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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01404481
Acronym
SURE
Enrollment
23
Registered
2011-07-28
Start date
2010-03-31
Completion date
2013-04-30
Last updated
2015-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Retention

Keywords

Urinary retention, CISC, Single use, Re use

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.

Interventions

DEVICEclean 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

Sponsors

St George Hospital, Australia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Urinary Tract Infection16 weeksUrine specimens are sent at 4 weekly intervals over 16 weeks to check for Urinary tract infection

Secondary

MeasureTime frameDescription
Economic Cost16 weeksDifference in econimic cost of single use Catheterisation and re use catheterisation and the impact on the patient

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026