Randomized Clinical Trial Comparing Endoscopic Treatment With Dextranomer Hyaluronic Acid Copolymer and Cohen's Ureteral Reimplantation for Vesicoureteral Reflux: Long-Term Results
abstract
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Access this abstract now Full Text Available for ClinicalKey SubscribersPurpose: To compare efficacy of Cohen's ureteral reimplantation and endoscopic treatment with Dx/HA in patients with primary VUR grades II, III and IV.
Methods: From April 2002 to June 2004, patients over 1 year old with VUR grade I, II, III or IV were included. Patients were randomized into two groups: endoscopic treatment (ET) or ureteral reimplantation (UR). In the ET group, an ultrasonography study was performed 24 h and 1 month after surgery, and two voiding cystourethrographies at 3 and 6 months post treatment. In the UR group, an ultrasonography study was done 7 days and 1 month after surgery and a micturial cystography 6 months post surgery. A postoperative nuclear direct cystogram was performed 5 years later in both groups.
Results: A total of 41 patients were included in this study: in ET 22 patients with 35 refluxing ureters and in UR 19 patients with 32 refluxing ureters. The VUR grades in ET were: 16 grade II, 16 grade III and 3 grade IV; and in UR: 15 grade II, 12 grade III and 5 grade IV. VUR was resolved in 91% (32/35) of ET (28% of ureters needed a second injection), and in 100% of UR group. Five years after the procedure, VUR was still resolved in 30/32 of ET and 32/32 of UR.
Conclusion: Short- and long-term follow up shows that multiple endoscopic treatment of VUR grades II, III and IV with Dx/HA is as effective as ureteral reimplantation.
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Randomized Clinical Trial Comparing Endoscopic Treatment With Dextranomer Hyaluronic Acid Copolymer and Cohen's Ureteral Reimplantation for Vesicoureteral Reflux: Long-Term Results
J Pediatr Urol 2013 Aug 01;9(4)483-487, L Garcia-Aparicio, J Rovira, E Blazquez-Gomez, L García-García, A Giménez-Llort, J Rodo, L MoralesFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
This report presents a prospective randomized trial of endoscopic therapy using Deflux compared with the traditional Cohen ureteral reimplantation in managing patients with vesicoureteral reflux (VUR). This is a very important area of investigation, and the authors are to be credited with making the effort to perform this study. The results suggest that the cure rate for grades II–IV VUR treated with endoscopic therapy is very high, and the procedure is more cost-effective than open ureteral reimplantation surgery.
The reader must be cautious in over-interpreting these data due to several limitations in the study and its reporting.
While such studies are needed, they must be conducted with care and their results reported more rigorously and interpreted with caution. This is a very poorly powered study, yet I can imagine it will be cited regularly in the upcoming years.