Reuse of Intermittent Urethral Catheters

Study Overview
=================
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.

Official Title
-----------------
Is Reuse of Intermittent Urethral Catheters Safe and Preferred? A Prospective, Observational Study Evaluating Reuse of Catheters and Switch to Single-use.

Conditions
-----------------
Intermittent Urethral Catheterization

Intervention / Treatment
-----------------
* Device: LoFric catheters


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LoFric<br>LoFric catheters | Device: LoFric catheters<br>* LoFric single use catheters to be used 4-6 times daily for 4 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of catheters with bacterial contamination (Y/N) | Proportion of catheters with bacterial contamination verified by culturing/incubation and visual inspection by Scanning Electron Microscope (SEM). | At Baseline (Visit 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |