Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux

Urinary Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926353
• Other study ID #: SLMC13-100
• Status: Completed
• Phase: N/A
• First received: August 17, 2013
• Last updated: April 5, 2015
• Start date: July 2013
• Est. completion date: February 2014

Study information

• Verified date: April 2015
• Source: St. Luke's Medical Center, Philippines
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Department of HealthPhilippines: Ethics CommitteePhilippines: Philippine Council for Health Research and Development
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Urinary Tract Infection
• Urinary Tract Infections
• Vesico-Ureteral Reflux
• Vesicoureteral Reflux (VUR)

Locations

Country	Name	City	State
Philippines	St. Luke's Medical Center	Quezon City	NCR

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's Medical Center, Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Treatment success	Rate of complete resolution of VUR on follow-up VCUG at 3 months and 1 year.	3 months, 1 year	Yes
Secondary	Rate of renal scar development	The rate of Renal scarring is defined as consistent decreased tracer activity noted in follow-up DMSA scan.	at 3 months, 1 year	Yes
Secondary	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.	1 year	Yes
Secondary	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.	3 months, 1 year	Yes