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% 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.

• Authors: Fabio J Nascimento, Rodrigo F Pereira, Jarques L Silva 2nd, Alessandro Tavares, Antonio C L Pompeo
• Journal: International braz j urol : official journal of the Brazilian Society of Urology (Int Braz J Urol) 2011 May-Jun Vol. 37 Issue 3 Pg. 314-9 ISSN: 1677-6119 [Electronic] Brazil
• PMID: 21756378 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Glucocorticoids
• Betamethasone Valerate
• Hyaluronoglucosaminidase

Topics

• Administration, Topical
• Betamethasone Valerate (administration & dosage)
• Child
• Child, Preschool
• Double-Blind Method
• Drug Administration Schedule
• Glucocorticoids (administration & dosage)
• Humans
• Hyaluronoglucosaminidase (administration & dosage)
• Male
• Phimosis (drug therapy)
• Prospective Studies
• Treatment Outcome