Safety and Performance of a New Coating for Urinary Intermittent Catheters

Not Applicable

Completed

• Conditions: Intermittent Urethral Catheterization
• Interventions: Device: ZN-D catheter; Device: ZN-C catheter; Device: SpeediCath catheter

• Registration Number: NCT01800903
• Lead Sponsor: Coloplast A/S

Brief Summary

The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2013-11-29
• Results First Submitted QC: 2014-01-27
• Results First Posted: 2014-03-14
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

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 interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)
4. Known hypersensitivity toward any of the test products -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 6	SpeediCath catheter	ZN-C catheter then ZN-D catheter then SpeediCath catheter
Sequence 2	ZN-C catheter	SpeediCath catheter then ZN-C catheter then ZN-D catheter
Sequence 5	ZN-D catheter	ZN-C catheter then SpeediCath catheter then ZN-D catheter
Sequence 2	ZN-D catheter	SpeediCath catheter then ZN-C catheter then ZN-D catheter
Sequence 1	SpeediCath catheter	SpeediCath catheter then ZN-D catheter then ZN-C catheter
Sequence 3	ZN-D catheter	ZN-D catheter then SpeediCath catheter then ZN-C catheter
Sequence 1	ZN-D catheter	SpeediCath catheter then ZN-D catheter then ZN-C catheter
Sequence 1	ZN-C catheter	SpeediCath catheter then ZN-D catheter then ZN-C catheter
Sequence 2	SpeediCath catheter	SpeediCath catheter then ZN-C catheter then ZN-D catheter
Sequence 3	ZN-C catheter	ZN-D catheter then SpeediCath catheter then ZN-C catheter
Sequence 4	ZN-C catheter	ZN-D catheter then ZN-C catheter then SpeediCath catheter
Sequence 4	SpeediCath catheter	ZN-D catheter then ZN-C catheter then SpeediCath catheter
Sequence 6	ZN-C catheter	ZN-C catheter then ZN-D catheter then SpeediCath catheter
Sequence 3	SpeediCath catheter	ZN-D catheter then SpeediCath catheter then ZN-C catheter
Sequence 4	ZN-D catheter	ZN-D catheter then ZN-C catheter then SpeediCath catheter
Sequence 5	ZN-C catheter	ZN-C catheter then SpeediCath catheter then ZN-D catheter
Sequence 5	SpeediCath catheter	ZN-C catheter then SpeediCath catheter then ZN-D catheter
Sequence 6	ZN-D catheter	ZN-C catheter then ZN-D catheter then SpeediCath catheter

Primary Outcome Measures

Name	Time	Method
Overall Discomfort During Catheterization	1 day	Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.

Trial Locations

Locations (1)

Department of Urology; 🇩🇰 Copenhagen, Denmark