Topical betamethasone and hyaluronidase in the treatment of phimosis in boys: a double-blind, randomized, placebo-controlled trial

ABSTRACT

PURPOSE: To compare the efficacy of three different formulations containing Betamethasone Valerate versus placebo in the topical treatment of phimosis. As a secondary goal, we compared the outcomes after 30 and 60 days of treatment. MATERIALS AND METHODS: Two hundred twenty boys aged 3 to 10 years old with clinical diagnosis of phimosis were enrolled. Patients were randomized to one of the following groups: Group 1: Betamethasone Valerate 0.2 percent plus Hyaluronidase; Group 2: Betamethasone Valerate 0.2 percent; Group 3: Betamethasone Valerate 0.1 percent or Group 4: placebo. Parents were instructed to apply the formula twice a day for 60 days and follow-up evaluations were scheduled at 30, 60 and 240 days after the first consultation. Success was defined as complete and easy foreskin retraction. RESULTS: One hundred ninety-five patients were included at our final analysis. Group 1 (N = 54), 2 (N = 51) and 3 (N = 52) had similar success and improvement rates, all treatment groups had higher success rates than placebo(N = 38). After 60 days of treatment, total and partial response rates for Groups 1, 2 and 3 were 54.8 percent and 40.1 percent, respectively, while placebo had a success rate of 29 percent. Success and improvement rates were significantly better in 60 days when compared to 30 days. CONCLUSIONS: Betamethasone Valerate 0.1 percent, 0.2 percent and 0.2 percent in combination with Hyaluronidase had equally higher results than placebo in the treatment of phimosis in boys from three to ten years-old. Patients initially with partial or no response can reach complete response after 60 days of treatment.