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Investigation of the efficacy of lyophilized prepuce on urinary reflux

Comparing the Efficacy and durability of a novel autologous bioscaffold (Prepuce extracellular matrix) versus Deflux as a bulking agent for treatment of vesicoureteral reflux in male children

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016062628641N1
Enrollment
80
Registered
2017-02-03
Start date
2015-09-23
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

Vesicoureteral reflux. Vesicoureteral-reflux-associated uropathy

Interventions

Intervention 1: In the intervention group, 1 cc of the lyophilized autologous prepuce will be injected in the submucosal area of the orifice of the ureter through endoscopic procedure in operating roo
Treatment - Drugs
In the intervention group, 1 cc of the lyophilized autologous prepuce will be injected in the submucosal area of the orifice of the ureter through endoscopic procedure in operating room.
In the control group, 1 cc of deflux as the gold standard will be injected in the submucosal area of the orifice of the ureter through an endoscopic procedure in operating room.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
6 Months to 13 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Vesicoureteral reflux grade 2-5 based on clinical and paraclinical evidence; Having the indication for stretching material endoscopic injection. Exclusion criteria: Having deflux contraindications based on the protocols announced by the deflux producer; Having the indication for stretching material endoscopic injection; Having prohibition of operation according to consultation with anesthesiologist and heart expert; Children with 1st grade reflux grade 1 and recurrent or febrile urinary tract infection

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Urinary Tract Infection. Timepoint: 3, 6, and 9 months after intervention. Method of measurement: Urinary culture.;The rate of urine rejection (return) from the bladder to the ureter. Timepoint: Before and 3, 6, and 9 months after intervention. Method of measurement: VCUG.

Secondary

MeasureTime frame
-. Timepoint: -. Method of measurement: -.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr MJ.Mohseni

Tehran University of Medical Sciences

mjmohseni.purc@gmail.com+98 21 6656 5400

Outcome results

None listed

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