Back to resultsEfficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance
Primary Purpose
Vesicoureteral Reflux
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endoscopic subureteric injection
Sponsored by
About this trial
This is an interventional treatment trial for Vesicoureteral Reflux focused on measuring vesicoureteral reflux, low compliant bladder
Eligibility Criteria
Inclusion Criteria:
- Who is aged 18 and greater
- Who underwent endoscopic subureteral injection for vesicoureteral reflux
Exclusion Criteria:
- Medical records of whom is not evaluabe
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with decreased bladder compliance
Patients with normal bladder compliance
Arm Description
Patients who have decreased bladder compliance
Patients who have normal bladder compliance
Outcomes
Primary Outcome Measures
Cure rate
Secondary Outcome Measures
adverse events
predictive factor for cure
Full Information
NCT ID
NCT00815334
First Posted
December 28, 2008
Last Updated
June 16, 2009
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00815334
Brief Title
Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance
Official Title
Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Endoscopic subureteral injection for vesicoureteral reflux has become an established alternative to ureter reimplantation in children. Some recent studies suggest that ESI can be also a primary treatment option for VUR in adults. However, the experience with ESI in adults who have VUR associated with decreased bladder compliance is limited. We evaluated the efficacy of endoscopic subureteral injection treatment for vesicoureteral reflux in adults with decreased bladder compliance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vesicoureteral Reflux
Keywords
vesicoureteral reflux, low compliant bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with decreased bladder compliance
Arm Type
Experimental
Arm Description
Patients who have decreased bladder compliance
Arm Title
Patients with normal bladder compliance
Arm Type
Active Comparator
Arm Description
Patients who have normal bladder compliance
Intervention Type
Procedure
Intervention Name(s)
Endoscopic subureteric injection
Intervention Description
Endoscopic subureteric injection for the treatment of vesicoureteral reflux using variable materials (polydimethylsiloxane, collagen, and dextranomer/hyaluronic acid copolymer)
Primary Outcome Measure Information:
Title
Cure rate
Time Frame
3, 12 months
Secondary Outcome Measure Information:
Title
adverse events
Time Frame
3, 12 months
Title
predictive factor for cure
Time Frame
3, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Who is aged 18 and greater
Who underwent endoscopic subureteral injection for vesicoureteral reflux
Exclusion Criteria:
Medical records of whom is not evaluabe
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, Ph.D., M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
15149753
Citation
Choo MS, Hong B, Ji YH, Chung H, Choe JH, Park WH, Park T, Lee KS. Endoscopic treatment of vesicoureteral reflux with polydimethylsiloxane in adult women. Eur Urol. 2004 Jun;45(6):787-9. doi: 10.1016/j.eururo.2003.11.025.
Results Reference
background
PubMed Identifier
17070296
Citation
Okeke Z, Fromer D, Katz MH, Reiley EA, Hensle TW. Endoscopic management of vesicoureteral reflux in women presenting with pyelonephritis. J Urol. 2006 Nov;176(5):2219-21. doi: 10.1016/j.juro.2006.07.076.
Results Reference
background
PubMed Identifier
11148731
Citation
Puri P. Endoscopic correction of vesicoureteral reflux. Curr Opin Urol. 2000 Nov;10(6):593-7. doi: 10.1097/00042307-200011000-00010.
Results Reference
background
Learn more about this trial
Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance
We'll reach out to this number within 24 hrs