Quality of Life Intermittent Catheter Study

Coloplast A/S125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

125

Conditions

Neurogenic Bladder Dysfunction Nos

Interventions

SpeediCath CompactDEVICE

The SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra.

Standard careDEVICE

The coated intermittent catheter normally used by subject

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

PrivatHospitalet Danmark, privat hospital,

Charlottenlund, Denmark

Rigshospitalet, Urology clinic,

Copenhagen, Denmark

CCBR Vejle, Clinical research site,

Vejle, Denmark

Outcomes

Primary Outcomes

Quality of Life (0-100 Point)

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.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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