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Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC | Active Comparator | Speedicath (SC) catheter is a catheter for intermittent catherisation |
|
| SCCM | Experimental | SpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent catheter | Device | SpeediCath catherter (SC) for intermittent catherisation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Urine Measured by Ultra Sound | 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjectively Measured Handling | ||
| Subjectively Measured Insertion of the Catheter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Bagi, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | København Ø | 2100 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | SC Then SCCM | SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period |
| FG001 | SCCM Then SC | SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Period |
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| Second Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SC Then SCCM | SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period |
| BG001 | SCCM Then SC | SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Residual Urine Measured by Ultra Sound | Posted | Mean | Standard Deviation | ml | 2 |
|
|
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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 | SC Then SCCM | SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristine Gjødsbøl, PhD | Coloplast A/S | +4549113557 | dkkg@coloplast.com |
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| ID | Term |
|---|---|
| D006417 | Hematuria |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Compact intermittent catheter |
| Device |
SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males |
|
| NOT COMPLETED |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Subjectively Measured Handling | Not Posted |
| Secondary | Subjectively Measured Insertion of the Catheter | Not Posted |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | SCCM Then SC | SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period | 0 | 18 | 0 | 18 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |