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Completed

NCT Number: NCT01404481

Clean Intermittant Self Catheterisation: A 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pelvic Floor Bladder Unit St George Hospital

Sydney, New South Wales, 2217, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clean intermittent self catheterisation single use vs re use

Device

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

Primary outcomes

  1. Rate of Urinary Tract Infection

    Time frame: 16 weeks

    Urine specimens are sent at 4 weekly intervals over 16 weeks to check for Urinary tract infection

Secondary outcomes

  1. Economic Cost

    Time frame: 16 weeks

    Difference in econimic cost of single use Catheterisation and re use catheterisation and the impact on the patient

Sponsors and collaborators

Lead sponsor

St George Hospital, Australia

Other

Registry information

Official study title

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

Acronym: SURE

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 28, 2011
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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