Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux

N/ACompletedNCT01926353

St. Luke's Medical Center, Philippines25 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Vesicoureteral Reflux (VUR)Urinary Tract Infection

Eligibility

Sex: ALLMin age: 1 YearMax age: 5 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Rate of Treatment success

Rate of complete resolution of VUR on follow-up VCUG at 3 months and 1 year.

Time frame: 3 months, 1 year

Secondary Outcomes

Rate of renal scar development

The rate of Renal scarring is defined as consistent decreased tracer activity noted in follow-up DMSA scan.

Time frame: 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.

Time frame: 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.