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Evaluation of a New Catheter Material for Intermittent Catheterization

NCT01295281 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2021-11-11

Study results available
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Summary

The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e. clinically non-inferior when using POBE 2.0 compared to PVC.

Secondary objectives are to evaluate the safety and the subject's perception associated with the use of the catheters, assessed by the recording of adverse events and the ease of handling by means of a subjective assessment scale.

Conditions

  • Catheterization (Clean, Intermittent Urinary Catheterization)

Interventions

DEVICE

LoFric POBE 2.0

To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.

DEVICE

LoFric PVC

To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.

Sponsors & Collaborators

  • Wellspect HealthCare

    lead INDUSTRY

Principal Investigators

  • Birgit Johansson, Urotherapist · Kärnsjukhuset Skövde

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Sweden

Study Locations

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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 NCT01295281 on ClinicalTrials.gov