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

NACompletedINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

August 1, 2021

Study Completion Date

August 1, 2021

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.

All Listed Sponsors
lead

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

NCT03424499 - Sterile Single-use vs Reused Polyvinylchloride Catheter For Intermittent Catheterization In Neurogenic Bladder | Biotech Hunter | Biotech Hunter