Clinical trial NCT04231149: Explorative Clinical Study on the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers
Official title: Explorative Clinical Study Investigating the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compliance, Patient
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

The subjects must sign a separate consent form for this purpose and can participate in the investigation without participating in the interview. In addition, subjects will be asked for consent to tape recording and filming during the interviews, but can participate in interviews without this.

In addition, a Coloplast representative will interview the Investigator and her representatives after LPO with questions related to their experience with the catheters.

The investigation is planned to be conducted in August 2018-Januar 2019. The visit window will be minimum five days between the visits (catheterisations), to ensure time for healing of any potential urethral trauma. However, the maximum time between visits should be adjusted to ensure the subject is terminated before LPO.

No biobank will be established for this investigation. All urine samples in the clinical investigation (for evaluating in- and exclusion criteria and for evaluating end points) will be destructed immediately after analysis.

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

Primary outcomes:
measure: Urine Flow Rate
timeFrame: 2 hour
Secondary outcomes:
measure: Post-void Residual Urine
timeFrame: 2 hour
measure: Number of Participants With Hematuria
timeFrame: 2 hour
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Coloplast A/S
name: Birte Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References: