A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation
- Conditions
- Urinary Catheterization
- Registration Number
- NCT00753298
- Lead Sponsor
- Wellspect HealthCare
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Subject's Sensation When Using Test Catheter At 4 weeks Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain)
Subject's Perception Regarding Handling of Test Catheter Before Insertion 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)
Subject's Perception Regarding Handling of Test Catheter at Insertion 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)
Subject's Perception Regarding Handling of Test Catheter at Withdrawal 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)
Subject's Perception Regarding Handling of Test Catheter After Withdrawal 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)
Subject's General Satisfaction With Test Catheter 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Medical University of Vienna, Department of Urology
🇦🇹Vienna, Austria
NRZ Greifswald
🇩🇪Greifswald, Germany
Kliniken Maria Hilf GmbH, Zentrum für Kontinenz und Neuro-Urologie, Krankenhaus St. Franziskus
🇩🇪Mönchengladbach, Germany
BG-Klinik Tübingen
🇩🇪Tübingen, Germany
Ospedale Careggi, Unità Spinale
🇮🇹Firenze, Italy
Primario U.O. Neuro-Urologia, Direttore Dipartimento delle Mielolesioni
🇮🇹Torino, Italy
Ziekenhuis Lievensberg, Afdeling Urologie
🇳🇱Bergen op Zoom, Netherlands
Albert Schweitzer Ziekenhuis, Locatie Dordwijk
🇳🇱Dordrecht, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Radboud Univesity Nijmegen Medical Centre
🇳🇱Nijmegen, Netherlands
Scroll for more (3 remaining)Medical University of Vienna, Department of Urology🇦🇹Vienna, Austria