Artificial urinary sphincter significantly better than fixed sling for moderate post-prostatectomy stress urinary incontinence: a propensity score-matched study.

OBJECTIVE: To compare the efficacy of artificial urinary sphincter (AUS) vs retrourethral transobturator sling (RTS) in men with moderate post-prostatectomy urinary incontinence (PPI) using propensity score-matching analysis to enhance the validity of the comparison (Canadian Task Force classification II-2). PATIENTS AND METHODS: Consecutive men with moderate (3-5 pads/day) stress-prevalent PPI were included if implanted with a RTS (TiLOOP® Male; pfm medical, Köln, Germany) or AUS (AMS800® ; Boston Scientific, Boston, MA, USA) since July 2011 to December 2017 and with ≥12 months of follow-up. Preoperative assessment included 24-h pad usage, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), urethrocystoscopy, and urodynamics if indicated. Propensity score-matching analysis was based on age, body mass index, Charlson Comorbidity Index, pad usage, previous radiotherapy, and urethrotomy. The primary outcome was at least 'much improved' response at 12-months according to the Patient Global Impression of Improvement questionnaire, without additional PPI surgery or prosthesis explantation. RESULTS: Of 109 included patients, 70 patients were matched and the study groups were well balanced for the baseline matched variables. The median baseline 24-h pad usage was four in both groups (P = 0.10), and median follow-up was 51.2 months for AUS and 47.2 months (P = 0.5) for RTS patients. In the AUS and RTS cohorts, respectively, 33 (94.3%) and 24 (68.6%) patients achieved the primary outcome (P < 0.001), the 0-1 pad/day rates was 94.3% vs 68.6% (P = 0.012) at 12 months, and 91.4% vs 68.6% (P = 0.034) at last follow-up. At the last follow-up, the median 24-h leakage volumes, median ICIQ-SF scores and satisfaction rates were 0 vs 15 mL (P = 0.017), 4 vs 10 (P = 0.001), and 94.3% vs 68.6% (P = 0.012) in the AUS and RTS cohorts, respectively. There were no significant differences in overall rates of complications and re-interventions, although Clavien-Dindo Grade III complications (n = 3) occurred only in the AUS group. At sensitivity analysis, the study was reasonably robust to hidden bias. CONCLUSION: We found that AUS implantation significantly outperformed RTS in patients with moderate PPI for both subjective and objective outcomes.

Extensive impact of COVID-19 pandemic on pelvic floor dysfunctions care: A nationwide interdisciplinary survey.

AIMS: To investigate the impact of COVID-19 pandemic on health-care provision to patients suffering from pelvic floor dysfunctions in Italy. METHODS: A retrospective web-based interdisciplinary survey was mailed by the Italian Society of Urodynamics to members involved in pelvic floor dysfunctions management from June 22, 2020 to July 17, 2020. The 84-item questionnaire investigated the period March-June 2020 (first epidemic wave) and showed high content validity. The primary outcome was the mean rate of cancellation for health-care services. Secondary outcomes included estimation of the accumulated surgeries backload until return to baseline activity and of the recovery pattern, using linear regression and scenario-based forecasting. RESULTS: A total of 85 participants provided complete responses. Respondents were mostly urologists (47%), followed by gynecologists (29.5%) and physiatrists (17.6%). On average, 78.4% of outpatient services and 82.7% of functional surgeries were canceled, without significant differences by geographical distribution. An impact on patients' quality of life was anticipated by most of the respondents (87%) and 48.2% also reported potentially serious health risks for patients. Thirty-three percent of the respondents reported the use of telemedicine. If the nation-wide surgical activity increases by 20% postpandemic, it would take 37 months to clear the backlog of functional surgeries. We acknowledge the inherent limitations of the survey methodology and retrospective design. CONCLUSIONS: Access to care for patients suffering from pelvic floor dysfunctions has been dramatically affected by the COVID-19 outbreak. The indirect effects of this unprecedented disruption on pelvic floor dysfunctions care may last for several months.

Patient pad count is a poor measure of urinary incontinence compared with 48-h pad test: results of a large-scale multicentre study.

OBJECTIVE: To determine in a large population of community-dwelling incontinent patients the accuracy and determinants of pad count as a measure of urinary incontinence (UI), using data from a multicentre 48-h pad test study. MATERIALS AND METHODS: Incontinent patients, who were provided with absorbent products for the period January 2012 to March 2016, volunteered to perform a 48-h home-based pad test and to fill in a diary with information on pad usage. Correlations between UI measures (48-h pad count and pad weight gain, mean pad weight gain per pad) were calculated. Logistic regression analyses were conducted to investigate patient-related and pad usage-related factors influencing pad count. RESULTS: A total of 14 493 patients (median age 81 years) were included, with a total of 98 362 continence products used overall during the study period. The 48-h pad count showed a weak correlation with 48-h pad weight gain (R2 = 0.12; 0.19 for men and 0.11 for women) and mean pad weight gain per pad (R2 = -0.03). The weakest correlation was observed among patients using >6 pads/48 h (R2 = 0.02). A statistically significant negative association between pad absorption capacity and pad count was observed. Patients using products with a shaped and rectangular design had 34% and 40% higher propensity to use more pads than those using briefs (P < 0.001), respectively. CONCLUSIONS: The results of this very large observational study confirmed that pad count is a poor measure of UI severity. Pad count only measured 12% of the variability of UI volume and was affected by several patient-related and pad usage-related factors. Consequently, pad count should not be used instead of the pad test as an objective measure of UI when an accurate evaluation is required for research or clinical purposes.

Management of Iatrogenic Bladder Injury due to Vascular Surgery: Case Report and Literature Review.

We report an unusual case of a 53-year-old male patient, previously undergone an extra-anatomic right-to-left iliofemoral bypass graft, who has developed gross hematuria after 4 months. The cystoscopic examination revealed a wall injury due to the presence of the graft crossing the bladder. Iatrogenic bladder injuries during vascular surgery are extremely rare. In the literature, only 11 cases of transvesical graft are reported. The complication has been resolved with the removal of the misplaced graft and the reconstruction of the bypass with silver-coated Dacron prosthesis. Despite the rarity of this complication, postoperative ultrasound of the bladder is recommended to timely detect any injury and adopt a correct surgical strategy.

Can Neutrophil-to-Lymphocyte ratio predict the response to BCG in high-risk non muscle invasive bladder cancer?

OBJECTIVES: To evaluate the neutrophil-to-lymphocyte ratio (NLR) as a prognostic factor for response of high risk non muscle invasive bladder cancer (HRNMIBC) treated with BCG therapy. MATERIALS AND METHODS: Between March 2010 and February 2014 in a tertiary center 100 consecutive patients with newly diagnosed HRNMIBC were retrospectively analyzed. Patients were divided according to NLR value: 46 patients with NLR value less than 3 (NLR < 3 group), and 54 patients with NLR value more than 3 (NLR ≥ 3 group). At the end of follow-up 52 patients were high grade disease free (BCG-responder group) and 48 patients underwent radical cystectomy for high grade recurrence or progression to muscle invasive disease (BCG non-responder group). The average follow-up was 60 months. INTERVENTION: analysis and correlation of preoperative NLR value with response to BCG in terms of recurrence and progression. RESULTS: The optimal cut-off for NLR was ≥ 3 according to the receiver operating characteristics analysis (AUC 0.760, 95% CI, 0.669-0.850). Mean NLR value was 3.65 ± 1.16 in BCG non-responder group and 2.61 ± 0.77 in BCG responder group (p = 0.01). NLR correlated with recurrence (r = 0.55, p = 0.01) and progression risk scores (r = 0.49, p = 0.01). In multivariate analysis, NLR (p = 0.02) and EORTC recurrence risk groups (p = 0.01) were associated to the primary endpoint. The log-rank test showed statistically significant difference between NLR < 3 and NLR ≥ 3 curves (p < 0.05). CONCLUSIONS: NLR value preoperatively evaluated could be a useful tool to predict BCG response of HRNMIBC. These results could lead to the development of prospective studies to assess the real prognostic value of NLR in HRNMIBC.

ElectroMotive drug administration (EMDA) of Mitomycin C as first-line salvage therapy in high risk "BCG failure" non muscle invasive bladder cancer: 3 years follow-up outcomes.

BACKGROUND: In case of high grade non-muscle invasive bladder cancer (HG-NMIBC), intravesical BCG represents the first-line treatment; despite the "gold" standard therapy, up to 50% of patients relapse, needing radical cystectomy. Hence, alternative therapeutic strategies have been developed. The aim of the study was to evaluate a first-line salvage treatment with EMDA®-MMC in patients with HGNMIBC unresponsive to BCG. METHODS: We carried out a prospective, single-center, single-arm Phase II study in order to evaluate the efficacy (in terms of recurrence and progression) and the safety of the EMDA®-MMC treatment in 26 (21 male, 5 female) consecutive patients with "BCG refractory" HGNMIBC on a 3 years follow-up. EMDA®-MMC treatment consisted of 40 mg of MMC diluted in 100 ml of sterile water retained in the bladder for 30 min with 20 mA pulsed electric current. EMDA®-MMC regimen consisted of an induction course of 6 weekly instillations followed by a maintenance course of 6 monthly instillations. Follow-up was performed with systematic mapping biopsies of the bladder (with sampling in the prostatic urethra for men), voiding and washing urinary cytology, radiological study of the upper urinary tract. We performed Survival Kaplan-Meier curves and Log-rank test in order to analyze high grade disease-free survival. RESULTS: At the end of follow-up, 16 patients (61.5%) preserved their native bladder; 10 patients (38.4%) underwent radical cystectomy, in 6 patients (23.1%) for recurrent HGNMIBC and in 4 patients (15.4%) for progression to muscle-invasive disease. At the end of follow-up, stratifying patients based on TNM classification (TaG3, T1G3, Cis, TaT1G3 + Cis), disease-free rates were 75, 71.4, 50 and 25%, respectively; survival curves showed statistically significant differences (p value < 0.05). Regarding toxicity, we reported severe adverse systemic event of hypersensitivity to the MMC in 3 patients (11.5%), and local side effects in 6 patients (26.1%). CONCLUSIONS: In the field of alternative strategies to radical cystectomy, the EMDA®-MMC could be considered safe and effective in high-risk NMIBC unresponsive to BCG, as a "bladder sparing" therapy in selected patients. Multicenter studies with a larger number of patients and a longer follow-up might confirm our preliminary results. TRIAL REGISTRATION: EudraCT2017-002585-43. 17 June 2017 (retrospectively registered).

Objectively improving appropriateness of absorbent products provision to patients with urinary incontinence: The DIAPPER study.

AIMS: To objectively assess and enhance the appropriateness of continence products provision to sufferers from urinary incontinence (UI) managed with containment strategies. METHODS: Incontinent patients of five Italian continence care services were included in this industry-supported study from 01/2012 to 03/2016. All patients/carers have been invited to perform a 48-h home-based pad test and to fill in a diary. The primary outcome was the product appropriateness defined as the use of a pad with maximum absorbent capacity (MAC) from 30% to 50% higher than the individually measured urine load. Pads provision was corrected accordingly. Meaningful factors affecting products appropriateness and patient's satisfaction with the new products were also assessed. RESULTS: The study included 14 493 subjects (mean age 78 years; 26% males, 74% females) using overall during the study days 98 362 pads. Sixty percent of the products were found to be not appropriate. In most of cases, (75%) products were inappropriate because too large. Age and pad weight gain, followed by gender, body weight, waist circumference, level of autonomy and mobility, pad wearing time, skin health status, and health district were independently associated to the propensity to inappropriateness. After correction of products prescription, a significant reduction (-31%) of the use of largest products was observed. At 6 months evaluation, 88% of evaluable participants were satisfied with the new prescription. CONCLUSIONS: Most of patients are provided with not appropriate containment products. The use of the 48-h pad test allows improving on an individual basis the appropriateness of products provision.

Intraprostatic botulinum toxin type "A" injection in patients with benign prostatic hyperplasia and unsatisfactory response to medical therapy: A randomized, double-blind, controlled trial using urodynamic evaluation.

AIMS: The injection of botulinum neurotoxin A (BTA) into the prostate represents a minimally invasive treatment in patients with lower urinary tract symptoms (LUTS) associated to benign prostatic hyperplasia (BPH). We evaluated the effectiveness of BTA in treating patients with BPH unresponsive to combined medical therapy (CMT), using urodynamic investigations. METHODS: This is a randomized, placebo-controlled, double blind trial. Twenty consecutive patients were randomly assigned to receive intraprostatic BTA injection (n = 10) or saline solution (SS) (n = 10). Patients in the intervention group (IG) received 200-300 UI of BTA diluted in 6-8 mL of SS and injected into the transitional zone. Patients in the control group (CG) were treated with SS alone. Primary endpoint was International Prostate Symptom Score (IPSS). Secondary endpoints were: maximum flow rate (Qmax), postvoid residual volume (PVR), maximum cystometric capacity (MCC), bladder outlet obstruction index (BOOI), safety, quality of life (QoL) score, and Patient Reported Outcome (PROs). RESULTS: All patients in the IG reported subjective improvement starting after 1 month. At 3 months of follow-up IPSS, QoL, PVR were reduced by 55,3% (P < 0.01), and 50% (P < 0.01), 80,6%, (P < 0.01), respectively. Qmax was increased by 68% (P < 0.01). MCC increased by 27% (P < 0.01) and BOOI decreased by 54% (P < 0.01). PROs analysis revealed that 90% of patients in the IG reported a subjective symptomatic relief and treatment satisfaction. No local or systemic side effects were observed in any group. CONCLUSIONS: These results indicated that intraprostatic BTA is safe and can improve LUTS and QoL in patients with BPH and unsatisfactory response to CMT.

SOCS3 Immunohistochemical Expression Seems to Support the 2005 and 2014 International Society of Urological Pathology (ISUP) Modified Gleason Grading System.

BACKGROUND: In the 2014, The International Society of Urological Pathology (ISUP) consensus conference update the grading of prostate, last revised in 2005. In this study we evaluate the SOCS3 immunohistochemical protein expression in different Gleason prostatic adenocarcinoma: classical Gleason grade 3, classical Gleason grade 3 upgraded to Gleason grade 4 according to the ISUP modifications and classical and modified Gleason grade 4. The major conclusions were: (i) Cribriform glands should be assigned a Gleason pattern 4, regardless of morphology; (ii) Glomeruloid glands should be assigned a Gleason pattern 4, regardless of morphology; (iii) Grading of mucinous carcinoma of the prostate should be based on its underlying growth pattern rather than all as pattern 4; and (iv) Intraductal carcinoma of the prostate without invasive carcinoma should not assigned Gleason grade and a comment about aggressive carcinoma probably associated should be made. In a recent report we analyzed the methylathion status of cytokine signaling (SOCS) proteins 3 (SOCS3) gene and the consequences of promoter hypermethylation on mRNA and protein expression in a collection of prostate cancer and benign prostate hyperplasia (BPH) and for the first time we demonstrated that a hypermethylation of SOCS3 with a significant reduction of its mRNA and protein expression identifies a subgroup of prostate cancer with a more aggressive behavior. Moreover we demonstrated that the immunohystochemical analysis of SOCS3 protein expression in prostatic cancer biopsies may provide a useful and easier method than SOCS3 methylation analysis to individuate in cancer with intermediate-high grade Gleason score a subgroup of prostate cancer with a more aggressive behavior. METHODS: A total of 148 radical prostatectomy with diagnosis of prostatic acinar adenocarcinoma were stratified into three different categories on the basis of Gleason grade: (i) Twenty-six prostatic adenocarcinoma with classical and modified Gleason grade 3; (ii) Fifty seven prostatic adenocarcinoma with classical Gleason grade 3 upgraded to Gleason grade 4 by 2005 and 2014 ISUP Consensus Conference; and (iii) Sixty five prostatic adenocarcinoma with classical and modified Gleason grade 4. Immunohistochemical analysis for SOCS3 was performed and SOCS3 staining intensity were evaluated by two pathologists in three different ways on the basis of the intensity of cytoplasmatic staining: positive (intense cytoplasmatic staining in more than 50% of neoplastic cells) (+), negative (absence of cytoplasmatic staining in more than 50% of neoplastic cells) (-), weakly positive (weak cytoplasmatic staining in more than 50% of neoplastic cells (+/-). RESULTS: In the group of prostatic adenocarcinoma Gleason grade 3 we found that SOCS3 positivity (+) were observed in 19 out of 26 cases (73.1%); in 5 out of 26 prostatic adenocarcinoma the neoplastic glands showed weak intensity SOCS3 staining (+/-) (19.2%), while in only two cases we found SOCS-3 negativity (-) (7.7%); in the group of cases with prostatic adenocarcinoma with Gleason grade 4, 16 out 65 cases (24.6%) showed SOCS3 positivity (+); 18 out 65 cases (27.7%) SOCS3 weakly positive (+/-), and in 31 cases (47.7%) SOCS3 negative staining (-) were observed. Interestingly, the group of prostatic adenocarcinoma with histological Gleason 3 pattern upgraded to Gleason 4 pattern according to the 2005 and 2014 ISUP modified grading system, showed SOCS3 positivity (+) in 16 out of 57 cases (28%), in 16 out 57 cases (28%) a weakly positive for SOCS3 (+/-) were observed, while 25 cases (44%) showed negative SOCS3 staining (-). CONCLUSIONS: In this study we demonstrated a significant association of SOCS3 positivity (+) with prostatic carcinoma classical Gleason pattern 3 (P < 0.0001), while SOCS3 negative pattern (-) or SOCS3 weakly positive pattern (+/-) were associated to prostatic carcinomas with Gleason pattern 3 upgraded to Gleason pattern 4 (P = 0.0002) and with classical Gleason pattern 4. The significant difference of SOCS3 immunohistochemical expression between classical Gleason grade 3 and Gleason grade 4 upgraded to grade 4 seems to support the definitions and the modifications of Gleason grade 4 of the 2005 and the 2014 International Society of Urological Pathology (ISUP). The hypoexpression of SOCS3 protein in glomeruloid glands could support the hypothesis that from molecular point of view this growth pattern could be different from classical Gleason pattern 3 and biologically more closely to Gleason pattern 4, confirming the conclusions of the 2014 ISUP Conference assigning a Gleason pattern 4 to glomeruloid glands regardless of morphology. Prostate 77: 597-603, 2017. © 2017 Wiley Periodicals, Inc.

Pharmacological methods for the preclinical assessment of therapeutics for OAB: an up-to-date review.

