Test Catheter Pilot Study in Healthy Volunteers (Test catheter)

Coloplast

Status: Completed

Conditions: Healthy

Treatments: Device: SpeediCath Compact Male; Device: Speedicath

Study type: Interventional

Funder types: Industry

Identifiers

NCT00832078

DK058CC

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.

Enrollment: 28 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older
• Male
• Signed informed consent
• Negative urine multistix

Exclusion criteria

• Abnormalities, diseases or surgical procedures performed in the lower urinary tract

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Group A

Other group

Description:

SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2

Treatment:

Device: Speedicath

Device: SpeediCath Compact Male

Group B

Other group

Description:

SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2

Treatment:

Device: Speedicath

Device: SpeediCath Compact Male