Urinary Catheterization Clinical Trial
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.
| NCT number | NCT00753298 |
| Other study ID # | YA-CLO-0002 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2007 |
| Est. completion date | March 2008 |
| Verified date | September 2012 |
| Source | Wellspect HealthCare |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 195 |
| Est. completion date | March 2008 |
| Est. primary completion date | March 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna, Department of Urology | Vienna | |
| Germany | NRZ Greifswald | Greifswald | |
| Germany | Kliniken Maria Hilf GmbH, Zentrum für Kontinenz und Neuro-Urologie, Krankenhaus St. Franziskus | Mönchengladbach | |
| Germany | BG-Klinik Tübingen | Tübingen | |
| Italy | Ospedale Careggi, Unità Spinale | Firenze | |
| Italy | Primario U.O. Neuro-Urologia, Direttore Dipartimento delle Mielolesioni | Torino | |
| Netherlands | 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 | |
| Sweden | Verksamhet Urologi, Sahlgrenska Universitets sjukhuset | Göteborg | |
| United Kingdom | Sheffield Teaching Hospitals NHS Foundation trust, Royal Hallamshire Hospital | Sheffield | |
| United Kingdom | Royal National Orthopaedic Hospital, Spinal Injuries Unit, Brockley Hill Stanmore | Stanmore |
| Lead Sponsor | Collaborator |
|---|---|
| Wellspect HealthCare |
Austria, Germany, Italy, Netherlands, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Subject's Perception Regarding Handling of Test Catheter Before Insertion | Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | At 4 weeks | |
| Primary | Subject's Perception Regarding Handling of Test Catheter at Insertion | Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | At 4 weeks | |
| Primary | Subject's Perception Regarding Handling of Test Catheter at Withdrawal | Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | At 4 weeks | |
| Primary | Subject's Perception Regarding Handling of Test Catheter After Withdrawal | Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | At 4 weeks | |
| Primary | Subject's General Satisfaction With Test Catheter | Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified) | At 4 weeks | |
| Primary | Subject's Sensation When Using Test Catheter | Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain) | At 4 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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