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

Phase 1

Withdrawn

• Conditions: Spinal Cord Injury
• Interventions: Device: Intermittent catheterisation; Device: NonCE marked intermittent catheter/red; Device: NonCE marked intermittent catheter/blue; Device: NonCE marked intermittent catheter/green

• Registration Number: NCT01292941
• Lead Sponsor: Coloplast A/S

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Study Start: 2011-03
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-06
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active comparator/Yellow catheter	Intermittent catheterisation	SpeediCath coated catheter
NonCE marked intermittent catheter/red	NonCE marked intermittent catheter/red	-
NonCE marked intermittent catheter/Blue	NonCE marked intermittent catheter/blue	-
NonCE marked intermittent catheter/green	NonCE marked intermittent catheter/green	-

Primary Outcome Measures

Name	Time	Method
Discomfort during catheterisation measured by VAS-scale (0-10)	10 measurements in an 11 week period. 10 min after each catheterisation	A subject is assesing a VAS scale after each catheterisation.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark