Clinical and economic impact of the introduction of pre-biopsy MRI-based assessment on a large prostate cancer centre diagnostic population and activity: 10 years on.

INTRODUCTION: Prostate mpMRI was introduced in 2011 as a secondary test and subsequently integrated into a prostate cancer (PCa) diagnostics unit representing a population of approximately 550,000 people. The following represents an audit of its step-wise introduction between 2 index years, 2009 and 2018, focusing on the activity, patient outcomes and economic benefits. PATIENTS AND METHODS: The 2 distinct years were selected for relying on a transrectal ultrasound biopsy pathway in 2009 to an mpMRI-based pathway in 2018. All referrals were retrospectively screened and compared for age, PSA levels, DRE findings, biopsy history, biopsy and mpMRI allocation data. Cost analysis was determined using local unit procedure costs. RESULTS: Patients referred included 648 in 2009 and 714 in 2018. mpMRI seldomly informed decision to biopsy in 2009 (9.8%), while in 2018 it was performed in the pre-biopsy setting in 87.9% cases and enabled biopsy avoidance in 137 patients. In 2018, there was a 31.8% decrease in the number of biopsies in patients without previous PCa diagnosis, coupled with an increase in diagnostic rates of csPCa, from 28.6 to 49.0% (p < 0.0001) and a reduction in negative biopsy rates from 52.3 to 33.8%. mpMRI had a positive impact on the system with reduced patient morbidity and post-procedural complications. The estimated overall cost savings amount to approximately £75,000/year for PCa diagnosis and £11,000/year due to reduced complications. CONCLUSION: Our evaluation shows the mpMRI-based pathway has improved early detection of csPCa and reduction of repeat biopsies, resulting in significant financial benefits for the local healthcare system.

Laparoscopic Pyelolithotomy for treating urolithiasis in ectopic pelvic kidneys

ABSTRACT Introduction: The management of urolithiasis ectopic pelvic kidneys (EPK) can be challenging because of the aberrant anatomy (1-4). We demonstrate the step-by-step technique of the laparoscopic approach for treating urolithiasis in EPK. Patients and methods: Three men with EPK (2 left, 1 right) underwent laparoscopic pyelolithotomy through a transperitoneal approach. After establishing the pneumoperitoneum, the parietal peritoneum was opened at the parietal colic sulcus and the bowel displaced medially. The kidney was identified in the retroperitoneum and the renal pelvis exposed after removal of the perirenal adipose tissue. The renal pelvis was opened, and the stones were identified and retrieved with forceps in 2 cases and with a flexible nephroscope in 1 case. The renal pelvis was closed with a 3/0 running barbed suture. A DJ stent was placed in all patients. Results: For the first time, a laparoscopic technique for treating stones in the ectopic kidney is demonstrated in detail. Mean patient age was 52.6 years (44-58). The mean stone size was 22.3 mm (20-24 mm). Stones were in the renal pelvis in 2 cases and in the inferior calyx in 1 case. Mean operative time was 146 minutes (135-155 min). Mean estimated blood loss was 116 ml (60-140 ml). No complications were observed. The mean hospital stay was 3 days. The DJ stents were removed after 3 weeks. All patients were stone free at the postoperative CT scan with a mean follow-up of 3.3 months (1-6 months). Conclusions: Laparoscopic pyelolithotomy can be an effective and reproducible minimally invasive technique for treating urolithiasis in EPK.

What to expect from the novel pulsed thulium:YAG laser? A systematic review of endourological applications.

INTRODUCTION: Several preclinical studies about a novel pulsed-thulium:yttrium-aluminum-garnet (p-Tm:YAG) device have been published, demonstrating its possible clinical relevance. METHODS: We systematically reviewed the reality and expectations for this new p-Tm:YAG technology. A PubMed, Scopus and Embase search were performed. All relevant studies and data identified in the bibliographic search were selected, categorized, and summarized. RESULTS: Tm:YAG is a solid state diode-pumped laser that emits at a wavelength of 2013 nm, in the infrared spectrum. Despite being close to the Ho:YAG emission wavelength (2120 nm), Tm:YAG is much closer to the water absorption peak and has higher absorption coefficient in liquid water. At present, there very few evaluations of the commercially available p-Tm:YAG devices. There is a lack of information on how the technical aspects, functionality and pulse mechanism can be maximized for clinical utility. Available preclinical studies suggest that p-Tm:YAG laser may potentially increase the ablated stone weight as compared to Ho:YAG under specific condition and similar laser parameters, showing lower retropulsion as well. Regarding laser safety, a preclinical study observed similar absolute temperature and cumulative equivalent minutes at 43° C as compared to Ho:YAG. Finally, laser-associated soft-tissue damage was assessed at histological level, showing similar extent of alterations due to coagulation and necrosis when compared with the other clinically relevant lasers. CONCLUSIONS: The p-Tm:YAG appears to be a potential alternative to the Ho:YAG and TFL according to these preliminary laboratory data. Due to its novelty, further studies are needed to broaden our understanding of its functioning and clinical applicability.

Continence-Sparing Techniques in Radical Prostatectomy: A Systematic Review of Randomized Controlled Trials.

Background: Numerous continence-sparing radical prostatectomy techniques have been developed to enhance postoperative early continence (EC) recovery; however, evidence regarding the best approach remains controversial. The objectives are to provide a critical appraisal of various prostatectomy techniques, based on the evidence of quality-assessed randomized control trials (RCTs); to summarize the immediate continence and the EC reported; and to propose a new standardization for continence outcomes reporting. Methods: Data acquired from five medical registries were reported to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards. Evidence from published, English, full-text RCTs reporting postoperative urinary continence outcomes within 6 months from surgery was included. The heterogeneity of surgical techniques and continence definitions did not allow a meta-analysis. All RCTs were critically appraised, and quality assessed. Results: In total, 39 RCTs were included: 19 of 39 studies were low-quality RCTs, presenting small cohort, monocentric, or single-surgeon data. The best RCT-supported evidence is in favor of robot-assisted radical prostatectomy (RARP) compared with laparoscopic radical prostatectomy (LRP) and of the Retzius-sparing (RS) technique over the traditional prostatectomy. Other techniques such as bladder neck and puboprostatic ligament (PPL) preservation, posterior reconstruction with or without combination of anterior suspension technique, and nerve-sparing (NS) approach seem to enhance EC. Oppositely, the endopelvic fascia preservation, bladder neck mucosa eversion/plication/slings, and the selective ligature of dorsal venous complex (DVC) were not significantly associated with EC improvements. RCTs are lacking on pubovesical complex-sparing, seminal vesicle preservation, anterior reconstruction of the puboprostatic collar, musculofascial reconstruction, and DVC suspension to the periosteum of the pubic bone techniques. Conclusions: RARP and RS have high-quality evidence supporting their ability to enhance postoperative EC recovery. NS, bladder neck, and PPL preservation may contribute to better EC recovery, although the evidence level is low. Further multicenter RCTs are needed to establish the optimal combination of standard surgical techniques. A new continence outcome-reporting standardization was proposed.

Transperineal US-MRI Fusion-Guided Biopsy for the Detection of Clinical Significant Prostate Cancer: A Systematic Review and Meta-Analysis Comparing Cognitive and Software-Assisted Technique.

INTRODUCTION: We aimed to find potential differences in clinically significant prostate cancer (csPCa) detection rates between transperineal software-assisted fusion biopsy (saFB) and cognitive fusion biopsies (cFB). METHODS: A systematic review of the literature was performed to identify comparative studies using PubMed, EMBASE, and Scopus according to the PICOS criteria. Cancer detection and complication rates were pooled using the Cochran-Mantel-Haenszel method with the random effect model and reported as odds ratios (ORs), 95% confidence intervals (CI), and p-values. A meta-analysis was performed using Review Manager (RevMan) 5.4 software by Cochrane Collaboration. The quality assessment of the included studies was performed using the Cochrane Risk of Bias tool, using RoB 2 for randomized studies and ROBINS-I for retrospective and nonrandomized ones. RESULTS: Eight studies were included for the meta-analysis, including 1149 cases in software-based and 963 cases in cognitive fusion biopsy. The detection rates of csPCa were similar between the two groups (OR 1.01, 95% CI 0.74-1.37, p = 0.95). Study heterogeneity was low (I2 55%). CONCLUSION: There is no actual evidence of the superiority of saFB over cFB in terms of the csPCa detection rate. Operator experience and software availability can drive the choice of one fusion technique over the other.

Laparoscopic Pyelolithotomy for treating urolithiasis in ectopic pelvic kidneys.

INTRODUCTION: The management of urolithiasis ectopic pelvic kidneys (EPK) can be challenging because of the aberrant anatomy (1-4). We demonstrate the step-by-step technique of the laparoscopic approach for treating urolithiasis in EPK. PATIENTS AND METHODS: Three men with EPK (2 left, 1 right) underwent laparoscopic pyelolithotomy through a transperitoneal approach. After establishing the pneumoperitoneum, the parietal peritoneum was opened at the parietal colic sulcus and the bowel displaced medially. The kidney was identified in the retroperitoneum and the renal pelvis exposed after removal of the perirenal adipose tissue. The renal pelvis was opened, and the stones were identified and retrieved with forceps in 2 cases and with a flexible nephroscope in 1 case. The renal pelvis was closed with a 3/0 running barbed suture. A DJ stent was placed in all patients. RESULTS: For the first time, a laparoscopic technique for treating stones in the ectopic kidney is demonstrated in detail. Mean patient age was 52.6 years (44-58). The mean stone size was 22.3 mm (20-24 mm). Stones were in the renal pelvis in 2 cases and in the inferior calyx in 1 case. Mean operative time was 146 minutes (135-155 min). Mean estimated blood loss was 116 ml (60-140 ml). No complications were observed. The mean hospital stay was 3 days. The DJ stents were removed after 3 weeks. All patients were stone free at the postoperative CT scan with a mean follow-up of 3.3 months (1-6 months). CONCLUSIONS: Laparoscopic pyelolithotomy can be an effective and reproducible minimally invasive technique for treating urolithiasis in EPK.

External Validation of the "Tor Vergata" 3D Printed Models of the Upper Urinary Tract and Stones for High-Fidelity Simulation of Retrograde Intrarenal Surgery.

Introduction: Novel training modalities are being investigated to overcome the challenges associated with learning retrograde intrarenal surgery (RIRS). Consequently, a series of 3D printed models of the upper urinary tract and stones designed for ex vivo surgical simulation was introduced in 2021. This study aims to provide external validation of the training model and assess its role in the development of surgical skills. Materials and Methods: A mixed cohort of 20 urologists at different levels of expertise participated in a whole-day live simulation event to examine the model and perform a timed simulation of intrarenal navigation, stone relocation, and laser fragmentation. Operative times were recorded and two independent expert endourologists scored the simulations according to a modified "Objective Structured Assessment of Technical Skills" (OSATS) scale. Five novice urologists from the cohort performed three further simulations in a subsequent event to assess improvement in surgical skills. Results: Face validity was demonstrated with a median score of ≥4/5 in each of the 11 items investigated. Content validity was also effectively reached, with 100% positive impressions with regard to the usefulness for the acquisition of surgical skills. Significant differences were observed among operative times stratified per surgeon experience (all p < 0.0050), thus providing construct validity. Median total OSATS score for novices was 14 (range 8, 25) and was found to be significantly different from expected expert performance (p = 0.0010). Repeated simulations by novices led to a progressive reduction of operative times (p = 0.0313) and increase in median total OSATS (p = 0.0625). Conclusion: The 3D printed models of upper urinary tract and synthetic training stones for the high-fidelity simulation of each phase of RIRS were validated by this study. The results encourage the usage of the models in simulation courses and the evaluation of their potential role in standardized training curricula.

Vector Prostate Biopsy: A Novel Magnetic Resonance Imaging/Ultrasound Image Fusion Transperineal Biopsy Technique Using Electromagnetic Needle Tracking Under Local Anaesthesia.

