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Bladder Scan of Residual Urine With New Catheter

Primary Purpose

Urinary Incontinence

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Test Catheter - SpeediCath Compact Male

SpeediCath

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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).
Subject has known abnormalities in the lower urinary tract.

Sites / Locations

Werner-Wicker-Klinik, Abteilung für Neuro-Urologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SpeediCath catheter

Test product

Arm Description

Standard treatment

Outcomes

Primary Outcome Measures

Mean Residual Urine Volume

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)

Median Absolute RU Volume

Full Information

NCT ID

NCT01048541

First Posted

January 11, 2010

Last Updated

August 2, 2012

Sponsor

Coloplast A/S

1. Study Identification

Unique Protocol Identification Number

NCT01048541

Brief Title

Bladder Scan of Residual Urine With New Catheter

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coloplast A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

See brief summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SpeediCath catheter

Arm Type

Active Comparator

Arm Description

Standard treatment

Arm Title

Test product

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Test Catheter - SpeediCath Compact Male

Other Intervention Name(s)

SpeediCath, Test catheter

Intervention Description

Compact catheter for intermittent catheterisation

Intervention Type

Device

Intervention Name(s)

SpeediCath

Other Intervention Name(s)

Test catheter

Intervention Description

Catheter for intermittent catheterisation

Primary Outcome Measure Information:

Title

Mean Residual Urine Volume

Description

Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation

Time Frame

3 catheterisations on 1 day

Secondary Outcome Measure Information:

Title

The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs)

Time Frame

Study period

Title

Median Absolute RU Volume

Time Frame

3 catheterisations on 1 day

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is a male IC user able to self-catheterise Subject has used hydrophilic-coated ICs for at least 1 month Subject is at least 18 years old. Subject has provided informed consent. Exclusion Criteria: 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). Subject has known abnormalities in the lower urinary tract.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Burkhard Domurath, Dr. med.

Organizational Affiliation

Werner Wicker Klinik

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Henrik S Knoth, M.Sc Pharm

Organizational Affiliation

Coloplast A/S

Official's Role

Study Director

Facility Information:

Facility Name

Werner-Wicker-Klinik, Abteilung für Neuro-Urologie

City

Bad Wildungen

State/Province

Hessen

ZIP/Postal Code

34537

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

34699062

Citation

Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.

Results Reference

derived

PubMed Identifier

21358718

Citation

Domurath B, Kutzenberger J, Kurze I, Knoth HS. Clinical evaluation of a newly developed catheter (SpeediCath Compact Male) in men with spinal cord injury: residual urine and user evaluation. Spinal Cord. 2011 Jul;49(7):817-21. doi: 10.1038/sc.2011.14. Epub 2011 Mar 1.

Results Reference

derived

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Bladder Scan of Residual Urine With New Catheter

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