Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux

NCT01926353 | Completed DMC

• 1 other identifier: SLMC13-100
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Vesicoureteral Reflux (VUR); Urinary Tract Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of renal scar development

  at 3 months, 1 year

• Length of VUR treatment related hospital stay

  1 year

• Rate of failed treatment response

  3 months, 1 year

Study Arms (3)

Vantris

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

Patient underwent surgical management were all had ureteral re-implatation with Cohen technique done by single experienced pediatric urologist.

Continuous Antibiotic Prophylaxis

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.

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children diagnosed with primary VUR grade 2-4 from 2006-2012 treated by a single urologist with different treatment modalities- conservative continuous antibiotic prophylaxis, endoscopic correction with PPC and open ureteral re-implantation with Cohen technique.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Luke's Medical Center, Philippines: lead

Study Sites (1)

St. Luke's Medical Center

Quezon City, NCR, 1102, Philippines

Location

MeSH Terms

Conditions

Vesico-Ureteral Reflux; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Study Officials

• Marcelino L Morales, MD

  Institute of Urology, St. Luke's Medical Center, Quezon City, Philippines

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Staff

Study Record Dates

• First Submitted: August 17, 2013
• First Posted: August 20, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

PH (1)