An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
The investigational device is either a CE-marked LoFric® OrigoTM , 40 cm, CH12/CH14 or LoFric® SenseTM, 15 cm, CH12. They are all intermittent urinary catheters with a Nelaton tip from a more sustainable manufacturing process. All subjects will use the investigational device for 30 days each.
Leitung der Neuro-Urologie Klinik der Urologie und Kinderurologie Universitätsklinikum Bonn
Bonn, Germany
Gemeinschaftspraxis für Urologie
Dierdorf, Germany
Zentrum für Kontinenz und Neuro-Urologie Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen, Mönchengladbach
Mönchengladbach, Germany
Subjects' satisfaction, when practicing IC (insertion/withdrawal) using study device.
The subject's assessment of satisfaction using a five-level scale in a pPRO (Wellspect Follow-up questionnaire): How satisfied have you been with the catheterization (insertion/withdrawal) when using the investigational device? 1. = completely unsatisfied 2. = unsatisfied 3. = neutral 4. = satisfied 5. = completely satisfied
Time frame: 30 days
Reason for dissatisfaction (if any) when practicing IC with study device.
The proportion of subjects that are unsatisfied/completely unsatisfied and specifying the reason in free text. pPRO (Wellspect questionnaire)
Time frame: 30 days
Experience of any problems before, during and after catheterization with investigational device.
The proportion of subjects that experienced any problems. A yes/no scale, if yes, a specification (free text) is required. pPRO (Wellspect questionnaire)
Time frame: 30 days
Catheter usability (incl. ease of use) when practicing IC with investigational device.
The mean of all subject's answers/domain score of ISC-Q (ease of use) completed at the end of investigation visits. pPRO (Wellspect questionnaire) and ISC-Q - domain ease of use.
Time frame: 30 days
QoL when practicing IC with investigational device.
ISC-Q total mean score The mean of all subjects' total score of ISC-Q completed at the end of investigation visits.
Time frame: 30 days
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