Reuse of Intermittent Urethral Catheters
Completed · Not applicable
Conditions studied: Intermittent Urethral Catheterization
In brief
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.
Key facts
- Study ID
- NCT02129738
- Run by
- Wellspect HealthCare
- People needed
- 39
- Starts
- 2014-06-20
- Expected to finish
- 2017-03-23
- Last updated by the study team
- 2017-10-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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
Where it is running
- North Idaho Urology — Coeur d'Alene, Idaho, United States
- University of Pennsylvania, Penn Urology — Philadelphia, Pennsylvania, United States
- Froedtert Medical College and Specialty Clinic — Milwaukee, Wisconsin, United States
- Royal Rehab — Ryde, New South Wales, Australia
- Prince of Wales Hospital Spinal Unit — Sydney, New South Wales, Australia
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
- Caulfield Hospital, Spinal Rehabilitation Unit — Melbourne, Victoria, Australia
Full record on ClinicalTrials.gov
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