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Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization

NCT01305681 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2019-08-07

No results posted yet for this study

Summary

The primary objective of our study is to examine characteristics of bacteria that are discovered in urine from pediatric patients that utilize either LoFric® or non-LoFric® catheters for self intermittent catheterization. The investigators hypothesize that the hydrophilic nature of the LoFric® catheter will alter the microbial environment and reduce clinically significant urinary tract infections in patients with neurogenic bladder compared to a similar population using standard catheters.

Secondary outcomes will be comparing the incidence of clinical urinary tract infections between patients that use standard catheters and those that use LoFric catheters.

Lastly, patient satisfaction using LoFric catheters compared to standard catheters will be assessed.

Conditions

  • Neurogenic Bladder
  • Urinary Retention

Interventions

DEVICE

LoFric® catheters during clean intermittent catheterization

LoFric® catheters during clean intermittent catheterization

Sponsors & Collaborators

  • Dentsply Sirona Implants and Consumables

    collaborator INDUSTRY

  • Nationwide Children's Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-06
Primary Completion
2012-02-21
Completion
2012-02-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01305681 on ClinicalTrials.gov