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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Urinary Tract Infection

In brief

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.

Key facts

Study ID

NCT07508124

Run by

Baylor College of Medicine

People needed

40

Starts

2026-05-08

Expected to finish

2027-12-01

Last updated by the study team

2026-08-07

Who can join

Age: any, up to 0. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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