Clinical Study in Healthy Volunteers Evaluating the Performance and Handling of a Urinary Intermittent Catheter With a Newly Developed Swelling Media.

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04633291
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Actual Duration (Days): 23
• Patients Per Site Per Month: 29.1

Study Details

Study Description

Brief Summary

The investigation is conducted at one site. The study is a single blinded, randomised, crossover study including 22 healthy men, each catheterised two times with 4-15 days between the catheterisations. Nurses will perform the catheterisation. As there is a visual difference in the products, it is only possible to blind the subjects

Condition or Disease	Intervention/Treatment	Phase
Catheter Site Discomfort	Device: CP279	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Clinical Study in Healthy Volunteers Evaluating the Performance and Handling of a Urinary Intermittent Catheter With a Newly Developed Swelling Media.
• Actual Study Start Date: Nov 5, 2019
• Actual Primary Completion Date: Nov 28, 2019
• Actual Study Completion Date: Nov 28, 2019

Outcome Measures

Primary Outcome Measures

1. The primary endpoint is evaluation of overall discomfort during catheterisation measured by the Visual Analogue Scale (VAS). [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Have given written informed consent

2. Be at least 18 years of age and have full legal capacity

3. Be a male

4. Willing to refrain from using analgesics up to 24 hours prior to catheterisation visits

5. Have a negative urine multistix - erythrocytes (Microscopic haematuria)

6. Have a negative urine multistix:

• Leukocytes

• Nitrite Or if positive, subsequent negative for bacterial growth in urine culture

Exclusion Criteria:

1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract

2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)

3. Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation

4. Known hypersensitivity toward any of the investigational device

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshopsitalet	Copenhagen	København Ø	Denmark	2100

Sponsors and Collaborators

• Coloplast A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT04633291
• Other Study ID Numbers: CP279
• First Posted: Nov 18, 2020
• Last Update Posted: Nov 18, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 18, 2020