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An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LoFric® OrigoTM or LoFric® SenseTM | Experimental | Hydrophilic male (LoFric Origo) and female (LoFric Sense) urinary catheters for single use. Target subject population are subjects suffering from bladder voiding dysfunction and are experienced in intermittent catheterization (IC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LoFric® OrigoTM and LoFric® SenseTM | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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?
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30 days |
| Experience of any problems before, during and after catheterization with investigational device. |
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Inclusion Criteria:
For inclusion in the study, subjects must fulfil all of the following criteria:
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Wittebo, M.Sc. Pharm. | Wellspect HealthCare | Study Director |
| Ruth Kirschner-Hermanns, Univ.-Prof. Dr. med. | Universitätsklinikum Bonn, Germany | Principal Investigator |
| Antje Foresti, Dr. med. | Zentrum für Kontinenz und Neuro-Urologie, Kliniken Maria Hilf GmbH, Mönchengladbach | Principal Investigator |
| Alexander Höinghaus, Dr. med. | Gemeinschaftspraxis für Urologie, Dierdorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leitung der Neuro-Urologie Klinik der Urologie und Kinderurologie Universitätsklinikum Bonn | Bonn | 53127 | Germany | |||
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 20, 2024 | |
| Reset | Jul 31, 2024 | |
| Release | Aug 22, 2024 | |
| Reset | Nov 1, 2024 | |
| Release | Dec 19, 2024 | |
| Reset | Jan 30, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 20, 2024 | Jul 31, 2024 | |||
| Aug 22, 2024 |
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The proportion of subjects that experienced any problems. A yes/no scale, if yes, a specification (free text) is required. pPRO (Wellspect questionnaire) |
| 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. | 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. | 30 days |
| Gemeinschaftspraxis für Urologie |
| Dierdorf |
| 56269 |
| Germany |
| Zentrum für Kontinenz und Neuro-Urologie Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen, Mönchengladbach | Mönchengladbach | 41063 | Germany |
| Nov 1, 2024 |
| Dec 19, 2024 | Jan 30, 2025 |