Topical betamethasone and hyaluronidase in the treatment of phimosis in boys: a double-blind, randomized, placebo-controlled trial
Autor: | Antonio Carlos Lima Pompeo, Jarques Lucio Silva Ii, Rodrigo Fernando Pereira, Fábio J. Nascimento, Alessandro Tavares |
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Jazyk: | angličtina |
Rok vydání: | 2011 |
Předmět: |
Male
medicine.medical_specialty Urology Administration Topical Placebo-controlled study Hyaluronoglucosaminidase Betamethasone 17-valerate lcsh:RC870-923 Placebo Drug Administration Schedule law.invention Double blind chemistry.chemical_compound Randomized controlled trial Double-Blind Method law Hyaluronidase Topical betamethasone Medicine Humans Prospective Studies Prospective cohort study Child Glucocorticoids Betamethasone Valerate child therapy business.industry Phimosis lcsh:Diseases of the genitourinary system. Urology Betamethasone valerate phimosis Surgery Treatment Outcome chemistry Child Preschool business medicine.drug |
Zdroj: | International braz j urol v.37 n.3 2011 International Braz J Urol Sociedade Brasileira de Urologia (SBU) instacron:SBU International braz j urol, Volume: 37, Issue: 3, Pages: 314-319, Published: JUN 2011 International Brazilian Journal of Urology, Vol 37, Iss 3, Pp 314-319 (2011) |
Popis: | 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. |
Databáze: | OpenAIRE |
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