title: Topical steroid application versus circumcision in pediatric patients with phimosis: a prospective randomized placebo controlled clinical trial.
abstract: OBJECTIVE
  Topical steroids have been advocated as an effective alternative treatment to circumcision in boys with phimosis. We evaluated the effectiveness of topical steroid therapy compared to a placebo neutral cream in 240 patients with phimosis.
  
  
  METHODS
  A prospective study was carried out over a 24-months period, on an out-patient basis on two groups of patients with phimosis. One-hundred twenty patients applied a steroid cream twice a day for 4 weeks, and another group of 120 pts used a placebo cream twice a day for 4 weeks. Patients were assigned to either group by a computer-generated random choice.
  
  
  RESULTS
  All patients in our series completed the two treatment periods without interruption. At a median follow-up of 20 months (6-30 months) therapeutic success was obtained in 43.75% (99/240) of cases, independently of the protocol. In particular, therapeutic success was obtained in 65.8% (79/120) of cases in the steroids group and in 16.6% (20/120) of cases in the placebo group, the difference being statistically significant (P < 0.0001, Mann-Withney test).
  
  
  CONCLUSIONS
  Our study shows that topical steroids represent a good alternative to surgery in case of phimosis. Steroid therapy using monometasone furoate 0.1% in our series gave better results that placebo with an overall efficacy of 65.8%. In patients where a phimotic ring persist after steroid therapy, circumcision is mandatory.
authors.affiliation: Department of Experimental and Clinical Medicine, Magna Graecia University, Campus SVenuta, Viale Europa 11, 88100 Catanzaro, Italy. ciroesp2@unicz.it
authors.forename: Ciro
authors.initials: C
authors.lastname: Esposito
authors.forename: Antonella
authors.initials: A
authors.lastname: Centonze
authors.forename: Francesca
authors.initials: F
authors.lastname: Alicchio
authors.forename: Antonio
authors.initials: A
authors.lastname: Savanelli
authors.forename: Alessandro
authors.initials: A
authors.lastname: Settimi
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002944:Circumcision, Male / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008297:Male; D010688:Phimosis / Q000188:drug therapy* / Q000601:surgery*; D011446:Prospective Studies; D013256:Steroids / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D013256:Steroids