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Bladder Scan of Residual Urine With New Catheter

NCT ID: NCT01048541

Last Updated: 2012-09-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-06-30

Brief Summary

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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

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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SpeediCath catheter

Standard treatment

Group Type ACTIVE_COMPARATOR

SpeediCath

Intervention Type DEVICE

Catheter for intermittent catheterisation

Test product

Group Type EXPERIMENTAL

Test Catheter - SpeediCath Compact Male

Intervention Type DEVICE

Compact catheter for intermittent catheterisation

Interventions

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Test Catheter - SpeediCath Compact Male

Compact catheter for intermittent catheterisation

Intervention Type DEVICE

SpeediCath

Catheter for intermittent catheterisation

Intervention Type DEVICE

Other Intervention Names

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SpeediCath Test catheter Test catheter

Eligibility Criteria

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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.
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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Burkhard Domurath, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Werner Wicker Klinik

Henrik S Knoth, M.Sc Pharm

Role: STUDY_DIRECTOR

Coloplast A/S

Locations

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Werner-Wicker-Klinik, Abteilung für Neuro-Urologie

Bad Wildungen, Hesse, Germany

Site Status

Countries

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Germany

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)

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.

Reference Type DERIVED
PMID: 21358718 (View on PubMed)

Other Identifiers

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CP061CC

Identifier Type: -

Identifier Source: org_study_id