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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
Sponsor:
Information provided by (Responsible Party):
Michael E. Chua, 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.

Condition or disease
Vesicoureteral Reflux (VUR) Urinary Tract Infection

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

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


Locations
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Philippines
St. Luke's Medical Center
Quezon City, NCR, Philippines, 1102
Sponsors and Collaborators
St. Luke's Medical Center, Philippines
Investigators
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Study Director: Marcelino L Morales, MD Institute of Urology, St. Luke's Medical Center, Quezon City, Philippines

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Responsible Party: Michael E. Chua, Urology Staff, St. Luke's Medical Center, Philippines
ClinicalTrials.gov Identifier: NCT01926353     History of Changes
Other Study ID Numbers: SLMC13-100
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Michael E. Chua, St. Luke's Medical Center, Philippines:
Vesicoureteral Reflux (VUR)
Complicated Urinary Tract Infection
Vantris
Polyacrylate Polyalcohol Copolymer
Additional relevant MeSH terms:
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Urinary Tract Infections
Gastroesophageal Reflux
Vesico-Ureteral Reflux
Infection
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urologic Diseases
Urinary Bladder Diseases