UTN)
Trial acronym
SURE
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - clean intermittent self catheterisation single use vs re use

Single use group - New catheter for each Clean Intermittent Self Catheterisation (CISC), then discard.

Re use of catheters group - Use same catheter for 1week- Cleaning with sunlight liquid soap, air dry or dry with lint free towel, store in a snap lock bag.

Discard catheter and snap lock bag at end of each week.


Treatment: Devices: clean intermittent self catheterisation single use vs re use
Over the 16 week period all patient will participate in 8 weeks of single use cathetersation and 8 weeks of re use catheterisation. The study is a randomised control crossover trial
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Urinary Tract Infection
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
Economic Cost
Timepoint [1] 0 0
16 weeks

Eligibility
Key inclusion criteria
* over 18 years old
* CISC > 2/day
* No current symptomatic UTI
* Willing to change catheter use method
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Symptomatic Urinary Tract infection despite treatment
* <18 years old

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Pelvic Floor Bladder Unit St George Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
St George Hospital, Australia
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Kate Moore, A/Professor
Address 0 0
St George Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01404481