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Sponsored by: |
Samsung Medical Center |
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Information provided by: | Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT00815334 |
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.
Condition | Intervention |
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Vesicoureteral Reflux Bladder With Decreased Compliance |
Procedure: Endoscopic subureteric injection |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Parallel Assignment |
Official Title: | Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance |
Enrollment: | 47 |
Study Start Date: | October 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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D-BC: Experimental
Patients who have decreased bladder compliance
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Procedure: Endoscopic subureteric injection
Endoscopic subureteric injection for the treatment of vesicoureteral reflux using variable materials (polydimethylsiloxane, collagen, and dextranomer/hyaluronic acid copolymer)
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N-BC: Active Comparator
Patients who have normal bladder compliance
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Procedure: Endoscopic subureteric injection
Endoscopic subureteric injection for the treatment of vesicoureteral reflux using variable materials (polydimethylsiloxane, collagen, and dextranomer/hyaluronic acid copolymer)
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 135-710 |
Principal Investigator: | Kyu-Sung Lee, Ph.D., M.D. | Samsung Medical Center |
Responsible Party: | Samsung Medical Center ( Kyu-Sung Lee/Professor ) |
Study ID Numbers: | 2008-10-094 |
Study First Received: | December 28, 2008 |
Last Updated: | December 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00815334 |
Health Authority: | Korea: Food and Drug Administration |
Vesico-Ureteral Reflux Cystocele Urologic Diseases Hyaluronic Acid Urinary Bladder Diseases |