Explorative Clinical Study on the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers
Compliance, Patient
Bottom Line
View on ClinicalTrials.gov: NCT04231149 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test product 2 (Device); Test product 3 (Device); Comparator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Coloplast A/S
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urine Flow Rate |
5.43; 5.47; 2.88 | — |
| SECONDARY Post-void Residual Urine |
38.33; 34.63; 27.75 | — |
| SECONDARY Number of Participants With Hematuria |
0; 0; 0 | — |
Summary
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04231149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.