N/A
Completed N=195
A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation
Urinary Catheterization
Source: ClinicalTrials.gov NCT00753298 ↗
Enrolled (actual)
195
Serious AEs
1.5%
Results posted
Jun 2009
Primary outcomePrimary: Subject's Perception Regarding Handling of Test Catheter Before Insertion — 1.71; 1.76 Score on scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject's Perception Regarding Handling of Test Catheter Before Insertion |
1.71; 1.76 | — |
| PRIMARY Subject's Perception Regarding Handling of Test Catheter at Insertion |
1.81; 1.55 | — |
| PRIMARY Subject's Perception Regarding Handling of Test Catheter at Withdrawal |
1.55; 1.44 | — |
| PRIMARY Subject's Perception Regarding Handling of Test Catheter After Withdrawal |
1.63; 1.69 | — |
| PRIMARY Subject's General Satisfaction With Test Catheter |
2.01; 1.75 | — |
| PRIMARY Subject's Sensation When Using Test Catheter |
1.86; 1.91 | — |
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
Data sourced from ClinicalTrials.gov (NCT00753298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.