Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study (STRUMI-T)

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Tract Infection
• Intervention / Treatment: Drug: betamethasone valerate 0.1% cream; Drug: Placebo cream

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sowdhamini Wallace, DO, MS; Phone Number: 18328245447; Email: swallace@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Texas Children's Hospital Main campus
      • Contact: Sowdhamini Wallace, DO, MS; Phone Number: 832-824-5447; Email: swallace@bcm.edu
      • Principal Investigator: Sowdhamini Wallace, DO, MS
      • Sub-Investigator: Grace Truong, MD
      • Sub-Investigator: Chester Koh, MD, MBA
      • Sub-Investigator: Jaqueline Broda, MPAS, PA-C
      • Sub-Investigator: Saamia Masoom, MD
    • Katy, Texas, United States, 77094
      • Not yet recruiting
      • Texas Children's Hospital West Campus
      • Contact: Sowdhamini Wallace, DO, MS; Phone Number: 832-824-5447; Email: swallace@bcm.edu
      • Principal Investigator: Sowdhamini Wallace, DO, MS
      • Sub-Investigator: Marina Bishai, DO
  • Washington
    • Seattle, Washington, United States, 98105
      • Not yet recruiting
      • Seattle Children's Hospital
      • Contact: Eric Coon, MD, MS; Email: Eric.Coon@seattlechildrens.org
      • Principal Investigator: Eric Coon, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Participants randomized to receive steroid cream	Drug: betamethasone valerate 0.1% cream; Steroid cream applied to the foreskin and glans twice a day for four weeks.
Placebo Comparator: Participants randomized to receive placebo cream.	Drug: Placebo cream; Placebo cream is applied to the foreskin and glans twice a day for four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment across different settings	Defined as the consent rate of >= 20% as stratified by setting (clinic/EC/inpatient)	up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recurrent urinary tract infection	Defined as at least one subsequent urinary tract infection as confirmed through parent report and medical record review.	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.
Total number of recurrent urinary tract infections		6 month follow up period
Number of subsequent hospitalizations for recurrent urinary tract infections	Subsequent hospitalizations for recurrent urinary tract infections	6 month follow up period
Number of subsequent emergency department visits for recurrent urinary tract infection	Subsequent emergency department visits, including urgent care, for recurrent UTI	Within 6 month follow up period
Rate of provider diagnosed recurrent urinary tract infection	Number of recurrent urinary tract infections that are diagnosed by the physician but do not necessarily meet laboratory criteria for urinary tract infection.	6 month follow up period
Number of Lumbar punctures	Number of lumbar punctures received during a subsequent emergency department visit or hospitalization for recurrent urinary tract infection	6 month follow up period
Self reported Rate of Referral for Circumcision	Parent reports referral to Urology for circumcision or circumcision performed within the 6 month follow up period.	During the 6 month follow up period
Self Reported Adherence to Applying Topical Cream Regimen	Adherence to applying the topical cream measured by asking the frequency of application in a questionnaire completed by the legal guardian.	Measured at 4 week follow up visit
Rate of Adverse effects of cream	Local or systemic side effects of the cream (e.g., irritation, local infection)	At 4 weeks
Number of infants with Congenital anomalies of the kidney and urinary tract	Number of participants with previously known or newly diagnosed genitourinary anomalies	From time of enrollment through last follow up visits 6 months later
Number of subsequent clinic visits for recurrent urinary tract infection	Subsequent clinic visits may include visits to the primary care physician or another physician in the clinic	During the 6 month follow up period
Attrition rate	Total number of missed visits at 4 weeks and 6 months. This will be measured by tracking of study visits.	Through the 6 month follow up period for each participant
Parental acceptability of the study design	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.	At the 6 month follow up visit for each participant

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Seattle Children's Hospital

Publications and helpful links

General Publications

• Conway PH, Cnaan A, Zaoutis T, Henry BV, Grundmeier RW, Keren R. Recurrent urinary tract infections in children: risk factors and association with prophylactic antimicrobials. JAMA. 2007 Jul 11;298(2):179-86. doi: 10.1001/jama.298.2.179.
• Dave S, Afshar K, Braga LH, Anderson P. Canadian Urological Association guideline on the care of the normal foreskin and neonatal circumcision in Canadian infants (full version). Can Urol Assoc J. 2018 Feb;12(2):E76-E99. doi: 10.5489/cuaj.5033. Epub 2017 Dec 1. No abstract available.
• Shaikh N, Morone NE, Bost JE, Farrell MH. Prevalence of urinary tract infection in childhood: a meta-analysis. Pediatr Infect Dis J. 2008 Apr;27(4):302-8. doi: 10.1097/INF.0b013e31815e4122.
• Lee JW, Cho SJ, Park EA, Lee SJ. Topical hydrocortisone and physiotherapy for nonretractile physiologic phimosis in infants. Pediatr Nephrol. 2006 Aug;21(8):1127-30. doi: 10.1007/s00467-006-0104-8. Epub 2006 Jun 22.
• Chen CJ, Satyanarayan A, Schlomer BJ. The use of steroid cream for physiologic phimosis in male infants with a history of UTI and normal renal ultrasound is associated with decreased risk of recurrent UTI. J Pediatr Urol. 2019 Oct;15(5):472.e1-472.e6. doi: 10.1016/j.jpurol.2019.06.018. Epub 2019 Jun 25.
• Moreno G, Ramirez C, Corbalan J, Penaloza B, Morel Marambio M, Pantoja T. Topical corticosteroids for treating phimosis in boys. Cochrane Database Syst Rev. 2024 Jan 25;1(1):CD008973. doi: 10.1002/14651858.CD008973.pub3.
• Khan A, Jhaveri R, Seed PC, Arshad M. Update on Associated Risk Factors, Diagnosis, and Management of Recurrent Urinary Tract Infections in Children. J Pediatric Infect Dis Soc. 2019 May 11;8(2):152-159. doi: 10.1093/jpids/piy065.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 21, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: urinary tract infection; steroid cream; uncircumcised male infants; betamethasone cream
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Betamethasone; Betamethasone Valerate
• Other Study ID Numbers: H-57427

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

After publication of this study, a releasable database will be produced and completely de-identified in accordance with the definitions provided in the Health insurance Portability and Accountability Act (HIPAA). Namely, all identifiers specified in HIPAA will be recoded in a manner that will make it impossible to deduce or impute the specific identity of any patient. The database will not contain any institutional identifiers.

The PI will prepare a data dictionary that provides a concise definition of every data element included in the database. The releasable database will be provided to users in electronic form.

• IPD Sharing Time Frame: The de-identified database and data dictionary will be available after publication of this study and up to five years after the publication date.
• IPD Sharing Access Criteria: The database and data dictionary would be made available to researchers and clinicians after publication of this study. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to Sowdhamini Wallace (swallace@bcm.edu).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No