Evaluation of Residual Urine After Intermittent Catheterisation - Full Text View

Purpose

Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.

Condition	Intervention
Healthy	Device: Intermittent catheter

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Official Title:	Evaluation of Residual Urine After Intermittent Catheterisation – Comparison of 2 Hydrophilic Coated, Intermittent Catheters

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:

Residual urine measured by ultra sound

Secondary Outcome Measures:

Hematuria measured by urine multi-dipstick
Subjectively measured discomfort
Subjectively measured handling
Subjectively measured insertion of the catheter

Estimated Enrollment:	24
Study Start Date:	April 2006
Estimated Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male
18 years and above
A negative urine dip-stick
Have signed informed written consent to participate

Exclusion Criteria:

The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324233

Locations


Denmark, København Ø
	Rigshospitalet
	Copenhagen, København Ø, Denmark, 2100

Sponsors and Collaborators

Coloplast A/S

Investigators


Principal Investigator:	Per Bagi, MD	Rigshospitalet, Denmark

More Information

Study ID Numbers:	DK052CC
First Received:	May 9, 2006
Last Updated:	May 25, 2007
ClinicalTrials.gov Identifier:	NCT00324233
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Coloplast A/S:

Residual urine

Hematuria

Ultra sound

Study placed in the following topic categories:

Hematuria

Healthy

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Coloplast A/S
Information provided by:	Coloplast A/S
ClinicalTrials.gov Identifier:	NCT00324233