Using a steroid cream to prevent repeat urinary tract infections in uncircumcised baby boys
Official title: Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants With a First Febrile Urinary Tract Infection: a Multi-center Pilot Study
Run by Baylor College of Medicine · NCT07508124 · Data updated 2026-11-12
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 |
| Ages | 0 Months to 5 Months |
| Sex | Men only |
| Enrollment | 40 (estimated) |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 3 sites (Houston, Texas and 2 other locations) |
| Status | Recruiting |
| Started | May 8, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT07508124 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: swallace@bcm.edu
- Phone: 18328245447
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.