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Evaluation of Residual Urine After Intermittent Catheterisation

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ClinicalTrials.gov Identifier: NCT00324233
Recruitment Status : Completed
First Posted : May 10, 2006
Results First Posted : January 1, 2013
Last Update Posted : January 1, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Healthy Device: Intermittent catheter Device: Compact intermittent catheter

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Residual Urine After Intermittent Catheterisation - Comparison of 2 Hydrophilic Coated, Intermittent Catheters
Study Start Date : April 2006
Primary Completion Date : June 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Residual Urine Measured by Ultra Sound [ Time Frame: 2 ]

Secondary Outcome Measures :
  1. Subjectively Measured Handling
  2. Subjectively Measured Insertion of the Catheter

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00324233     History of Changes
Other Study ID Numbers: DK052CC
First Posted: May 10, 2006    Key Record Dates
Results First Posted: January 1, 2013
Last Update Posted: January 1, 2013
Last Verified: November 2012

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