Safety and Performance of a New Coating for Urinary Intermittent Catheters

Coloplast

Status: Completed

Conditions: Intermittent Urethral Catheterization

Treatments: Device: ZN-D catheter; Device: SpeediCath catheter; Device: ZN-C catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01800903

CP235 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 6 patient groups

Sequence 1

Active Comparator group

Description:

SpeediCath catheter then ZN-D catheter then ZN-C catheter

Treatment:

Device: SpeediCath catheter

Device: ZN-D catheter

Device: ZN-C catheter

Sequence 2

Experimental group

Description:

SpeediCath catheter then ZN-C catheter then ZN-D catheter

Treatment:

Device: SpeediCath catheter

Device: ZN-D catheter

Device: ZN-C catheter

Sequence 3

Experimental group

Description:

ZN-D catheter then SpeediCath catheter then ZN-C catheter

Treatment:

Device: SpeediCath catheter

Device: ZN-D catheter

Device: ZN-C catheter

Sequence 4

Experimental group

Description:

ZN-D catheter then ZN-C catheter then SpeediCath catheter

Treatment:

Device: SpeediCath catheter

Device: ZN-D catheter

Device: ZN-C catheter

Sequence 5

Experimental group

Description:

ZN-C catheter then SpeediCath catheter then ZN-D catheter

Treatment:

Device: SpeediCath catheter

Device: ZN-D catheter

Device: ZN-C catheter

Sequence 6

Experimental group

Description:

ZN-C catheter then ZN-D catheter then SpeediCath catheter

Treatment:

Device: SpeediCath catheter

Device: ZN-D catheter

Device: ZN-C catheter