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Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon. This length is defined by hospital standards although it is known that the male urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There is a lack of clinical data documenting that male ICs that are shorter and more or less flexible than standard catheters can sufficiently empty the bladder of male subjects. This will be tested using ultrasound to measure residual urine in the bladder following catheterisation with new product and standard length catheter.
See brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpeediCath catheter | Active Comparator | Standard treatment |
|
| Test product | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Catheter - SpeediCath Compact Male | Device | Compact catheter for intermittent catheterisation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Residual Urine Volume | Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation | 3 catheterisations on 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs) | Study period | |
| Median Absolute RU Volume | 3 catheterisations on 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Burkhard Domurath, Dr. med. | Werner Wicker Klinik | Principal Investigator |
| Henrik S Knoth, M.Sc Pharm | Coloplast A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Werner-Wicker-Klinik, Abteilung für Neuro-Urologie | Bad Wildungen | Hesse | 34537 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34699062 | Derived | Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5. | |
| 21358718 | Derived | Domurath B, Kutzenberger J, Kurze I, Knoth HS. Clinical evaluation of a newly developed catheter (SpeediCath Compact Male) in men with spinal cord injury: residual urine and user evaluation. Spinal Cord. 2011 Jul;49(7):817-21. doi: 10.1038/sc.2011.14. Epub 2011 Mar 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AB: First Test Catheter Then Standard Catheter | Test catheter (SpeediCath Compact Male)used in the first period and Standard catheter (SpediCath straight) used in the second period |
| FG001 | BA: First Standard Catheter Then Test Catheter | Standard catheter (SpediCath straight)used in the first period and test catheter (SpeediCath Compact Male) used in the second period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study | Includes groups randomized to standard catheter first and test catheter first |
| 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 | Mean Residual Urine Volume | Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation | Posted | Mean | Standard Deviation | mL | 3 catheterisations on 1 day |
|
|
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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 | Test Catheter | Test catheter (SpeediCath Compact Male) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning in the urethra | Renal and urinary disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristine Gjødsbøl, PhD | Coloplast | +4549113557 | dkkg@coloplast.com |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| SpeediCath | Device | Catheter for intermittent catheterisation |
|
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs) | Not Posted | Study period |
| Secondary | Median Absolute RU Volume | Not Posted | 3 catheterisations on 1 day |
| 0 |
| 36 |
| 1 |
| 36 |
| EG001 | Standard Catheter | Standard catheter (SpediCath straight) | 0 | 36 | 0 | 36 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |