Early Outcomes of Spongiosum-guided Topographic Anatomical Reassembly Compared with Tubularized Incised Plate Repair for Distal Hypospadias: A Single-Center Pilot Randomized Trial

Abstract Background: Spongiosum-tissue-guided anatomical reassembly (STAR) is a newerapproach to distal hypospadias repair that emphasizes spongioplasty and limitsglanular dissection. We compared early outcomes after STAR and tubularized incisedplate (TIP) repair in a pilot randomized trial. Methods: Boys younger than 16 years with primary distal hypospadias wererandomized at a single center between January 2024 and August 2025. Of 104participants, 52 were allocated to each group. Three participants were lost to follow-up,leaving 51 in the STAR group and 50 in the TIP group for the primary analysis. Theprimary outcome was complication-free status 3 months after surgery. HOSE scoresand complication status at 12 months were secondary outcomes. Results: At 3 months, 42 of 51 participants (82.4%) in the STAR group and 45 of 50(90.0%) in the TIP group were complication-free. The difference in rates (STAR minusTIP) was −7.6 percentage points (95% CI, −21.5 to 6.3; p = 0.266). The trial was notlarge enough to establish superiority, non-inferiority, or equivalence. Conclusion: In this pilot trial, the 3-month complication-free rate was numerically lowerafter STAR than after TIP, but the estimate was imprecise. The findings do not explainthe difference or establish that either procedure is superior. Larger trials are needed tocompare outcomes reliably. Trial registration: ClinicalTrials.gov, NCT07832760; registered September 2026, afterenrollment began in January 2024 following IRB approval.