Promising results for hypospadias repair using alloderm® (Regen): A randomized controlled trial

Abstract

INTRODUCTION;: Hypospadias is a congenital disorder of urethra in which meatus is not at its correct place and occurs in 1 of 250 live male birth. Many techniques have been used for the repair of hypospadias and to decrease the incidence of fistula. Alloderm has been recently used for the repair of urologic congenital defects, and reconstructive surgeries, but not used in hypospadias in a randomized controlled trial. Therefore, the aim of this study was to assess the efficacy of Alloderm® (Regen) to reduce fistula rate in hypospadias repair.

Methods & materials: This was a randomized controlled trial. Sixty patients were divided into two groups, 30 children underwent surgery using Alloderm® (Regen) as the Alloderm group and 30 without using it as controls. In the Alloderm group, 21 underwent primary surgery (12 mid-shaft hypospadias who underwent concurrent chordee correction and urethroplasty, and 9 penoscrotal who underwent 2 stage surgery, chordee was first corrected and then 6 months later TIP was performed), and 9 underwent fistula repair due to previous surgeries. In the control group, 24 patients underwent primary surgery (15 mid-shaft, and 9 penoscrotal) and 6 fistula repair the same as the Alloderm group but without using Alloderm.

Results: There was no meaningful difference between the two groups regarding age (P = 0.634). There was no meaningful difference regarding the operation type between the two groups (P = 0.371). There was no meaningful difference regarding the meatal location between the two groups (P = 0.781). There were no significant post-operative complications in the both groups. No bleeding or diverticulum occurred. Recurrence of fistula occurred in one patient in the Alloderm group after fistula repair and in 2 in the control group. Overall, In the Alloderm group, 3 (2 after TIP and 1 after fistula repair) patients and in the control group 8 (6 after TIP, 2 after fistula repair) patients developed fistulas after surgery (10% vs 26.7%). There was a statistically meaningful difference regarding fistula formation between the two groups using Chi-square test (P = 0.014).

Conclusion: Alloderm® (Regen) can be used for hypospadias and fistula repair with very few complications and good results. Fistula was less probably occurred in the Alloderm group compared to the standard repair of hypospadias.

Keywords: Alloderm; Fistula; Hypospadias; TIP.