We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00815334
First Posted: December 30, 2008
Last Update Posted: June 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Samsung Medical Center
  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: None (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 ]

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

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)
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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
  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
First Submitted: December 28, 2008
First Posted: December 30, 2008
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