Vesicoureteral Reflux (VUR)NCT01926353
Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux
An observational study of Vesicoureteral Reflux (VUR) and Urinary Tract Infection, run by St. Luke's Medical Center, Philippines at 1 site in Philippines.
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… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Vesicoureteral Reflux (VUR), Urinary Tract Infection
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 1 sitePhilippines
- Study dates
- Jul 2013to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tissue Bulking Agent -Polyacrylate Polyalcohol Copolymer for Endoscopic Correction of Vesicoureteral Reflux in Children: A Comparative Study
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.
- Keywords
- Vesicoureteral Reflux (VUR), Complicated Urinary Tract Infection, Vantris, Polyacrylate Polyalcohol Copolymer
- Medical subject headings
- Vesico-Ureteral Reflux, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Treatment success
Rate of complete resolution of VUR on follow-up VCUG at 3 months and 1 year.
Measured: 3 months, 1 year
Secondary outcomes (3)
Rate of renal scar development
The rate of Renal scarring is defined as consistent decreased tracer activity noted in follow-up DMSA scan.
Measured: at 3 months, 1 year
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.
Measured: 1 year
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.
Measured: 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vesicoureteral Reflux (VUR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Medical Center, Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael E. Chua, St. Luke's Medical Center, Philippines
- Investigators
- Marcelino L Morales, MD, Study director, Institute of Urology, St. Luke's Medical Center, Quezon City, Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926353
- Sponsor's protocol ID
- SLMC13-100
- Status last verified
- Apr 2015
- First submitted
- 17 Aug 2013
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Bulking Agent -Polyacrylate Polyalcohol Copolymer for Endoscopic Correction of Vesicoureteral Reflux in Children: A Comparative Study
- ClinicalTrials.gov ID
- NCT01926353
- Acronym / sponsor ID
- SLMC13-100
- Keywords
- Vesicoureteral Reflux (VUR), Complicated Urinary Tract Infection, Vantris, Polyacrylate Polyalcohol Copolymer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- St. Luke's Medical Center, PhilippinesUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Rate of renal scar development
Time frame: at 3 months, 1 year
Length of VUR treatment related hospital stay
Time frame: 1 year
Rate of failed treatment response
Time frame: 3 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
Related trials for Vesicoureteral Reflux (VUR)
Recruiting
Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
VUR - Vesicoureteric Reflux
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelino L Morales, MD study director
Institute of Urology, St. Luke's Medical Center, Quezon City, Philippines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vesicoureteral Reflux (VUR) and Urinary Tract Infection, run by St. Luke's Medical Center, Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Treatment success (time frame: 3 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.