INTRODUCTION: Licenced oral pharmacotherapies for overactive bladder (OAB) act on muscarinic receptors or ß3-adrenoceptors. The search for new drugs to treat OAB that have novel mechanisms of action is very active, with the aim of discovering more effective and/or better tolerated agents. METHODS: A literature review of the most frequently used pharmacological methods for the preclinical assessment of new agents aimed at treating OAB, such as isolated organ technique, electrophysiological techniques, radioligand binding assay, and animal models, was carried out. Novel potential developments based on recent knowledge of urothelial and neural mechanisms are also discussed. RESULTS: The isolated organ technique, electrophysiological techniques, and the radioligand binding assay are very effective methods for the demonstration that a novel pharmacological target with a specific and high affinity binding site for a new drug is present in the bladder and its modulation regulates functions critical for the pathophysiology of OAB. Afterward, the new drug should be shown to be effective in animal models of OAB, although the translational value of these models is limited by a poor pathophysiological relationship with human OAB. Exciting novel perspectives focusing in particular on the theory of the mucosal-bladder network have recently opened new paths in the discovery and assessment of new therapeutics in this field. CONCLUSIONS: Available experimental models still play a central role in the appraisal of OAB therapeutics; however, their shortcomings and the paucity of very effective drugs indicate the need for new models that better reproduce the pathophysiological features of OAB. Some emerging lines of research show promise. A change of perspective in the future evaluation of putative drugs is required, especially in the light of the latest knowledge on the key role of the mucosal-bladder network and the brain-bladder neural pathways.

Innovative pharmacotherapies for women with overactive bladder: where are we now and what is in the pipeline?

INTRODUCTION AND HYPOTHESIS: The impressive prevalence of overactive bladder (OAB) and the relevant limitations of current treatments urge the need for novel therapeutic approaches. METHODS: A systematic literature and web search was performed to identify investigational drugs that entered the early and late phases of clinical development for women with OAB symptoms. RESULTS: Approved pharmacological therapies for OAB (antimuscarinics, beta-3 agonists, and botulinum toxin) are evolving with the development of alternative administration methods, combination strategies, and novel compounds, expected to improve effectiveness, bladder selectivity, and dose flexibility. A wealth of investigational compounds, developed with both public and companies' indoor nonclinical disease-oriented studies, entered the early and late stages of clinical development in the last decade. Most non-anticholinergic compounds in ongoing clinical trials target central and peripheral neurotransmitter receptors involved in neurological modulation of micturition, nonadrenergic-noncholinergic mechanisms, cyclic nucleotide metabolism, different subtypes of ion channels or peripheral receptors of prostaglandins, vanilloids, vitamin D3, and opioids. Fascinating advances are ongoing also in the field of genetic therapy. CONCLUSIONS: New pharmaceutical formulations and drug combinations are expected to be available in the next decade in order to overcome the limitations of current drugs for OAB. Although proof-of-concept, patient-oriented studies yielded disappointing results for several tentative drugs, a lot of clinical research is ongoing that is expected to provide clinicians with novel therapeutic agents in the near future.

OnabotulinumtoxinA injection therapy in men with LUTS due to primary bladder-neck dysfunction: objective and patient-reported outcomes.

OBJECTIVE: To determine efficacy and safety of OnabotulinumtoxinA (BoNT-A) injection therapy in medically refractory patients with lower urinary tract symptoms (LUTS) due to primary bladder-neck dysfunction (PBND). MATERIALS AND METHODS: Thirty-five consecutive ambulatory males diagnosed with PBND and refractory to medical therapy, with IPSS > 15, Qmax < 15 ml/sec, and total prostate volume < 30 cm(3), were screened from January 2010 to December 2011. Eligible patients underwent transurethral bladder-neck injection of BoNT-A (200 U, 50 U/ml × 4 sites) and were assessed at baseline, 2-, 6-, 9-, and 12-month postprocedure and until duration of clinical response. The primary outcome was the change from baseline in total IPSS, and secondary outcome were storage- and voiding-IPSS, QoL score, Qmax, and postvoiding residual volume (PVR), patient-reported outcomes. Adverse effects were also recorded, including ejaculatory dysfunctions. RESULTS: Of 30 enrolled patients (mean age 33.8 years), 29 (96.7%) completed the study. A statistically significant improvement of total IPSS was observed from 21.9 at baseline, to 7.8, 10.3, and 16.6 at 2, 6, and 9 months, respectively (P < 0.000). Statistically significant improvements from baseline of storage- and voiding-IPSS, QoL score, Qmax, and PVR were also observed until 9-month postprocedure. The proportion of patients with overall satisfaction was favorable although decreasing from 80% at 2 months, to 44.8% at 12 months. No significant adverse effects or ejaculatory dysfunctions were noted. CONCLUSIONS: BoNT-A injection therapy appears effective and safe in medically refractory men with PBND, although repeated procedures are required for long-term sustained benefit. Randomized controlled trials are warranted in order to corroborate these results.

