Back to resultsClinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers
Primary Purpose
Incontinence, Urinary
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Coloplast Test Catheter
Speedicath
Sponsored by
About this trial
This is an interventional basic science trial for Incontinence, Urinary
Eligibility Criteria
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:
- Abnormalities, diseases or surgical procedures performed in the lower urinary tract
- Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
- Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation
- Known hypersensitivity toward any of the test products -
Sites / Locations
- Rigshopsitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
First Coloplast Test Catheter; then Speedicath
First Speedicath; then Coloplast Test Catheter
Arm Description
The subjects allocated to this arm first test Coloplast Test Catheter and then after cross over test the comparator Speedicath Catheter
The subjects allocated to this arm first test Speedicath Catheter and then after cross over test Coloplast Test Catheter
Outcomes
Primary Outcome Measures
Pain
Pain experienced by the subjects at catheterisation is measure with the VAS scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02965105
Brief Title
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers
Official Title
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to test the performance and safety of a newly developed intermittent catheter
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence, Urinary
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First Coloplast Test Catheter; then Speedicath
Arm Type
Experimental
Arm Description
The subjects allocated to this arm first test Coloplast Test Catheter and then after cross over test the comparator Speedicath Catheter
Arm Title
First Speedicath; then Coloplast Test Catheter
Arm Type
Experimental
Arm Description
The subjects allocated to this arm first test Speedicath Catheter and then after cross over test Coloplast Test Catheter
Intervention Type
Device
Intervention Name(s)
Coloplast Test Catheter
Intervention Description
This is a newly developed intermittent catheter
Intervention Type
Device
Intervention Name(s)
Speedicath
Intervention Description
This is a marketed Catheter which is used as comparator
Primary Outcome Measure Information:
Title
Pain
Description
Pain experienced by the subjects at catheterisation is measure with the VAS scale
Time Frame
1 day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
Abnormalities, diseases or surgical procedures performed in the lower urinary tract
Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation
Known hypersensitivity toward any of the test products -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Bagi, MD
Organizational Affiliation
MD at the clinic for urology at Rigshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshopsitalet
City
Copenhagen
State/Province
København Ø
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers
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