Carilli Marco, Asimakopoulos Anastasios D, Pastore Serena, Germani Stefano, Orecchia Luca, Agrò Enrico Finazzi, Miano Roberto
Division of Urology, Fondazione PTV Policlinico Tor Vergata, Rome, Italy.
Department of Surgical Sciences, Division of Urology, University of Rome Tor Vergata, Rome, Italy.
Transl Androl Urol. 2021 Nov;10(11):4152-4160. doi: 10.21037/tau-21-673.
Circumcision as surgical treatment of adult phimosis is not devoid of complications. Efficacy of alternative non-surgical options is unclear. PhimoStop 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 device for the treatment of adult male phimosis.
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 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.
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.
PhimoStop 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.
包皮环切术作为成人包茎的外科治疗并非没有并发症。其他非手术方法的疗效尚不清楚。PhimoStop是一种治疗方案，涉及使用尺寸逐渐增大的形状合适的硅胶管状体，以实现包皮的非强制扩张。本研究的目的是评估PhimoStop装置治疗成年男性包茎的疗效和结果的持久性。
2018年至2020年对85例连续的成年男性包茎患者进行了一项前瞻性试验，这些患者均有包皮环切术指征。患者接受PhimoStop方案治疗，并在基线期和治疗后通过主观评估（患者自我报告其性功能各个领域的信息）和客观评估（根据Kikiros量表在治疗前后评估包茎严重程度分级、治疗后重新评估包皮环切术指征以及有效问卷评分）进行评估。主要终点是使33%的入组患者避免计划中的包皮环切术。
71例患者（84%）按照研究方案完成了装置使用阶段。管状体应用的中位持续时间为60天。37例患者（52.1%）治疗后无包皮环切术指征。即使将失访患者视为治疗失败，43.5%的病例达到了主要终点。治疗后包茎分级显著降低（P<0.001）。此外，国际勃起功能指数-5（IIEF-5）在治疗后显示出统计学上的显著改善（P<0.001）。达到主要终点的30/37例患者（81%）在中位随访24个月时仍成功解决了包茎问题，避免了包皮环切术。
PhimoStop装置对治疗Kikiros分级≤2级的成年男性包茎有效。在中位随访24个月时，大多数患者的结果似乎是持久的。需要进行随机临床试验以证实我们的结果并评估成本效益。
