MedTrace Logo

Sterile Single-use vs Reused Polyvinylchloride Catheter For Intermittent Catheterization In Neurogenic Bladder

NCT03424499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2022-07-06

No results posted yet for this study

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 bladder due to spina bifida that require intermittent catheterization for bladder emptying. The investigators conducted a clinical trial with an 8-week follow-up comparing single-use and reused (washed with soap and water, and stored in a container with benzalkonium chloride or washed with soap and water alone) PVC intermittent catheterization. Evaluations were established on days 0, 7, 14, 28, 42, and 56. Participants reported symptoms and urine culture results, collecting urine samples from a fresh midstream catheter specimen using a sterile technique.

Conditions

  • Neurogenic Bladder Due to Spina Bifida (Disorder)

Interventions

PROCEDURE

Single-use catheter

Each urethral catheterization will be done with a new sterile catheter in a period of 8 weeks. Frequency of urethral catheterization will depend of the conditions of each patient (from 3-5 per day). Patients and parents were instructed to use clean technique by hand washing with water and soup, and penis/vulva cleansing with antiseptic wipes. Researchers reinforced the intermittent catheterization technique before the trial.

PROCEDURE

Reused catheter

Each catheter is programmed to last 1 week. Evaluation will last a period of 8 weeks. Frequency of urethral catheterization will depend of the conditions of each patient (from 3-5 per day). after catheterization. Each catheter was programmed to last a week. Patients and parents were instructed to use clean technique by hand washing with water and soup, and penis/vulva cleansing with antiseptic wipes. Researchers reinforced the intermittent catheterization technique before the trial.

DIAGNOSTIC_TEST

Urine culture

A midstream urine sample will be obtained using sterile catheterization for urine culture performed by health provider. Urine cultures will be done in days 0, 7, 14, 28, 42 and 56.

Sponsors & Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

    lead OTHER

Principal Investigators

  • Adrian Gutiérrez-González · Universidad Autónoma de Nuevo León

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2021-08-01
Completion
2021-08-01

More Related Trials

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 NCT03424499 on ClinicalTrials.gov