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Completed

NCT Number: NCT00753298

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

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.

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Key information

Conditions

Urinary Catheterization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna, Department of Urology, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of informed consent
  • Males and females aged 18 years and over
  • Experienced users of LoFric Primo with a minimum of one month of use
  • Practice CIC with LoFric Primo at least 3 times per day
  • Adults able to read, write and understand information given to them regarding the study

Exclusion criteria

  • Ongoing symptomatic UTI
  • Suspicions of possible poor compliance with CIC during the study period
  • Previous enrolment or randomisation of treatment in the present study
  • Pregnancy
  • Subjects not able to perform self-catheterisation

Treatment and study plan

LoFric Primo (POBE) single-use urinary catheter

Device

LoFric Primo (POBE) single-use urinary catheter

LoFric Primo (PVC) single-use urinary catheter

Device

LoFric Primo (PVC) single-use urinary catheter

Primary outcomes

  1. Subject's Perception Regarding Handling of Test Catheter Before Insertion

    Time frame: At 4 weeks

    Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)

  2. Subject's Perception Regarding Handling of Test Catheter at Insertion

    Time frame: At 4 weeks

    Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)

  3. Subject's Perception Regarding Handling of Test Catheter at Withdrawal

    Time frame: At 4 weeks

    Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)

  4. Subject's Perception Regarding Handling of Test Catheter After Withdrawal

    Time frame: At 4 weeks

    Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)

  5. Subject's General Satisfaction With Test Catheter

    Time frame: At 4 weeks

    Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified)

  6. Subject's Sensation When Using Test Catheter

    Time frame: At 4 weeks

    Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain)

Sponsors and collaborators

Lead sponsor

Wellspect HealthCare

Industry

Registry information

Official study title

A Multi-centre, Double-blind, Randomized, Parallel Groups Study Comparing PVC and Polyolefin-based Elastomer (POBE) as Catheter Materials, Outcomes Will be Measured by Subject Perception.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 16, 2008
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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