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Completed

NCT Number: NCT01142115

Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers

The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet, dep. 2112

Copenhagen, 2100, Denmark

About this study

Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.

Coloplast has developed a new intermittent catheter. In this investigation this new test catheter will be compared with SpeediCath by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.

Healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years or older
  • Male
  • signed informed Consent,
  • Neg. urine multistix

Exclusion criteria

  • Abnormalities,
  • diseases or surgical procedures performed in the lower urinary-tract

Treatment and study plan

Intermittent catheter CP063CC

Device

intermittent catheterisation

Other names: Intermittent catheter,

SpeediCath

Device

intermittent catheterisation

Other names: Intermittent catheter

Primary outcomes

  1. Discomfort Measured on the Visual Analog Scale (VAS)

    Time frame: 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1

    Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).

Secondary outcomes

  1. Irritation During Voiding After Catheterization

    Time frame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1

    After each catheterization subjects were asked if they felt any irritation during voiding with answer option yes or no.

    Yes - they experienced irritation. No - they did not experience irritation.

  2. Ease of Use Measured on a 5 Point Scale: Insertion Effort

    Time frame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1

    After each catheterization the nurse who conducted the catheterization answered how the catheter insertion had been.

    There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy

  3. Ease of Use Measured on a 5 Point Scale: Withdrawal Effort

    Time frame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1

    After each catheterization the nurse who conducted the catheterization answered how the catheter withdrawal had been.

    There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy

  4. Visible Blood

    Time frame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1

    Visual blood observed on the catheter or in the urine in connection to catheterization.

    The nurse who conducted the catheterization could answer yes or no as follows:

    Yes = visible blood observed. No = no visible blood observed.

  5. Haematuria

    Time frame: 2 hours after catheterisation at visits 1 and 2

    Negative or positive result on a multistix urin analysis.

    Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Comparative Study of Two Different Urine Catheters.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 11, 2010
Registry last updated
Oct 7, 2011

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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