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Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 17, 2013
First Posted Date August 20, 2013
Last Update Posted Date April 7, 2015
Study Start Date July 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2013)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 17, 2013)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux
Official Title Tissue Bulking Agent -Polyacrylate Polyalcohol Copolymer for Endoscopic Correction of Vesicoureteral Reflux in Children: A Comparative Study
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Vesicoureteral Reflux (VUR)
  • Urinary Tract Infection
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 17, 2013)
25
Original Actual Enrollment Same as current
Actual Study Completion Date February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 5 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Philippines
Removed Location Countries  
 
Administrative Information
NCT Number NCT01926353
Other Study ID Numbers SLMC13-100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michael E. Chua, St. Luke's Medical Center, Philippines
Study Sponsor St. Luke's Medical Center, Philippines
Collaborators Not Provided
Investigators
Study Director: Marcelino L Morales, MD Institute of Urology, St. Luke's Medical Center, Quezon City, Philippines
PRS Account St. Luke's Medical Center, Philippines
Verification Date April 2015