Randomized Trial of Antibiotic Prophylaxis for Prevention of Symptomatic UTI in Stented, Distal Hypospadias Repair
Stephen Canon, MD, Ismael Zamilpa, MD, Ashay Patel, DO.
Arkansas Children's Hospital, Pediatric Urology, Little Rock, AR, USA.
Background: The usage of prophylactic oral antibiotics following distal hypospadias repair with stenting has been recently challenged since the prevalence of symptomatic urinary tract infection (UTI) following this procedure is low. The aim of this study is to evaluate the prevalence of symptomatic UTIs following stented, distal hypospadias repair and the impact of prophylactic antibiotic therapy.
Methods: A prospective, randomized trial was conducted in boys undergoing primary distal hypospadias repair with urethral stenting at our institution. Families of patients 0-5 years of age with distal penile through glanular hypospadias were counselled on the potential risks/benefits and debate of prophylactic antibiotics in this setting and invited to participate in this study. Patients with proximal hypospadias, prior hypospadias surgery, or concurrent UTI/antibiotic therapy at the time of surgery were excluded. Urinalysis/urine culture was obtained intraoperatively, and a 6F or 8F urethral catheter was utilized for 5-8 days with single diapering. Operative techniques utilized included tubularized incised plate (TIP) +/- inlay graft or Thiersch Duplay hypospadias repair with correction of penile curvature repair when present. Patients were randomized to either Group 1 treated with sulfamethoxazole/trimethoprim (2-3 mg/kg daily) or Group 2 treated with no prophylactic antibiotic therapy. Postoperative urinalysis/urine cultures were obtained in patients with signs of symptomatic UTI (fever, dysuria, hematuria, or abdominal pain) with confirmed UTI for patients with pyuria and > 50,000 CFUs per mL of a single uropathogen. Reassessment was performed after surgery by phone interview at 1 month and upon follow up 3-6 months after surgery. Secondary outcomes for the study include surgical site infections (SSIs), complications of hypospadias repair, and family decision for study participation. Statistical comparison was performed with Fisher’s exact test.
Results: 38/47 consecutive patients were consented and randomized for the study with 9 (19.1%) families declining inclusion due to concerns over potentially unnecessary antibiotics or participation in research. 5/38 (13.2%) patients were excluded due to concurrent antibiotic therapy (2), concurrent UTI (1), intraoperative finding of midshaft meatus (1), and inadvertent administration of intraoperative antibiotic therapy (1). 33 patients were randomized to either Group 1 (16) or Group 2 (17). One patient in Group 1 was diagnosed with and treated for a symptomatic UTI postoperatively, and no patients in Group 2 had a symptomatic UTI (p=0.48). All patients were surveyed 1 month postoperatively, and 16 patients have returned for follow up 3-6 months after surgery. No SSIs were observed in either group. Four patients had hypospadias repair complications with 3 in Group 1 (2 fistulas and 1 dehiscence) compared to 1 in Group 2 (1 meatal stenosis) (p=0.33).
Conclusions: The prevalence of symptomatic urinary tract infection following stented, distal hypospadias repair is low, and prophylactic antibiotic therapy following this procedure does not lower the prevalence of symptomatic urinary tract infection. Family concern for utilization of prophylactic antibiotic therapy or participation in research in this setting limited patient enrollment.
*Note: This study was supported by an internal institutional grant.
Back to 2016 Fall Congress