Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux

NCT ID: NCT01926353

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-02-28

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Cohen reimplantation

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Luke's Medical Center, Philippines

OTHER

Sponsor Role: lead

Responsible Party

Michael E. Chua

Urology Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcelino L Morales, MD

Role: STUDY_DIRECTOR

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

Locations

St. Luke's Medical Center

Quezon City, NCR, Philippines

Countries

Philippines

Other Identifiers

SLMC13-100

Identifier Type: -

Identifier Source: org_study_id