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

NCT ID: NCT00753298

Last Updated: 2021-11-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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LoFric Primo (POBE) single-use urinary catheter

Group Type EXPERIMENTAL

LoFric Primo (POBE) single-use urinary catheter

Intervention Type DEVICE

LoFric Primo (POBE) single-use urinary catheter

LoFric Primo (PVC) single-use urinary catheter

Group Type ACTIVE_COMPARATOR

LoFric Primo (PVC) single-use urinary catheter

Intervention Type DEVICE

LoFric Primo (PVC) single-use urinary catheter

Interventions

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LoFric Primo (POBE) single-use urinary catheter

LoFric Primo (POBE) single-use urinary catheter

Intervention Type DEVICE

LoFric Primo (PVC) single-use urinary catheter

LoFric Primo (PVC) single-use urinary catheter

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wellspect HealthCare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alfred J Witjes, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Radboud Univesity Nijmegen Medical Centre

Locations

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Medical University of Vienna, Department of Urology

Vienna, , Austria

Site Status

NRZ Greifswald

Greifswald, , Germany

Site Status

Kliniken Maria Hilf GmbH, Zentrum für Kontinenz und Neuro-Urologie, Krankenhaus St. Franziskus

Mönchengladbach, , Germany

Site Status

BG-Klinik Tübingen

Tübingen, , Germany

Site Status

Ospedale Careggi, Unità Spinale

Florence, , Italy

Site Status

Primario U.O. Neuro-Urologia, Direttore Dipartimento delle Mielolesioni

Torino, , Italy

Site Status

Ziekenhuis Lievensberg, Afdeling Urologie

Bergen op Zoom, , Netherlands

Site Status

Albert Schweitzer Ziekenhuis, Locatie Dordwijk

Dordrecht, , Netherlands

Site Status

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

Radboud Univesity Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Verksamhet Urologi, Sahlgrenska Universitets sjukhuset

Gothenburg, , Sweden

Site Status

Sheffield Teaching Hospitals NHS Foundation trust, Royal Hallamshire Hospital

Sheffield, , United Kingdom

Site Status

Royal National Orthopaedic Hospital, Spinal Injuries Unit, Brockley Hill Stanmore

Stanmore, , United Kingdom

Site Status

Countries

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Austria Germany Italy Netherlands Sweden United Kingdom

Other Identifiers

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YA-CLO-0002

Identifier Type: -

Identifier Source: org_study_id