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

Comparative Study of Two Different Urine Catheters.

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: Intermittent catheter CP063CC; Device: SpeediCath

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet, dep. 2112

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monza; nonCE marked intermittent catheter	Device: Intermittent catheter CP063CC; intermittent catheterisation; Other Names: Intermittent catheter,
Active Comparator: control; SpeediCath coated catheter	Device: Intermittent catheter CP063CC; intermittent catheterisation; Other Names: Intermittent catheter,; Device: SpeediCath; intermittent catheterisation; Other Names: Intermittent catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discomfort Measured on the Visual Analog Scale (VAS)	Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).	10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irritation During Voiding After Catheterization	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.	10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Ease of Use Measured on a 5 Point Scale: Insertion Effort	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	10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Ease of Use Measured on a 5 Point Scale: Withdrawal Effort	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	10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Visible Blood	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.	10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Haematuria	Negative or positive result on a multistix urin analysis. Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter.	2 hours after catheterisation at visits 1 and 2

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Study Director: Rikke Otttesen, CTM, Coloplast A/S

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: June 10, 2010
• First Posted (Estimate): June 11, 2010

Study Record Updates

• Last Update Posted (Estimate): October 7, 2011
• Last Update Submitted That Met QC Criteria: October 4, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: CP063CC