Patient-reported Outcome Measures and Experience Measures After Active Surveillance Versus Radiation Therapy Versus Radical Prostatectomy for Prostate Cancer: A Systematic Review of Prospective Comparative Studies.

BACKGROUND AND OBJECTIVE: Current management options for localized prostate cancer (PCa) include radical prostatectomy (RP), radiotherapy (RT), and active surveillance (AS). Despite comparable oncological outcomes, there is still lack of evidence on their comparative effectiveness in terms of patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs). We conducted a systematic review of studies comparing PROMs and PREMs after all recommended management options for localized PCa (RP, RT, AS). METHODS: A literature search was performed in the MEDLINE, EMBASE, and Cochrane CENTRAL databases in accordance with recommendations from the European Association of Urology Guidelines Office and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. All prospective clinical trials reporting PROMs and/or PREMs for comparisons of RP versus RT versus AS were included. A narrative synthesis was used to summarize the review findings. No quantitative synthesis was performed because of the heterogeneity and limitations of the studies available. KEY FINDINGS AND LIMITATIONS: Our findings reveal that RP mostly affects urinary continence and sexual function, with better results for voiding symptoms in comparison to other treatments. RT was associated with greater impairment of bowel function and voiding symptoms. None of the treatments had a significant impact on mental or physical quality of life. Only a few studies reported PREMs, with a high rate of decision regret for all modalities (up to 23%). CONCLUSIONS AND CLINICAL IMPLICATIONS: All recommended treatments for localized PCa have an impact on PROMs and PREMs, but for different domains and with differing severity. We found significant heterogeneity in PROM collection, so standardization in real-world practice and clinical trials is warranted. Only a few studies have reported PREMs, highlighting an unmet need that should be explored in future studies. PATIENT SUMMARY: We reviewed differences in patient reports of their outcomes and experiences after surgical prostate removal, radiotherapy, or active surveillance for prostate cancer. We found differences in the effects on urinary, bowel, and sexual functions among the treatments, but no difference for mental or physical quality of life. Our results can help doctors and prostate cancer patients in shared decision-making.

Impact of minimally invasive surgical procedures for Male Lower Urinary Tract Symptoms due to benign prostatic hyperplasia on ejaculatory function: a systematic review.

BACKGROUND: Surgical treatments for lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) are affected by potentially bothersome side effects on sexual, and, above all, ejaculatory function. Several minimally invasive techniques have been proposed in the last years in order to overcome these consequences. Our aim is to summarize and evaluate the efficacy on LUTS relieve and the impact on sexual/ejaculatory function of Rezum, prostate artery embolization (PAE), implantation of a prostatic urethral lift (PUL) and the temporary implantable nitinol device (TIND). METHODS: A systematic review of the English-language literature was conducted using the MEDLINE, Embase, and Web of Science databases from January 2000 to October 2022, according to the PRISMA guidelines (PROSPERO ID: CRD42023466515). Randomized controlled trials (RCTs), prospective studies and non-comparative or comparative studies assessing the impact on functional and ejaculatory function after minimally invasive surgical therapies for Male LUTS were evaluated. Risk of bias assessment was performed according to the Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I) tool for comparative studies, and the revised Cochrane risk-of-bias tool for randomized trials (RoB 2) for RCTs. RESULTS: Overall, 47 studies were included (n = 4 for TIND; n = 9 for Rezum; n = 13 for PUL; n = 21 for PAE). Most studies relied on prospective patient cohorts and were rated as low risk of bias. Across studies assessing the efficacy of Rezum, a significant improvement in terms of IPSS (ranging from -47% to -56%) and Qmax (ranging from +39% to +87%) was reported. On the other hand, according to IIEF-5 score, Rezum had a minimal impact on sexual function (ranging from -1% to -3%). PUL showed a positive impact on IPSS (ranging from -35% to -58.2%) and Qmax (ranging from +49.9% to +114.7%) and sexual function. Finally, PAE showed encouraging functional results with IPSS score reducing from -12.8% to 63.3% and Qmax improving from +8% to 114.9% but the available evidence regarding the potential impact of PAE on sexual outcomes were limited. CONCLUSION: Rezum, PAE, PUL and TIND are safe and feasible techniques associated with a significant functional improvement. While available data suggest a minimal impact of Rezum and PUL on ejaculatory function, the evidence after PAE and TIND are still limited. Therefore, our review lays the foundation for further research aiming to identify the criteria to select best candidates for uMIST to tailor the management in light of specific patient- and disease- factors.

Hyperglycemia and microRNAs in prostate cancer.

BACKGROUND: Hyperglycemia can promote the development of prostate cancer (PCa). Differential expression levels of miRNAs between PCa patients and controls were also reported. Therefore, we examined the relationship between hyperglycemia and miRNA levels in PCa. METHODS: Relative expression of urinary miR-574-3p, miR-375, miR-205-5p, miR-200b-3p, miR-187-3p, miR-182-5p, and miR-100-5p were investigated in 105 PCa patients and 138 noncancer controls by Real-Time quantitative PCR. Fasting plasma glucose measurements were retrieved from clinical records. The differential miRNA expressions among groups were compared using non-parametric tests. Correlations with glucose and prostate-specific antigen (PSA) were tested using Pearson correlation coefficient. RESULTS: When we analyzed miRNA expression according to glycemic state, significant down-regulations were found for miR-200b-3p, miR-187-3p, miR-182-5p, and miR-100-5p in noncancer controls with high glucose. The lowest down-regulations were observed for miR-187-3p, miR-182-5p, and miR-100-5p. Subsequently, when hyperglycemia was considered in PCa, significant dysregulations of selected miRNAs were found in hyperglycemic PCa patients than in controls with high glucose. In particular, miR-375 and miR-182-5p showed a 3-FC in hyperglycemic PCa patients than controls who left hyperglycemia untreated. Conversely, only a down-regulation of miR-574-3p was observed in PCa patients regardless of glycemic status and only modest down-regulation of miR-574-3p, miR-200b-3p, miR-187-3p and miR-182-5p were found in normoglycemic PCa patients. Next, significant correlations between miRNAs and glucose (miR-200b-3p, miR-100-5p) and PSA (miR-205-5p and miR-187-3p) were detected in controls. Similarly, miR-205-5p and miR-187-3p were correlated with glucose in PCa patients, while miR-574-3p and miR-375 showed inverse relationships. CONCLUSIONS: miRNA dysregulations can occur in hyperglycemic PCa patients as compared to noncancer controls who left hyperglycemia untreated. Hyperglycemia can consistently promote the expression of miR-375 and miR-182-5p. Uncontrolled hyperglycemic state could contribute to the creation of a suitable microenvironment for later PCa development by promoting gene expression.

Morbidity of Transrectal MRI-Fusion Targeted Prostate Biopsy at a Tertiary Referral Academic Centre: An Audit to Guide the Transition to the Transperineal Approach.

Despite transrectal prostate biopsy (TRPB) being still widespread globally, the EAU Guidelines strongly recommend the transperineal approach, due to the reported lower infectious risk. Our study aims to evaluate the impact of a standardized clinical pathway for TRPB on post-operative complications. We prospectively collected data from all patients undergoing mpMRI-targeted TRPB at our Academic Centre from January 2020 to December 2022. All patients followed a standardized, structured multistep pathway. Post-procedural complications were collected and classified according to the Clavien-Dindo (CD) Classification. Among 458 patients, post-procedural adverse events were reported by 203 (44.3%), of which 161 (35.2%) experienced CD grade 1 complications (hematuria [124, 27.1%], hematochezia [22, 4.8%], hematospermia [14, 3.1%], or a combination [20, 4.4%]), and 45 (9.0%) reported CD grade 2 complications (acute urinary retention or hematuria needing catheterization, as well as urinary tract infections, of which 2 cases required hospitalization). No major complications, including sepsis, were observed. At uni- and multivariable analysis, age > 70 years and BMI > 25 kg/ m2 for patients were identified as predictors of post-operative complications. The results of our study confirm that TRPB is a safe and cost-effective procedure with a low risk of severe adverse events in experienced hands and following a standardized pathway.

The First Entirely 3D-Printed Training Model for Robot-assisted Kidney Transplantation: The RAKT Box.

Background: Robot-assisted kidney transplantation (RAKT) is increasingly performed at selected referral institutions worldwide. However, simulation and proficiency-based progression training frameworks for RAKT are still lacking, making acquisition of the RAKT-specific skill set a critical unmet need for future RAKT surgeons. Objective: To develop and test the RAKT Box, the first entirely 3D-printed, perfused, hyperaccuracy simulator for vascular anastomoses during RAKT. Design setting and participants: The project was developed in a stepwise fashion by a multidisciplinary team including urologists and bioengineers via an iterative process over a 3-yr period (November 2019-November 2022) using an established methodology. The essential and time-sensitive steps of RAKT were selected by a team of RAKT experts and simulated using the RAKT Box according to the principles of the Vattituki-Medanta technique. The RAKT Box was tested in the operating theatre by an expert RAKT surgeon and independently by four trainees with heterogeneous expertise in robotic surgery and kidney transplantation. Surgical procedure: Simulation of RAKT. Measurements: Video recordings of the trainees' performance of vascular anastomoses using the RAKT Box were evaluated blind by a senior surgeon according to the Global Evaluative Assessment of Robotic Skills (GEARS) and Assessment of Robotic Console Skills (ARCS) tools. Results and limitations: All participants successfully completed the training session, confirming the technical reliability of the RAKT Box simulator. Tangible differences were observed among the trainees in both anastomosis time and performance metrics. Key limitations of the RAKT Box include lack of simulation of the ureterovesical anastomosis and the need for a robotic platform, specific training instruments, and disposable 3D-printed vessels. Conclusions: The RAKT Box is a reliable educational tool to train novice surgeons in the key steps of RAKT and may represent the first step toward the definition of a structured surgical curriculum in RAKT. Patient summary: We describe the first entirely 3D-printed simulator that allows surgeons to test the key steps of robot-assisted kidney transplantation (RAKT) in a training environment before performing the procedure in patients. The simulator, called the RAKT Box, has been successfully tested by an expert surgeon and four trainees. The results confirm its reliability and potential as an educational tool for training of future RAKT surgeons.

Urinary Continence Recovery after Robotic Radical Prostatectomy without Anterior or Posterior Reconstruction: Experience from a Tertiary Referral Center.

BACKGROUND: The aim of our study is to evaluate the prevalence and predictive factors of short- (30 d) and mid-term continence in a contemporary cohort of patients treated with robotic-assisted laparoscopic prostatectomy (RALP) without any posterior or anterior reconstruction at our referral academic center. METHODS: Data from patients undergoing RALP between January 2017 and March 2021 were prospectively collected. RALP was performed by three highly experienced surgeons following the principles of the Montsouris technique, with a bladder-neck-sparing intent and maximal preservation of the membranous urethra (if oncologically safe) without any anterior/posterior reconstruction. (Self-assessed urinary incontinence (UI) was defined as the need of one or more pads per die (excluding the need for a safety pad/die. Univariable and multivariable logistic regression analysis was used to assess the independent predictors of early incontinence among routinely collected patient- and tumor-related variables). RESULTS: A total of 925 patients were included; of these, 353 underwent RALP (38.2%) without nerve-sparing intent. The median patient age and BMI were 68 years (IQR 63-72) and 26 (IQR 24.0-28.0), respectively. Overall, 159 patients (17.2%) reported early (30 d) incontinence. In multivariable analysis adjusting for patient- and tumor-related features, a non-nerve-sparing procedure (OR: 1.57 [95% CI: 1.03-2.59], p = 0.035) was independently associated with the risk of urinary incontinence in the short-term period, while the absence of cardiovascular diseases before surgery (OR: 0.46 [95% CI: 0.320.67], p ≤ 0.01) was a protective factor for this outcome. At a median follow-up of 17 months (IQR 10-24), 94.5% of patients reported to be continent. CONCLUSIONS: In experienced hands, most patients fully recover urinary continence after RALP at mid-term follow-up. On the contrary, the proportion of patients who reported early incontinence in our series was modest but not negligible. The implementation of surgical techniques advocating anterior and/or posterior fascial reconstruction might improve the early continence rate in candidates for RALP.

Contemporary techniques and outcomes of surgery for locally advanced renal cell carcinoma with focus on inferior vena cava thrombectomy: The value of a multidisciplinary team.

Objective: To report the outcomes of surgery for a contemporary series of patients with locally advanced non-metastatic renal cell carcinoma (RCC) treated at a referral academic centre, focusing on technical nuances and on the value of a multidisciplinary team. Methods: We queried our prospective institutional database to identify patients undergoing surgical treatment for locally advanced (cT3-T4 N0-1 M0) renal masses suspected of RCC at our centre between January 2017 and December 2020. Results: Overall, 32 patients were included in the analytic cohort. Of these, 12 (37.5%) tumours were staged as cT3a, 8 (25.0%) as cT3b, 5 (15.6%) as cT3c, and 7 (21.9%) as cT4; 6 (18.8%) patients had preoperative evidence of lymph node involvement. Nine (28.1%) patients underwent nephron-sparing surgery while 23 (71.9%) received radical nephrectomy. A template-based lymphadenectomy was performed in 12 cases, with evidence of disease in 3 (25.0%) at definitive histopathological analysis. Four cases of RCC with level IV inferior vena cava thrombosis were successfully treated using liver transplant techniques without the need for extracorporeal circulation. While intraoperative complications were recorded in 3 (9.4%) patients, no postoperative major complications (Clavien-Dindo ≥3) were observed. At histopathological analysis, 2 (6.2%) patients who underwent partial nephrectomy harboured oncocytoma, while the most common malignant histotype was clear cell RCC (62.5%), with a median Leibovich score of 6 (interquartile range 5-7). Conclusion: Locally advanced RCC is a complex and heterogenous disease posing several challenges to surgical teams. Our experience confirms that provided careful patient selection, surgery in experienced hands can achieve favourable perioperative, oncological, and functional outcomes.

The role of COVID-19 in prostate tissue inflammation: first pathological evidence.

According to current studies, COVID-19 might have an impact on semen quality. Therefore, SARS-CoV-2 may affect other traits of male reproductive system, including the prostate. Thus, we recruited patients who experienced COVID-19 infection in-between prostate biopsy and radical prostatectomy and compared prostate samples inflammation, measured with IRANI score, to those who did not. Indeed, we recruited 20 patients, aged 69 (62-73) years, finding no difference between the 10 patients with COVID-19 infection and the others in IRANI score and all its sub-scores. Hence, according to our exploratory and limited results, COVID-19 infection might have no gross effect on prostate inflammation.

Segmental Ureterectomy Versus Radical Nephroureterectomy in Older Patients Treated for Upper Tract Urothelial Carcinoma.

INTRODUCTION: The world population is ageing and surgical procedures for older patients are associated with higher perioperative morbidity and mortality rates than in younger patients. Segmental ureterectomy (SU) has been proposed as an alternative to radical nephroureterectomy (RNU) for selected upper tract urothelial carcinomas (UTUC), to reduce post-operative morbidity, and preserve renal function. The aim of this study was to compare RNU and SU in terms of post-operative complications, functional outcomes, and overall survival (OS) in older patients treated for UTUC. MATERIALS AND METHODS: Data of patients aged 75 years or older and treated for UTUC were included. The primary outcome was to compare RNU versus SU according to post-operative complications, the estimated glomerular filtration rate (eGFR) variation, and OS. Complications were defined according to the Clavien-Dindo classification. eGFR was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Un-adjusted OS curves were plotted using the Kaplan-Meier method. RESULTS: Overall, 177 patients (150 RNU and 27 SU) were eligible for the analysis. Pre- and post-operative characteristics were similar between the 2 groups. RNU patients showed higher incidence of post-operative complications (34.0% vs. 7.4%, P = .011). The mean post-operative serum creatinine was lower in SU patients in comparison with the RNU ones (1.23 vs. 1.69 mg/dL, P = .046), but no differences were found in terms of eGFR variation (P = .258). At 3 years of follow-up, the OS was comparable between the two surgical techniques (P = .129). CONCLUSION: In older patients diagnosed with UTUC, SU could offer lower rates of post-operative complications without affecting survival.

Male reproductive system inflammation after healing from coronavirus disease 2019.

