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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02129738




Registration number
NCT02129738
Ethics application status
Date submitted
30/04/2014
Date registered
2/05/2014
Date last updated
12/10/2017

Titles & IDs
Public title
Reuse of Intermittent Urethral Catheters
Scientific title
Is Reuse of Intermittent Urethral Catheters Safe and Preferred? A Prospective, Observational Study Evaluating Reuse of Catheters and Switch to Single-use.
Secondary ID [1] 0 0
LOF-0028
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intermittent Urethral Catheterization 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - LoFric catheters

Experimental: LoFric - LoFric catheters


Treatment: Devices: LoFric catheters
LoFric single use catheters to be used 4-6 times daily for 4 weeks.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of catheters with bacterial contamination (Y/N)
Timepoint [1] 0 0
At Baseline (Visit 1)
Secondary outcome [1] 0 0
Bacterial quantification by incubation.
Timepoint [1] 0 0
At Baseline (Visit 1)
Secondary outcome [2] 0 0
Pathogen identification by incubation.
Timepoint [2] 0 0
At Baseline (Visit 1)
Secondary outcome [3] 0 0
Material properties and bacteria/particle/tissue visualization by SEM.
Timepoint [3] 0 0
At Baseline (Visit 1)
Secondary outcome [4] 0 0
Presence of reuse found in medical records, patient reported questionnaires and patient interviews.
Timepoint [4] 0 0
At Baseline (Visit 1) and at 4 weeks (Visit 2)
Secondary outcome [5] 0 0
Bacterial level in urine sample
Timepoint [5] 0 0
At Baseline and 4 weeks

Eligibility
Key inclusion criteria
* Provision of informed consent
* Female and/or male aged 18 years and over
* Intermittent self-catheterization as primary bladder management method, defined as a normal catheterization frequency of at least 4 times daily
* Reuse of the same silicon, rubber (latex) or plastic (e.g. vinyl, PVC) catheter
* Accustomed intermittent catheterization user, defined as intermittent catheterization use for at least 3 months
* Able to use catheters of size:

40 cm, CH12 or CH14; 16'', FR12 or FR14; 15 cm, CH10 or CH12; 6'', FR10 or FR12;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Antibiotic treatment within 4 weeks prior study inclusion
* Drug or alcohol abuse or other disease of addiction
* Immunocompromising diseases or medications
* Known urological/renal anatomical abnormalities with potential impact on subject´s compliance as judged by the investigator
* Diagnosis of severe fecal incontinence that may compromise study participation as judged by the investigator
* Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
* Previous enrollment in the present study
* Simultaneous participation in another clinical study that may interfere with the present study, as judged by the investigator
* Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/03/2017
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Rehab - Ryde
Recruitment hospital [2] 0 0
Prince of Wales Hospital Spinal Unit - Sydney
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Caulfield Hospital, Spinal Rehabilitation Unit - Melbourne
Recruitment postcode(s) [1] 0 0
1680 - Ryde
Recruitment postcode(s) [2] 0 0
2031 - Sydney
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3162 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Idaho
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wellspect HealthCare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bonne Lee, Dr
Address 0 0
Prince of Wales Hospital, Randwick, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02129738