Randomized Open Label Trial Comparing Prescription Triamcinolone to Over-the-Counter Hydrocortisone for the Treatment of Phimosis
Crystal Dorgalli, MS, Christina L. Chalmers, NP, Joshua D. Chamberlin, MD, Maryellen S. Kelly, DNP, Ahmed Abdelhalim, MD, Irene M. McAleer, MD, Elias J. Wehbi, MD, Kai-wen Chuang, MD, Heidi A. Stephany, MD, Antoine E. Khoury, MD.
University of California Irvine, Children's Hospital of Orange County, Orange, CA, USA.
BACKGROUND: Phimosis can cause penile infections, inflammatory changes and urinary retention. The initial treatment for symptomatic non-retractile foreskin includes prescription topical steroids. We compared the use of prescription triamcinolone to over-the-counter hydrocortisone for the initial medical management of phimosis in a randomized controlled fashion.
METHODS: A single institution, prospective randomized open label trial for the treatment of grades 4-5 phimosis was conducted. Boys 3-13 years of age were included and randomized to either 0.1% triamcinolone cream or 1% hydrocortisone cream dosed either 2 or 4 times per day for a 12-week course. Education on appropriate application and manual retraction of the foreskin was provided. Evaluations were performed at 4, 8 and 12 weeks. Successful completion of the study was determined by reaching phimosis grade 2 or less or after completing a 12-week course of treatment. Boys with steroid-resistant phimosis were offered circumcision.
RESULTS: A total of 54 boys were enrolled in the trial with 27 completing the 12-week duration. Fourteen boys in the hydrocortisone arm completed the study and success was seen in 29% at 4 weeks, 50% at 8 weeks, and 57% at 12 weeks. Thirteen boys completed the triamcinolone arm and success was seen in 23% at 4 weeks, 54% at 8 weeks, and 62% at 12 weeks. A total of 8 patients ultimately underwent circumcision, 5 in the hydrocortisone arm and 3 in the triamcinolone arm. Despite successful medical treatment in one boy from each arm, both families desired an elective circumcision. Success rates were not statistically different between the 2 arms at each interval (p=0.74, 0.84, 0.54 at 4, 8 and 12 weeks, respectively). Factors that led to study drop-out included incidental identification of phimosis compared to primary referral for phimosis and insufficient compliance with treatment.
CONCLUSIONS: Over-the-counter hydrocortisone cream appears to be as effective as triamcinolone cream when paired with manual retraction for the treatment of grade 4-5 phimosis. Risk factors that led to circumcision included a tight phimotic band, foreskin scarring and family desire for elective circumcision.
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