BACKGROUND: There is evidence that, after severe acute respiratory syndrome coronavirus 2 infection, male reproductive function and semen quality may be damaged OBJECTIVES: To evaluate a panel of inflammatory mediators in semen in patients recovered from coronavirus disease 2019. MATERIAL AND METHODS: Sexually active men with previous severe acute respiratory syndrome coronavirus 2 infection and proven recovery from coronavirus disease 2019 were enrolled in a prospective cohort study. Clinical, uro-andrological data and semen specimens were prospectively collected. For previously hospitalized coronavirus disease 2019 patients, data on serum inflammatory markers were retrospectively collected. RESULTS: A total of 43 men were enrolled in the study. Of these, 32 men were normozoospermic, three were oligozoospermic, and eight were crypto-azoospermic. Serum inflammatory markers (procalcitonin and C-reactive protein) were analyzed in previously hospitalized patients both at admission and at peak of infection. Levels at admission were statistically significantly higher in patients resulting in crypto-azoospermic with respect to those resulting in normozoospermic (p = 0.05; p = 0.03 and p = 0.02, respectively) after healing. Seminal cytokine levels were similar among all groups. Interleukin-1ß and tumor necrosis factor-α levels were significantly negatively related to sperm total number and concentration, whereas interleukin-4 was correlated with sperm motility. DISCUSSION AND CONCLUSION: Negative correlations between interleukin-1ß and tumor necrosis factor-α and sperm number and the overall high levels of semen cytokines indicate a potential detrimental role of severe acute respiratory syndrome coronavirus 2 driven inflammation on spermatogenesis. Overall, our results indicate that male patients recovering from coronavirus disease 2019 deserve accurate follow-up for their fertility status.

Proctored Step by Step Training Program for GreenLight Laser Anatomic Photovaporization of the Prostate: A Single Surgeon's Experience.

Objectives: To evaluate the feasibility and safety of a proctored step-by-step training program for GreenLight laser anatomic photovaporization (aPVP) of the prostate. Methods: Data from patients undergoing aPVP between January 2019 and December 2020 operated by a single surgeon following a dedicated step-by-step proctored program were prospectively collected. The procedure was divided into five modular steps of increasing complexity. Preoperative patients' data as well as total operative time, energy delivered on the prostate and postoperative data, were recorded. Then, we assessed how the overall amount of energy delivered and the operative times varied during the training program. Surgical steps were analyzed by cumulative summation. Univariable and multivariable regression models were built to assess the predictors of the amount of energy delivered on the prostate. Results: Sixty consecutive patients were included in the analysis. Median prostate volume was 56.5 mL. The training program was succesfully completed with no intraoperative or meaningful post-operative complications. The energy delivered reached the plateau after the 40th case. At multivariable analysis, increasing surgeon experience was associated with lower amounts of energy delivered as well as lower operative times. Conclusions: A step-by-step aPVP training program can be safely performed by surgeons with prior endoscopic experience if mentored by a skilled proctor. Considering the energy delivered as an efficacy surrogate metrics (given its potential impact on persistent postoperative LUTS), 40 cases are needed to reach a plateau for aPVP proficiency. Further studies are needed to assess the safety of our step-by-step training modular program in other clinical contexts.

Case Report: Optimizing Pre- and Intraoperative Planning With Hyperaccuracy Three-Dimensional Virtual Models for a Challenging Case of Robotic Partial Nephrectomy for Two Complex Renal Masses in a Horseshoe Kidney.

Objective: To report a case of robot-assisted partial nephrectomy (RAPN) for two highly complex renal tumors in a patient with a Horseshoe kidney (HSK), focusing on the utility of hyperaccuracy three-dimensional (HA3D) virtual models for accurate preoperative and intraoperative planning of the procedure. Methods: A 74-year-old Caucasian male patient was referred to our Unit for incidental detection of two complex renal masses in the left portion of a HSK. The 50 × 55 mm, larger, predominantly exophytic renal mass was located at the middle-lower pole of the left-sided kidney (PADUA score 9). The 16 × 17 mm, smaller, hilar renal mass was located at the middle-higher pole of the left-sided kidney (PADUA score 9). Contrast-enhanced CT scan images in DICOM format were processed using a dedicated software to achieve a HA3D virtual reconstructions. RAPN was performed by a highly experienced surgeon using the da Vinci Si robotic platform with a three-arm configuration. A selective delayed clamping strategy was adopted for resection of the larger renal mass while a clampless strategy was adopted for the smaller renal mass. An enucleative resection strategy was pursued for both tumors. Results: The overall operative time was 150 min, with a warm ischemia time of 21 min. No intraoperative or postoperative complications were recorded. Final resection technique according to the SIB score was pure enucleation for both masses. At histopathological analysis, both renal masses were clear cell renal cell carcinoma (ccRCC) (stage pT1bNxMx and pT3aNxMx for the larger and smaller mass, respectively). At a follow-up of 7 months, there was no evidence of local or systemic recurrence. Conclusions: Surgical management of complex renal masses in patients with HSKs is challenging and decision-making is highly nuanced. To optimize postoperative outcomes, proper surgical experience and careful preoperative planning are key. In this regard, 3D models can play a crucial role to refine patient counseling, surgical decision-making, and pre- and intraoperative planning during RAPN, tailoring surgical strategies and techniques according to the single patient's anatomy.

