Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance - Full Text View

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00815334

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 Bladder With Decreased Compliance	Procedure: Endoscopic subureteric injection

MedlinePlus related topics: Endoscopy

Drug Information available for: Hyaluronate Sodium Hyaluronic acid Baysilon Polydimethylsiloxane

U.S. FDA Resources

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

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
D-BC: Experimental 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)
N-BC: Active Comparator 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

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

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:

Choo MS, Hong B, Ji YH, Chung H, Choe JH, Park WH, Park T, Lee KS. Endoscopic treatment of vesicoureteral reflux with polydimethylsiloxane in adult women. Eur Urol. 2004 Jun;45(6):787-9.

Okeke Z, Fromer D, Katz MH, Reiley EA, Hensle TW. Endoscopic management of vesicoureteral reflux in women presenting with pyelonephritis. J Urol. 2006 Nov;176(5):2219-21.

Puri P. Endoscopic correction of vesicoureteral reflux. Curr Opin Urol. 2000 Nov;10(6):593-7. Review.

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

Study placed in the following topic categories:

Vesico-Ureteral Reflux
Cystocele
Urologic Diseases
Hyaluronic Acid
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on January 15, 2009