Post‐Marketing Study on Efficacy, Tolerability and Safety of Two Generations of the Novoglan Device for Conservative Treatment of Adult Phimosis

ABSTRACT Novoglan is a device that provides a non‐surgical treatment of phimosis. It consists of a balloon placed under the foreskin, which the patient inflates in a controlled manner to stretch the foreskin and promote the generation of new skin cells. The balloon inflation had been originally controlled by an air plunger, which was later replaced by a bulb and a stop cock, while the balloon was changed from latex to medical‐grade silicone. We conducted a post‐marketing survey to assess patient‐reported efficacy, usability, tolerability and safety of the Novoglan treatment and compare two generations of the device. Specifically designed questionnaires were emailed to 9700 Novoglan customers. Complete responses from 811 customers were de‐identified and included in the analysis. The use of Novoglan with a bulb and a stop cock instead of an air plunger and a change of the balloon material produced an improvement in patient‐reported efficacy from 85.0% to 93.5%. Usability has also improved, with the number of patients reporting difficulty in Novoglan use dropping from 13.8% to 6.7%. Similarly, the number of patients willing to recommend Novoglan treatment to other men increased from 92.2% to 98.1%. Neither group reported side effects that required cessation of the treatment or medical intervention, and 96.3% of all patients were able to tolerate the treatment. Of note, 97.7% reported that phimosis negatively impacts their mental well‐being, and 88.8% reported that Novoglan had improved their mental health. The Novoglan post‐marketing study revealed improvement in patient‐reported efficacy, usability, tolerability and overall satisfaction with the introduction of the bulb and stop cock into the Novoglan device. It demonstrated the exceptional safety of the Novoglan treatment with no significant side effects reported and an improvement in the mental well‐being of almost 90% of patients. These findings highlight the role of Novoglan treatment as an effective and safe non‐surgical management of phimosis.