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OpenTrials
Completed

NCT Number: NCT02965066

Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers

The aim of the study is to test the performance and safety of a newly developed intermittent catheter in healthy volunteers.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Coppenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Have given written informed consent and signed letter of authority
  • Be at least 18 years of age and have full legal capacity
  • Be a male
  • Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
  • Have a negative urine multistix - erythrocytes (Microscopic haematuria)
  • Have a negative urine multistix:
  • Leukocytes
  • Nitrite Or if positive, subsequent negative for bacterial growth in urine culture

Exclusion criteria

  • Abnormalities, diseases or surgical procedures performed in the lower urinary tract
  • Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
  • Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation
  • Known hypersensitivity toward any of the test products -

Treatment and study plan

Coloplast Test Catheter

Device

Newly developed intermittent catheter

Coloplast Speedicath

Device

Marketed Coloplast Speedicath catheter

Primary outcomes

  1. Pain

    Time frame: 1 day

    The VAS scale is used to measure the pain experienced by the subjects at catheterisation

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 16, 2016
Registry last updated
Nov 16, 2016

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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