MedTrace Logo

A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation

NCT00753298 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2021-11-11

Study results available
· View outcomes & findings →

Summary

The study is designed as a randomized, double-blind, parallel-group, multi centre study comparing perception and tolerability of investigational product and comparator. In the randomized part of the study the subjects will be given either LoFric Primo (POBE) or the comparator LoFric Primo (PVC) for use over 4 weeks. The hypothesis is that subject perception and satisfaction of POBE is equal to or better than for PVC.

Conditions

  • Urinary Catheterization

Interventions

DEVICE

LoFric Primo (POBE) single-use urinary catheter

LoFric Primo (POBE) single-use urinary catheter

DEVICE

LoFric Primo (PVC) single-use urinary catheter

LoFric Primo (PVC) single-use urinary catheter

Sponsors & Collaborators

  • Wellspect HealthCare

    lead INDUSTRY

Principal Investigators

  • Alfred J Witjes, Prof Dr · Radboud Univesity Nijmegen Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Austria
  • Germany
  • Italy
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00753298 on ClinicalTrials.gov