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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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015022321211N1
Enrollment
100
Registered
2015-04-24
Start date
2013-08-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vesicouretral reflux. Congenital vesico-uretero-renal reflux

Interventions

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. Interventi
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'usin
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

Sponsors

Vice Chancellor Of Research Of Tabriz University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 10 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Grade of VUR. Timepoint: 3 months. Method of measurement: Grading system for VUR on VCUG, )International Reflux Study Committee ).

Secondary

MeasureTime frame
Unimproved VUR. Timepoint: 3 months. Method of measurement: Grading system for VUR on VCUG, )International Reflux Study Committee ).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Roshandel

Tabriz Univercity Of Medical Scinces

roshandelmr@yahoo.com+98 41 3335 7328

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026