N/A N=25 Randomized Single-blind Treatment

Test Catheter Pilot Study in Healthy Volunteers

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT00832078 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2012

Primary outcome: Primary: Discomfort — 2.25; 2.52 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SpeediCath Compact Male (Device); Speedicath (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Coloplast A/S
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Discomfort	2.25; 2.52	—
SECONDARY Handling	—	—
SECONDARY Preference	—	—
SECONDARY Haematuria	—	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00832078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.