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

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

doi:10.21037/tau-21-673

Cited by 5 publications

(16 citation statements)

References 18 publications

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“…Fourteen studies (46,7%) were classified as case-series [4], [16][17][18][19][20][21][22][23][24][25][26][27][28] and 6 studies (20,0%) were classified as case-comparative series, in both cases with a retrospective evaluation of the reported data [29][30][31][32][33][34]. Finally, 10 (33,3 %) were prospective case-control studies [6], [35][36][37][38][39][40][41][42][43].…”

Section: Resultsmentioning

confidence: 99%

“…Through the constant application of PhimoStop™, the scar ring is weakened and thinned, allowing the growth of new elastic cells that replace, in a short period of time, the inelastic ones. A single-center prospective study evaluated the effectiveness of the device in both the short and long-term follow-up on 85 patients with acquired phimosis (grade ≤2 according to Kikiros) and indication for circumcision [6]. Primary outcome was to avoid circumcision in 30% of the patients [6].…”

Section: Phimostop™mentioning

confidence: 99%

“…The treatment of phimosis varies depending on the age of the patient and severity of disease. Conservative treatment is an option both in congenital and acquired phimosis, especially if grade 0-2 [5,6].…”

Section: Introductionmentioning

confidence: 99%

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Phimosis in adults: narrative review of the current treatments

Rosato,

Miano,

Germani

et al. 2023

Preprint

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Background: Phimosis is the inability to completely retract the foreskin and expose the glans. The treatment of phimosis varies depending on the age of the patient and the severity of the disease; a great number of conservative or surgical treatments are currently available. Aim: To provide the first review summarizing the available options for the treatment of adult phimosis. Methods: A PubMed, Cochrane and Embase search for peer-reviewed studies, published between January 2001 - December 2022 was performed using the search terms “phimosis AND treatment”. Results: A total of 288 publications were initially identified through database searching. Thirty manuscripts were ultimately eligible for inclusion in this review. Conservative treatment is an option and it includes topical steroid application and the new medical silicon tubes (Phimostop™) application for gentle prepuce dilation. Concerning the surgical approach, the gold-standard treatment is represented by circumcision in which tissue synthesis after prepuce removal can be also obtained with barbed sutures, fibrin glues or staples. Laser circumcision seems providing superior outcomes in terms of operative time and postoperative complication rate when compared to the traditional one. Several techniques of preputioplasty and use of in-situ devices (which crush the foreskin and simultaneously create haemostasis) have been also described. These in-situ devices seem feasible, safe and effective in treating phimosis while they also reduce the operative time when compared to the traditional circumcision. Patient satisfaction rates, complications and impact on sexual function of the main surgical treatments are presented. Conclusion: Many conservative and surgical treatments are available for the treatment of the adult phimosis. The choice of the right treatment depends on the grade of phimosis, results, complications, and cost-effectiveness.

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Section: Resultsmentioning

confidence: 99%

Section: Phimostop™mentioning

confidence: 99%

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Phimosis in adults: narrative review of the current treatments

Rosato,

Miano,

Germani

et al. 2023

Preprint

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“…Notably, twenty-four individuals (6.09%) were smokers. Phimosis is a condition when the penile foreskin becomes unretractable and can be classified based on Kikiro’s grading [ 21 ]. In our study, 338 (85.79%), 14 (3.55%), and 42 (10.66%) individuals were in phimosis grades of 0–1, 2–3, and 4–5, respectively.…”

Section: Resultsmentioning

confidence: 99%

“…Patients’ age, height, weight, body mass index (BMI), stretched penile length, penile circumference, phimosis grading, diabetes mellitus, glycated hemoglobin (HbA1c), hypertension (HTN), gout, end-stage renal disease (ESRD), human immunodeficiency virus (HIV) infection, and smoking habit were recorded before the circumcision. We graded the extent of phimosis according to the scale proposed by Kikiros et al [ 21 ]. We would also survey the patient’s HbA1c if they mentioned underlying diabetes mellitus (DM) or any clinical signs of DM.…”

Section: Methodsmentioning

confidence: 99%

A Retrospective Taiwanese-Population-Based Clinical Study on Determining the Efficacy and Safety of Disposable Circumcision Anastomat

