Safety, efficacy and tolerability of the Novoglan foreskin tissue expander product as a conservative treatment for adult phimosis.

The Novoglan-01 clinical trial is expected to provide evidence for the use of the Novoglan foreskin tissue expander as an alternative to steroid creams in the conservative treatment of adult phimosis. The Novoglan product is a medical device commercially available and listed in Australia but it has never been tested for efficacy in a clinical study. Treatment with the Novoglan product is carried out by the participant in the comfort of his home over a period of 6 to 8 weeks. Before starting a treatment, the participant cleans his foreskin and glans with the alcohol swabs and cotton buds provided in the Novoglan product pack. The core of the Novoglan device is a latex or silicone balloon which is inserted underneath the foreskin and progressively inflated by the participant. Once inflated, the balloon is left in place for about 15 to 30 minutes. At the end of this daily treatment period, the balloon is deflated, removed and cleaned for further usage with alcohol swabs provided in the Novoglan product pack. By progressively inflating the Novoglan balloon under the foreskin daily over a period of 6 to 8 weeks, new tissue grows at the base of the foreskin which becomes looser and eventually is able to retract over the glans. Insertion of the Novoglan balloon stimulates the growth of new skin cells and increases the circumference of the foreskin, allowing it to retract properly. The Novoglan product is supplied in a pack containing all the required accessories, including latex and silicone balloons, balloon insertion rods, a squeeze bulb inflator, alcohol swabs, cotton buds and various accessories. Latex balloons are used initially to start the treatment and silicone balloons are used in the final stages of treatment. At all time the balloon inflation is under the control of the participant in order to avoid pain or discomfort. The Novoglan product pack used by the participants in the study is provided to them by the Study Investigator, urologists Professor David Gillatt or Associate Professor Eric Chung or by the Study Clinical Research Nurse following an in-depth face-to-face training session during Study Visit 1, minimum 1 week post Enrolment Visit, at Macquarie University Hospital (Prof Gillatt) or Princess Alexandra Hospital (A/Prof Chung). Progress with the Novoglan treatment is monitored during Study Visit 2 over the phone at 1 week post Study Visit 1, Study Visit 3 also over the phone at 4 weeks post Study Visit 1 and Final Study Visit face-to-face with the Study Investigator at 6 to 8 Study Visit 1 and Final Study Visit face-to-face with the Study Investigator at 6 to 8 weeks post Study Visit 1. At any time during the treatment, the participant is invited to call the Study Investigator or Clinical Trial Nurse if he is having any problem or concern with the Novoglan treatment. If required, additional training sessions, over the phone or in person can then be organised.