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Completed

NCT Number: NCT01048541

Bladder Scan of Residual Urine With New Catheter

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Werner-Wicker-Klinik, Abteilung für Neuro-Urologie

Bad Wildungen, Hesse, 34537, Germany

About this study

See brief summary

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Test Catheter - SpeediCath Compact Male

Device

Compact catheter for intermittent catheterisation

Other names: SpeediCath, Test catheter

SpeediCath

Device

Catheter for intermittent catheterisation

Other names: Test catheter

Primary outcomes

  1. Mean Residual Urine Volume

    Time frame: 3 catheterisations on 1 day

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

Secondary outcomes

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

    Time frame: Study period

  2. Median Absolute RU Volume

    Time frame: 3 catheterisations on 1 day

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 13, 2010
Registry last updated
Sep 3, 2012

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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