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

Completed

• Conditions: Urinary Retention
• Interventions: Device: clean intermittent self catheterisation single use vs re use

• Registration Number: NCT01404481
• Lead Sponsor: St George Hospital, Australia

Brief Summary

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

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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-07-27
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Re use of catheters group	clean intermittent self catheterisation single use vs re use	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.
Single use group	clean intermittent self catheterisation single use vs re use	New catheter for each Clean Intermittent Self Catheterisation (CISC), then discard.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Economic Cost	16 weeks	Difference in econimic cost of single use Catheterisation and re use catheterisation and the impact on the patient

Trial Locations

Locations (1)

Pelvic Floor Bladder Unit St George Hospital; 🇦🇺 Sydney, New South Wales, Australia