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Completed

NCT Number: NCT00324233

Evaluation of Residual Urine After Intermittent Catheterisation

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.

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Key information

Conditions

Healthy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematuria Hemorrhage Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, København Ø, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent catheter

Device

SpeediCath catherter (SC) for intermittent catherisation

Compact intermittent catheter

Device

SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males

Primary outcomes

  1. Residual Urine Measured by Ultra Sound

    Time frame: 2

Secondary outcomes

  1. Subjectively Measured Handling

  2. Subjectively Measured Insertion of the Catheter

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Evaluation of Residual Urine After Intermittent Catheterisation - Comparison of 2 Hydrophilic Coated, Intermittent Catheters

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
May 10, 2006
Registry last updated
Jan 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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