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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Supportive Care
Allocation to intervention
N/A
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
Not Applicable
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
The purpose of this study is to investigate and document real life safety and satisfaction of
re-use of urethral catheters for intermittent self catheterization. The study will collect
re-used catheters from included patients and compare those to a control group with regard to
bacterial contamination and mechanical properties. A four week prospective evaluation will
follow where the patients will be given catheters intended for single-use.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02129738
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