Efficacy of additional tunica vaginalis flap coverage for protecting against urethrocutaneous fistulas in tubularized incised plate urethroplasty: A prospective, randomized controlled trial

Purpose: We compared the protective effect of additional tunica vaginalis flap coverage combined with a dartos flap against urethrocutaneous fistulas in tubularized incised plate (TIP) urethroplasty in a randomized controlled trial. Materials and Methods: This prospective, randomized controlled trial in a single tertiary center enrolled 50 patients in whom it was feasible to perform single TIP urethroplasty between 2016 and 2017. Consecutive children were randomly allocated to study group A (additional tunica vaginalis flap coverage, n=25) or control group B (dartos-only coverage, n=25). All patients were examined in the outpatient clinic at 1, 3, 12, and 24 months. Postoperative cosmetic outcomes were evaluated by surgeons and parents using the Pediatric Penile Perception Scale questionnaire. Results: In group B, 1 of 25 patients (4.0%) developed an urethrocutaneous fistula within 12 months. An additional two cases of fistula were found in all proximal-type hypospadias patients at 24 months in the same group without statistical significance (p=0.07). The penile cosmetic satisfaction rate was not significantly different between the groups according to scores on the Pediatric Penile Perception Scale. Conclusions: Our randomized controlled trial did not show a significant decrease in the incidence of or a significant slowing of the progression of postoperative fistulas after TIP urethroplasty by the use of additional tunica vaginalis coverage. A tunica vaginalis flap is not routinely recommended but could have a selective role in proximal-type TIP urethroplasty with deficient dartos and subcutaneous tissue to cover the neourethra.