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

RecruitingPhase 4Ages 0 Months - 5 MonthsMaleBaylor College of Medicine
NCT07508124 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • betamethasone valerate 0.1% cream
  • Placebo cream
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Where

3 sites
Texas Children's Hospital Main campus
Houston, United States
Texas Children's Hospital West Campus
Katy, United States
Seattle Children's Hospital
Seattle, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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