Antibiotic Use in Distal Hypospadias Repair

Randomized Trial of Antibiotic Prophylaxis for Prevention of Symptomatic UTI in Stented, Distal Hypospadias Repair

Hypospadias is a common condition where the opening of the penis is not located at the tip, but along the underside of the penis. It is estimated to occur in 1/300 live male births, making it one of the most common birth defects. Degrees of hypospadias ranged from minor to severe depending on the location of the opening. Surgical repair is often required and involves placement of a catheter for the urine to drain with known urinary colonization found on prior retrospective studies. The current practice of using preventative antibiotics as long as the catheter is in place is conflicting with resent studies that show antibiotics may not be necessary to prevent urinary tract infections (UTIs).

The purpose of this study was to see how common symptomatic UTIs were after hypospadias repair surgery; and to see whether routine antibiotic use after surgery affected the rate of UTIs. Subjects were randomized to either receive antibiotics or no antibiotics after distal hypospadias repair. The research coordinator made follow-up phone calls with the family and the primary care provider (PCP) after stent removal, 30 days post surgery and after the 3 month post surgical visit.

Study Overview

• Status: Completed
• Conditions: Hypospadias
• Intervention / Treatment: Other: Randomization to receive prophylactic antibiotics after surgery; Other: Randomization to not receive prophylactic antibiotics after surgery.

Detailed Description

Males undergoing distal hypospadias repair involving stent placement were randomized to either receive or not to receive antibiotics post-operative. All subjects did not receive intra-operative antibiotics. Routine follow-up included having the stent removed one week post-op and a return visit at 3 months. The research nurse made follow-up phone calls to the family or the (PCP) one week after the stent was removed and at one month post-op to see how things were going with the child and again after teh 3 month post surgical visit, if the subject did not return after multiple rescheduling attempts.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Males undergoing primary distal hypospadias repair with open urethral stent drainage.

Exclusion Criteria:

• Males undergoing fistula repair or glandular hypospadias repair without incontinent urethral stent drainage and hypospadias repair of mid or more proximal degrees of hypospadias were excluded from this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Antibiotics prophylaxis cohort; Subjects were prescribed prophylactic antibiotics after the hypospadias surgery.	Other: Randomization to receive prophylactic antibiotics after surgery; In general, the antibiotic given is a combination sulfamethoxazole/ trimethoprim oral suspension (2-3 mg trimethoprim/kg by mouth once a day); or if indicated, nitrofurantoin (1mg/kg by mouth once daily). All subjects did not receive intraoperative antibiotics.
Active Comparator: Antibiotic-sparing cohort; Subjects were not prescribed prophylactic antibiotics after the hypospadias surgery.	Other: Randomization to not receive prophylactic antibiotics after surgery.; No antibiotics were ordered after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of symptomatic UTI within 30 days post-surgery	Assess the prevalence of symptomatic UTI in subjects receiving standard of care dispensation of prophylaxis versus subjects selected to an antibiotic-sparing cohort.	30 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of surgical site infections (SSIs) and complications of hypospadias repair	Surgical site infections (SSIs) are measured using physical assessments at the stent removal visit. Complications of hypospadias repair (urethral fistula, meatal stenosis, dehiscence, and diverticulum) are measured using physical assessments at the stent removal visit and/or contact with the family or the PCP office 1 week after the stent removal; at the 30 day post operative time point; and at the 3 month follow-op visit.	Approximately post surgery: 2 weeks (stent is in approximately 1 week and then 1 week after the stent is removed); 30 days; and 3 months

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute
• Investigators: Principal Investigator: Stephen Canon, Arkansas Children's Hospital, Pediatric Urology

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2015
• Primary Completion (Actual): February 17, 2017
• Study Completion (Actual): April 19, 2017

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (Actual): September 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: urinary tract infection; distal hypospadias repair; prophylactic antibiotic use
• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Hypospadias; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: IRB# 203532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No