OBJECTIVE: To evaluate the treatment of phimosis using topical steroid. MATERIAL AND METHODS: This was a follow-up study after a prospective, randomized, double-blind study. A total of 137 boys with phimosis were randomly assigned to either betamethasone treatment or placebo for 4 weeks, with application of the cream twice daily. Non-responders to treatment were offered steroid treatment for a further 4 weeks. All patients were invited to a follow-up examination after 18 months. RESULTS: The mean pre-treatment phimosis grades in the steroid and control groups were 5.08+/-0.66 and 4.97+/-0.70, respectively. At the 4-week follow-up, 49 boys (74%) in the steroid group were cured, compared to only 31 (44%) in the control group. Fourteen boys were circumcised after another 4 weeks of treatment; 43 of the remaining 57 boys (17 in the steroid group; 40 in the control group) had been cured. After a total of 92 boys took part in the 18-month follow-up study: 79 had been cured and 13 had suffered a relapse. Twenty-six patients did not took part in the follow-up investigation. No side-effects were noted. CONCLUSIONS: When treatment is necessary for phimosis, we recommend application of topical steroid as first-line treatment because surgery can then be avoided in 85% of cases. This first randomized, double-blind, follow-up study shows that the treatment effect persists for at least 18 months.
RCT Entities:
OBJECTIVE: To evaluate the treatment of phimosis using topical steroid. MATERIAL AND METHODS: This was a follow-up study after a prospective, randomized, double-blind study. A total of 137 boys with phimosis were randomly assigned to either betamethasone treatment or placebo for 4 weeks, with application of the cream twice daily. Non-responders to treatment were offered steroid treatment for a further 4 weeks. All patients were invited to a follow-up examination after 18 months. RESULTS: The mean pre-treatment phimosis grades in the steroid and control groups were 5.08+/-0.66 and 4.97+/-0.70, respectively. At the 4-week follow-up, 49 boys (74%) in the steroid group were cured, compared to only 31 (44%) in the control group. Fourteen boys were circumcised after another 4 weeks of treatment; 43 of the remaining 57 boys (17 in the steroid group; 40 in the control group) had been cured. After a total of 92 boys took part in the 18-month follow-up study: 79 had been cured and 13 had suffered a relapse. Twenty-six patients did not took part in the follow-up investigation. No side-effects were noted. CONCLUSIONS: When treatment is necessary for phimosis, we recommend application of topical steroid as first-line treatment because surgery can then be avoided in 85% of cases. This first randomized, double-blind, follow-up study shows that the treatment effect persists for at least 18 months.