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

NCT00815334 | Completed

• 1 other identifier: 2008-10-094
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Vesicoureteral Reflux

Keywords

vesicoureteral reflux; low compliant bladder

Outcome Measures

Primary Outcomes (1)

• Cure rate

  3, 12 months

Secondary Outcomes (2)

• adverse events

  3, 12 months

• predictive factor for cure

  3, 12 months

Study Arms (2)

Patients with decreased bladder compliance

EXPERIMENTAL

Patients who have decreased bladder compliance

Procedure: Endoscopic subureteric injection

Patients with normal bladder compliance

ACTIVE COMPARATOR

Patients who have normal bladder compliance

Procedure: Endoscopic subureteric injection

Interventions

Endoscopic subureteric injection PROCEDURE

Endoscopic subureteric injection for the treatment of vesicoureteral reflux using variable materials (polydimethylsiloxane, collagen, and dextranomer/hyaluronic acid copolymer)

Patients with decreased bladder compliance; Patients with normal bladder compliance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Who is aged 18 and greater
• Who underwent endoscopic subureteral injection for vesicoureteral reflux

You may not qualify if:

• Medical records of whom is not evaluabe

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (3)

• 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. doi: 10.1016/j.eururo.2003.11.025.

  PMID: 15149753 BACKGROUND

• 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. doi: 10.1016/j.juro.2006.07.076.

  PMID: 17070296 BACKGROUND

• Puri P. Endoscopic correction of vesicoureteral reflux. Curr Opin Urol. 2000 Nov;10(6):593-7. doi: 10.1097/00042307-200011000-00010.

  PMID: 11148731 BACKGROUND

MeSH Terms

Conditions

Vesico-Ureteral Reflux

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kyu-Sung Lee, Ph.D., M.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 28, 2008
• First Posted: December 30, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 17, 2009

Record last verified: 2009-02

Locations

KR (1)