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

June 16, 2009 updated by: Samsung Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cure rate
Time Frame: 3, 12 months
3, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: 3, 12 months
3, 12 months
predictive factor for cure
Time Frame: 3, 12 months
3, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Kyu-Sung Lee, Ph.D., M.D., Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 28, 2008

First Submitted That Met QC Criteria

December 28, 2008

First Posted (Estimate)

December 30, 2008

Study Record Updates

Last Update Posted (Estimate)

June 17, 2009

Last Update Submitted That Met QC Criteria

June 16, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-10-094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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