Efficacy, tolerability, and safety of two generations of Novoglan device designed for conservative treatment of adult phimosis.

Presenter:

Dr Dmitry Polikarpov is a medical practitioner in Sydney, Australia, aiming to join a urological training program. He has experience in basic, translational and clinical urology research and holds a Master of Research and a Doctor of Philosophy degrees focusing on urologic oncology.

Purpose:

Novoglan is a device for non-surgical treatment of phimosis. It consists of a balloon that is placed under the foreskin and inflated by the patient in a controlled manner to produce stretching of the foreskin and promote generation of new skin cells. The 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 compare the two generations of the device, assess patient-reported efficacy of the Novoglan treatment as well as its usability, tolerability, safety and impact on mental wellbeing.

Methods:

Specifically designed questionnaires were emailed to 9700 Novoglan customers. Complete responses from 811 customers were de-identified and included in the analysis.

Results:

The use of Novoglan with a bulb and a stop cock instead of an air plunger and change of the balloon material produced an improvement in patient-reported efficacy from 85.0% to 93.5%. Usability was 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 any 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 had a negative impact on their mental wellbeing and 88.8% reported that treatment with Novoglan had improved it.

Conclusion(s):

The Novoglan post-marketing study revealed improvement in patient-reported efficacy, usability, tolerability and overall satisfaction with introduction of the bulb and stop cock into the Novoglan device. It demonstrated exceptional safety of the Novoglan treatment with no significant side effects reported and improvement in mental wellbeing of almost 90% of patients. These findings highlight the role of Novoglan treatment in non-surgical management of phimosis.

Authors: Dmitry Polikarpov, Eric Chung, Hubert Mazure, Andrew James, Hassan Doosti, Douglas Campbell, David Gillatt