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

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

Study Overview

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

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

Contacts and Locations

Study Locations

• Denmark
  • København Ø
    • Copenhagen, København Ø, Denmark, 2100
      • Rigshopsitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain experienced by the subjects at catheterisation is measure with the VAS scale	1 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 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 (Actual): March 1, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

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: CP271

Plan for Individual participant data (IPD)

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