Test Catheter Pilot Study in Healthy Volunteers

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: SpeediCath Compact Male; Device: Speedicath

• Registration Number: NCT00832078
• Lead Sponsor: Coloplast A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2012-01-09
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-02
• Last Update Submitted: 2012-08-02
• Results First Posted: 2012-09-05
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Speedicath	SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2
Group A	SpeediCath Compact Male	SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2
Group B	SpeediCath Compact Male	SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2
Group B	Speedicath	SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2

Primary Outcome Measures

Name	Time	Method
Discomfort	After each catheterisation	Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)

Secondary Outcome Measures

Name	Time	Method
Handling	After each catheterisation
Preference	At study termination
Haematuria	After each catheterisation

Trial Locations

Locations (1)

Rigshopsitalet; 🇩🇰 Copenhagen, København Ø, Denmark