Development of a Bladder Injury Classification System for Endoscopic Procedures: A Mixed-methods Study Involving Expert Consensus and Validation.

BACKGROUND AND OBJECTIVE: The widespread adoption and rapid integration of new technologies and techniques in endoscopic and laser bladder interventions, particularly endoscopic enucleation, have led to new types of bladder injuries. This underscores the need for an intraoperative injury classification system. This study aims to develop and validate the Bladder Injury Classification System for Endoscopic Procedures (BICEP), which standardizes the classification of complications and intervention requirements. METHODS: This mixed-methods study involved experts from the European Association of Urology Section of Urotechnology to standardize and validate the BICEP classification system. An iterative process involving focus groups, expert surveys, and revisions assessed clarity, relevance, comprehensiveness, and practicality. Validity was confirmed through expert surveys conducted in two rounds for face and content validity, using a 5-point Likert scale to correlate ratings with expected outcomes. KEY FINDINGS AND LIMITATIONS: The novel BICEP classification system categorizes bladder injuries into ten subcategories with scores ranging from 0 to 4, reflecting injury severity and management requirements. Face validity was demonstrated by a 95% consensus on the system's clarity, relevance, and comprehensiveness. Content validity was supported by high acceptance rates in expert surveys, with average scores of 4.53 and 4.58 in the first and second rounds, respectively. This demonstrates strong support for its applicability in clinical practice. However, the primary limitation is the lack of external validation. CONCLUSIONS AND CLINICAL IMPLICATIONS: Our study demonstrates that the BICEP system is a robust and comprehensive classification system, with strong support for its face and content validity. The BICEP system is a proposal based on expert opinion, and additional studies are necessary to ensure its widespread adoption and efficacy. PATIENT SUMMARY: Our study addressed the critical need for standardized classification in the increasingly widespread context of urology endoscopic technologies by focusing on intraoperative evaluation, reporting, and standardization of bladder injuries. This study provides a globally standardized basis for the classification and treatment of bladder injuries in urology endoscopic procedures.

Comparison of Current International Guidelines on Premature Ejaculation: 2024 Update.

Premature ejaculation (PE) is a common male sexual dysfunction that can cause significant distress in the patient and partner. This study aimed to compare the current international guidelines on PE to highlight their similarities and differences. We examined the latest guidelines from the European Association of Urology (EAU), American Urological Association/Sexual Medicine Society of North America (AUA/SMSNA), and International Society of Sexual Medicine (ISSM) by comparing definitions, classifications, epidemiology, pathophysiology, and recommendations on diagnosis and therapy. The quality of guidelines was assessed using the Appraisal of Guidelines for Research and Evaluation (AGREE) Global Rating Scale (GRS). We found significant variations in the definitions of PE and recommendations on management of patients. The EAU guidelines were the most recent, the AUA/SMSNA guidelines lacked detail in some areas, and the ISSM guidelines were the most complete but also the least updated. The search for a unified definition and the development of standardized diagnostic and therapeutic pathways remain concrete issues to improve the management of patients with PE worldwide.

Prospective randomized multicenter study to evaluate holmium vs. new thulium fiber laser for prostate enucleation.

