Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00815334
First received: December 28, 2008
Last updated: June 16, 2009
Last verified: February 2009
  Purpose

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
Vesicoureteral Reflux
Procedure: Endoscopic subureteric injection

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Cure rate [ Time Frame: 3, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: 3, 12 months ] [ Designated as safety issue: Yes ]
  • predictive factor for cure [ Time Frame: 3, 12 months ] [ Designated as safety issue: No ]

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
Experimental: Patients with decreased bladder compliance
Patients who have decreased bladder compliance
Procedure: Endoscopic subureteric injection
Endoscopic subureteric injection for the treatment of vesicoureteral reflux using variable materials (polydimethylsiloxane, collagen, and dextranomer/hyaluronic acid copolymer)
Other Name: Endoscopic subureteric injection
Active Comparator: Patients with normal bladder compliance
Patients who have normal bladder compliance
Procedure: Endoscopic subureteric injection
Endoscopic subureteric injection for the treatment of vesicoureteral reflux using variable materials (polydimethylsiloxane, collagen, and dextranomer/hyaluronic acid copolymer)
Other Name: Endoscopic subureteric injection

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00815334

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Kyu-Sung Lee, Ph.D., M.D. Samsung Medical Center
  More Information

Publications:
Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00815334     History of Changes
Other Study ID Numbers: 2008-10-094
Study First Received: December 28, 2008
Last Updated: June 16, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
vesicoureteral reflux
low compliant bladder

Additional relevant MeSH terms:
Gastroesophageal Reflux
Vesico-Ureteral Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 28, 2014