N/A Completed N=41 Randomized Single-blind Treatment

Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers

Spinal Cord Injury

Source: ClinicalTrials.gov NCT01142115 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2011

Primary outcomePrimary: Discomfort Measured on the Visual Analog Scale (VAS) — 3.7; 2.6 cm — p=0.0018

Summary

The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.

Outcome Measures

Outcome	Result	p-value
PRIMARY Discomfort Measured on the Visual Analog Scale (VAS)	3.7; 2.6	0.0018 sig
SECONDARY Irritation During Voiding After Catheterization	21; 7; 17; 32	<0.0001 sig
SECONDARY Ease of Use Measured on a 5 Point Scale: Insertion Effort	2; 7; 16; 20; 13; 8	0.6160
SECONDARY Ease of Use Measured on a 5 Point Scale: Withdrawal Effort	28; 28; 10; 11; 0; 0	0.8014
SECONDARY Visible Blood	3; 1; 35; 38	0.3085
SECONDARY Haematuria	10; 9; 28; 30	0.4324

Eligibility Criteria

Inclusion Criteria

18 years or older
Male
signed informed Consent,
Neg. 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 (NCT01142115). 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. Informational only — not medical advice.