Use of the Novoglan Device and Steroid Cream in Adult Men With Phimosis

Participants will receive a combination of topical corticosteroid therapy and the Novoglan penile tissue expander as a non-surgical treatment for adult phimosis. The Novoglan device is a CE-marked Class 1 medical device designed to gently stretch the foreskin via controlled pneumatic expansion. Intervention protocol: Topical corticosteroid: Betamethasone valerate 0.05% cream will be applied directly to the phimotic ring twice daily (morning and evening). Mechanical therapy: The Novoglan device, a soft silicone balloon system, is inserted under the foreskin and manually inflated using a handheld pump to gently stretch the phimotic ring. The device will be applied for 10 minutes twice daily, at least 30–60 minutes after corticosteroid application to allow sufficient absorption of the cream. Treatment will be self-administered at home following standardised verbal and written instructions provided by an urology clinician. The intervention period is 6-8 weeks, with participants reviewed at baseline, 4 weeks, 6 weeks and 8 weeks in the outpatient urology clinic. Monitoring adherence: Adherence to the intervention will be monitored through structured discussions during scheduled outpatient reviews at 4, 6 and 8 weeks. At each visit, clinicians will assess participant-reported use of the cream and device, troubleshoot any difficulties, and reinforce correct technique. A study-specific adherence questionnaire will also be completed at the final visit to document overall adherence and participant experience.