Topical hydrocortisone and physiotherapy for nonretractile physiologic phimosis in infants.
Jung Won Lee, Su Jin Cho, Eun Ae Park...
https://pubmed.ncbi.nlm.nih.gov/16791612Actively Recruiting
Phase 4
Age: 0Months - 5Months
MALE
ID07508124
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants With a First Febrile Urinary Tract Infection: a Multi-center Pilot Study
Led by Baylor College of Medicine · Updated on 2026-04-02
40
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
S
Seattle Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether applying a steroid cream can help prevent recurrent urinary tract infections (UTIs) in uncircumcised male infants under 6 months old who have had their first UTI. This pilot study aims to test the study design and recruitment strategies across multiple hospital and clinic settings to prepare for a larger future study. Male infants who meet the criteria are randomly assigned to receive either the steroid cream or a placebo cream. Participants will have the cream applied to their foreskin and glans twice a week for four weeks. The study includes two follow-up visits: one about 28 to 38 days after enrollment or hospital discharge to assess cream adherence and early effects, and another 6 to 7 months later to evaluate urinary tract infection recurrence and parental feedback. The research team will instruct caregivers on how to apply the cream properly. Throughout the study, researchers will collect data on the number of recurrent UTIs, hospitalizations, emergency visits, and any side effects from the cream. They will also monitor parental acceptance of the study design. The trial lasts approximately six months after treatment, involving clinical assessments, lab confirmations, and questionnaires to understand outcomes and safety.
CONDITIONS
Brief Title
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
Who Can Participate
Age: 0Months - 5Months
MALE
Eligibility Criteria
You may qualify if you...
- Uncircumcised male infants younger than 6 months old
- Confirmed first urinary tract infection by both physician and laboratory tests
- Fever of 38.0 C or higher, or hypothermia below 36.0 C, reported by emergency/hospital or parents
You will not qualify if you...
- Legal guardian unavailable to provide informed consent
- Infant in Child Protective Services custody
- Legal guardian requests urology referral for circumcision
- Circumcision medically needed due to recurrent balanitis or foreskin ballooning during urination
- Past diagnosis of penile abnormalities such as epispadias, hypospadias, or congenital penile curvature
- Prior use of topical steroid therapy for phimosis
- History of hypersensitivity to topical steroids
- Legal guardian not fluent in English or Spanish
- Foreskin fully retractable
- Open wounds on penis or groin area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 4 weeks
Participants apply the assigned cream to the foreskin and glans twice a day for four weeks.
1 baseline visit at enrollment and 1 follow-up visit 28 to 38 days after enrollment or hospital discharge, whichever is later
Follow-up
Duration - 6 to 7 months
Participants are monitored for recurrent urinary tract infections and other outcomes for up to 6 to 7 months after enrollment or hospital discharge.
1 final follow-up visit 6 to 7 months after enrollment or hospital discharge
Trial Site Locations
Total: 3 locations
1
Texas Children's Hospital Main campus
Houston, Texas, United States, 77030
Actively Recruiting
2
Texas Children's Hospital West Campus
Katy, Texas, United States, 77094
Not Yet Recruiting
3
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Not Yet Recruiting
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Research Team
S
Sowdhamini Wallace, DO, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.
C J Chen, A Satyanarayan, B J Schlomer
https://pubmed.ncbi.nlm.nih.gov/31345734Topical corticosteroids for treating phimosis in boys.
Gladys Moreno, Cristian Ramirez, Javiera Corbalán...
https://pubmed.ncbi.nlm.nih.gov/38269441Canadian Urological Association guideline on the care of the normal foreskin and neonatal circumcision in Canadian infants (full version).
Sumit Dave, Kourosh Afshar, Luis H Braga...
https://pubmed.ncbi.nlm.nih.gov/29381458Recurrent urinary tract infections in children: risk factors and association with prophylactic antimicrobials.
Patrick H Conway, Avital Cnaan, Theoklis Zaoutis...
https://pubmed.ncbi.nlm.nih.gov/17622599Update on Associated Risk Factors, Diagnosis, and Management of Recurrent Urinary Tract Infections in Children.
Anum Khan, Ravi Jhaveri, Patrick C Seed...
https://pubmed.ncbi.nlm.nih.gov/30053044Prevalence of urinary tract infection in childhood: a meta-analysis.
Nader Shaikh, Natalia E Morone, James E Bost...
https://pubmed.ncbi.nlm.nih.gov/18316994