Bladder Scan of Residual Urine With New Catheter

August 2, 2012 updated by: Coloplast A/S

A Non-Inferiority Bladder Scan Study to Investigate Residual Urine After Use of Intermittent Catheters in Male Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See brief summary

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Bad Wildungen, Hessen, Germany, 34537
        • Werner-Wicker-Klinik, Abteilung für Neuro-Urologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test product
Device: Test Catheter - SpeediCath Compact Male
Compact catheter for intermittent catheterisation
Other Names:
  • Test catheter
  • SpeediCath
Active Comparator: SpeediCath catheter
Standard treatment
Device: SpeediCath
Catheter for intermittent catheterisation
Other Names:
  • Test catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Residual Urine Volume
Time Frame: 3 catheterisations on 1 day
Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation
3 catheterisations on 1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Investigators

  • Principal Investigator: Burkhard Domurath, Dr. med., Werner Wicker Klinik
  • Study Director: Henrik S Knoth, M.Sc Pharm, Coloplast A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 2, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP061CC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Incontinence

Clinical Trials on SpeediCath

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe