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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by St George Hospital, Australia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St George Hospital, Australia
ClinicalTrials.gov Identifier:
NCT01404481
First received: July 27, 2011
Last updated: NA
Last verified: March 2010
History: No changes posted
  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 St George Hospital, Australia:

Primary Outcome Measures:
  • Rate of Urinary Tract Infection [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Difference in econimic cost of single use Catheterisation and re use catheterisation and the impact on the patient


Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404481

Contacts
Contact: Hayley Leek, RN 612 9113 3278 hayley.leek@sesiahs.health.nsw.gov.au

Locations
Australia, New South Wales
Pelvic Floor Bladder Unit St George Hospital Recruiting
Sydney, New South Wales, Australia, 2217
Contact: Hayley Leek, RN    612 9113 3278    hayley.leek@sesiahs.health.nsw.gov.au   
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

No publications provided

Responsible Party: A/Professor Kate Moore, St George Hospital, Australia
ClinicalTrials.gov Identifier: NCT01404481     History of Changes
Other Study ID Numbers: 09/STG/176
Study First Received: July 27, 2011
Last Updated: July 27, 2011
Health Authority: Australia: Human Research Ethics Committee

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

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases

ClinicalTrials.gov processed this record on July 31, 2014