A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study

Spinal Cord Injuries Clinical Trial

Official title:

A Randomised, Cross-over, Open-labelled Study Evaluating the Acceptance of Test Catheters Compared to SpeediCath Catheters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990093
• Other study ID #: CP062CC
• Status: Completed
• Phase: N/A
• First received: October 5, 2009
• Last updated: August 2, 2012
• Start date: November 2009
• Est. completion date: March 2010

Study information

• Verified date: August 2012
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection AuthorityFrance: The national physicians authority
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.

Description:

See brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Has normal/impaired sensation in the urethra

• Self-catheterises at least 4 times per day

• Has used clean self-intermittent catheterisation for at least 14 days

• Is able to open and prepare the catheters for catheterisation

• Has signed the informed consent before any study related-activities.

Exclusion Criteria:

• Has a symptomatic urinary tract infection as assessed by the investigator

• Is mentally unstable as assessed by the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• test intermittent catheter
CH 12 hydrophilic coated catheter
• Intermittent catheterization
CH 12 hydrophilic catheter

Locations

Country	Name	City	State
Denmark	Klinik for Rygmarvsskader	Hornbæk

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 a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.	Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.; At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)	14 days	No