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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LoFric | Experimental | LoFric catheters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LoFric catheters | Device | LoFric single use catheters to be used 4-6 times daily for 4 weeks. |
|
| 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) |
| 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Bonne Lee, Dr | Prince of Wales Hospital, Randwick, Australia | Principal Investigator |
| Diane Newman, Professor | University of Pennsylvania, Philadelphia, US | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Idaho Urology | Coeur d'Alene | Idaho | 83814 | United States | ||
| University of Pennsylvania, Penn Urology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32172456 | Derived | Newman DK, New PW, Heriseanu R, Petronis S, Hakansson J, Hakansson MA, Lee BB. Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life. Int Urol Nephrol. 2020 Aug;52(8):1443-1451. doi: 10.1007/s11255-020-02435-9. Epub 2020 Mar 14. |
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| 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 |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Froedtert Medical College and Specialty Clinic | Milwaukee | Wisconsin | 53226 | United States |
| Royal Rehab | Ryde | New South Wales | 1680 | Australia |
| Prince of Wales Hospital Spinal Unit | Sydney | New South Wales | 2031 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Caulfield Hospital, Spinal Rehabilitation Unit | Melbourne | Victoria | 3162 | Australia |