Quality of Life Intermittent Catheter Study - A Prospective, Randomized, Cross-over, Multicenter Study Comparing Quality of Life Using Compact Versus Standard Urinary Intermittent Catheters

Coloplast A/S11 sites in 5 countries125 target enrollmentNovember 2011

ConditionsNeurogenic Bladder Dysfunction Nos

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Neurogenic Bladder Dysfunction Nos
Sponsor: Coloplast A/S
Enrollment: 125
Locations: 11
Primary Endpoint: Quality of Life (0-100 Point)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

May 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Coloplast A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is at least 18 years of age
•Has given written informed consent
•Has neurogenic bladder dysfunction
•Has used coated intermittent catheter as primarily bladder emptying method for at least 6 months
•Is able to self-catheterise
•Is able to use SpeediCath® compact catheters
•If spinal cord injury subject, injury must have occurred more than 12 months ago
•Covered by Social security system

Exclusion Criteria

•Has used SpeediCath® compact catheters (not including screening for this investigation)
•Is admitted to rehabilitation centre
•Subjects using primarily catheter sets
•Is pregnant or breast-feeding

Outcomes

Primary Outcomes

Quality of Life (0-100 Point)

Time Frame: 6 weeks

Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life.