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

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ClinicalTrials.gov Identifier: NCT00815334
Recruitment Status : Completed
First Posted : December 30, 2008
Last Update Posted : June 17, 2009
Sponsor:
Information provided by:
Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Vesicoureteral Reflux Procedure: Endoscopic subureteric injection Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance
Study Start Date : October 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD

Arm Intervention/treatment
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)

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)




Primary Outcome Measures :
  1. Cure rate [ Time Frame: 3, 12 months ]

Secondary Outcome Measures :
  1. adverse events [ Time Frame: 3, 12 months ]
  2. predictive factor for cure [ Time Frame: 3, 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00815334     History of Changes
Other Study ID Numbers: 2008-10-094
First Posted: December 30, 2008    Key Record Dates
Last Update Posted: June 17, 2009
Last Verified: February 2009

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