Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux

Completed

• Conditions: Urinary Tract Infection; Vesicoureteral Reflux (VUR)

• Registration Number: NCT01926353
• Lead Sponsor: St. Luke's Medical Center, Philippines

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-17
• Study First Submitted QC: 2013-08-17
• Study First Posted: 2013-08-20
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-05
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Treatment success	3 months, 1 year	Rate of complete resolution of VUR on follow-up VCUG at 3 months and 1 year.

Secondary Outcome Measures

Name	Time	Method
Length of VUR treatment related hospital stay	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.
Rate of renal scar development	at 3 months, 1 year	The rate of Renal scarring is defined as consistent decreased tracer activity noted in follow-up DMSA scan.
Rate of failed treatment response	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.

Trial Locations

Locations (1)

St. Luke's Medical Center; 🇵🇭 Quezon City, NCR, Philippines