Status:
COMPLETED
Sterile Single-use vs Reused Polyvinylchloride Catheter For Intermittent Catheterization In Neurogenic Bladder
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Neurogenic Bladder Due to Spina Bifida (Disorder)
Eligibility:
All Genders
2+ years
Phase:
NA
Brief Summary
The objective of the study is to determine whether single-use polyvinylchloride (PVC) catheters reduce urinary tract infections (UTI) compared to reused PVC catheters for patients with neurogenic blad...
Detailed Description
The investigators performed a 3-arm clinical trial at the "Dr. José Eleuterio González" University Hospital, a tertiary-care academic hospital in Monterrey, Mexico. The study population were patients ...
Eligibility Criteria
Inclusion
- age ≥ 2 years,
- diagnosis of spina bifida,
- had self-IC or performed by a trained person ≥ 3 months using reused PVC catheter (1 per week) with clean technique,
- able to read and understand informed consent
Exclusion
- other causes of neurogenic bladder,
- symptomatic UTI at the time of initial evaluation,
- inconsistent IC,
- indwelling catheter,
- allergy to PVC,
- urethral pathology (ie stricture, false passage, hypospadias)
- rejection to participate in trial
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT03424499
Start Date
August 1 2016
End Date
August 1 2021
Last Update
July 6 2022
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