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

Spinal Cord Injury Clinical Trial

Official title:

Comparative Study of Two Different Urine Catheters.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142115
• Other study ID #: CP063CC
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: October 4, 2011
• Start date: January 2010
• Est. completion date: May 2010

Study information

• Verified date: October 2011
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Intermittent catheter CP063CC
intermittent catheterisation
• SpeediCath
intermittent catheterisation

Locations

Country	Name	City	State
Denmark	Rigshospitalet, dep. 2112	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes