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A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study

NCT ID: NCT00990093

Last Updated: 2012-09-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-03-31

Brief Summary

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The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.

Detailed Description

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See brief summary

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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test intermittent catheter

CH 12 hydrophilic coated catheter

Group Type EXPERIMENTAL

test intermittent catheter

Intervention Type DEVICE

CH 12 hydrophilic coated catheter

intermittent catheter

CH 12 hydrophilic coated catheter

Group Type EXPERIMENTAL

Intermittent catheterization

Intervention Type DEVICE

CH 12 hydrophilic catheter

Interventions

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test intermittent catheter

CH 12 hydrophilic coated catheter

Intervention Type DEVICE

Intermittent catheterization

CH 12 hydrophilic catheter

Intervention Type DEVICE

Other Intervention Names

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Test catheter SpeediCath

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age
* Has normal/impaired sensation in the urethra
* Self-catheterises at least 4 times per day
* Has used clean self-intermittent catheterisation for at least 14 days
* Is able to open and prepare the catheters for catheterisation
* Has signed the informed consent before any study related-activities.

Exclusion Criteria

* Has a symptomatic urinary tract infection as assessed by the investigator
* Is mentally unstable as assessed by the investigator
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Coloplast A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fin Biering-Sørensen, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik for Rygmarvsskader, Rigshospitalet

Locations

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Klinik for Rygmarvsskader

Hornbæk, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 34699062 (View on PubMed)

Chartier-Kastler E, Lauge I, Ruffion A, Goossens D, Charvier K, Biering-Sorensen F. Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study. Spinal Cord. 2011 Jul;49(7):844-50. doi: 10.1038/sc.2011.5. Epub 2011 Feb 22.

Reference Type DERIVED
PMID: 21339763 (View on PubMed)

Other Identifiers

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CP062CC

Identifier Type: -

Identifier Source: org_study_id