Clinical trial NCT00753298: A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Catheterization
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Subject's Perception Regarding Handling of Test Catheter Before Insertion
timeFrame: At 4 weeks
measure: Subject's Perception Regarding Handling of Test Catheter at Insertion
timeFrame: At 4 weeks
measure: Subject's Perception Regarding Handling of Test Catheter at Withdrawal
timeFrame: At 4 weeks
measure: Subject's Perception Regarding Handling of Test Catheter After Withdrawal
timeFrame: At 4 weeks
measure: Subject's General Satisfaction With Test Catheter
timeFrame: At 4 weeks
measure: Subject's Sensation When Using Test Catheter
timeFrame: At 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Urology
city: Greifswald
country: Germany
facility: NRZ Greifswald
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH, Zentrum für Kontinenz und Neuro-Urologie, Krankenhaus St. Franziskus
city: Tübingen
country: Germany
facility: BG-Klinik Tübingen
city: Firenze
country: Italy
facility: Ospedale Careggi, Unità Spinale
city: Torino
country: Italy
facility: Primario U.O. Neuro-Urologia, Direttore Dipartimento delle Mielolesioni
city: Bergen op Zoom
country: Netherlands
facility: Ziekenhuis Lievensberg, Afdeling Urologie
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis, Locatie Dordwijk
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud Univesity Nijmegen Medical Centre
city: Göteborg
country: Sweden
facility: Verksamhet Urologi, Sahlgrenska Universitets sjukhuset
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation trust, Royal Hallamshire Hospital
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital, Spinal Injuries Unit, Brockley Hill Stanmore
Study officials:
affiliation: Radboud Univesity Nijmegen Medical Centre
name: Alfred J Witjes, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: