Abstract and Introduction
Abstract
Background: 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.
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™ 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™ 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.
Introduction
Phimosis is defined as the inability to retract the foreskin or prepuce behind the glans penis. Pathologic phimosis is the adult form of the disease as a result of local scarring, infection or inflammation due to poor hygiene, recurrent balanitis and/or posthitis, diabetes mellitus and balanitis xerotica obliterans (BXO). Forceful foreskin retraction can lead to fissures, bleeding, scarring and consequent worsening of the condition.[1]
Treatment of adult phimosis varies depending on the age of the patient and severity of the condition. Traditionally, surgical treatment through circumcision under local anaesthesia is considered the gold standard treatment of adult male phimosis and several surgical techniques have been described.[2] Usually, circumcision is a simple and safe surgical procedure. Nevertheless, is not devoid of complications, with an overall complication risk of 3.8%.[3] Bleeding, pain, wound infection, concealed penis, skin bridge, urinary retention, recurrent phimosis, fistulas, necrosis, iatrogenic hypospadias and epispadias, meatitis, meatal stenosis, chordee, redundant skin, non-satisfying cosmetic appearance and impotence are the described complications, most of which may significantly impact on healthcare costs.[4,5]
Several therapeutic options alternative to or assisting conventional circumcision have been described, these often involve the application of several in-situ devices which generally aim to crush the foreskin while simultaneously creating hemostasis; the foreskin is then excised or allowed to slough off. Use of circumcision devices requires local anaesthesia and may significantly reduce operative times at the risk of an increase of moderate adverse effects.[6–8]
Non-surgical treatment of adult phimosis is principally based on the application of topical corticosteroid ointments of different potency and concentration, for 4–8 weeks. Compared to placebo or manual reduction, corticosteroids significantly increase complete or partial clinical resolution of phimosis; however, no long-term follow-up data have been reported on the durability of the results.[9,10]
In clinical practice, is not unusual that patients refuse circumcision: in fact, postoperative care can be bothersome, and not all patients accept the impact of surgery on genital self-image. In some cases, circumcision could result in "overtreatment", especially in mild phimosis.
Hypothesis is that the use of a non-surgical treatment protocol, such as the novel minimally invasive device PhimoStop™, could avoid circumcision in a significant number of patients with mild-moderate phimosis. Objective of the study was to prospectively assess the efficacy and durability of results of PhimoStop™.
We present the following article in accordance with the TREND reporting checklist (available at https://dx.doi.org/10.21037/tau-21-673).
Transl Androl Urol. 2021;10(11):4152-4160. © 2021 AME Publishing Company
