Clean Intermittant Self Catheterisation: A Trial Comparing Single Use vs Reuse of Nelaton Catheters

Study Overview
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Brief Summary
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The purpose of the study is to compare single use of catheters with reuse of catheters for intermittant self catheterisation.

Detailed Description
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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.

Official Title
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Clean Intermittant Self Catheterisation: A Randomised Control Trial Comparing Single Use vs Reuse of Nelaton Catheters

Conditions
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Urinary Retention

Intervention / Treatment
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* Device: clean intermittent self catheterisation single use vs re use


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single use group<br>New catheter for each Clean Intermittent Self Catheterisation (CISC), then discard. | Device: clean intermittent self catheterisation single use vs re use<br>* 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<br>* Other names: Catheters;|
| Re use of catheters group<br>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<br>* 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<br>* Other names: Catheters;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Urinary Tract Infection | Urine specimens are sent at 4 weekly intervals over 16 weeks to check for Urinary tract infection | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic Cost | Difference in econimic cost of single use Catheterisation and re use catheterisation and the impact on the patient | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary retention, CISC, Single use, Re use