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The aims of this prospective, randomized study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIC using LoFric Primo | Experimental | Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters, i.e. Drug + Device. |
|
| Anticholinergic medication | Active Comparator | Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIC using LoFric Primo | Device | Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, and start of CIC using LoFric Primo catheters, i.e. Drug + Device. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks. | Number of micturitions per day was assessed using a patient diary during three days at baseline and after 8 weeks of treatment. The relative change in mean number of micturitions was compared between the groups. The change was calculated as percent change = ((measure at 8 weeks - measure at baseline)/measure at baseline)*100%. | Baseline and 8 weeks after randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clare Fowler, Prof. | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Liège Ourthe Ambléve | Esneux | 4130 | Belgium | |||
| UZ Gasthuisberg |
The study had a screening period between enrolment and randomization. Four (4) of the enroled patients were never randomized due to either withdrawal of consent or not fulfilling inclusion/exclusion criteria at randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | CIC Using LoFric Primo | Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start and start of CIC using LoFric Primo catheters. |
| FG001 | Anticholinergic Medication |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Anticholinergic medication | Drug | Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug. |
|
| Leuven |
| 3000 |
| Belgium |
| St. Hedwig Hospital, Department of Urology | Berlin | 10115 | Germany |
| UMC ST Radboud Nijmegen, Department of Urology | Nijmegen | 6500 HB | Netherlands |
| University College of London, Institute of Neurology | London | WC1N 3BG | United Kingdom |
Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CIC Using LoFric Primo | Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device |
| BG001 | Anticholinergic Medication | Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks. | Number of micturitions per day was assessed using a patient diary during three days at baseline and after 8 weeks of treatment. The relative change in mean number of micturitions was compared between the groups. The change was calculated as percent change = ((measure at 8 weeks - measure at baseline)/measure at baseline)*100%. | Posted | Mean | Standard Deviation | percent change | Baseline and 8 weeks after randomization. |
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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 | CIC Using LoFric Primo | Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device | 1 | 13 | 1 | 13 | ||
| EG001 | Anticholinergic Medication | Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug. | 0 | 7 | 1 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dikran Shamoun | Wellspect HealthCare | +46313764000 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Male |
|