Does the addition of hyaluronidase to betamethasone in topical treatment of phimosis improves results? – A randomized double-blind clinical trial

Abstract

Phimosis is defined as the inability to retract the foreskin, preventing partial or complete exposure of the glans. To compare the efficacy of topical treatment with betamethasone alone and in combination with hyaluronidase, evaluate systemic absorption of cortisol, and identify factors that predispose the success of topical treatment of phimosis in children aged 3-10 years. This randomized double-blinded clinical trial involved 152 participants (3-10 years old) with phimosis. The children were divided into two groups: betamethasone associated with hyaluronidase (betamethasone valerate 2.5mg+hyaluronidase 150 UTR; Group A) and betamethasone (betamethasone valerate 2.5mg; Group B). Parents were instructed on how to use the ointment (twice a day, after hygiene, for 60 days) and on collecting salivary cortisol measurements at 11pm and 9am, before and after treatment. Participants were evaluated after 30 and 60 days. Fisher's exact test and paired t-test were used to analyze the data. Ninety children (69.77%) were successfully treated with the proposed treatment, with the success rate for Group A being 75.38% versus 64.06% for Group B, p=0.18). Systemic absorption evaluated by salivary cortisol did not show differences after the intervention (p>0.05), indicating that there was no systemic absorption when using ointments with or without hyaluronidase. The factors of age (OR=0.98 - CI: 0.97-1.00), adherence (OR=1.49 - CI: 0.53-4.16), balanoposthitis (OR=1.85 - CI: 0.47-7.19), and previous use of corticosteroids (OR=1.21 - CI: 0.53-2.72) also did not show influenced results CONCLUSION: Topical therapy for true phimosis with betamethasone 0.2%+hyaluronidase, despite showing no differences when compared with betamethasone 0.2% alone, for a period of up to 60 days, proved to be safe, effective, and with good results. The variables analyzed could not predict the expected clinical response. RBR-76bhgyb.