Explorative Clinical Study on the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers

Coloplast A/S9 enrolled

Overview

Performance and acceptance of new intermittent catheters tested in healthy volunteers

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Compliance, Patient

Interventions

Test product 2DEVICE

Test catheter 2

Test product 3DEVICE

Test catheter 3

ComparatorDEVICE

SpeediCath Flex

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Coloplast A/S

Humlebæk, Denmark

Outcomes

Primary Outcomes

Urine Flow Rate

On day of study visits 1-5 rate of urine flow through catheter measured in mL/s

Time frame: 2 hour

Secondary Outcomes

Post-void Residual Urine

On day of study visits 1-5 rate volume of urine left in the bladder post catheterisation (in mL)

Time frame: 2 hour

Number of Participants With Hematuria

On day of study visits 1-5 blood in urine post catheterisation (measured as yes/no to blood in urine)

Time frame: 2 hour

Data from ClinicalTrials.gov

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