BACKGROUND: Prostate magnetic resonance imaging (MRI) is now standard for assessment of suspected prostate cancer (PCa). A variety of approaches to MRI-based targeting has revolutionised prostate biopsies. OBJECTIVE: To describe the procedure and show the accuracy and tolerability of a novel Vector MRI/ultrasound fusion transperineal (TP) biopsy technique that uses electromagnetic (EM) needle tracking under local anaesthesia (LA). DESIGN, SETTING, AND PARTICIPANTS: Vector prostate biopsy using BiopSee fusion software, EM tracking technology, and transrectal ultrasound was performed in 69 patients meeting the biopsy criteria in two UK centres between September 2020 and August 2022. SURGICAL PROCEDURE: Stepper-mounted rectal ultrasound images were fused with MRI scans. LA was applied into two defined perineal tracks and a needle sheath with an EM sensor was inserted. The biopsy needle was directed precisely through the sheath to MRI targets under EM tracking. Biopsies were taken without antibiotic prophylaxis. MEASUREMENTS: Cancer detection (any PCa; grade group ≥2), side effects, and patient experience measures were recorded. RESULTS AND LIMITATIONS: Cancer detection in patients with Likert 4-5 lesions was 98% for any PCa and 83% for grade group ≥2. According to the 50 questionnaires returned, 42 patients (84%) reported no or minimal pain, while 40 (80%) reported no or minimal discomfort. No episodes of postoperative urinary retention occurred, and only one patient required treatment for infection. Limitations include the low patient number and incomplete responses to questionnaires. CONCLUSIONS: This novel Vector technique provides a feasible and tolerable procedure for MRI/ultrasound fusion TP biopsy under LA, with high cancer detection rates. This is achieved while maintaining patient comfort and with minimal rates of complications. PATIENT SUMMARY: We report a novel technique that uses electromagnetic needle tracking to perform highly accurate and comfortable prostate biopsies through the perineum under local anaesthetic.

Natural History of Patients with Prostate MRI Likert 1-3 and Development of RosCaP: a Multivariate Risk Score for Clinically Significant Cancer.

INTRODUCTION: Clinically significant prostate cancer (csCaP) with Gleason ≥3 + 4 is found in 10% negative prebiopsy multiparametric (mp) MRI cases and varies widely for equivocal mpMRI cases. The objective of this study was to investigate long-term outcomes of patients with negative and equivocal mpMRIs and to develop a predictive score for csCaP risk stratification in this group. PATIENTS AND METHODS: Patients who underwent an upfront mpMRI between May 2015 and March 2018 with an MRI score Likert 1 to 3 were included in the study. Patients had either a CaP diagnosis at MRI-targeted biopsy or were not diagnosed and attended follow-up in the community. Outcomes were analysed through the Kaplan-Meier estimator and Cox Model. Regression coefficients of significant variables were used to develop a Risk of significant Cancer of the Prostate score (RosCaP). RESULTS: At first assessment 281/469 patients had mpMRI only and 188/469 mpMRI and biopsy, 26 csCaP were found at biopsy, including 10/26 in Likert 3 patients. 12/371 patients discharged without CaP after first assessment were diagnosed with csCaP during a median of 34.2 months' follow-up, 11/12 diagnosis occurred in patients omitting initial biopsy. csCaP diagnosis-free survival was 95.7% in the MRI group and 99.1% in the biopsy group. From these outcomes, a continuous RosCaP score was developed: RosCaP = 0.083 x Age - 0.202 x (1/PSA Density) + 0.786 (if Likert 3), and 4 risk classes were proposed. Limitations include retrospective design and absence of external validation. CONCLUSION: Age, PSA Density and MRI Likert score were significantly associated to the risk of csCaP and utilised to devise the novel RosCap predictive score focused to support risk assessment in patients with negative or equivocal mpMRI results.

Survey on prostate MRI reading and interpretation among urology residents in Italy, Brazil and the UK: a cry for help.

BACKGROUND: Prostate MRI is an essential tool in the diagnostic pathway of prostate cancer and its accurate reading helps decision to biopsy. The aim of this study was to assess the Urology residents' level of confidence in reading and interpreting prostate MRI, their interest in new learning opportunities and whether prostate MRI training should be part of the urology core curriculum during residency. METHODS: A 23-item survey has been created and distributed via Web to an international cohort of Urology residents over a 3-month period. Surveys obtained from Countries representing >10% total distribution of responses were analyzed. RESULTS: A total of 304 complete surveys were obtained from Urology residents, with a geographical prevalence from Europe (59.54%, 181/304) and South America (29.28%, 89/304). Only 17-20% of residents reported having received formal prostate MRI training during residency. Overall, <20% residents expressed to feel confident in reading and interpreting prostate MRI. As a result, >90% Urology trainees stated they would be willing to receive a formal training and would be interested in new learning opportunities in MRI reading and interpretation during residency, independently of their year of training. Despite UK Urology trainees showed to have a higher availability of MRI resources and MRI-based biopsies compared to the other countries, they still expressed concerns in regard to not feeling confident with MRI reading and interpretation and requested a formal training. CONCLUSIONS: This survey highlights the need for major learning opportunities and a formal training in prostate MRI reading and interpretation during urology residency.