BACKGROUND: Benign prostatic hyperplasia (BPH) commonly causes lower urinary tract symptoms (LUTS) in men. Holmium (HoLEP) and thulium (ThuLEP) laser enucleation are established techniques for BPH treatment. Thulium fiber laser (TFL) for prostate enucleation (ThuFLEP) shows promising outcomes. METHODS: A prospective randomized multicenter study was conducted. Patients with BPH and LUTS unresponsive to medical therapy were enrolled. Preoperative, surgical, perioperative and postoperative data were recorded with follow-up at 3 and 6 months. The primary outcome was functional improvement, and the secondary outcome was safety in terms of complications. RESULTS: Two hundred patients were included (HoLEP 100, ThuFLEP 100). No significant baseline difference was found between groups. At 3 and 6 months we found statistically significant improvements from baseline for both HoLEP and ThuFLEP in efficacy: International Prostatic Symptoms Score (IPSS), IPSS-Quality of Life (QoL), maximum urinary flow rate (Qmax), and post-void residual volume (PVR; P<0.05). At 6 months, mean±SD IPSS, IPSS-QoL, Qmax, and PVR for HoLEP vs. ThuFLEP were 5.8±4.9 vs. 4.8±5.0 points (P=0.57), 1.6±1.4 vs. 0.7±1.1 points (P=0.09), 29.9±12.5 vs. 29.6±8.0 mL/s (P=0.8), and 16.3±17.7 vs. 15.5±13.4 mL (P=0.92), respectively. No intraoperative complication was recorded. No Clavien-Dindo ≥III complications occurred during hospitalization. After 6 months, 8 (8%) and 6 (6%) patients reported mild stress urinary incontinence in HoLEP and ThuFLEP groups, respectively (P=0.24). Urethral stenosis was observed in 3 men (3%) in the HoLEP group and 1 subject (1%) in the ThuFLEP group (P=0.72). CONCLUSIONS: HoLEP and ThuFLEP are effective and safe for BPH treatment, with comparable functional outcomes and complication rates at 6 months. Further research is needed to confirm these findings.

Penile prosthesis implantation is safe and effective in Peyronie's disease patients with and without erectile dysfunction.

Penile prosthesis (PP) is the mainstay of treatment in Peyronie's disease (PD) with co-existent refractory erectile dysfunction (ED). This study aimed to assess the clinical outcomes of patients who underwent PP as the first-line surgical treatment in PD without ED. A total of 636 patients underwent PP for PD from 2012 to 2022, but only 168 patients who underwent PP as first-line surgical management for PD with or without ED were included in the study. The mean (SD) age of 168 patients was 56.3 years (12.4). The mean curvature of the "PD with ED" group and the "PD without ED" group were 38.2 (5.6) degrees and 42.2 (5.9) degrees. The median (IQR) follow-up was 56.0 months (34.5- 61.4). Most (86.9%) patients underwent 3-piece inflatable PP. An important finding is that 33 patients (19.6%) without ED had undergone PP. Mechanical failure requiring revision surgery was less common in the 'without ED' group than in the ED group (6.8% vs. 10.2%, p 0.04). Most PD patients without ED (87.9%, 29/33) and with ED (88.9%, 120/135) were "satisfied" after PP implantation at six months, as defined by a score of ≥4 on a 5-point Likert scale. If surgery is offered in PD, PP may be considered a safe and effective first-line surgical treatment regardless of the ED, given the acceptable complications and high satisfaction rates. However, this new concept warrants further research.

Da Vinci and Hugo RAS Platforms for robot-assisted partial nephrectomy: a preliminary prospective comparative analysis of the outcomes.

BACKGROUND: Robot-assisted partial nephrectomy (RAPN) has emerged as the preferred approach for T1 renal-cell-carcinoma. As new robotic platforms like Hugo RAS emerge, we seek to understand their potential in achieving similar RAPN outcomes as the established Da Vinci system. METHODS: A prospective single-center comparative study was conducted, and 50 patients selected for RAPN were enrolled (25 Da Vinci Xi; 25 Hugo RAS). The choice of robotic system was based solely on hospital logistics criteria. Surgeries were performed by expert surgeons. Demographic data, tumor characteristics, operative details and postoperative outcomes were collected. SPSS version 22.0 was used for statistical analyses. RESULTS: The average age of patients was 62.52±9.47 years, with no significant differences in median age, sex, and nephrometry scores between groups. Da Vinci group showed a significantly shorter docking time (12.56 vs. 20.08 min; P<0.01), while other intraoperative measures like console time and warm ischemia time were similar. The Hugo RAS group had a shorter renorraphy time (14.33 vs. 18.84 min; P=0.024). Postoperative outcomes and surgical margin positivity showed no significant differences. Each group had one patient (4%) who developed major surgical complications (Clavien IIIa). Trifecta rates were comparable between both groups (Da Vinci 88% vs. Hugo RAS 84%; P=0.93). CONCLUSIONS: Initial findings suggest similar perioperative outcomes for RAPN when using Hugo RAS compared to the Da Vinci system. Further research with long-term follow-up is necessary to evaluate oncological and functional outcomes.

Da Vinci vs. Hugo RAS for robot-assisted radical prostatectomy: a prospective comparative single-center study.

PURPOSE: To evaluate Hugo RAS against the Da Vinci system for Robot-Assisted Radical Prostatectomy (RARP) in prostate cancer treatment. METHODS: We compared outcomes of 150 patients with prostate cancer undergoing RARP with either Hugo or Da Vinci systems. Our analysis included operative, postoperative, pathological, and functional outcomes. RESULTS: Both groups had 75 patients. Baseline characteristics and tumor features were similar. Intraoperatively, Da Vinci had a shorter docking time (10.45 vs. 18.62 min, p = 0.02), but total operative times were comparable (145.34 vs 138.95, p = 0.85). Hugo outperformed in neck dissection and lymphadenectomy times (22 vs 13.67 min, p = 0.027 and 37.82 vs 45.77 min, p = 0.025). Postoperative metrics like stay duration, catheter time, and complications showed no significant difference. Functional results, using IPSS and IIEF5, were similar between systems. Six Da Vinci patients (8%) and nine Hugo patients (12%) experienced social incontinence (p = 0.072). Pathological outcomes like T stage, Gleason Score, and nodes removed were alike. However, Hugo had more positive surgical margins (20% vs. 10.67%, p = 0.034). CONCLUSIONS: RARP outcomes using Hugo RAS were similar to the Da Vinci system in our study. More research and extended follow-up are required to ascertain long-term oncological and functional results.

Cell therapy for male sexual dysfunctions: systematic review and position statements from the European Society for Sexual Medicine.

Background: Cell therapy (CT) is a form of regenerative medicine under investigation for the management of male sexual dysfunction (MSD). Aim: We sought to perform a systematic review of published information on CT for MSD and provide an official position statements for the European Society for Sexual Medicine. Methods: A comprehensive bibliographic search on the MEDLINE, Web of Science, Scopus, and Cochrane Library databases was conducted in February 2023. Articles were selected based on the Population, Intervention, Comparator, Outcome, Study design (PICOS) model if they included male patients (P) undergoing CT (I) with or without comparison with other treatments (C) and evaluated the impact of CT on sexual function (O). Quantitative data were reported as found in the original studies (S). Level of evidence and grade of recommendation according to the Oxford Centre for Evidence-Based Medicine were assigned to each statement. Outcomes: Outcomes were determined based on assessment of erectile function, ejaculatory function, orgasmic function, sexual desire, and penile curvature. Results: A total of 19 studies and 421 patients were included. Most articles (n = 12, 63%) were case series, whereas a minority of papers (n = 6, 32%) had a comparative group; only 2 articles reported randomized controlled trials (RCTs) and 1 article reported a post hoc analysis of RCTs. Most articles (16, 84%) investigated patients with erectile dysfunction (ED). Improvements in the International Index of Erectile Function-Erectile Function Domain (IIEF-EF) or the IIEF 5-item version (IIEF-5) were found in 11/15 (73%) studies, with mean increases in IIEF-EF, mean IIEF-5, and median IIEF-EF between 8 and 14 points, 2 and 9 points, and 4.5 and 6 points, respectively. Two papers (20%) evaluated men with Peyronie's disease (PD). In both ot these articles penile curvature improvement and plaque volume reduction were described in all patients (n = 16, 100%). Objective measurements were performed in 1 study, which showed 10°-120° (15%-100%) curvature improvement and 90%-100% plaque reduction. Mild transient adverse events at the donor or administration sites were found in 7/16 (44%) papers on ED. Priapism was reported in one case (20%) and mild penile skin complications were reported in the majority of patients after CT for PD. No severe adverse events were described. Clinical Implications: Although high-quality evidence is lacking, CT appears to have potential benefits from application in patients with ED or PD. Strengths and Limitations: This report is to our knowledge the most comprehensive and up-to-date systematic review on the topic of CT for the management of MSD, including the position statements of the European Society for Sexual Medicine. Overall the assessment of available studies demonstrated low quality and significant heterogeneity. Conclusion: Preliminary findings support potential efficacy and safety of CT in patients with ED or PD. Low-quality papers, high methodological heterogeneity, uncertainty about the magnitude of the beneficial effects, and lack of long-term data limit the available evidence.

