Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers

Spinal Cord Injury Clinical Trial

Official title:

Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01292941
• Other study ID #: CP065CC
• Status: Withdrawn
• Phase: Phase 1
• First received: February 9, 2011
• Last updated: August 6, 2015
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: August 2015
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)

Description:

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

Coloplast have developed a new intermittent catheters. In this investigation this new test catheter will be compared with SpeediCat 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.

55 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• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • =18 years

• Male

• Signed informed consent

• Negative urine stix (erythrocytes, leucocytes and nitrite)

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Intermittent catheterisation
Speedicath, Intermittent catheterisation
• NonCE marked intermittent catheter/red
Paris, Intermittent catheterisation
• NonCE marked intermittent catheter/green
Paris, Intermittent catheter
• NonCE marked intermittent catheter/blue
Paris, Intermittent catheter

Locations

Country	Name	City	State
Denmark	Rigshospitalet	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 during catheterisation measured by VAS-scale (0-10)	A subject is assesing a VAS scale after each catheterisation.	10 measurements in an 11 week period. 10 min after each catheterisation	No
Secondary	Safety	Safety is evalueted continues while the subjects are testing the devices	During the investigation 11 Weeks per subject	Yes
Secondary	Discomfort during urination post catheterisation	Subjects own assesment. Yes or no can be answered to discomfort during urination post catheterisation	10 measurements in an 11 week period. 10 min after each catheterisation	No
Secondary	Haematuria	Urine test after each catheterisation, and measured on a urine stix	10 measurements in an 11 week period. 10 min after each catheterisation	Yes
Secondary	Handling during insertion, withdrawal	Ease of use assessed by nurses, measured on a 5 point scale	10 measurements in an 11 week period. 10 min after each catheterisation	No