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NCT Number: NCT07508124

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

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Key information

Conditions

Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

0 month–5 month

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Texas Children's Hospital Main campus, Houston, Texas, United States

Loading trial locations.

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

betamethasone valerate 0.1% cream

Drug

Steroid cream applied to the foreskin and glans twice a day for four weeks.

placebo cream

Drug

Placebo cream is applied to the foreskin and glans twice a day for four weeks.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Rate of recurrent urinary tract infection

    Time frame: Between 14 days of completing antibiotics for the first urinary tract infection and through the last follow up visit, which occurs 6 months after randomization.

    Defined as at least one subsequent urinary tract infection as confirmed through parent report and medical record review.

  2. Total number of recurrent urinary tract infections

    Time frame: 6 month follow up period

  3. Number of subsequent hospitalizations for recurrent urinary tract infections

    Time frame: 6 month follow up period

    Subsequent hospitalizations for recurrent urinary tract infections

  4. Number of subsequent emergency department visits for recurrent urinary tract infection

    Time frame: Within 6 month follow up period

    Subsequent emergency department visits, including urgent care, for recurrent UTI

  5. Rate of provider diagnosed recurrent urinary tract infection

    Time frame: 6 month follow up period

    Number of recurrent urinary tract infections that are diagnosed by the physician but do not necessarily meet laboratory criteria for urinary tract infection.

  6. Number of Lumbar punctures

    Time frame: 6 month follow up period

    Number of lumbar punctures received during a subsequent emergency department visit or hospitalization for recurrent urinary tract infection

  7. Self reported Rate of Referral for Circumcision

    Time frame: During the 6 month follow up period

    Parent reports referral to Urology for circumcision or circumcision performed within the 6 month follow up period.

  8. Self Reported Adherence to Applying Topical Cream Regimen

    Time frame: Measured at 4 week follow up visit

    Adherence to applying the topical cream measured by asking the frequency of application in a questionnaire completed by the legal guardian.

  9. Rate of Adverse effects of cream

    Time frame: At 4 weeks

    Local or systemic side effects of the cream (e.g., irritation, local infection)

  10. Number of infants with Congenital anomalies of the kidney and urinary tract

    Time frame: From time of enrollment through last follow up visits 6 months later

    Number of participants with previously known or newly diagnosed genitourinary anomalies

  11. Number of subsequent clinic visits for recurrent urinary tract infection

    Time frame: During the 6 month follow up period

    Subsequent clinic visits may include visits to the primary care physician or another physician in the clinic

  12. Attrition rate

    Time frame: Through the 6 month follow up period for each participant

    Total number of missed visits at 4 weeks and 6 months. This will be measured by tracking of study visits.

  13. Parental acceptability of the study design

    Time frame: At the 6 month follow up visit for each participant

    Perceptions on any facilitators and barriers to participating in the study as related to enrollment, administration of the study cream and attending follow up visits. Qualitatively measured using semi-structured interviews.

Study contacts

Contact information is provided by the study sponsor or research team.

Sowdhamini Wallace, DO, MS

CONTACT

[email protected]

18328245447

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Seattle Children's Hospital

Registry information

Official study title

Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants With a First Febrile Urinary Tract Infection: a Multi-center Pilot Study

Acronym: STRUMI-T

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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