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

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02965105
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Days): 30
• Patients Per Site Per Month: 28.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Incontinence, Urinary	Device: Coloplast Test Catheter; Device: 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 Catheters in Healthy Volunteers
• Actual Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: First Coloplast Test Catheter; then Speedicath The subjects allocated to this arm first test Coloplast Test Catheter and then after cross over test the comparator Speedicath Catheter	Device: Coloplast Test Catheter; This is a newly developed intermittent catheter; Device: Speedicath; This is a marketed Catheter which is used as comparator
Experimental: First Speedicath; then Coloplast Test Catheter The subjects allocated to this arm first test Speedicath Catheter and then after cross over test Coloplast Test Catheter	Device: Coloplast Test Catheter; This is a newly developed intermittent catheter; Device: Speedicath; This is a marketed Catheter which is used as comparator

Outcome Measures

Primary Outcome Measures

1. Pain [1 day]

   Pain experienced by the subjects at catheterisation is measure with the VAS scale

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	Rigshopsitalet	Copenhagen	København Ø	Denmark	2100

Sponsors and Collaborators

• Coloplast A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT02965105
• Other Study ID Numbers: CP271
• First Posted: Nov 16, 2016
• Last Update Posted: Mar 1, 2017
• Last Verified: Feb 1, 2017

• 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 Mar 1, 2017