The effect of oral steroids on post-operative complications in proximal hypospadias repair: a prospective, randomized, placebo-controlled study
Mary Killian, MD1, Rajeev Chaudhry, MD1, Patrick J. Fox, MD1, Michelle J. Barlas, PharmD1, Heidi A. Stephany, MD2, Pankaj Dangle, MD3, Moira Dwyer, MD4, Glenn M. Cannon, MD1, Francis X. Schneck, MD1.
1Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA, USA, 2University of California Irvine, Irvine, CA, USA, 3Children's Hospital of Alabama, University of Alabama at Birmingham Department of Urology, Birmingham, AL, USA, 4Geisinger Medical Center, Danville, PA, USA.
Background: Proximal hypospadias is a complicated diagnosis with the treatment being equally problematic. Complication rates for proximal hypospadias repairs reach as high as 50% in the literature. Here we present preliminary data on a novel therapy to attempt to reduce complications and improve wound healing in proximal hypospadias repair.
Methods: We obtained IRB approval and designed a randomized, double-blind, placebo-controlled trial. Patients with proximal hypospadias (proximal shaft, penoscrotal, or scrotal) undergoing single-stage or staged repairs were prospectively enrolled after obtaining informed consent. Patients received either methylprednisolone (1.5mg/kg/day divided in two doses) or placebo for 5 days post-operatively. Urethral stents were kept for 7-10 days post-operatively. Patients had scheduled follow-up at 6 weeks, 6 mos and annually thereafter. Primary outcome was post-operative complication rate, while secondary outcomes included compliance with and safety of medication.
Results: Twenty-two patients were prospectively enrolled in the study. Fourteen patients (64%) were penoscrotal, 6 patients (27%) were proximal shaft and 2 patients (9%) were scrotal. Eighteen patients (82%) underwent single stage repairs, while 4 patients (18%) underwent staged repairs. Median age at surgery was 8.5 months (IQR 7.2-11.2). Thirteen patients (60%) were in the prednisone arm and 9 patients (40%) in the placebo arm. There was 1 complication in the prednisone group (8%), and 2 complications in the placebo group (24%) (p = 0.5), for a total complication rate of 14% among both cohorts. Complications were noted as early as 10 days and up to 6 weeks post-operatively and included one glans dehiscence, and 2 urethrocutaneous fistulae. The patient with the complication in the prednisone arm also had early dislodgement of urethral catheter. There was a 95% compliance rate with medication, 1 patient only completed 9/10 doses. There were no adverse events with the medication.
Conclusion: This is the first randomized, placebo-controlled trial evaluating the effect of post-operative steroids on proximal hypospadias repair. While the results do not reach significance, we had a low overall complication rate with only one complication rate in the prednisone arm. There were no adverse events from the medication and all patients tolerated it well. We plan to continue enrolling patients and look to long-term follow-up to better assess the outcomes.
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