Antibiotic prophylaxis in urologic interventions: Who, when, where?

BACKGROUND: Periprocedural prophylaxis in medicine encompasses the set of measures (physical, chemical, and pharmacological) used to reduce the risk of infection. Antibiotic prophylaxis (AP) refers to the administration of a short-term regimen of antibiotics shortly before a medical procedure to reduce the risk of infectious complications that can result from diagnostic and therapeutic interventions. The outspreading growth of multidrug-resistant bacterial species and changes in the bacterial local ecosystem have impeded the development of a unique scheme of AP in urology. OBJECTIVES: To review the literature and current guidelines regarding AP for urological diagnostic and therapeutic procedures, and to define agents, timing, and occasions when administering pharmacological prophylaxis. Secondly, according to current literature, to open new scenarios where AP can be useful or useless. RESULTS: Major gaps in evidence still exist in this field. AP appears useful in many invasive procedures and some sub-populations at risk of infectious complications. AP is not routinely recommended for urodynamic exams, diagnostic cystoscopy, and extracorporeal shock-wave lithotripsy. The available data regarding the use of AP during the transperineal prostate biopsy are still unclear; conversely, in the case of the transrectal approach AP is mandatory. AP is still considered the gold standard for the prevention of postoperative infective complications in the case of ureteroscopy, percutaneous nephrolithotomy, endoscopic resection of bladder tumor, endoscopic resection of the prostate, and prosthetic or major surgery. CONCLUSION: The review highlights the complexity of determining the appropriate candidates for AP, emphasizing the importance of considering patient-specific factors such as comorbidities, immunocompetence, and the nature of the urologic intervention. The evidence suggests that a one-size-fits-all approach may not be suitable, and a tailored strategy based on the specific procedure and patient characteristics is essential.

Efficacy of transurethral botulinum toxin A injections for bladder outlet obstruction: A systematic review and meta-analysis.

INTRODUCTION: Botulinum toxin A (BoNT-A) injections in the prostate gland have been used as a minimally invasive option for treating bladder outlet obstruction (BOO). However, the efficacy of transurethral BoNT-A injections for BOO is not well established in the literature. The aim of this study is to collect evidence on the efficacy of transurethral BoNT-A injections for the treatment of BOO. MATERIALS AND METHODS: This systematic review and meta-analyses was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. A systematic literature search was performed till December 2022. The study population consisted of adult patients diagnosed with BOO, who underwent transurethral injections of BoNT-A for the treatment of BOO. EVIDENCE SYNTHESIS: Out of 883 records, we identified seven studies enrolling 232 participants, of which only one nonrandomized controlled trial was found. Four prospective studies and two retrospective studies. Three studies included patients with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH) and were included in the meta-analysis. Three studies included patients with urethral sphincter hyperactivity. One study included patients with primary bladder neck disease (PBND). All studies showed significant improvements from baseline in maximum urinary flow rate (Qmax), International Prostate Symptom Score (IPSS), and postvoid residual (PVR) at 3 and 6 months. The adverse events were mild in all studies. Hematuria, UTI, and urinary retention were reported across all studies. CONCLUSION: In conclusion, transurethral BoNT-A injections have been shown to improve LUTS, QoL, and urodynamic parameters of individuals with BOO at 3 and 6 months after injections, and no serious adverse effects have been reported. However, data on the long-term benefits of this treatment are scarce, and more prospective, randomized studies with larger samples examining various injection techniques, dosages, and extended follow-up of recurrent injections are needed.

Perioperative Outcomes of Robotic Radical Prostatectomy with Hugo™ RAS versus daVinci Surgical Platform: Propensity Score-Matched Comparative Analysis.

Background/Objectives: There is an urgent need for comparative analyses of the intraoperative, oncological, and functional outcomes of different surgical robotic platforms. We aimed to compare the outcomes of RARP performed at a tertiary referral robotic centre with the novel HugoTM RAS system with those performed with a daVinci surgical system, which is considered the reference standard. Methods: We analysed the data of 400 patients undergoing RARP ± pelvic lymph node dissection between 2021 and 2023, using propensity score (PS) matching to correct for treatment selection bias. All procedures were performed by three surgeons with HugoTM RAS or daVinci. Results: The PS-matched cohort included 198 patients with 99 matched pairs, balanced for all covariates. Positive surgical margins (PSMs) were found in 22.2% and 25.3% (p = 0.616) of patients, respectively, in the HugoTM RAS and daVinci groups. No significant differences were found for other important perioperative outcomes, including median (1st-3rd q) operative time (170 (147.5-195.5) vs. 166 (154-202.5) min; p = 0.540), median (1st-3rd q) estimated blood loss (EBL) (100 (100-150) vs. 100 (100-150) ml; p = 0.834), Clavien-Dindo (CD) ≥ 2 complications (3% vs. 4%; p = 0.498), and social continence at 3 months (73.7% vs. 74.7%; p = 0.353). In multiple analyses, no associations were found between surgical outcomes (PSM, length of PSM, operative time, EBL, length of catheterization, length of hospital stay, social continence at three months after surgery, and CD ≥ 2 complications) and the robotic platform. Conclusions: Our findings demonstrate that HugoTM RAS enables surgeons to safely and effectively transfer the level of proficiency they reached during their previous experience with the daVinci systems.