The feasibility of multimodal fiber optic spectroscopy analysis in bladder cancer detection, grading, and staging.

OBJECTIVE: To prove the feasibility of Multimodal Fiber Optic Spectroscopy (MFOS) analysis in bladder cancer (BCa) detection, grading, and staging. MATERIALS AND METHODS: Bladder specimens from patients underwent TURBT or TURP were recorded and analyzed with MFOS within 30 min from excision. In detail, our MFOS combined fluorescence, Raman spectroscopy, and diffuse reflectance. We used these optical techniques to collect spectra from bladder biopsies, then we compared the obtained results to gold standard pathological analysis. Finally, we developed a classification algorithm based on principal component analysis-linear discriminant analysis. RESULTS: A total of 169 specimens were collected and analyzed from 114 patients, 40 (23.7%) healthy (from TURP), and 129 (76.3%) with BCa. BCa specimens were divided according to their grade-34 (26.4%) low grade (LG) and 95 (73.6%) high grade (HG) BCa-and stage-64 (49.6%) Ta, 45 (34.9%) T1, and 20 (15.5%) T2. MFOS-based classification algorithm correctly discriminated healthy versus BCa with 90% accuracy, HG versus LG with 83% accuracy. Furthermore, it assessed tumor stage with 75% accuracy for Ta versus T1, 85% for T1 versus T2, and 86% for Ta versus T2. CONCLUSIONS: Our preliminary results suggest that MFOS could be a reliable, fast, and label-free tool for BCa assessment, providing also grading and staging information. This technique could be applied in future for in vivo inspection as well as of ex vivo tissue biopsies. Thus, MFOS might improve urothelial cancer management. Further studies are required.

Contrast-enhanced ultrasound (CEUS) imaging for active surveillance of small renal masses.

PURPOSE: To assess the safety and efficacy of contrast-enhanced ultrasound (CEUS) imaging for monitoring small (< 4 cm) renal masses (SRM) in patients undergoing active surveillance (AS). METHODS: We retrospectively selected all consecutive patients with SRMs who underwent AS for at least 6 months at our Institution between January 2014 and December 2018. CEUS imaging was performed by two experienced genitourinary radiologists at established time points. The accuracy of CEUS for monitoring SRM size was compared with that of CT scan. For solid SRMs, four enhancement patterns (EP) were recorded. Radiological progression was defined as SRM growth rate ≥ 5 mm/year. RESULTS: Overall, 158/1049 (15.1%) patients with SRMs underwent AS. At a median follow-up of 25 months (IQR 13-39), no patient died due to renal cell carcinoma (RCC). No patients experienced CEUS-related adverse events. There was a large variability in the pattern of growth of SRMs (overall median growth rate: 0.40 mm/year), with 9.5% of SRMs showing radiological progression. The median SRM size was comparable between CEUS and CT scan examinations at all time points. The vast majority (92.7%) of SRMs did not show a change in their EP over time; and there was no association between the SRM's EP and radiological progression or SRM size. Overall, 43 (27.2%) patients underwent delayed intervention (DI); median SRM size, and median growth rate were significantly higher in these patients as compared to those continuing AS. CONCLUSION: In experienced hands, CEUS is a safe and effective strategy for active monitoring of SRMs in well-selected patients undergoing AS.

Which Drug to Discontinue 3 Months After Combination Therapy of Tadalafil plus Tamsulosin for Men with Lower Urinary Tract Symptom and Erectile Dysfunction? Results of a Prospective Observational Trial.

