Topical Steroids to Prevent Recurrent UTIs in Uncircumcised Male Infants

This pilot study is testing if a steroid cream, betamethasone valerate 0.1%, could help prevent repeat urinary tract infections (UTIs) in uncircumcised male infants. The main goal is to see how well we can recruit families for a larger study in the future. Infants up to 5 months old who have had their first UTI with a fever can join. You would apply either the steroid cream or a placebo cream (a cream without medicine) to your baby's foreskin and glans twice a day for four weeks. The study will then follow your baby to see if they get more UTIs and to understand your experience.

Study design
This is an interventional pilot study planning to enroll 40 uncircumcised male infants. Participants will be randomly assigned to receive either the active drug or a placebo.
What's involved
Participants will apply cream twice a day for four weeks. There will be two follow-up visits: one 28-38 days after enrollment/discharge, and another 6-7 months after enrollment/discharge.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6-7 months after enrollment or hospital discharge to check for UTIs and gather parent feedback.

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NCT07508124

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

Recruiting
PHASE4Ages 0–5InterventionalTreatment
Baylor College of Medicine
~40 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:betamethasone valerate 0.1% creamPlacebo cream

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of recruitment across different settings
Measured over up to 2 weeks
Urinary Tract Infection
3 sites across 2 states
Texas2
Washington1

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  • Feasibility of recruitment across different settingsup to 2 weeks

    Defined as the consent rate of \>= 20% as stratified by setting (clinic/EC/inpatient)