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

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.

This is a multi-center pilot study involving recruitment of uncircumcised male infants < 6 months of age from outpatient clinics, emergency department and inpatient settings in Houston, Texas. Additionally, the pilot study will involve recruitment of hospitalized infants from Seattle Children's Hospital in Seattle, Washington.

Various strategies for screening and recruitment will be piloted across settings to identify the most effective processes for the future study. Hospitalized infants would be enrolled prior to discharge. Children recruited from the clinic or emergency department would be enrolled in the Texas Children's Hospital Clinical Research Center. Randomization would occur after enrollment and would be conducted by the investigational pharmacy. The research investigators will teach the legal guardians of the infants how to apply the cream.

The first follow up visit would occur after completion of the cream treatment and would be 28-38 days after being enrolled or after hospital discharge, whichever came later. The last follow up visit would occur 6-7 months after being enrolled or hospital discharge.

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