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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01404481
First Posted: July 28, 2011
Last Update Posted: July 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hayley Leek, St George Hospital, Australia
  Purpose
The purpose of the study is to compare single use of catheters with reuse of catheters for intermittant self catheterisation.

Condition Intervention
Urinary Retention Device: clean intermittent self catheterisation single use vs re use

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clean Intermittant Self Catheterisation: A Randomised Control Trial Comparing Single Use vs Reuse of Nelaton Catheters

Further study details as provided by Hayley Leek, St George Hospital, Australia:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Economic Cost [ Time Frame: 16 weeks ]
    Difference in econimic cost of single use Catheterisation and re use catheterisation and the impact on the patient


Enrollment: 23
Study Start Date: March 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Continence clinic, community patients, hospital patients
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404481


Locations
Australia, New South Wales
Pelvic Floor Bladder Unit St George Hospital
Sydney, New South Wales, Australia, 2217
Sponsors and Collaborators
St George Hospital, Australia
Investigators
Principal Investigator: Kate Moore, A/Professor St George Hospital
Principal Investigator: Dr Emmanuel Karantanis, Doctor St George Hospital
  More Information

Responsible Party: Hayley Leek, Hayley Leek CNS Urology/Continence NCA, St George Hospital, Australia
ClinicalTrials.gov Identifier: NCT01404481     History of Changes
Other Study ID Numbers: 09/STG/176
First Submitted: July 27, 2011
First Posted: July 28, 2011
Last Update Posted: July 24, 2015
Last Verified: July 2015

Keywords provided by Hayley Leek, St George Hospital, Australia:
Urinary retention
CISC
Single use
Re use

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases