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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014