The authors evaluated whether the new nickel-titanium alloy stent (NTAS) is superior to the traditional silicone stent used in hypospadias repair surgery in preventing complications such as urinary fistula. This retrospective cohort study included 576 patients with hypospadias who underwent NTAS or traditional silicone stent placement after hypospadias surgery between March of 2002 and August of 2019. The primary outcome was the rate of urinary fistula occurrence at 4 weeks (stent removal time), and the secondary outcomes were the rate of other complications, such as urethral stricture, urethral diverticulum, infection, and so on. The occurrence of complications in both groups was compared, and the important contributing factors of urinary fistula and urethral stricture were determined. Among 576 patients, 398 were assigned to the NTAS group, and 178 were assigned to the silicone group. Thirty-five patients in the NTAS group and 30 in the silicone group developed urinary fistula, with a rate of 8.8% and 16.9%, respectively ( P = 0.005). Subgroup analysis showed that the differences were mainly in preschool patients (6 years or younger) ( P = 0.004) and those with the penile type of hypospadias ( P = 0.008). In addition, urethral stricture complicated five patients in the NTAS group and two in the silicone group, with a rate of 1.3% and 1.1%, respectively ( P = 1.000). Logistic regression showed that hypospadias type ( P = 0.001) and stent type ( P = 0.001) are the important risk factors for urethral fistula. The NTAS reduced the occurrence of urinary fistula complications after hypospadias repair in preschool patients, and can be presented as a better choice for hypospadias surgery. Therapeutic, III.
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