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IRCT2015022321211N1 IRCT 2015-04-24 Vice Chancellor Of Research Of Tabriz University Of Medical Sciences Comparison of treatment outcomes between endoscopic injection of new agent of Vantris® and open surgery of Gil-vernet in 1-10 year-aged children with primary vesicoureteral reflux Comparison of treatment outcomes between endoscopic injection of new bulking agent of Vantris® and open surgery of Gil-vernet in 1-10 year-aged children with primary vesicoureteral reflux(VUR) 2013-08-22 anticipated 100 Complete https://irct.ir/trial/18646 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Vesicouretral reflux. Intervention 1: Control: Gil-vernet open surgery ;The ureteral orifices are advanced across the trigone by means of a single submucosal mattress suture in order to increase the intramural length and muscular support of each distal ureter. Intervention 2: Intervention: ٍEndoscopic Vantris; In patients with grade I-III VUR, the usual technique of subureteric transurethral injection, with the needle is to be introduced submucosally under the ureteral orifice at the 6 o’clock position'using cystocopes 6 Fr and needles 3.7 Fr. in those with a widely open orifice, the injection is to be performed inside the orifice,as needed.
public Mohammad Reza Roshandel
Urology department, Imam Reza Hospital, Golgasht street, Tabriz university of medical sciences
Tabriz Iran (Islamic Republic of) +98 41 3335 7328 roshandelmr@yahoo.com Tabriz Univercity Of Medical Scinces scientific Dr Fahimeh Kazemi Rashed
Urology department, Imam Reza Hospital, Golgasht street, Tabriz university of medical sciences
Tabriz Iran (Islamic Republic of) +98 41 3335 7328 kazemirashedf@yahoo.com Tabriz university of medical sciences Iran (Islamic Republic of) Iinclusion criteriae: 1)1-10 years of old ; 2) II to IV grade VURs, as defined below: a) Symptomatic UTIs(such as fever,dysuria,poor feeding, FTT); New renal scarring despite of antibiotic prophylaxis; bilateral VUR; Intolerance to prophylactic antibiotics; parent tendency to surgical repair. Exclusion criteriae: 1)Grades I and V ; 2) previously open or endoscopic surgeries on bladder or ureters ; 3) Anantomic malformations of urinary tract such as obstructive disorders or complete duplication of pyelocaliceal system ; 4)suspicion to or confirmed voiding disorder : a. presence of related clinical findings including abnormal neurologic exam or elimination disorder(instinal and urinary, with together); b.VCUG or ultrasonographic abnormalities such as bladder wall abnormalities or diverticuli ortrabeculation or decreased vesical capacity ; 5)Neurogenic bladder 1 year 10 years Both Q62.7 Congenital vesico-uretero-renal reflux Treatment - Surgery Treatment - Surgery Control: Gil-vernet open surgery ;The ureteral orifices are advanced across the trigone by means of a single submucosal mattress suture in order to increase the intramural length and muscular support of each distal ureter. Intervention: ٍEndoscopic Vantris; In patients with grade I-III VUR, the usual technique of subureteric transurethral injection, with the needle is to be introduced submucosally under the ureteral orifice at the 6 o’clock position'using cystocopes 6 Fr and needles 3.7 Fr. in those with a widely open orifice, the injection is to be performed inside the orifice,as needed. Grade of VUR. Timepoint: 3 months. Method of measurement: Grading system for VUR on VCUG, )International Reflux Study Committee ). Unimproved VUR. Timepoint: 3 months. Method of measurement: Grading system for VUR on VCUG, )International Reflux Study Committee ). Vice Chancellor Of Research Of Tabriz University Of Medical Sciences Approved 2015-02-08 the Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences (TUOMS International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, Golgasht street,University Street, PO Box: 516566593 Tabriz Iran (Islamic Republic of)