Can circumcision be avoided in adult male with phimosis? Results of the PhimoStopTM prospective trial

Marco Carilli; Anastasios D Asimakopoulos; Serena Pastore; Stefano Germani; Luca Orecchia; Enrico Finazzi Agrò; Roberto Miano

doi:10.21037/tau-21-673

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

Transl Androl Urol. 2021 Nov;10(11):4152-4160. doi: 10.21037/tau-21-673.

Authors

Marco Carilli^#¹, Anastasios D Asimakopoulos^#¹, Serena Pastore¹, Stefano Germani¹, Luca Orecchia¹, Enrico Finazzi Agrò², Roberto Miano²

Affiliations

¹ Division of Urology, Fondazione PTV Policlinico Tor Vergata, Rome, Italy.
² Department of Surgical Sciences, Division of Urology, University of Rome Tor Vergata, Rome, Italy.

^# Contributed equally.

Abstract

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.

Keywords: Kikiros grade; Phimosis; adult male phimosis; circumcision; non-surgical treatment of phimosis.