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Completed

NCT Number: NCT01926353

Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux

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.

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Key information

Conditions

Vesicoureteral Reflux (VUR) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Bladder Diseases Urinary Tract Infection Urinary Tract Infections Urogenital Diseases Urologic Diseases Vesico-Ureteral Reflux

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Luke's Medical Center

Quezon City, NCR, 1102, Philippines

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Rate of Treatment success

    Time frame: 3 months, 1 year

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

Secondary outcomes

  1. Rate of renal scar development

    Time frame: at 3 months, 1 year

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

  2. Length of VUR treatment related hospital stay

    Time frame: 1 year

    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.

  3. Rate of failed treatment response

    Time frame: 3 months, 1 year

    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.

Sponsors and collaborators

Lead sponsor

St. Luke's Medical Center, Philippines

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2013
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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