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The objective of the study is to explore and understand how urodynamic parameters are affected when emptying the bladder with an intermittent catheter.
The investigation is an explorative open single arm investigation including 30 male subjects. 10 healthy volunteers, 10 patients with SCI and 10 patients with BPH.
The healthy volunteers included into the study will have an information visit and three study visits - an inclusion visit (visit 0), a visit 1 measuring endpoints while spontaneous voiding of the bladder (0-7 days after visit 0) followed by a visit 2 measuring endpoints while emptying the bladder using a standard IC (4-15 days after visit 1). (Visit 0 and visit 1 can be the same day).
The subjects with SCI and enlarged prostate will have an information visit and two study visits. - an inclusion visit (visit 0) where a urine culture is analysed and prophylactic antibiotic is prescribed per the result of the analysis. (Most IC users have bacteria in the urine and to decrease the risk of acquiring a urinary tract infection from the urodynamic examination, urine cultures are performed and prophylactic antibiotics will be prescribed per the result). The second visit (visit 1) is conducted while the patient is on antibiotic treatment measuring all endpoints while emptying the bladder with a standard IC (4-15 days after visit 0 while subject is on prophylaxis antibiotics).
The investigation is conducted at one site and is an explorative study, estimated to last eight (8) months.
Due to the explorative nature of the investigation, no primary endpoint is defined but explorative endpoints are divided into three categories dependent on their relation to bladder, urethra or urine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Measurement of endpoints | Experimental | In healthy volunteers the endpoint are measured while spontaneous voiding of the bladder and while emptying the bladder using a standard intermittent catheter. In subjects with spinal cord injury or enlarged prostata the endpoint are measured while emptying the bladder using a standard intermittent catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpeediCath | Device | SpeediCath is a standard intermittent catheter that is on the market. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort During Catheter Insertion on a Visual Analogue Scale | On a scale ranging from 0 "no discomfort" to 10 "worst possible discomfort" caused by the catheter, set a vertical line indicating how you experienced the insertion of the catheter. Higher scores mean a worse outcome. | Filled out after 5 minutes per catheterisation. |
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Inclusion Criteria:
Exclusion Criteria:
Only male subjects are included as the intermittent catheter used in the investigation is a male catheter
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| Name | Affiliation | Role |
|---|---|---|
| Nazarena Mazarro | Vice president Medical Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Rigshospitalet | Copenhagen | 2100 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | 10 healthy volunteers |
| FG001 | Spinal Cord Injury (SCI) | 10 spinal cord injured patients |
| FG002 | Benign Prostate Hyperplasia | 10 benign prostate hyperplasia patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Urodynamic Parameters During Catheterisation | Exploratory measurements of Urodynamic parameters |
| 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 | Discomfort During Catheter Insertion on a Visual Analogue Scale | On a scale ranging from 0 "no discomfort" to 10 "worst possible discomfort" caused by the catheter, set a vertical line indicating how you experienced the insertion of the catheter. Higher scores mean a worse outcome. | 8 healthy volunteers, 10 subjects with spinal cord injury and 10 subjects with enlarged prostate | Posted | Mean | 95% Confidence Interval | score on a scale | Filled out after 5 minutes per catheterisation. |
|
Through study completion, an average of 15 days.
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other parties, whether related to the medical device(s), or the procedures involved or not. This could include events such as headache or dizziness.
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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 | Measurement of Endpoints | In healthy volunteers the endpoint are measured while spontaneous voiding of the bladder and while emptying the bladder using a standard intermittent catheter (SpeediCath). In subjects with spinal cord injury or enlarged prostata the endpoint are measured while emptying the bladder using a standard intermittent catheter. SpeediCath: SpeediCath is a standard intermittent catheter that is on the market. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Medical Affairs | Coloplast A/S | +45 49111111 | clinical-studies@coloplast.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2018 | Jan 31, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| D014947 | Wounds and Injuries |