Compliance, Patient Clinical Trial
Official title:
Explorative Clinical Study Investigating the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers
Verified date | January 2020 |
Source | Coloplast A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Performance and acceptance of new intermittent catheters tested in healthy volunteers
Status | Completed |
Enrollment | 10 |
Est. completion date | December 20, 2018 |
Est. primary completion date | December 20, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Has given written informed consent and signed letter of authority Is at least 18 years of age and has full legal capacity Is a male Willing to comply without using analgetica up to 24 hours prior to catheterisation visits Exclusion Criteria: Has a previous history of genitourinary disease including congenital abnormalities and surgical procedures performed in the urinary tract Has symptoms of urinary tract infections (frequent urination, stinging and pain at urination) Are participating in any other clinical investigation related to urinary tract system during this investigation (inclusion to termination) Known hypersensitivity toward any of the test products |
Country | Name | City | State |
---|---|---|---|
Denmark | Coloplast A/S | Humlebæk |
Lead Sponsor | Collaborator |
---|---|
Coloplast A/S |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urine flow rate | Average flow rate of urine through the catheter | 4-5 weeks | |
Secondary | Post void residual urine | Urine volume in the bladder post catheterisation | 4-5 weeks | |
Secondary | Hematuria | Macroscopic and microscopic hematuria | 4-5 weeks |
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