Urinary Tract InfectionPhase 4STRUMI-TNCT07508124
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
A Phase 4 study testing betamethasone valerate 0.1% cream in people with Urinary Tract Infection, run by Baylor College of Medicine at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 5 months, men only
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- betamethasone valerate 0.1% cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 May 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 5 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Texas Children's Hospital Main campus
Houston, Texas, 77030
Sowdhamini Wallace, DO, MS, 832-824-5447, swallace@bcm.edu
Sowdhamini Wallace, DO, MS
- Not yet recruiting
Texas Children's Hospital West Campus
Katy, Texas, 77094
Sowdhamini Wallace, DO, MS, 832-824-5447, swallace@bcm.edu
Sowdhamini Wallace, DO, MS
- Not yet recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Eric Coon, MD, MS, Eric.Coon@seattlechildrens.org
Eric Coon, MD, MS
About this study
Official 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
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.
Read the 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.
- Conditions
- Urinary Tract Infection
- Being tested
- betamethasone valerate 0.1% cream, Placebo cream
- Keywords
- urinary tract infection, uncircumcised male infants, betamethasone cream, steroid cream
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
betamethasone valerate 0.1% creamDrug
Steroid cream applied to the foreskin and glans twice a day for four weeks.
Placebo creamDrug
Placebo cream is applied to the foreskin and glans twice a day for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Participants randomized to receive steroid cream | Active comparator | Not described Receives: Drug: betamethasone valerate 0.1% cream |
| Participants randomized to receive placebo cream. | Placebo comparator | Not described Receives: Drug: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment across different settings
Defined as the consent rate of >= 20% as stratified by setting (clinic/EC/inpatient)
Measured: up to 2 weeks
Secondary outcomes (13)
Rate of recurrent urinary tract infection
Defined as at least one subsequent urinary tract infection as confirmed through parent report and medical record review.
Measured: 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
Measured: 6 month follow up period
Number of subsequent hospitalizations for recurrent urinary tract infections
Subsequent hospitalizations for recurrent urinary tract infections
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: At the 6 month follow up visit for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start8 May 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital
- Responsible party
- Principal investigator, Sowdhamini Wallace, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508124
- Sponsor's protocol ID
- H-57427
- Acronym
- STRUMI-T
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 16791612Chen 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.
PubMed 31345734Moreno 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.
PubMed 38269441Dave 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.
PubMed 29381458Conway 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.
PubMed 17622599Khan 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.
PubMed 30053044Shaikh 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.
PubMed 18316994
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07508124
- Acronym / sponsor ID
- STRUMI-T / H-57427
- Conditions
- Urinary Tract Infection
- Keywords
- urinary tract infection, uncircumcised male infants, betamethasone cream, steroid cream
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital
- Study start
- 8 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants randomized to receive steroid cream | Active comparator | Drug: betamethasone valerate 0.1% cream |
| Participants randomized to receive placebo cream. | Placebo comparator | Drug: Placebo cream |
Who may qualify
- Ages
- 0 to 5 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| betamethasone valerate 0.1% creamSteroid cream applied to the foreskin and glans twice a day for four weeks. | Drug | Participants randomized to receive steroid cream |
| Placebo creamPlacebo cream is applied to the foreskin and glans twice a day for four weeks. | Drug | Participants randomized to receive placebo cream. |
Primary outcome
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)
13 secondary outcomes
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.
Total number of recurrent urinary tract infections
Time frame: 6 month follow up period
Number of subsequent hospitalizations for recurrent urinary tract infections
Time frame: 6 month follow up period
Number of subsequent emergency department visits for recurrent urinary tract infection
Time frame: Within 6 month follow up period
Rate of provider diagnosed recurrent urinary tract infection
Time frame: 6 month follow up period
Number of Lumbar punctures
Time frame: 6 month follow up period
Self reported Rate of Referral for Circumcision
Time frame: During the 6 month follow up period
Self Reported Adherence to Applying Topical Cream Regimen
Time frame: Measured at 4 week follow up visit
Rate of Adverse effects of cream
Time frame: At 4 weeks
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 subsequent clinic visits for recurrent urinary tract infection
Time frame: During the 6 month follow up period
Attrition rate
Time frame: Through the 6 month follow up period for each participant
Parental acceptability of the study design
Time frame: At the 6 month follow up visit for each participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 16791612Lee 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.
- Background: PubMed 31345734Chen 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.
- Background: PubMed 38269441Moreno 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.
- Background: PubMed 29381458Dave 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.
- Background: PubMed 17622599Conway 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.
- Background: PubMed 30053044Khan 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.
- Background: PubMed 18316994Shaikh 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Urinary Tract Infection
Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing betamethasone valerate 0.1% cream in people with Urinary Tract Infection, run by Baylor College of Medicine at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sowdhamini Wallace, DO, MS (18328245447, swallace@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment across different settings (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07508124, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.