Can circumcision be avoided in adult male with phimosis? Results of the PhimoStop(TM) prospective trial

BACKGROUND: Circumcision as surgical treatment of adult phimosis is not devoid of complications. Efficacy of alternative non-surgical options is unclear. PhimoStop(TM) is a therapeutic protocol which involves the use of appropriately shaped silicone tuboids of increasing size to obtain a non-forced dilation of the prepuce. The aim of the study was to evaluate the efficacy and durability of results of PhimoStop(TM) device for the treatment of adult male phimosis. METHODS: A prospective trial was conducted between 2018 and 2020 on 85 consecutive adult male patients affected by phimosis and with an indication for circumcision. Patients were treated with PhimoStop(TM) protocol and they were evaluated at baseline and after treatment through a subjective (patient self-reported information on various domains of his sexual function) and an objective assessment (evaluation of phimosis severity grade according to the Kikiros scale pre- and post-treatment, re-assessment of indication for circumcision post-treatment and validated questionnaires scores). Primary endpoint was to avoid the scheduled circumcision in 33% of the patients enrolled. RESULTS: Seventy-one patients (84%) completed the device usage phase as per study protocol. Median duration of tuboid application was 60 days. Thirty-seven patients (52.1%) had no indication for circumcision after treatment. Even considering patients lost to follow-up as failures, primary endpoint was reached in 43.5% of cases. There was a significant reduction of the grade of phimosis after treatment (P<0.001). Moreover IIEF-5 showed a statistically significant improvement after treatment (P<0.001). Thirty/37 patients who met the primary endpoint (81%) still have a successful resolution of their phimosis avoiding circumcision at a median follow-up of 24 months. CONCLUSIONS: PhimoStop(TM) device is effective for the treatment of adult male phimosis of Kikiros grade ≤2. The results seem to be durable in most patients at a median follow-up of 24 months. Randomized clinical trials are necessary in order to confirm our results and assess cost-efficacy.