Phimostop is a medical device validated by the Italian Ministry of Health and it is the subject of a clinical research at the Tor Vergata University Polyclinic in Rome. The clinical research was coordinated by Prof. Miano, and the results were published in the international scientific journal Translational Urology and Andrology.
Clinical research
CLINICAL RESEARCH PARTICIPANTS
Here are the main results of the research:
- Phimostop can be an alternative to circumcision surgery in cases of phimosis. The objectives of the research authorised by the Scientific Ethics Committee were largely achieved. The object of the clinical research was “INCREASING TREATMENT OF PHIMOSIS WITH PHIMOSTOP DEVICE”.
- 81% of the patients who reached the primary endpoint confirmed the resolution of their phimosis 24 months after using Phimostop, thus avoiding circumcision. Prior to using the medical device, all patients selected for the research were instructed to undergo surgical treatment to resolve their phimosis
The research was carried out with the old Phimostop model, which had recently been improved in terms of ergonomics and components (from 13 tubes to 22).
Phimostop was created with the intention of offering an alternative to circumcision for men who do not wish to undergo surgery and removal of the foreskin.The medical device acts mechanically and a minimum of manual skill and patience is required to use it.
TIGHT or CONGENITAL phimosis will take longer to heal, NO TIGHT or ACQUIRED phimosis will heal faster.
In the case of phimosis caused by DIABETES, the device will help to increase the opening of the foreskin but, given the persistence of the cause (diabetes), phimosis may reoccur over time. In this case, it is necessary to reinsert the appropriate tuboids until a new adequate foreskin opening is achieved.
In the case of LICHEN SCLEROSUS the effectiveness of Phimostop is reduced as the foreskin has less elasticity and responds less to stimulation.
