Novoglan device for treatment of adult phimosis: Novoglan-01 open-label clinical trial on safety, efficacy and tolerability.

ABSTRACT:

Background

At present, the only definitive treatment for adult phimosis is circumcision, which is a surgical removal of the prepuce. Novoglan is a novel device that could offer patients with phimosis an alternative to surgery. It is based on application of custom-moulded balloons for gradual skin remodelling and prepuce dilatation. This open-label clinical trial aimed to investigate the safety, efficacy and tolerability of the Novoglan treatment.

Methods

A prospective trial was conducted on 20 patients with adult phimosis recruited at Macquarie University Hospital and Princess Alexandra Hospital. After eligibility screening and enrolment, patients were provided with the Novoglan product and training. The treatment involved twice daily 10-minute applications for a duration of

SUBMITTER: Chung E 

PROVIDER: S-EPMC10406538 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature