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Bladder Scan of Residual Urine With New Catheter

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01048541
First received: January 11, 2010
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Urinary Incontinence
 Device: Test Catheter - SpeediCath Compact Male
Device: SpeediCath
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Mean Residual Urine Volume [ Time Frame: 3 catheterisations on 1 day ] [ Designated as safety issue: No ]
    Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation


Secondary Outcome Measures:
  • The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs) [ Time Frame: Study period ] [ Designated as safety issue: Yes ]
  • Median Absolute RU Volume [ Time Frame: 3 catheterisations on 1 day ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SpeediCath catheter
Standard treatment
 Device: SpeediCath
Catheter for intermittent catheterisation
Other Names:
  • SpeediCath
  • Test catheter
Experimental: Test product Device: Test Catheter - SpeediCath Compact Male
Compact catheter for intermittent catheterisation
Other Names:
  • SpeediCath
  • Test catheter

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048541

Locations
Germany
Werner−Wicker−Klinik, Abteilung für Neuro−Urologie
Bad Wildungen, Hessen, Germany, 34537
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Burkhard Domurath, Dr. med. Werner−Wicker−Klinik
Study Director: Henrik S Knoth, M.Sc Pharm Coloplast A/S
  More Information

No publications provided by Coloplast A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01048541     History of Changes
Other Study ID Numbers: CP061CC
Study First Received: January 11, 2010
Results First Received: January 9, 2012
Last Updated: August 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013