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

Urinary Retention Clinical Trial

— SURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404481
• Other study ID #: 09/STG/176
• Status: Completed
• Phase: N/A
• First received: July 27, 2011
• Last updated: July 22, 2015
• Start date: March 2010
• Est. completion date: April 2013

Study information

• Verified date: July 2015
• Source: St George Hospital, Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Urinary Retention

Intervention

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

Locations

Country	Name	City	State
Australia	Pelvic Floor Bladder Unit St George Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
St George Hospital, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Urinary Tract Infection	Urine specimens are sent at 4 weekly intervals over 16 weeks to check for Urinary tract infection	16 weeks	Yes
Secondary	Economic Cost	Difference in econimic cost of single use Catheterisation and re use catheterisation and the impact on the patient	16 weeks	No