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

N/ACompletedNCT00990093

Coloplast A/S36 enrolled

Overview

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

See brief summary

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries

Interventions

test intermittent catheterDEVICE

CH 12 hydrophilic coated catheter

Intermittent catheterizationDEVICE

CH 12 hydrophilic catheter

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinik for Rygmarvsskader

Hornbæk, Denmark

Outcomes

Primary Outcomes

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)

Time frame: 14 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.