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

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

Study Overview

• Status: Completed
• Conditions: Incontinence, Urinary
• Intervention / Treatment: Device: Coloplast Test Catheter; Device: Coloplast Speedicath

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Coppenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	The VAS scale is used to measure the pain experienced by the subjects at catheterisation	1 day

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Per Bagi, MD, MD at the clinic of urology at Rigshospitalet

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 11, 2016
• First Submitted That Met QC Criteria: November 11, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Estimate): November 16, 2016
• Last Update Submitted That Met QC Criteria: November 11, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: CP269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO