Topical steroid application versus circumcision in pediatric patients with phimosis: a prospective randomized placebo controlled clinical trial

World J Urol. 2008 Apr;26(2):187-90. doi: 10.1007/s00345-007-0231-2. Epub 2007 Dec 19.

Abstract

Objectives: 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).

Conclusion: 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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Adolescent
  • Child
  • Child, Preschool
  • Circumcision, Male / methods*
  • Dose-Response Relationship, Drug
  • Humans
  • Male
  • Phimosis / drug therapy*
  • Phimosis / surgery*
  • Prospective Studies
  • Steroids / administration & dosage
  • Steroids / therapeutic use*
  • Treatment Outcome

Substances

  • Steroids