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Evaluation of Residual Urine After Intermittent Catheterisation

Not Applicable
Completed
Conditions
Healthy
Interventions
Device: Intermittent catheter
Device: Compact intermittent catheter
Registration Number
NCT00324233
Lead Sponsor
Coloplast A/S
Brief Summary

Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
36
Inclusion Criteria
  • Male
  • 18 years and above
  • A negative urine dip-stick
  • Have signed informed written consent to participate
Exclusion Criteria
  • The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
SCIntermittent catheterSpeedicath (SC) catheter is a catheter for intermittent catherisation
SCCMCompact intermittent catheterSpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males
Primary Outcome Measures
NameTimeMethod
Residual Urine Measured by Ultra Sound2
Secondary Outcome Measures
NameTimeMethod
Subjectively Measured Handling
Subjectively Measured Insertion of the Catheter

Trial Locations

Locations (1)

Rigshospitalet

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Copenhagen, København Ø, Denmark

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