Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux
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|ClinicalTrials.gov Identifier: NCT01926353|
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : April 7, 2015
|Condition or disease|
|Vesicoureteral Reflux (VUR) Urinary Tract Infection|
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||Tissue Bulking Agent -Polyacrylate Polyalcohol Copolymer for Endoscopic Correction of Vesicoureteral Reflux in Children: A Comparative Study|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
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.
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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926353
|St. Luke's Medical Center|
|Quezon City, NCR, Philippines, 1102|
|Study Director:||Marcelino L Morales, MD||Institute of Urology, St. Luke's Medical Center, Quezon City, Philippines|