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Bladder Scan of Residual Urine With New Catheter

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ClinicalTrials.gov Identifier: NCT01048541
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : September 3, 2012
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Study Description
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Brief Summary:
Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon. This length is defined by hospital standards although it is known that the male urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There is a lack of clinical data documenting that male ICs that are shorter and more or less flexible than standard catheters can sufficiently empty the bladder of male subjects. This will be tested using ultrasound to measure residual urine in the bladder following catheterisation with new product and standard length catheter.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Device: Test Catheter - SpeediCath Compact Male Device: SpeediCath Phase 2 Phase 3

Detailed Description:
See brief summary
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Non-Inferiority Bladder Scan Study to Investigate Residual Urine After Use of Intermittent Catheters in Male Subjects
Study Start Date : January 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: SpeediCath catheter
Standard treatment
 Device: SpeediCath
Catheter for intermittent catheterisation
Other Name: Test catheter
Experimental: Test product Device: Test Catheter - SpeediCath Compact Male
Compact catheter for intermittent catheterisation
Other Names:
  • SpeediCath
  • Test catheter


Outcome Measures
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Primary Outcome Measures :
  1. Mean Residual Urine Volume [ Time Frame: 3 catheterisations on 1 day ]
    Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation


Secondary Outcome Measures :
  1. The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs) [ Time Frame: Study period ]
  2. Median Absolute RU Volume [ Time Frame: 3 catheterisations on 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is a male IC user able to self-catheterise
  2. Subject has used hydrophilic-coated ICs for at least 1 month
  3. Subject is at least 18 years old.
  4. Subject has provided informed consent.

Exclusion Criteria:

  1. Subject has symptoms of UTI (ie, fever, autonomic dysreflexia, spasticity, discomfort or pain over the kidney or bladder, onset/increase in incontinence episodes, cloudy urine with increased odour, malaise, lethargy, or sense of unease).
  2. Subject has known abnormalities in the lower urinary tract.
Contacts and Locations
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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): NCT01048541


Locations
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Germany
Werner-Wicker-Klinik, Abteilung für Neuro-Urologie
Bad Wildungen, Hessen, Germany, 34537
Sponsors and Collaborators
Coloplast A/S
Investigators
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Principal Investigator: Burkhard Domurath, Dr. med. Werner Wicker Klinik
Study Director: Henrik S Knoth, M.Sc Pharm Coloplast A/S
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01048541    
Other Study ID Numbers: CP061CC
First Posted: January 13, 2010    Key Record Dates
Results First Posted: September 3, 2012
Last Update Posted: September 3, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations