Intermittent Urethral Catheterization
Conditions
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.
Interventions
DEVICELoFric catheters
LoFric single use catheters to be used 4-6 times daily for 4 weeks.
Sponsors
Wellspect HealthCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of catheters with bacterial contamination (Y/N) | At Baseline (Visit 1) | Proportion of catheters with bacterial contamination verified by culturing/incubation and visual inspection by Scanning Electron Microscope (SEM). |
Secondary
| Measure | Time frame |
|---|---|
| Bacterial quantification by incubation. | At Baseline (Visit 1) |
| Pathogen identification by incubation. | At Baseline (Visit 1) |
| Material properties and bacteria/particle/tissue visualization by SEM. | At Baseline (Visit 1) |
| Presence of reuse found in medical records, patient reported questionnaires and patient interviews. | At Baseline (Visit 1) and at 4 weeks (Visit 2) |
| Bacterial level in urine sample | At Baseline and 4 weeks |
Countries
Australia, United States
Outcome results
None listed