Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux

Study Overview
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Brief Summary
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Endoscopic correction of VUR has gained its popularity due to its less invasiveness, associated low morbidity and short hospital stay. Although short term follow-up had justified their efficacy; however, long term recurrence and complications following endoscopic correction were also being reported in the literatures (6). Currently, there are insufficient evidences on the efficacy and safety of biocompatible tissue augmenting materials used for endoscopic correction of VUR; particularly on the new tissue bulking agents. (6) Polyacrylate polyalcohol copolymer (PPC)-Vantris ® (Promedon, Cordoba, Argentina) is the newest tissue augmenting biocompatible Acrylics used for endoscopic correction of VUR.

Official Title
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Tissue Bulking Agent -Polyacrylate Polyalcohol Copolymer for Endoscopic Correction of Vesicoureteral Reflux in Children: A Comparative Study

Conditions
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Vesicoureteral Reflux (VUR), Urinary Tract Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Included patients for the study were only those who had 1- 3months and >1year post-treatment follow-up study with voiding cystourethrogram (VCUG), kidney ultrasound, dimercaptosuccinic acid(DMSA) renal scan, and urine culture. Exclusion Criteria: Excluded cases were patients who had VUR grade 1 and grade 5, no complete follow-up work ups, concomitant neurogenic bladder, anatomical malformation of the urinary tract (obstruction, complete duplicated pelvocaliceal system), previous surgical or endoscopic procedures, and suspected or confirmed dysfunctional voiding by clinical findings or abnormal results (irregular bladder wall, diverticulum) on VCUG or urodynamic study.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vantris<br>Patient who categorized as who underwent endoscopic correction procedure, were patients who under general anesthesia performed by a single experienced surgeon using a 10Fr Storz® cystoscope with PPC (Vantris®) subureteral or intraureteral injection, or a combination of both techniques, depending on the anatomy of the ureteral meatus and VUR grade. | |
| Cohen reimplantation<br>Patient underwent surgical management were all had ureteral re-implatation with Cohen technique done by single experienced pediatric urologist. | |
| Continuous Antibiotic Prophylaxis<br>Group of patient treated with conservative management were children treated with culture guided antibiotics and maintained on 1st or 2nd generation cephalosporin as continuous antibiotic prophylaxis until time of 1 year follow-up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Treatment success | Rate of complete resolution of VUR on follow-up VCUG at 3 months and 1 year. | 3 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of renal scar development | The rate of Renal scarring is defined as consistent decreased tracer activity noted in follow-up DMSA scan. | at 3 months, 1 year | 
| Length of VUR treatment related hospital stay | Number of hospital days incurred related to VUR treatment, such as hospital admission on treatment period, recovery period, and subsequent admissions for complicated UTI secondary to VUR. | 1 year | 
| Rate of failed treatment response | Rate of VUR with resoultion noted on 3 month follow-up; however, VUR noted on 1 year VCUG follow-up. Failed treatment defined as persistent VUR or VUR grade progressed despite treatment. | 3 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vesicoureteral Reflux (VUR), Complicated Urinary Tract Infection, Vantris, Polyacrylate Polyalcohol Copolymer