Randomisation to topical corticosteroids or placebo for the treatment of the non-retractile foreskin

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2005
INTERVENTION: Boys of 3 years and above who are referred to the outpatient clinic with a physiological non‐retractile foreskin will be invited to participate in the study. The boys and their parent/carer will be interviewed by the primary investigator and given the patient information sheet. If they agree to participate in the study, written consent will be obtained. The patient will be randomised by the pharmacy department to receive either placebo, 1% hydrocortisone or 0.1% betnovate ointment. The parents will be instructed to apply the ointment to the tip foreskin every morning and evening for 6 weeks. The patients will be assessed by the primary investigator after 6 weeks. If the treatment has been successful, ie. the foreskin is retractile, no further treatment is given. If the treatment has been unsuccessful, ie. partial or no retraction, the patients will be offered corticosteroid ointment (0.1% betnovate as this is the more potent steroid) for a further 6 weeks, following which time they will be reassessed. After 6 months all patients will be reassessed and foreskin retractility will be graded (full/partial/no retraction). The code for which ointment each patient used will be broken at the end of the study. All patients with persistent problems such as infection or a non‐retractile foreskin at the end of the study period will be offered circumcision. All results will be recorded on data sheets in the patient's records and on a confidential database. CONDITION: Urological and Genital Diseases: Penile diseases ; Urological and Genital Diseases ; Redundant prepuce, phimosis and paraphimosis PRIMARY OUTCOME: Retraction of the foreskin SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: Boys of 3 years and over with a physiological non‐retractile foreskin
Epistemonikos ID: eddc093fcf0b8cf6235cf562d03913fc1cabfb61
First added on: Aug 21, 2024