Status:
COMPLETED
A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation
Lead Sponsor:
Wellspect HealthCare
Conditions:
Urinary Catheterization
Eligibility:
All Genders
18+ years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00753298
Start Date
January 1 2007
End Date
March 1 2008
Last Update
November 11 2021
Active Locations (13)
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1
Medical University of Vienna, Department of Urology
Vienna, Austria, A-1090
2
NRZ Greifswald
Greifswald, Germany, 17487
3
Kliniken Maria Hilf GmbH, Zentrum für Kontinenz und Neuro-Urologie, Krankenhaus St. Franziskus
Mönchengladbach, Germany, 41063
4
BG-Klinik Tübingen
Tübingen, Germany, 72076