Evaluation of Residual Urine After Intermittent Catheterisation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00324233
First received: May 9, 2006
Last updated: November 29, 2012
Last verified: November 2012
  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
Device: Compact intermittent catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of Residual Urine After Intermittent Catheterisation - Comparison of 2 Hydrophilic Coated, Intermittent Catheters

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Residual Urine Measured by Ultra Sound [ Time Frame: 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjectively Measured Handling [ Designated as safety issue: No ]
  • Subjectively Measured Insertion of the Catheter [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: April 2006
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SC
Speedicath (SC) catheter is a catheter for intermittent catherisation
Device: Intermittent catheter
SpeediCath catherter (SC) for intermittent catherisation
Experimental: SCCM
SpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males
Device: Compact intermittent catheter
SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males

  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
Rigshospitalet
Copenhagen, København Ø, Denmark, 2100
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Per Bagi, MD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00324233     History of Changes
Other Study ID Numbers: DK052CC
Study First Received: May 9, 2006
Results First Received: January 9, 2012
Last Updated: November 29, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Coloplast A/S:
Residual urine
Hematuria
Ultra sound

ClinicalTrials.gov processed this record on April 17, 2014