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

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.

• Authors: Ciro Esposito, Antonella Centonze, Francesca Alicchio, Antonio Savanelli, Alessandro Settimi
• Journal: World journal of urology (World J Urol) Vol. 26 Issue 2 Pg. 187-90 (Apr 2008) ISSN: 0724-4983 [Print] Germany
• PMID: 18157674 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Steroids

Topics

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