Percutaneous Tibial Nerve Stimulation Improves Lower Urinary Tract Dysfunction and Infection Rate in a Kidney Transplant Recipient With Augmentation Cystoplasty: A Case Report and Literature Review.

Almost 20% of patients with congenital posterior urethral valves (PUV) reach end-stage kidney disease requiring kidney transplantation (KT). An augmentation cystoplasty (AC) is performed to treat significant lower urinary tract dysfunction (LUTD) which can persist afterwards due to residual valve bladder and lead to recurrent urinary tract infections (UTIs) and a worse graft survival. Percutaneous tibial nerve stimulation (PTNS) is a minimally invasive second-line neuromodulation therapy approved for the treatment of non-neurogenic LUTD performed in the outpatient setting. Herein, we reported the case of significant improvement of bladder voiding pattern and yearly UTI rates through PTNS in a 32-year-old male KT recipient with a history of congenital PUV and AC. The patient was referred to our institution at the beginning of 2019 for urgency, high post-void residual volume (PVR) and recurrent clinically significant UTIs (3 to 4/y). After assessment, the patient attended once-weekly 30-minute sessions of PTNS for 12 consecutive weeks. A significant improvement of urodynamic and infectious outcomes was observed through 3-day bladder diaries, questionnaires, and laboratory exams during the subsequent 3 years of regular follow-up. The present results might be significant for the prevention of antibiotic resistance and for better graft survival in KT recipients. We successfully treated a patient with AC, implying that the technique may be appliable also in this case. Neuromodulation in KT is still an unexplored field of research, we advocate for prospective assessment of the efficacy of PTNS in these patients, as reproducible results might lead to life-changing improvements.

Antimuscarinics for neurogenic overactive bladder in multiple sclerosis: real-life data.

Background: Antimuscarinics (AMs) represent the mainstay of treatment for storage lower urinary tract symptoms (LUTS) but few data are available on their impact in multiple sclerosis (MS) patients. Objective: To assess effectiveness and tolerability of AMs in MS patients with neurogenic detrusor overactivity (NDO). Methods: Sixty consecutive outpatients, who started treatment with AMs at one centre, were recruited. The primary endpoint was change in Patient's Perception of Intensity of Urgency Scale (PPIUS) at 6 months; secondary endpoints were post-void residual urine (PVR) and pads used daily. Incidence and severity of adverse events (AEs) were recorded. Results: Significant reduction (p < 0.001) of mean PPIUS and pads use were detected, as well as a significant increase (p < 0.001) of PVR (143 ±â€„42 ml).AEs, recorded in 53% of patients, were frequently multiple and caused suspension of AM in 10% of cases, mainly for xerostomia, which has been the commonest AE (26.6%). Neurological AEs appeared in 11.7% of subjects, mostly with oxybutynin. Worsening/onset of voiding LUTS, reported by 8.3% of MS, resulted to be the unique AE correlated to AM dosage. Conclusion: This study suggests that AMs are effective in MS patients, but their use should be tailored on every patient as even low dosages can be poorly tolerated. AEs, including neurological ones, are common.

Corrigendum: Is urology a gender-biased career choice? A survey-based study of the Italian medical students'; perception of specialties.

[This corrects the article DOI: 10.3389/fsurg.2022.962824.].

Optimal biopsy approach for detection of clinically significant prostate cancer.

