Explorative Clinical Study Investigating the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Urine Flow Rate
Study Overview
Brief Summary
Performance and acceptance of new intermittent catheters tested in healthy volunteers
Detailed Description
This study is a single blinded, randomised, crossover study. The study period consists of an information visit, an inclusion visit, three test visits and a termination visit.
Two prototypes of intermittent catheters (Test product 2 and 3) compared to the standard catheter SpeediCath® Flex (Comparator).
In the investigation ten subjects will be included. The subjects will be catheterised once per visit. The subjects will be catheterised with the two test catheters and comparator in a randomised order. The order of the catheterisations will be randomised to prevent bias.
During the test visits the primary, secondary and explorative endpoints will be registered.
Subjects will be asked to participate in an interview in continuation of their last visit (Test Visit 3). The interviews will be performed by a Coloplast representative asking questions related to their experience with the catheter.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Test product 2
Test catheter 2
Intervention: Test product 3 (Device)
Test product 2
Test catheter 2
Intervention: Comparator (Device)
Test product 3
Test catheter 3
Intervention: Test product 2 (Device)
Test product 3
Test catheter 3
Intervention: Comparator (Device)
Comparator
SpeediCath Flex
Intervention: Test product 2 (Device)
Comparator
SpeediCath Flex
Intervention: Test product 3 (Device)
Outcomes
Primary Outcomes
Urine Flow Rate
Time Frame: 2 hour
On day of study visits 1-5 rate of urine flow through catheter measured in mL/s
Secondary Outcomes
- Number of Participants With Hematuria(2 hour)
- Post-void Residual Urine(2 hour)