Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02965066
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 14

Study Details

Study Description

Brief Summary

The aim of the study is to test the performance and safety of a newly developed intermittent catheter in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Incontinence, Urinary	Device: Coloplast Test Catheter; Device: Coloplast Speedicath	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: First Coloplast Test catheter; then Speedicath catheter The subjects allocated to this arm first test Coloplast Test catheter and after cross over test the comparator speedicath catheter	Device: Coloplast Test Catheter; Newly developed intermittent catheter; Device: Coloplast Speedicath; Marketed Coloplast Speedicath catheter
Experimental: First Speedicath catheter; then Coloplast Test catheter The subjects allocated to this arm first test Speedicath catheter and after cross over test the Coloplast test catheter	Device: Coloplast Test Catheter; Newly developed intermittent catheter; Device: Coloplast Speedicath; Marketed Coloplast Speedicath catheter

Outcome Measures

Primary Outcome Measures

1. Pain [1 day]

   The VAS scale is used to measure the pain experienced by the subjects at catheterisation

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 and signed letter of authority

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

3. Be a male

4. Willing to refrain from using analgetics up to 24 hours prior to catheterization 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 test products -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Coppenhagen		Denmark	2100

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Principal Investigator: Per Bagi, MD, MD at the clinic of urology at Rigshospitalet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT02965066
• Other Study ID Numbers: CP269
• First Posted: Nov 16, 2016
• Last Update Posted: Nov 16, 2016
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis

Study Results

No Results Posted as of Nov 16, 2016