BACKGROUND: Safety and efficacy of tamsulosin and tadalafil for men with benign prostatic enlargement (BPE) and/or erectile dysfunction (ED) are defined. However, there are only a few pilot studies on combination therapy with these drugs for men with lower urinary tract symptom (LUTS)/BPE and ED. Moreover, preliminary reports are limited to 12 wk, without any information about subsequent therapies. OBJECTIVE: To evaluate the impact of discontinuation of tamsulosin versus tadalafil 12 wk after combination therapy. DESIGN, SETTING, AND PARTICIPANTS: Fifty consecutive patients with moderate-to-severe LUTS (International Prostate Symptom Score [IPSS] > 7) and mild-to-severe ED (International Index of Erectile Function-5 [IIEF-5] < 22) were treated with combination therapy (tamsulosin 0.4mg/d plus tadalafil 5mg/d) for 12 wk. After 12 wk, 25 patients discontinued tamsulosin (Group TAD), while 25 patients discontinued tadalafil (Group TAM). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Efficacy variables were IPSS (total, voiding, storage) and IIEF-5. Paired samples t test and analysis of variance were used. RESULTS AND LIMITATIONS: Groups TAD and TAM presented similar features (age, BMI, metabolic profile) including symptoms scores at baseline. Similar and significant improvements in IPSS (total, voiding, and storage) and IIEF-5 were recorded in both groups after 12 wk of combination therapy (all p< 0.001). Total IPSS was similar between the two groups at the end of the trial. However, we found between-group significant differences from baseline to 24 wk and from 12 to 24 wk in storage-IPSS (Group TAD: -3.32 vs Group TAM: -1.24, p= 0.002; Group TAD: +0.24 vs Group TAM: +1.20, p= 0.040, respectively) and in IIEF-5 (Group TAD: +4.64 vs Group TAM: +0.16, p< 0.001; Group TAD: -1.64 vs Group TAM: -4.40, p= 0.003). No significant treatment-related adverse event was recorded in both groups. CONCLUSIONS: After 12 wk of combination therapy, monotherapy with tadalafil for further 12 wk allows to preserve the improvement of storage IPSS and IIEF-5, in addition to total IPSS. PATIENT SUMMARY: In this report we evaluated the discontinuation of tamsulosin or tadalafil after 12 wk of combination therapy. We found that tadalafil monotherapy, for a further 12 wk, aids in retaining the improvement of storage symptoms and erectile function.

Comparison of Tumor Seeding and Recurrence Rate After Laparoscopic vs. Open Nephroureterectomy for Upper Urinary Tract Transitional Cell Carcinoma.

Introduction: Laparoscopic surgery for Upper Urinary Tract Urothelial Cell Carcinoma (UTUC) is still debated for its possible seeding risk and thus consequent oncological recurrences, especially for atypical ones. The aim of the study is to compare recurrence and survival after Laparoscopic vs. Open Radical Nephroureterectomy (RNU) for Upper Urinary Tract Urothelial Cancer (UTUC). Method: A retrospective evaluation of UTUC consecutive surgeries from 2008 to 2019 was conducted, including pT ≥ 2, High Grade UTUC who underwent RNU with bladder cuff excision without concomitant lymphadenectomy in three urological tertiary centers. Statistical analyses compared recurrence and cancer specific survival, based on surgical approach, while logistic multivariate analyses and Kaplan Meyer survival curve analyzed possible risk factors for recurrence and survival. Results: One hundred seven cases of RNU, 47 (43.9%) laparoscopic and 60 (56.1%) open, were included in this report. Preoperative characteristics were comparable between groups. However, tumor stage was higher in the Open arm [T3-T4 in 44 (73.3%) vs. 20 (43.4%) in Laparoscopic]. Mean follow-up was 91.6 months in laparoscopy RNU vs. 93.5 months in open RNU. Recurrence rate (RR) was comparable between groups (p = 0.594), and so was the site, although 3 (6.3%) peritoneal recurrences were found only in laparoscopic group (p = 0.057). At multivariate logistic regression, tumor stage and surgical approach were independent predictors of recurrence (p < 0.05), while only tumor stage was predictor of cancer specific death (p = 0.029). Conclusion: Surgical approach has no impact on recurrence site, overall survival, and RR. Still, according to our data peritoneal carcinomatosis was present only in laparoscopic arm, despite how it didn't reach statistical significance.

