Topical betamethasone and hyaluronidase in the treatment of phimosis in boys: a
double-blind, randomized, placebo-controlled trial.
Author(s): Nascimento FJ, Pereira RF, Silva JL 2nd, Tavares A, Pompeo AC.
Affiliation(s): Department of Urology, ABC Medical School, Santo Andre, SP, Brazil.
fabiojnascimento@terra.com.br
Publication date & source: 2011, Int Braz J Urol. , 37(3):314-9
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% plus Hyaluronidase;
Group 2: Betamethasone Valerate 0.2%; Group 3: Betamethasone Valerate 0.1% 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% and 40.1%, respectively, while placebo had a success rate of 29%. Success
and improvement rates were significantly better in 60 days when compared to 30
days.
CONCLUSIONS: Betamethasone Valerate 0.1%, 0.2% and 0.2% 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.
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