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

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

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

Study Overview

• Status: Completed
• Conditions: Urinary Retention
• Intervention / Treatment: Device: clean intermittent self catheterisation single use vs re use

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 Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2217
      • Pelvic Floor Bladder Unit St George Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Continence clinic, community patients, hospital patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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: Nelaton; Catheters
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: Nelaton; Catheters

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St George Hospital, Australia
• Investigators: Principal Investigator: Kate Moore, A/Professor, St George Hospital; Principal Investigator: Dr Emmanuel Karantanis, Doctor, St George Hospital

Publications and helpful links

General Publications

• Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: July 27, 2011
• First Submitted That Met QC Criteria: July 27, 2011
• First Posted (ESTIMATE): July 28, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 24, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Urinary retention; CISC; Single use; Re use
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: 09/STG/176