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

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. 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.

Timeline

Start

2026-04

Primary completion

2027-12

Completion

2027-12

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.

Drugs

Indications