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N/A N=195 Randomized Triple-blind Treatment

A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation

Urinary Catheterization

Bottom Line

View on ClinicalTrials.gov: NCT00753298 ↗
Enrolled (actual)
195
Serious AEs
1.5%
Results posted
Jun 2009
Primary outcome: Primary: Subject's Perception Regarding Handling of Test Catheter Before Insertion — 1.71; 1.76 Score on scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
LoFric Primo (POBE) single-use urinary catheter (Device); LoFric Primo (PVC) single-use urinary catheter (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Wellspect HealthCare
Primary completion
Mar 2008

Outcome Measures

OutcomeResultp-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 —

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.

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
View full record on ClinicalTrials.gov →

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.

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