Randomized Open Label Trial Comparing Topical Prescription Triamcinolone to Over-the-Counter Hydrocortisone for the Treatment of Phimosis

Summary Background Phimosis is a common condition affecting most infant boys and generally resolves over time without symptoms. Severe cases of phimosis can lead to balanoposthitis, urinary tract infections, and urinary retention. Medical treatment for symptomatic phimosis includes topical corticosteroids with manual foreskin retraction. Objective Over-the-counter hydrocortisone 1% cream was compared in a randomized controlled fashion with prescription triamcinolone 0.1% cream for the medical management of symptomatic phimosis. Methods The study institution conducted a randomized open-label trial for the treatment of grades 4–5 phimosis (phimosis grade scale 0–5). Boys aged 3–13 years were randomized to hydrocortisone 1% cream or triamcinolone 0.1% cream dosed at least twice daily for a course of 12 weeks. Instructions were provided for appropriate application and manual retraction of the foreskin. 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 12 weeks of treatment. Results A total of 52 boys enrolled in the trial, with a total of 32 boys completing the 12-week duration. Of the 13 boys in the hydrocortisone arm, there was a 30.8% success rate at 4 weeks, 53.8% success rate at 8 weeks, and 61.5% success rate at 12 weeks. Of the 19 boys in the triamcinolone arm, there was a 31.6% success rate at 4 weeks, 52.6% success rate at 8 weeks, and 68.4% success rate at 12 weeks. There was no statistical difference between the two arms at each interval. Discussion To the study authors' knowledge, this is the first open-label trial with direct comparison of hydrocortisone 1% cream with triamcinolone 0.1% cream. The study results support those reported in other studies when each topical steroid was compared with placebo. Limitations of the study include loss to follow-up, unblinded treatment allocation, and reduced power to detect differences by treatment frequency and duration. Conclusion Over-the-counter hydrocortisone 1% cream is not inferior to triamcinolone 0.1% cream when paired with manual retraction for the treatment of grade 4–5 phimosis. Successful treatment response may be seen up to 12 weeks. Summary table . Success rate of treatments Group No. patients/total no. (percentage) At 4 weeks At 8 weeks At 12 weeks Hydrocortisone 4/13 (30.8%) 7/13 (53.8%) 8/13 (61.5%) Triamcinolone 6/19 (31.6%) 10/19 (52.6%) 13/19 (68.4%) P value a 0.99 0.99 0.72 a Fisher's exact test.