Home › Urinary Tract Infections › NCT07508124

Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study

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

Who can join

0 Months – 5 Months · Men

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

About the study

The goal of this smaller clinical trial is to evaluate the study design of this research to help prepare for a larger research study in the future. The future larger study would focus on whether steroid cream can reduce recurrent urinary tract infections in male infants, who are not circumcised.

Male infants, who are enrolled in this study, would receive either the steroid cream or a placebo cream (a look alike cream without steroids). The cream would be applied twice a week for four weeks. Then there would be two follow up visits with the research team to measure whether the infant experienced any urinary tract infections and to measure parent perceptions of their experience participating in the study.

What is being tested

• betamethasone valerate 0.1% cream (drug)
• Placebo cream (drug)

Sponsor: Baylor College of Medicine · Participants: 40 · Started: May 8, 2026

Contact the study team

• Sowdhamini Wallace, DO, MS · Phone: 18328245447

Official record on ClinicalTrials.gov — NCT07508124

Locations in the U.S.

Conditions

• Urinary Tract Infections

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.