Prophylactic Antibiotics or Placebo After Hypospadias Repair (PROPHY)

Trimethoprim-sulfamethoxazole vs. Placebo After Hypospadias Repair: a Multicenter, Double-blind, Randomized Trial

The primary purpose of this study is to determine if routine use of prophylactic (preventive) antibiotics after repair of mid-to-distal hypospadias is beneficial.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypospadias
• Intervention / Treatment: Other: placebo; Drug: trimethoprim-sulfamethoxazole

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H Lurie Children's Hospital of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antibiotics; trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days	Drug: trimethoprim-sulfamethoxazole
Placebo Comparator: Placebo; placebo oral suspension, 0.5 mL/kg twice daily for 10 days	Other: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative infection	UTI; cellulitis/wound infection	up to 30 days
wound-healing complications	meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum	up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
adverse drug reaction	up to 14 days
C. difficile colitis	up to 6 months

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: The Hospital for Sick Children
• Investigators: Principal Investigator: Earl Y Cheng, MD, Ann & Robert H Lurie Children's Hospital of Chicago; Principal Investigator: Mark A Faasse, MD, MPH, Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

General Publications

• Faasse MA, Farhat WA, Rosoklija I, Shannon R, Odeh RI, Yoshiba GM, Zu'bi F, Balmert LC, Liu DB, Alyami FA, Beaumont JL, Erickson DL, Gong EM, Johnson EK, Judd S, Kaplan WE, Kaushal G, Koyle MA, Lindgren BW, Maizels M, Marcus CR, McCarter KL, Meyer T, Qureshi T, Saunders M, Thompson T, Yerkes EB, Cheng EY. Randomized trial of prophylactic antibiotics vs. placebo after midshaft-to-distal hypospadias repair: the PROPHY Study. J Pediatr Urol. 2022 Apr;18(2):171-177. doi: 10.1016/j.jpurol.2022.01.008. Epub 2022 Jan 25.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): December 1, 2018
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: March 24, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Hypospadias; Anti-Bacterial Agents
• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Hypospadias; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Anti-Dyskinesia Agents; Anti-Infective Agents, Urinary; Renal Agents; Cytochrome P-450 CYP2C8 Inhibitors; Trimethoprim; Sulfamethoxazole; Trimethoprim, Sulfamethoxazole Drug Combination
• Other Study ID Numbers: LC/Uro-MF-01