Assessing Trifecta and Pentafecta Success Rates between Robot-Assisted vs. Open Radical Cystectomy: A Propensity Score-Matched Analysis.

BACKGROUND: This study aimed to evaluate the surgical and oncological outcomes of robot-assisted radical cystectomy (RARC) versus open radical cystectomy (ORC) using trifecta and pentafecta parameters. METHODS: The clinical data of 41 patients who underwent RARC between 2018 and 2022 were prospectively collected and retrospectively compared to those of 330 patients undergoing ORC using 1:1 propensity score matching. Trifecta was defined as simultaneous negative surgical margins (SMs), a lymph node (LN) yield ≥ 16, and the absence of major complications (Clavien-Dindo grade III-V) within 90 days postoperatively. Pentafecta additionally included a 12-month recurrence-free rate and a time between the transurethral resection of a bladder tumor (TURBT) and radical cystectomy (RC) ≤ 3 months. The continuous variables were compared using the Mann-Whitney U test, and the categorical variables were analyzed using the chi-squared test. RESULTS: No statistically significant differences in trifecta and pentafecta success rates were observed between the RARC and ORC cohorts after propensity score matching. However, the RARC group exhibited significantly reduced blood loss (RARC: 317 mL vs. ORC: 525 mL, p = 0.01). CONCLUSIONS: RARC offers distinct advantages over ORC in terms of reduced blood loss, while trifecta and pentafecta success rates do not differ significantly between the two surgical approaches.

Robot-Assisted Radical Prostatectomy Performed with the Novel Hugo™ RAS System: A Systematic Review and Pooled Analysis of Surgical, Oncological, and Functional Outcomes.

Background/Objectives: to assess surgical, oncological, and functional outcomes of robot-assisted radical prostatectomy (RARP) performed using the novel Hugo™ RAS system. Methods: A systematic review was conducted following the PRISMA guidelines, using PubMed, Web of Science, Scopus, and Embase databases. Eligible papers included studies involving adult males undergoing RARP with the Hugo™ RAS platform, with at least ten patients analyzed. The pooled analysis was performed using a random-effect model. Results: Quantitative analysis was conducted on 12 studies including 579 patients. The pooled median docking time, console time, and operative time were 11 min (95% CI 7.95-14.50; I2 = 98.4%, ten studies), 142 min (95% CI 119.74-164.68; I2 = 96.5%, seven studies), and 176 min (95% CI 148.33-203.76; I2 = 96.3%, seven studies), respectively. The pooled median estimated blood loss was 223 mL (95% CI 166.75-280.17; I2 = 96.5%, eleven studies). The pooled median length of hospital stay and time to catheter removal were 2.8 days (95% CI 1.67-3.89; I2 = 100%, ten studies) and 8.3 days (95% CI 5.53-11.09; I2 = 100%, eight studies), respectively. The pooled rate of postoperative CD ≥ 2 complications was 4.1% (95% CI 1-8.5; I2 = 63.6%, eleven studies). The pooled rate of positive surgical margins and undetectable postoperative PSA were 20% (95% CI 12.6-28.5; I2 = 71.5%, nine studies) and 94.2% (95% CI 87.7-98.6; I2 = 48.9%, three studies), respectively. At three months, a pooled rate of social continence of 81.9% (95% CI 73.8-88.9; I2 = 66.7%, seven studies) was found. Erectile function at six months was 31% in one study. Conclusions: despite the preliminary nature of the evidence, this systematic review and pooled analysis underscores the feasibility, safety, and reproducibility of the Hugo™ RAS system in the context of RARP.

Robot-Assisted Radical Prostatectomy Performed with the Novel Surgical Robotic Platform Hugo™ RAS: Monocentric First Series of 132 Cases Reporting Surgical, and Early Functional and Oncological Outcomes at a Tertiary Referral Robotic Center.