Outcomes of combination therapy with daily tadalafil 5 mg plus tamsulosin 0.4 mg to treat lower urinary tract symptoms and erectile dysfunction in men with or without metabolic syndrome.

BACKGROUND: The aim of this study was to assess the impact of tadalafil 5 mg/die plus tamsulosin 0.4 mg/die combination therapy on lower urinary tract symptoms (LUTS) and erectile dysfunction (ED), according to presence vs. absence of metabolic syndrome (MetS). METHODS: Seventy-five consecutive men presenting with ED and LUTS were enrolled. Patients were divided into two groups according to MetS presence. All subjects were treated with combination therapy for 12 weeks. Patients were re-evaluated after treatment with uroflowmetry and post-void residual volume (PVR), International Prostate Symptoms Score (IPSS), IPSS Quality of Life (QoL), overactive bladder questionnaire (OAB-q) and International Index Erectile Function-5 (IIEF-5) Score. RESULTS: After enrollment, 50 patients were included: 31 (62.0%) with MetS and 19 (38.0%) without MetS. At baseline, patients without MetS showed a significantly better IPSS, IIEF and OAB-q, as compared to those with MetS. After 12 weeks of combination therapy LUTS, ED and flowmetry significantly improved in both groups (P<0.001). The improvement after 12 weeks was similar between groups in all parameters (P>0.05), except for ∆OAB-q that was significantly better for patients with MetS (P=0.028). Nevertheless, total IPSS, all IPSS subscores and OAB-q were significantly better at 12 weeks in men without MetS (P<0.05). Despite IIEF-5 was significantly different at baseline, after 12 weeks of combination therapy, erectile function was similar in men with or without METS: 16.3±3.8 vs. 17.7±4.7 (P=0.238). No serious adverse event (AE) was reported, and complications were comparable between groups (P>0.05). CONCLUSIONS: Patients with MetS have worse LUTS and ED profiles. However, tadalafil plus tamsulosin combination treatment provided them a similar ED profile and a greater relief of overactive bladder (OAB) symptoms at the end of the trial. Combination therapy had the same safety profile in men besides MetS. Further randomized controlled trials are needed.

The University of Florence Technique for Robot-Assisted Kidney Transplantation: 3-Year Experience.

Objective: To report the University of Florence technique for robot-assisted kidney transplantation (RAKT) from living donor (LD) and deceased donor (DD), highlighting the evolution of surgical indications and technical nuances in light of a single surgeon's learning curve. Materials and Methods: A dedicated program for RAKT from LDs was developed at our Institution in 2017 and implemented later with a specific framework for DDs. All RAKTs were performed by a single highly experienced surgeon. Data from patients undergoing RAKT between January 2017 and December 2019 were prospectively collected in a dedicated web-based data platform. In this report we provide a comprehensive step-by-step overview of our technique for RAKT, focusing on the potential differences in peri-operative and mid-term functional outcomes between LDs vs. DDs. Results: Overall, 160 KTs were performed in our center during the study period. Of these, 39 (24%) were performed with a robot-assisted laparoscopic technique, both from LDs (n = 18/39 [46%]) and from DDs (n = 21/39 [54%]). Eleven (11/39 [18%]), 13(13/39 [26%]), and 15 (15/39 [30%]) RAKTs were performed in 2017, 2018, and 2019, respectively, highlighting an increasing adoption of robotics for KT over time at our Institution. Median time for arterial (19 min for LD and 18 min for DD groups), venous (21 min for LD, 20 min for DD) and uretero-vesical (18 min for LD and 15 for DD) anastomosis were comparable between the two groups (all p > 0.05), as the median rewarming time (59 min vs. 56 min, p = 0.4). The rate of postoperative surgical complications according to Clavien-Dindo classification did not differ between the two study groups, except for Clavien-Dindo grade II complications (higher among patients undergoing RAKT from DDs, 76 vs. 44%, p = 0.042). Overall, 7/39 (18%) patients (all recipients from DDs) experienced DGF; two of them were on dialysis at last FU. Conclusions: Our experience confirms the feasibility, safety, and favorable mid-term outcomes of RAKT from both LDs and DDs in appropriately selected recipients, highlighting the opportunity to tailor the technique to specific recipient- and/or graft-characteristics. Further research is needed to refine the technique for RAKT and to evaluate the benefits and harms of robotics for kidney transplantation from DDs.