SURE: Clean Intermittant Self Catheterisation: A Trial Comparing Single Use vs Reuse of Nelaton Catheters
Study Details
Study Description
Brief Summary
The purpose of the study is to compare single use of catheters with reuse of catheters for intermittant self catheterisation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Patients with voiding dysfunction and chronic urinary retention are taught the technique Clean Intermittent Self Catheterisation (CISC) by specialist Nurse Continence Advisors.
For several decades, patients have been taught to catheterise using a "clean" technique where they rinse their catheter under tap water and store the catheter in a sterile solution (e.g. Milton). The catheter is re-used for up to one week. The risk of urinary tract infection (UTI) was known to be minimal (and certainly much less than having a permanent indwelling catheter).
Recently, the Therapeutics Goods Administration has issued a guideline that CISC catheters should be "single-use items" but no data to support this guideline appears to have been collected.
The aim of this project is to assess the incidence of urinary tract infection (UTI) when comparing single-use catheters with re-use of catheters for CISC, and to determine the cost differences between the two methods.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Single use group New catheter for each Clean Intermittent Self Catheterisation (CISC), then discard. |
Device: 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
Other Names:
|
| 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. |
Device: 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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Rate of Urinary Tract Infection [16 weeks]
Urine specimens are sent at 4 weekly intervals over 16 weeks to check for Urinary tract infection
Secondary Outcome Measures
- Economic Cost [16 weeks]
Difference in econimic cost of single use Catheterisation and re use catheterisation and the impact on the patient
Eligibility Criteria
Criteria
Inclusion Criteria:
-
over 18 years old
-
CISC > 2/day
-
No current symptomatic UTI
-
Willing to change catheter use method
Exclusion Criteria:
-
Symptomatic Urinary Tract infection despite treatment
-
<18 years old
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pelvic Floor Bladder Unit St George Hospital | Sydney | New South Wales | Australia | 2217 |
Sponsors and Collaborators
- St George Hospital, Australia
Investigators
- Principal Investigator: Kate Moore, A/Professor, St George Hospital
- Principal Investigator: Dr Emmanuel Karantanis, Doctor, St George Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 09/STG/176