Quality of Life Intermittent Catheter Study

Coloplast

Status and phase: Completed; Phase 4

Conditions: Neurogenic Bladder Dysfunction Nos

Treatments: Device: SpeediCath Compact; Device: Standard care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01523743

CP220

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

125 participants in 2 patient groups

Compact catheter

Experimental group

Description:

Compact intermittent catheter

Treatment:

Device: SpeediCath Compact

Standard Care

Active Comparator group

Description:

Standard Care: Coated intermittent catheter normally used by subject

Treatment:

Device: Standard care