Prophylactic Antibiotics or Placebo After Hypospadias Repair

Participants in this multicenter, double-blind study are randomized to receive trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively. Short- and intermediate-term results will be published after participants complete 6 months and 5 years of follow-up, respectively.

Inclusion criteria

• mid-to-distal shaft hypospadias
• single-stage hypospadias repair
• length of urethral repair (urethroplasty) less than or equal to 20 mm
• placement of an open-drainage urethral stent at the time of hypospadias repair, with intended duration of stenting for 5-10 days post-operatively

Exclusion criteria

• previous hypospadias repair
• prior adverse/allergic reaction or other contraindication to trimethoprim-sulfamethoxazole
• cross-reactivity of an existing medication with trimethoprim-sulfamethoxazole
• any patient condition with elevated risk of infection or adverse outcome from potential infection (e.g., HIV/AIDS, poorly controlled diabetes mellitus or other immunocompromising conditions, congenital heart disease)
• use of antibiotics within seven days prior to hypospadias repair
• foreskin reconstruction at the time of hypospadias repair
• prescription of oral antibiotics other than Study Medication at the time of hypospadias repair