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

Not Applicable

Completed

• Conditions: Incontinence, Urinary
• Interventions: Device: Coloplast Test Catheter; Device: Coloplast Speedicath

• Registration Number: NCT02965066
• Lead Sponsor: Coloplast A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Study First Submitted: 2016-11-11
• Study First Submitted QC: 2016-11-11
• Last Update Submitted: 2016-11-11
• Study First Posted: 2016-11-16
• Last Update Posted: 2016-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First Coloplast Test catheter; then Speedicath catheter	Coloplast Speedicath	The subjects allocated to this arm first test Coloplast Test catheter and after cross over test the comparator speedicath catheter
First Speedicath catheter; then Coloplast Test catheter	Coloplast Test Catheter	The subjects allocated to this arm first test Speedicath catheter and after cross over test the Coloplast test catheter
First Coloplast Test catheter; then Speedicath catheter	Coloplast Test Catheter	The subjects allocated to this arm first test Coloplast Test catheter and after cross over test the comparator speedicath catheter
First Speedicath catheter; then Coloplast Test catheter	Coloplast Speedicath	The subjects allocated to this arm first test Speedicath catheter and after cross over test the Coloplast test catheter

Primary Outcome Measures

Name	Time	Method
Pain	1 day	The VAS scale is used to measure the pain experienced by the subjects at catheterisation

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Coppenhagen, Denmark