Clean Intermittant Self Catheterisation: A Trial Comparing Single Use vs Reuse of Nelaton Catheters
SURE
1 other identifier
observational
23
1 country
1
Brief Summary
The purpose of the study is to compare single use of catheters with reuse of catheters for intermittant self catheterisation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 27, 2011
CompletedFirst Posted
Study publicly available on registry
July 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJuly 24, 2015
July 1, 2015
3.1 years
July 27, 2011
July 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Economic Cost
16 weeks
Study Arms (2)
Single use group
New catheter for each Clean Intermittent Self Catheterisation (CISC), then discard.
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.
Interventions
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
Eligibility Criteria
Continence clinic, community patients, hospital patients
You may qualify if:
- over 18 years old
- CISC \> 2/day
- No current symptomatic UTI
- Willing to change catheter use method
You may not qualify if:
- Symptomatic Urinary Tract infection despite treatment
- \<18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pelvic Floor Bladder Unit St George Hospital
Sydney, New South Wales, 2217, Australia
Related Publications (1)
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.
PMID: 34699062DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kate Moore, A/Professor
St George Hospital
- PRINCIPAL INVESTIGATOR
Dr Emmanuel Karantanis, Doctor
St George Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hayley Leek CNS Urology/Continence NCA
Study Record Dates
First Submitted
July 27, 2011
First Posted
July 28, 2011
Study Start
March 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
July 24, 2015
Record last verified: 2015-07