T Lindhagen1. 1. Dept of Surgery, University Hospital MAS, Malmö, Sweden.
Abstract
OBJECTIVE: To assess whether it is the steroid alone or the gentle physical retraction combined with ointment that is responsible for the excellent results observed with topical steroid treatment of unretractable foreskin. DESIGN: Prospective, randomised, double-blind study. SETTING:University hospital, Sweden. SUBJECTS:30 Boys randomised to be treated with clobetasol propionate (n = 15) or placebo (n = 15). INTERVENTIONS: The boys were examined 1, 2 and 6 months, respectively, after treatment. MAIN OUTCOME MEASURES: Comparison between the effects of clobetasol propionate and placebo. RESULTS: Two patients in the steroid group and one in the placebo group withdrew from the study. 10 Boys in the steroid group showed an improvement within 2 months. The remaining 3 boys had no effect and were circumcised. Histopathological examination showed lichen sclerosus et atrophicus. Seven boys in the placebo group improved. The 7 non-responders were prescribed clobetasol propionate ointment, and all 7 improved. CONCLUSION:17 of 27 boys referred with "phimosis" were successfully treated with an ointment and gentle traction. When clobetasol propionate was given the non-responders success rate was increased to 24/27 (89%).
RCT Entities:
OBJECTIVE: To assess whether it is the steroid alone or the gentle physical retraction combined with ointment that is responsible for the excellent results observed with topical steroid treatment of unretractable foreskin. DESIGN: Prospective, randomised, double-blind study. SETTING: University hospital, Sweden. SUBJECTS: 30 Boys randomised to be treated with clobetasol propionate (n = 15) or placebo (n = 15). INTERVENTIONS: The boys were examined 1, 2 and 6 months, respectively, after treatment. MAIN OUTCOME MEASURES: Comparison between the effects of clobetasol propionate and placebo. RESULTS: Two patients in the steroid group and one in the placebo group withdrew from the study. 10 Boys in the steroid group showed an improvement within 2 months. The remaining 3 boys had no effect and were circumcised. Histopathological examination showed lichen sclerosus et atrophicus. Seven boys in the placebo group improved. The 7 non-responders were prescribed clobetasol propionate ointment, and all 7 improved. CONCLUSION: 17 of 27 boys referred with "phimosis" were successfully treated with an ointment and gentle traction. When clobetasol propionate was given the non-responders success rate was increased to 24/27 (89%).