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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
The purpose of the study is to compare single use of catheters with reuse of catheters for
intermittant self catheterisation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01404481
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01404481