What is the purpose of this research project?
Two leading Australian urologists Professor David Gillatt, Macquarie University Hospital, Sydney, and Associate Professor Eric Chung, Princess Alexandra Hospital, Brisbane, are currently assessing the efficacy, safety and patient satisfaction of a TGA listed stretching device, with the hope that it can become a clinically recognised conservative “stretching” option to treat phimosis.
Can you participate?
To qualify for the trial, men must be aged 18 years of age or older and able to attend two appointments at either Princess Alexandra Hospital in Brisbane or Macquarie University Hospital in Sydney.
Participation is free of charge for eligible Australian residents, and some basic travel and reasonable parking costs will be covered. Once the clinical trials unit confirm men meet the inclusion criteria, participants will need to a referral from a GP.
During the trial (duration of approximately eight weeks) they will be under the care of either Professor David Gillatt, Clinical Investigator and Clinical Urologist, Sydney or Associate Professor Eric Chung, Clinical Urologist, Brisbane and their respective specialist Urology nursing staff.
The medical device will be provided free of charge as part of the trial. The device is a TGA listed class 1 penile foreskin stretching kit supplied as a procedure pack that delivers home-based treatment using gentle, regular and even pressure to help stretch a tight foreskin. When used correctly over several weeks, the device aims to gently stretch the skin of the foreskin gently, and in some cases avoid the need for irreversible surgery.
Results will help update current global treatment guidelines to potentially include this as a recommended conservative treatment option for men with adult phimosis.
The clinical trial will be free of charge for Australian residents, non-Medicare card holders may apply for special consideration. Parking as well as transport costs to the urology clinic will be reimbursed.
2 September 2019 - 28 February 2022.
Prof David Gillat, Professor of Urological Oncology and Robotic Surgery and Director of Medical Services
Macquarie University Hospital, 3 Technology Place, Macquarie University, NSW 2109
Where can you get more information?
For general enquiries about the project, please contact Ms Maizie Barakat at Maizie.Barakat@muh.org.au or +61 2 9812 3031.