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The study is designed as a randomized, double-blind, parallel-group, multi centre study comparing perception and tolerability of investigational product and comparator. In the randomized part of the study the subjects will be given either LoFric Primo (POBE) or the comparator LoFric Primo (PVC) for use over 4 weeks. The hypothesis is that subject perception and satisfaction of POBE is equal to or better than for PVC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LoFric Primo (POBE) single-use urinary catheter | Experimental |
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| LoFric Primo (PVC) single-use urinary catheter | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LoFric Primo (POBE) single-use urinary catheter | Device | LoFric Primo (POBE) single-use urinary catheter |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject's Perception Regarding Handling of Test Catheter Before Insertion | Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | At 4 weeks |
| Subject's Perception Regarding Handling of Test Catheter at Insertion | Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | At 4 weeks |
| Subject's Perception Regarding Handling of Test Catheter at Withdrawal | Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | At 4 weeks |
| Subject's Perception Regarding Handling of Test Catheter After Withdrawal | Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | At 4 weeks |
| Subject's General Satisfaction With Test Catheter | Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified) | At 4 weeks |
| Subject's Sensation When Using Test Catheter | Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain) | At 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfred J Witjes, Prof Dr | Radboud Univesity Nijmegen Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna, Department of Urology | Vienna | A-1090 | Austria | |||
| NRZ Greifswald |
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| ID | Title | Description |
|---|---|---|
| FG000 | LoFric Primo (POBE) | LoFric Primo (POBE) single-use urinary catheter (Arm A) |
| FG001 | LoFric Primo (PVC) | LoFric Primo (PVC) single-use urinary catheter (Arm B) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| LoFric Primo (PVC) single-use urinary catheter | Device | LoFric Primo (PVC) single-use urinary catheter |
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| Greifswald |
| 17487 |
| Germany |
| Kliniken Maria Hilf GmbH, Zentrum für Kontinenz und Neuro-Urologie, Krankenhaus St. Franziskus | Mönchengladbach | 41063 | Germany |
| BG-Klinik Tübingen | Tübingen | 72076 | Germany |
| Ospedale Careggi, Unità Spinale | Florence | 50139 | Italy |
| Primario U.O. Neuro-Urologia, Direttore Dipartimento delle Mielolesioni | Torino | Italy |
| Ziekenhuis Lievensberg, Afdeling Urologie | Bergen op Zoom | 4624 VT | Netherlands |
| Albert Schweitzer Ziekenhuis, Locatie Dordwijk | Dordrecht | 3300 AK | Netherlands |
| Catharina Ziekenhuis | Eindhoven | 5602 ZA | Netherlands |
| Radboud Univesity Nijmegen Medical Centre | Nijmegen | 6500 HB | Netherlands |
| Verksamhet Urologi, Sahlgrenska Universitets sjukhuset | Gothenburg | 413 45 | Sweden |
| Sheffield Teaching Hospitals NHS Foundation trust, Royal Hallamshire Hospital | Sheffield | S10 2JF | United Kingdom |
| Royal National Orthopaedic Hospital, Spinal Injuries Unit, Brockley Hill Stanmore | Stanmore | HA7 4LP | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LoFric Primo (POBE) | LoFric Primo (POBE) single-use urinary catheter (Arm A) |
| BG001 | LoFric Primo (PVC) | LoFric Primo (PVC) single-use urinary catheter (Arm B) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subject's Perception Regarding Handling of Test Catheter Before Insertion | Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | Posted | Mean | Standard Deviation | Score on scale | At 4 weeks |
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| Primary | Subject's Perception Regarding Handling of Test Catheter at Insertion | Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | Posted | Mean | Standard Deviation | Score on scale | At 4 weeks |
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| Primary | Subject's Perception Regarding Handling of Test Catheter at Withdrawal | Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | Posted | Mean | Standard Deviation | Score on scale | At 4 weeks |
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| Primary | Subject's Perception Regarding Handling of Test Catheter After Withdrawal | Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | Posted | Mean | Standard Deviation | Score on scale | At 4 weeks |
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| Primary | Subject's General Satisfaction With Test Catheter | Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified) | Posted | Mean | Standard Deviation | Score on scale | At 4 weeks |
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| Primary | Subject's Sensation When Using Test Catheter | Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain) | Posted | Mean | Standard Deviation | Score on scale | At 4 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LoFric Primo (POBE) | LoFric Primo (POBE) single-use urinary catheter (Arm A) | 2 | 97 | 3 | 97 | ||
| EG001 | LoFric Primo (PVC) | LoFric Primo (PVC) single-use urinary catheter (Arm B) | 1 | 98 | 7 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to neurological problems | Nervous system disorders |
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| Sepsis due to Urinary Tract Infection | Blood and lymphatic system disorders |
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| Pseudotumor cerebri | Nervous system disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders |
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Astra Tech shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed in order for Astra Tech to file patent applications.
| Title | Organization | Phone | Extension | |
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| Head of Therapeutic Area Health Care | Astra Tech AB | +46317763000 |
| >=65 years |
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