NCT07508124 · Baylor College of Medicine
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
(STRUMI-T)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
betamethasone valerate 0.1% cream
Steroid cream applied to the foreskin and glans twice a day for four weeks.
DRUG
Placebo cream
Placebo cream is applied to the foreskin and glans twice a day for four weeks.
Primary outcome measures
Feasibility of recruitment across different settings
Time frame: up to 2 weeks
Defined as the consent rate of \>= 20% as stratified by setting (clinic/EC/inpatient)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Houston, Texas
- Katy, Texas
- Seattle, Washington
Collaborators
Seattle Children's Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 2, 2026 · Source of record for eligibility and locations