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Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01926353
Enrollment
25
Registered
2013-08-20
Start date
2013-07-31
Completion date
2014-02-28
Last updated
2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infection, Vesicoureteral Reflux (VUR)

Keywords

Vesicoureteral Reflux (VUR), Complicated Urinary Tract Infection, Vantris, Polyacrylate Polyalcohol Copolymer

Brief summary

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.

Interventions

None listed

Sponsors

St. Luke's Medical Center, Philippines
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of Treatment success3 months, 1 yearRate of complete resolution of VUR on follow-up VCUG at 3 months and 1 year.

Secondary

MeasureTime frameDescription
Rate of renal scar developmentat 3 months, 1 yearThe rate of Renal scarring is defined as consistent decreased tracer activity noted in follow-up DMSA scan.
Length of VUR treatment related hospital stay1 yearNumber 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.
Rate of failed treatment response3 months, 1 yearRate 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.

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026