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

Vesicoureteral Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815334
• Other study ID #: 2008-10-094
• Status: Completed
• Phase: N/A
• First received: December 28, 2008
• Last updated: June 16, 2009
• Start date: October 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Vesico-Ureteral Reflux
• Vesicoureteral Reflux

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate		3, 12 months	No
Secondary	adverse events		3, 12 months	Yes
Secondary	predictive factor for cure		3, 12 months	No