Chou

Laih

2022

JCM

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Traditional approaches for male circumcision are tedious and could lead to complications such as peri-/postoperative pain, bleeding, and infection. Thus, for the first time, we investigated the surgical outcomes of recently the discovered Disposable Circumcision Anastomat Type A (Dongguan ZSR Biomedical Technology Company Ltd., China), a disposable circumcision suture device (DCSD), in terms of the operation time, surgical complexity, safety, satisfaction, and aesthetic outcomes and most importantly the prognostic factors for postoperative infection. A total of 394 individuals were circumcised, with a mean age, body mass index (BMI), stretched penile length (SPL), and penile circumference of 30.1 ± 7.05 years, 25.47 ± 4.73, 10.12 ± 1.61, and 7 ± 0.73 cm, respectively. Associated comorbidities included diabetes mellitus (6.09%), hypertension (2.03%), gout (1.02%), end-stage renal disease (ESRD, 0.25%), and HIV (0.25%). The mean operation time, average postoperative bleeding, and wound infection rate was 31.4 ± 9.96 min, 2.54%, and 9.39%, respectively. The mean VAS postoperative pain scores at D0 and D1 were 4.4 ± 2.4 and 1.9 ± 1.6, respectively. Moreover, 1.27% of subjects required reoperation, and a 2.03% rate of instrument malfunction was noted. The significant factors associated with the post-operative infection group were age (p = 0.0313), BW (p = 0.0081), BMI (p = 0.0026), penile circumference (p = 0.0343), and DM (p ≤ 0.001). Multivariate analyses revealed only DM as a statistically significant factor (p < 0.001). Our box–whisker plot revealed no significant difference between the HbA1c level of infection (Hb1Ac = 7.77 ± 1.39) and non-infection groups (Hb1Ac = 6.92 ± 1.84). However, a trend of higher glycemic index in the infection group was observed. Conclusively, DSCD could be an effective and safe alternative to performing circumcision. However, in the population with advanced aging, phimosis, elevated BMI, and DM (HbA1C > 9%), users should be highly cautious due to the increased risk of infection, dehiscence, and hematoma.

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Novoglan device for treatment of adult phimosis: Novoglan-01 open-label clinical trial on safety, efficacy and tolerability

Chung¹,

Polikarpov²,

Mazure³

et al. 2023

Transl Androl Urol

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Background At present, the only definitive treatment for adult phimosis is circumcision, which is a surgical removal of the prepuce. Novoglan is a novel device that could offer patients with phimosis an alternative to surgery. It is based on application of custom-moulded balloons for gradual skin remodelling and prepuce dilatation. This open-label clinical trial aimed to investigate the safety, efficacy and tolerability of the Novoglan treatment. Methods A prospective trial was conducted on 20 patients with adult phimosis recruited at Macquarie University Hospital and Princess Alexandra Hospital. After eligibility screening and enrolment, patients were provided with the Novoglan product and training. The treatment involved twice daily 10-minute applications for a duration of 4–8 weeks with patient’s degree of phimosis assessed before and at 6–8 weeks after the initiation of the treatment. Participants were also asked to complete questionnaires aimed to assess the safety and tolerability of the Novoglan treatment. Results The treatment was successful with improved foreskin retraction in 90% of patients and all patients achieving full foreskin retraction after the treatment. Ninety-five percent of patients reported reduced level of anxiety, and over 60% of patients reported reduced pain/discomfort during sexual activity or in general. Similarly, 95% of patients were moderately-to-very satisfied with the treatment and would recommend Novoglan to others. No adverse events were observed and only 15% of participants reported minor side effects. Conclusions The Novoglan-01 trial demonstrated high safety, efficacy and tolerability of the Novoglan treatment for adult phimosis and its high potential as a conservative alternative to circumcision or steroid cream treatment. Trial Registration The Novoglan-01 study has been registered with the Australia and New Zealand Clinical Trial Registry under the reference ACTRN 1262 10009 24853, dated 15 July 2021.

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

Cited by 5 publications

References 18 publications

Phimosis in adults: narrative review of the current treatments

Phimosis in adults: narrative review of the current treatments

A Retrospective Taiwanese-Population-Based Clinical Study on Determining the Efficacy and Safety of Disposable Circumcision Anastomat

Novoglan device for treatment of adult phimosis: Novoglan-01 open-label clinical trial on safety, efficacy and tolerability

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