Reuse of Intermittent Urethral Catheters
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | June 20, 2014 |
End Date: | March 23, 2017 |
Is Reuse of Intermittent Urethral Catheters Safe and Preferred? A Prospective, Observational Study Evaluating Reuse of Catheters and Switch to Single-use.
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.
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.
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;
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
We found this trial at
4
sites
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Milwaukee, Wisconsin 53226
Principal Investigator: Corey R O´Connor, Dr
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Philadelphia, Pennsylvania 19104
Principal Investigator: Diane Newman, Prof
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