CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 107 enrolled
Drug / intervention
LoFric POBE 2.0 +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01295281
NCT01295281N/ACompleted
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A Prospective, Randomized, Cross-over Study - Evaluation of a New Catheter Material for Intermittent Catheterization

Wellspect HealthCare·interventional·Posted Feb 14, 2011·Updated Nov 11, 2021

In Brief

A clinical study evaluating LoFric POBE 2.0 and LoFric PVC for Catheterization (Clean, Intermittent Urinary Catheterization). Completed, enrolled 107 participants across 6 sites.

Detailed Summary

The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e. clinically non-inferior when using POBE 2.0 compared to PVC. Secondary objectives are to evaluate the safety and the subject's perception associated with the use of the catheters, assessed by the recording of adverse events and the ease of handling by means of a subjective assessment scale.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCatheterization (Clean, Intermittent Urinary Catheterization)
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 14, 2011
Enrollment StartMar 1, 2011
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.4 years ago

Interventions

LoFric POBE 2.0device

To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.

LoFric PVCdevice

To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.