Prophylactic Antibiotics for Hypospadias

(PROPHY Trial)

Recruiting at 1 trial location

Age: < 18

Sex: Male

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Must not be taking: Antibiotics

Disqualifiers: Previous repair, Allergic reaction, Infection risk, others

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

93 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use antibiotics within seven days before the hypospadias repair or take oral antibiotics other than the study medication during the trial.

What data supports the effectiveness of the drug Trimethoprim-sulfamethoxazole for hypospadias?

Research shows that using Trimethoprim-sulfamethoxazole as a preventive measure after hypospadias surgery can help reduce the risk of urinary tract infections and other complications, making it an effective option for this condition. ^{1 2 3 4 5}

Is trimethoprim-sulfamethoxazole safe for use in humans?

Trimethoprim-sulfamethoxazole has been shown to be safe in various studies, with few side effects reported in the prevention of urinary tract infections and other conditions. It is generally well-tolerated in humans. ^{1 6 7 8 9}

How does the drug trimethoprim-sulfamethoxazole differ from other treatments for hypospadias?

Trimethoprim-sulfamethoxazole is unique because it combines two antibiotics to enhance antibacterial action and reduce the chance of bacteria developing resistance. This combination is effective in treating infections in the urinary tract and male reproductive organs, which may be relevant for preventing infections after hypospadias surgery. ^{6 7 10 11 12}

What is the purpose of this 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.

Research Team

Earl Y Cheng, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Mark A Faasse, MD, MPH

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

This trial is for boys with mid-to-distal shaft hypospadias who are getting a single-stage repair and an open-drainage urethral stent for 5-10 days. It's not for those who've had previous repairs, have allergies to trimethoprim-sulfamethoxazole, take conflicting meds, or have conditions like HIV/AIDS that increase infection risk.

Inclusion Criteria

My hypospadias is located in the middle or near the tip of my penis.

I had a one-time surgery for hypospadias.

My urethral repair was 20 mm or shorter.

Exclusion Criteria

Prior adverse/allergic reaction or other contraindication to trimethoprim-sulfamethoxazole

I have not taken antibiotics within the last week before my hypospadias surgery.

I had foreskin reconstruction during my hypospadias surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term Follow-up

Participants are monitored for long-term outcomes such as wound-healing complications

5 years

Treatment Details

Interventions

• Placebo
• Trimethoprim-sulfamethoxazole

Trial Overview The study is testing if giving preventive antibiotics (trimethoprim-sulfamethoxazole) after hypospadias surgery helps more than a placebo. Boys will be randomly given either the antibiotic or placebo to see which works better at preventing complications.

Participant Groups

Group I: Antibiotics Experimental Treatment 1 Intervention

trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days

Group II: Placebo Placebo Group 1 Intervention

placebo oral suspension, 0.5 mL/kg twice daily for 10 days

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Antibiotic Prophylaxis with Trimethoprim-Sulfamethoxazole versus No Treatment after Mid-to-Distal Hypospadias Repair: A Prospective, Randomized Study. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

The role of preoperative prophylactic antibiotics in hypospadias repair. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Quality of reporting for randomized controlled trials in the hypospadias literature: Where do we stand? [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Clinical analysis and treatment of hypospadias accompanied by associated anomalies in urogenital system]. [2003]

5. England pubmed.ncbi.nlm.nih.gov

Prevalence, repairs and complications of hypospadias: an Australian population-based study. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Postcoital antimicrobial prophylaxis for recurrent urinary tract infection. A randomized, double-blind, placebo-controlled trial. [2016]

7. Finland pubmed.ncbi.nlm.nih.gov

The penetration of sulfadiazine, sulfamethoxazole and trimethoprim into the prostate gland, epididymis and testis in man. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Prophylactic antimicrobial treatment in transurethral prostatectomy. How long should it be instituted? [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Trimethoprim-sulfamethoxazole for the prevention of spontaneous bacterial peritonitis in cirrhosis: a randomized trial. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Infection and male infertility: effect of different antibiotic regimens on semen quality. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[Antibacterial therapy of urinary tract infections. Results of a clinical trial with the combination sulfamoxol/Trimethoprim (= CN 3123) (author's transl)]. [2013]

12. Canada pubmed.ncbi.nlm.nih.gov

Long-term therapy of chronic bacterial prostatitis with trimethoprim-sulfamethoxazole. [2018]