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Crossover comparison of different flow meters with a digital home flow meter as a reference. Main hypothesis: Reapeated home flow measurements with a disposable device will provide a better understanding of the patients urinary flow than a single measurement performed in the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disposable device first, then Digital device | Experimental |
| |
| Digital device first, then Disposable device | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disposable device | Device | Disposable urine flow meter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Urine Flow Rate | Measurements with a disposable device and the current clinic gold standard measurement were compared to test the hypothesis that three repeated measurements with the disposable device was as accurate as one clinic flow measurement. A digital device was used as a reference of the most exact way to evaluate each patient's individual flow. | At every voiding event during approximately one week. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Jacobsson, Prof. | Dentsply Sirona Implants and Consumables | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Geffen school of Medicine at UCLA, Department of Urology | Los Angeles | California | 90095-1738 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Disposable Device First, Then Digital Device | 12 voidings recorded with the disposable device in the first intervention period, followed by 12 voidings recorded with the digital device in the second intervention period. |
| FG001 | Digital Device First, Then Disposable Device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Clinic Baseline Recording |
|
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| Digital device | Device | Digital urine flowmeter |
|
| Clinic flow measurement | Device | Clinic gold standard flow measurement |
|
| UMC ST Radboud Nijmegen, Department of Urology |
| Nijmegen |
| 6500 HB |
| Netherlands |
| Klinika Urology, Akademi Medycznej | Warsaw | 02005 | Poland |
| Clinical Research Unit, Morriston Hospital, Swansea NHS Trust | Swansea | SA6 6NL | United Kingdom |
12 voidings recorded with the digital device in the first intervention period, followed by 12 voidings recorded with the disposable device in the second intervention period. |
| COMPLETED |
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| NOT COMPLETED |
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| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to use the Disposable device first and the Digital device first. |
| 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, 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 | Mean Urine Flow Rate | Measurements with a disposable device and the current clinic gold standard measurement were compared to test the hypothesis that three repeated measurements with the disposable device was as accurate as one clinic flow measurement. A digital device was used as a reference of the most exact way to evaluate each patient's individual flow. | Intention to treat analysis. Number of participants analyzed differs between groups since data was missing mainly due to technical problems. | Posted | Mean | Standard Deviation | ml/s | At every voiding event during approximately one week. |
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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 | Disposable Device | Voidings recorded with the disposable device in either first intervention period or second intervention period. | 0 | 60 | 0 | 60 | ||
| EG001 | Clinic | Voidings recorded with the clinic gold standard. | 0 | 60 | 0 | 60 | ||
| EG002 | Digital Device | Voidings recorded with the digital device in either first intervention period or second intervention period. | 0 | 60 | 0 | 60 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Research Area Health Care | Astra Tech AB | +46317763000 |
| ID | Term |
|---|---|
| D001748 | Urinary Bladder Neck Obstruction |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Netherlands |
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| United Kingdom |
|
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | <0.0001 | 95 | Superiority or Other (legacy) |