Using a steroid cream to prevent repeat urinary tract infections in uncircumcised baby boys

Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants With a First Febrile Urinary Tract Infection: a Multi-center Pilot Study

This pilot will test whether applying a steroid cream twice weekly for four weeks can help prevent repeat urinary tract infections in uncircumcised male infants under 6 months who have had a first UTI.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 0 Months to 5 Months
• Sex: Male
• Sponsor: Baylor College of Medicine (Academic / other)
• Locations: 3 sites (Houston, Texas and 2 other locations)
• Trial ID: NCT07508124 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled pilot enrolls uncircumcised male infants under 6 months with a first, documented UTI at sites in Houston and Seattle. Enrolled infants are randomized to receive either betamethasone 0.1% cream or a matching placebo cream applied twice weekly for four weeks, with caregiver instruction provided by the study team. The protocol includes an early follow-up 28–38 days after enrollment and a final visit at 6–7 months to document recurrent UTIs and capture parent experience and feasibility outcomes. The pilot is also testing recruitment and screening strategies across ED, clinic, and inpatient settings to prepare for a larger definitive trial.

Who should consider this trial

Good fit: Uncircumcised male infants under 6 months old with a physician- and laboratory-confirmed first UTI and fever or hypothermia at presentation, whose legal guardian can consent in English or Spanish, are ideal candidates.

Not a fit: Infants with fully retractable foreskin, prior penile abnormalities, prior topical steroid treatment for phimosis, hypersensitivity to topical steroids, medically indicated circumcision, infants in CPS custody, or those whose guardians cannot consent or speak English/Spanish are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the approach could reduce recurrent UTIs in uncircumcised infants and lower the need for antibiotics, repeat hospital visits, or surgical procedures.

How similar studies have performed: Topical steroids are an established treatment for phimosis, but using them specifically to prevent recurrent UTIs in uncircumcised infants is a novel application that has not been proven in prior trials.

Eligibility criteria

Inclusion Criteria:

1. Uncircumcised male infants \< 6 months old
2. Both physician and laboratory confirmed diagnosis of first UTI
3. Fever (temperature ≥38.0 C) or hypothermia (temperature \<36.0 C) per ED/hospitalization or parental report

Exclusion Criteria:

1. Legal guardian not available to provide informed consent
2. Infant in Child Protective Services (CPS) custody
3. Legal guardian would like Urology referral for circumcision
4. Circumcision is medically indicated due to recurrent episodes of balanitis or ballooning of foreskin during urination
5. Past diagnosis of penile abnormalities (diagnoses of epispadius, hypospadias or congenital penile curvature (chordee))
6. Prior use of topical steroid therapy for phimosis
7. History of hypersensitivity to topical steroids
8. Legal guardian is not fluent in English OR Spanish
9. Foreskin assessed to be fully retractable
10. Open wounds present on penis or in groin region

Where this trial is running

Houston, Texas and 2 other locations

• Texas Children's Hospital Main campus — Houston, Texas, United States (Recruiting)
• Texas Children's Hospital West Campus — Katy, Texas, United States (Not_yet_recruiting)
• Seattle Children's Hospital — Seattle, Washington, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Sowdhamini Wallace, DO, MS

Conditions Urinary Tract Infection; urinary tract infection; uncircumcised male infants; betamethasone cream; steroid cream