Comparison in Detection Rate of Clinically Significant Prostate Cancer Between Microultrasound-guided Prostate Biopsy (ExactVu) and Multiparametric Resonance Imaging-guided Prostate Biopsy (Koelis System).

OBJECTIVES: To compare the detection rate of clinically significant prostate cancer (csPC) and prostate cancer (PC) and to find out the diagnostic concordance between microultrasound (mUS), a high-resolution imaging system that can identify suspicious prostate lesions and biopsy them in real time, and multiparametric magnetic resonance imaging (mpMRI)-guided prostate fusion biopsies. METHODS: A prospective, multicenter, single-blind, single cohort study was conducted involving 80 patients with clinically suspected PC who underwent concomitant mpMRI-guided fusion prostate biopsy (Koelis System) and mUS-guided biopsy (ExactVu System) RESULTS: The detection rate of csPC was slightly higher for image-guided fusion biopsy (21.25% vs 18.75%), but this difference was not statistically significant (P = .453). There was also no significant difference in overall PC diagnosis (50% vs 51.25%, P = .897). The degree of agreement between the 2 diagnostic techniques for the detection of csPC as assessed by Cohen's Kappa concordance index was satisfactory κ ̂ = 0.676. The degree of International Society of Urological Pathology of targeted biopsies obtained from concordant lesions was also represented by satisfactory concordance with a Kappa index of κ ̂ = 0. 696. CONCLUSION: mUS-guided biopsy is presented as an effective diagnostic method for the diagnosis of csPC compared to image-guided fusion biopsy. No differences are found in the detection rates of csPC and PC between the 2 strategies and satisfactory concordance is found in terms of histopathological findings.

Quality of life and sexuality with penile prosthesis: a systematic review and pooled analysis.

INTRODUCTION: Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) is the first validated questionnaire to specifically evaluate the satisfaction of patients undergoing penile prosthesis implantation. Our primary aim was to conduct a systematic review and pooled analysis of articles reporting QoLSPP. EVIDENCE ACQUISITION: A comprehensive bibliographic search on the MEDLINE, Scopus, Web of Science, and Cochrane Library databases was performed in April 2023. Studies were selected if they assessed male subjects (P) undergoing penile prosthesis implantation (I) with or without comparison with other treatments (C), reporting the patient satisfaction according to QoLSPP (O). Prospective and retrospective original studies were included (S). The risk of bias was assessed using the ROBINS-I tool and the Knoll method. Means and standard deviations (SDs) of QoLSPP scores were included in the pooled analysis. PROSPERO ID: "CRD42023427261." EVIDENCE SYNTHESIS: A total of 10 studies investigating 1105 patients were included in the systematic review; of these, eight articles describing the outcomes of 693 subjects were eligible for the pooled analysis. Overall serious risk of bias was found in 2/3 of nonrandomized comparative studies (66%), while seven single-arm studies (100%) were classified as having a high risk of bias. Pooled analysis of the QoLSPP-Functional domain revealed an overall effect size (ES) of 4.22 points (95% CI 4.04-4.40; P<0.001). The QoLSPP-Relational pooled score was 4.17 points (95% CI 4.03-4.31; P<0.001). The QoLSPP-Social pooled score corresponded to 4.21 points (95% CI 4.02-4.40; P<0.001). Pooled analysis of the QoLSPP-Personal domain showed an overall ES of 3.97 points (95% CI 3.61-4.32; P<0.001). There was insufficient data to pool QoLSPP total scores. CONCLUSIONS: Patients undergoing penile prosthesis implantation report positive scores in all QoLSPP domains, demonstrating high satisfaction levels. Future studies are needed to improve the evidence on the topic.