Reuse of Intermittent Urethral Catheters

Wellspect HealthCare

Status

Completed

Conditions

Intermittent Urethral Catheterization

Treatments

Device: LoFric catheters

Study type

Interventional

Funder types

Industry

Identifiers

NCT02129738

LOF-0028

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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