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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 November 2016 |
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Main ID: |
NCT02965066 |
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Date of registration:
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11/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers
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Scientific title:
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Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02965066 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Per Bagi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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MD at the clinic of urology at Rigshospitalet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Have given written informed consent and signed letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Be a male
4. Willing to refrain from using analgetics up to 24 hours prior to catheterization
visits
5. Have a negative urine multistix - erythrocytes (Microscopic haematuria)
6. Have a negative urine multistix:
- Leukocytes
- Nitrite Or if positive, subsequent negative for bacterial growth in urine
culture
Exclusion Criteria:
1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract
2. Symptoms of urinary tract infections (at least one of the following: frequent
urination, stinging or pain at urination)
3. Participating in other clinical investigations related to urinary tracts system
during this investigation (inclusion to termination) or have previously participated
in this investigation
4. Known hypersensitivity toward any of the test products -
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Incontinence, Urinary
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Intervention(s)
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Device: Coloplast Speedicath
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Device: Coloplast Test Catheter
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Primary Outcome(s)
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Pain
[Time Frame: 1 day]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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