BACKGROUND: Robotic-assisted surgery is the gold standard for performing radical prostatectomy (RARP), with new robotic devices such as HugoTM RAS gaining prominence worldwide. OBJECTIVE: We report the surgical, perioperative, and early postoperative outcomes of RARP using HugoTM RAS. DESIGN, SETTING, AND PARTICIPANTS: Between April 2022 and October 2023, we performed 132 procedures using the Montsouris technique with a four-robotic-arm configuration in patients with biopsy-proven prostate cancer (PCa). OUTCOME MEASURES: We collected intraoperative and perioperative data during hospitalization, along with follow-up data at predefined postoperative intervals of 3 and 6 months. RESULTS AND LIMITATIONS: Lymphadenectomy was performed in 25 procedures, with a bilateral nerve-sparing technique in 33 and a monolateral nerve-sparing technique in 33 cases. The mean total surgery time was 242 (±57) min, the mean console time was 124 (±48) min, and the mean docking time was 10 (±2) min. We identified 17 system errors related to robotic arm failures, 9 robotic instrument breakdowns, and 8 significant conflicts between robotic arms. One post-operative complication was classified as Clavien-Dindo 3b. None of the adverse events, whether singular or combined, increased the operative time. Positive margins (pR1) were found in 54 (40.9%) histological specimens, 37 (28.0%) of which were clinically significant. At 3 and 6 months post-surgery, the PSA levels were undetectable in 94.6% and 92.1% of patients, respectively. Social urinary continence was regained in 86% after 6 months. Limitations of our study include its observational monocentric case-series design and the short follow-up data for functional and oncological outcomes. CONCLUSIONS: Our initial experience highlights the reliability of the HugoTM RAS system in performing RARP. Additionally, we also list problems and solutions found in our daily work.

Elderly and bladder cancer: The role of radical cystectomy and orthotopic urinary diversion.

The incidence of bladder cancer (BC) depends on advancing age and other risk factors, significantly impacting on surgical, functional and oncological outcomes. Radical cystectomy (RC) with urinary diversion is the gold standard therapy for muscle invasive bladder cancer; however, it remains a complex surgery and requires careful analysis of risk factors in order to potentially decrease post-surgical complication rates. Age in surgery is a limiting factor that can modify surgical and oncological outcomes, and is correlated with a high rate of post-dimssion hospital readmissions. The reconstruction of the bladder with the intestine represents a crucial point of radical cystectomy and the urinary derivation (UD) is at the center of many debates. A non-continent UD seems to be the best choice in elderly patients (>75 years old), while orthotopic neobladder (ON) is poorly practiced. We reviewed the literature to identify studies reporting outcomes, complications, patient- selection criteria, and quality-of-life data on elderly patients, who underwent ON following radical cystectomy. Reviewing the literature there is no clear evidence on the use of age as an exclusion criterion. Certainly, the elderly patient with multiple comorbidities is not eligible for ON, preferring other UD or rescue therapies. A careful preoperative selection of elderly patients could greatly improve clinical, surgical and oncological outcomes, giving the chance to selected patients to receive an ON.

Predictive Factors for Major Complications and Urological Cancer Diagnosis in Older Adults (≥80 Years) Admitted to the Emergency Department for Hematuria.

Background: Gross Hematuria is a relevant cause of admission to the emergency department in the general population and particularly in older adults (≥80 years). This specific urological symptom is often underestimated and usually associated with benign conditions such as urinary infections or poor hydration. Nevertheless, hematuria could lead to severe acute complications or be the first symptom of urological cancers. Methods: We retrospectively analyzed clinical data from 1169 patients aged ≥80 years consecutively admitted to the emergency department for hematuria. The primary endpoint of the study was to identify risk factors for major complications, and the secondary endpoint was to analyze risk factors for urological cancer diagnosis. The median age was 85 years (IQR 82-88 years), and 908 (77%) were males. Among them, 449 (38.4%) had a past medical history of urological neoplasm (kidney, ureter, bladder, prostate, or urethral cancer). Results: Overall, 87 patients (7.4%) had major complications (patient death, septic shock, and admission to the intensive care unit). Worse vital signs at admission, fever, and confusion (p < 0.001, OR 18.0 IC 95% [5.5-58.7]; p = 0.015, OR 2.0 IC 95% [1.1-3.5]; p = <0.001, OR 4.2 IC 95% [1.9-3.5], respectively), as well as lower hemoglobin values and higher Charlson comorbidity index (p < 0.001, OR 0.8 IC 95% [0.7-0.9]), p = 0.002, OR = 1.2 [1.1-1.3]) were independent predictive factors for major complications. The multivariate analysis identified as risk factors for diagnosis of urological cancer older age, male sex and higher comorbidity (OR 1.05 IC95% [1-1.09]; OR 2.19 IC95% [1.42-3.39] and OR 1.11 IC95% [1.2-1.2], respectively); interestingly the presence of indwelling vesical catheter (IVC) (OR 0.44 IC95% [0.24-0.82]) resulted as an independent factor for absence of urological cancers. Conclusions: Hematuria is a frequent symptom in older adults admitted to the emergency department. While this is often associated with benign conditions, there are some risk factors for major complications and for urological cancer that must be taken into account to identify the patients who need further evaluation or prompt hospital admission.