Prostate cancer (PCa) diagnostic and therapeutic work-up has evolved significantly in the last decade, with pre-biopsy multiparametric MRI now widely endorsed within international guidelines. There is potential to move away from the widespread use of systematic biopsy cores and towards an individualised risk-stratified approach. However, the evidence on the optimal biopsy approach remains heterogeneous, and the aim of this review is to highlight the most relevant features following a critical assessment of the literature. The commonest biopsy approaches are via the transperineal (TP) or transrectal (TR) routes. The former is considered more advantageous due to its negligible risk of post-procedural sepsis and reduced need for antimicrobial prophylaxis; the more recent development of local anaesthetic (LA) methods now makes this approach feasible in the clinic. Beyond this, several techniques are available, including cognitive registration, MRI-Ultrasound fusion imaging and direct MRI in-bore guided biopsy. Evidence shows that performing targeted biopsies reduces the number of cores required and can achieve acceptable rates of detection whilst helping to minimise complications and reducing pathologist workloads and costs to health-care facilities. Pre-biopsy MRI has revolutionised the diagnostic pathway for PCa, and optimising the biopsy process is now a focus. Combining MR imaging, TP biopsy and a more widespread use of LA in an outpatient setting seems a reasonable solution to balance health-care costs and benefits, however, local choices are likely to depend on the expertise and experience of clinicians and on the technology available.

Introducing 3D printed models of the upper urinary tract for high-fidelity simulation of retrograde intrarenal surgery.

PURPOSE: Training in retrograde intrarenal surgery for the treatment of renal stone disease is a challenging task due to the unique complexity of the procedure. This study introduces a series of 3D printed models of upper urinary tract and stones designed to improve the training process. METHODS: Six different models of upper urinary tract were algorithmically isolated, digitally optimized and 3D printed from real-life cases. Soft and hard stones in different sizes were produced from 3D printed moulds. The models were fitted onto a commercially available part-task trainer and tested for retrograde intrarenal surgery. RESULTS: Each step of the procedure was simulated with extraordinary resemblance to real-life cases. The unique anatomical intricacy of each model and type of stones allowed us to reproduce surgeries of increasing difficulty. As the case-load required to achieve proficiency in retrograde intrarenal surgery is high, benchtop simulation could be integrated in training programs to reach good outcomes and low complication rates faster. Our models match incredible anatomical resemblance with low production cost and high reusability. Validation studies and objective skills assessment during simulations would allow comparison with other available benchtop trainers and the design of stepwise training programs. CONCLUSIONS: 3D printing is gaining a significant importance in surgical training. Our 3D printed models of the upper urinary tract might represent a risk-free training option to hasten the achievement of proficiency in endourology.

Delayed surgery for localised and metastatic renal cell carcinoma: a systematic review and meta-analysis for the COVID-19 pandemic.

PURPOSE: The COVID-19 pandemic has led to the cancellation or deferment of many elective cancer surgeries. We performed a systematic review on the oncological effects of delayed surgery for patients with localised or metastatic renal cell carcinoma (RCC) in the targeted therapy (TT) era. METHOD: The protocol of this review is registered on PROSPERO(CRD42020190882). A comprehensive literature search was performed on Medline, Embase and Cochrane CENTRAL using MeSH terms and keywords for randomised controlled trials and observational studies on the topic. Risks of biases were assessed using the Cochrane RoB tool and the Newcastle-Ottawa Scale. For localised RCC, immediate surgery [including partial nephrectomy (PN) and radical nephrectomy (RN)] and delayed surgery [including active surveillance (AS) and delayed intervention (DI)] were compared. For metastatic RCC, upfront versus deferred cytoreductive nephrectomy (CN) were compared. RESULTS: Eleven studies were included for quantitative analysis. Delayed surgery was significantly associated with worse cancer-specific survival (HR 1.67, 95% CI 1.23-2.27, p < 0.01) in T1a RCC, but no significant difference was noted for overall survival. For localised ≥ T1b RCC, there were insufficient data for meta-analysis and the results from the individual reports were contradictory. For metastatic RCC, upfront TT followed by deferred CN was associated with better overall survival when compared to upfront CN followed by deferred TT (HR 0.61, 95% CI 0.43-0.86, p < 0.001). CONCLUSION: Noting potential selection bias, there is insufficient evidence to support the notion that delayed surgery is safe in localised RCC. For metastatic RCC, upfront TT followed by deferred CN should be considered.

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

BACKGROUND: Circumcision as surgical treatment of adult phimosis is not devoid of complications. Efficacy of alternative non-surgical options is unclear. PhimoStopTM 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 PhimoStopTM 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 PhimoStopTM 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: PhimoStopTM 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.