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

Not Applicable

Completed

Conditions: Spinal Cord Injury

Interventions: Device: Intermittent catheter CP063CC
Device: SpeediCath

Registration Number: NCT01142115

Lead Sponsor: Coloplast A/S

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 41

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Monza	Intermittent catheter CP063CC	nonCE marked intermittent catheter
control	Intermittent catheter CP063CC	SpeediCath coated catheter
control	SpeediCath	SpeediCath coated catheter

Primary Outcome Measures

Name	Time	Method
Discomfort Measured on the Visual Analog Scale (VAS)	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 Outcome Measures

Name	Time	Method
Irritation During Voiding After Catheterization	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.
Ease of Use Measured on a 5 Point Scale: Insertion Effort	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
Ease of Use Measured on a 5 Point Scale: Withdrawal Effort	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
Visible Blood	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.
Haematuria	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.