Efficacy of Palmitoylethanolamide, Epilobium and Calendula suppositories for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome type III.

OBJECTIVE: The management of chronic prostatitis/ chronic pelvic pain syndrome type III (CP/CPPS) has been always considered complex due to several biopsychological factors underlying the disease. In this clinical study, we aimed to evaluate the efficacy of the treatment with Palmitoylethanolamide, Epilobium and Calendula extract in patients with CP/CPPS III. MATERIALS AND METHODS: From June 2023 to July 2023, we enrolled 45 consecutive patients affected by CP/CPPS type III in three different institution. We included patients aged between 18 and 75 years with symptoms of pelvic pain for 3 months or more before the study, a total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score ≥ 12 point and diagnosed with NIH category III, according to 4-glass test Meares-Stamey test. Patients were then allocated to receive rectal suppositories of PEA, Epilobium and Calendula, 1 suppository/ die for 1 month. All patients have been tested with standard urinalysis in order to assess urinary leukocytes (U-WBC). The primary endpoint of the study was the reduction of NIHCPSI. The secondary outcomes were the change of peak flow, post-void residual (PVR), IIEF-5, VAS score, PSA and decrease of U-WBC. RESULTS: A total of 45 patients concluded the study protocol. At baseline, the median age of all the patients included in the cohort was 49 years, the median PSA was 2.81 ng/ml, the median NIH-CPSI was 18.55, the median IIEF-5 was 18.27, the median U-WBC was 485.3/mmc, the median VAS score was 6.49, the median PVR was 26.5 ml and the median peak flow was 16.3 ml/s. After 1 month of therapy we observed a statistically significant improvement of NIH-CPSI, U-WBC, PSA, IIEF-5, peak flow, PVR and VAS. CONCLUSIONS: In this observational study, we showed the clinical efficacy of the treatment with PEA, Epilobium and Calendula, 1 suppository/die for 1 month, in patients with CP/CPPS III. The benefits of this treatment could be related to the reduction of inflammatory cells in the urine that could imply a reduction of inflammatory cytokines. These results should be confirmed in further studies with greater sample size.

Risk of unfavorable outcomes after penile prosthesis implantation - results from a national registry (INSIST-ED).

Like all surgeries, penile prosthesis implantation (PPI) has the potential for both postoperative complications and suboptimal patient satisfaction. In order to assess risk factors for poor satisfaction, we reviewed patients who had been prospectively recruited in a national multi-institutional registry of penile prostheses procedures (INSIST-ED) from 2014 to 20121. Patient baseline characteristics and postoperative complications were recorded. The primary endpoint of this study was unfavorable outcomes after inflatable PPI, defined as significant postoperative complications (Clavien-Dindo ≥2) and/or Sexuality with Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) scores below the 10th percentile. A total of 256 patients were included in the study. The median age was 60 years (IQR 56-67). The most common cause of erectile dysfunction (ED) was organic (42.2%), followed by pelvic surgery/radiotherapy (39.8%) and Peyronie's disease (18.0%). Postoperative complications were recorded in 9.6%. High-grade complications (Clavien ≥2) occurred in 4.7%. At 1-year follow-up, the median QoLSPP total score was 71 (IQR 65-76). In all, 14.8% of patients were classified as having experienced unfavorable outcomes because of significant postoperative complications and/or QoLSPP scores below the 10th percentile. Logistic regression analysis demonstrated patient age to be non-linearly associated with the risk of experiencing unfavorable outcomes. A U-shaped correlation showed a lower risk for younger and older patients and a higher risk for middle-aged men. ED etiology and surgical volume were not associated with PPI outcomes. Physicians should, therefore, be aware that middle-aged men may be at higher risk of being unsatisfied following PPI compared to both younger and older patients.

MRI-Cavernosography: A New Diagnostic Tool for Erectile Dysfunction Due to Venous Leakage: A Diagnostic Chance.

Erectile dysfunction caused by venous leakage is a vascular disease in which blood fails to accumulate in the corpora cavernosa due to the abrupt drainage of blood from the penis secondary to an abnormal venous network that affects 1 to 2% of men under 25 years old and about 10 to 20% over 60 years old, who do not raise a sufficient erection for penetrative sex. The study of the venous leak and its characterization in young patients with erectile dysfunction represent a diagnostic challenge, and imaging remains the best way to diagnose this condition. In the article, it is described the methods of execution and the diagnostic role of the cavernous MRI in the study of vasogenic erectile dysfunction from the venous leak, proposing it as a good alternative to the cavernous CT, considering the satisfactory results in terms of diagnostic interpretation, the absence of ionizing radiation, the higher soft tissue resolution of the imaging method and the lower administration of contrast agent.

Efficacy and safety profile of GreenLight laser photoselective vaporization of the prostate in ≥ 75 years old patients: results from the Italian GreenLight Laser Study Group.

BACKGROUND: Benign Prostatic Obstruction (BPO) is the most common non-malignant urological condition among men and its incidence rise with age. Among prostate treatments, GreenLight laser seems to reduce bleeding and would be safer in the aging population. AIMS: We aimed to compare the functional outcomes and safety profile of < 75 years old (Group A) and ≥ 75 years old (Group B) patients. METHODS: In a multicenter setting, we retrospectively analyzed all the patients treated with GreenLight Laser vaporization of the prostate (PVP). RESULTS: 1077 patients were eligible for this study. 757 belonged to Group A (median age 66 years) and 320 to Group B (median age 78 years). No differences were present between the two groups in terms of prostate volume, operative time, hospital stay, PSA decrease over time after surgery, complications and re-intervention rate with a median follow-up period of 18 months (IQR 12-26). Nevertheless, focusing on complications, GreenLight laser PVP demonstrated an excellent safety profile in terms of hospital stay, re-intervention and complications, with an overall 29.6% complication rate in older patients and only two cases of Clavien III. Functional outcomes were similar at 12 month and became in favor of Group A over time. These data are satisfactory with a Qmax improvement of 111.7% and an IPSS reduction of 69.5% in older patients. DISCUSSION AND CONCLUSIONS: GreenLight laser photoselective vaporization of the prostate is a safe and efficient procedure for all patients, despite their age, with comparable outcomes and an equal safety profile.

Which patient may benefit the most from penile prosthesis implantation?

BACKGROUND: Penile prosthesis implantation has been associated with overall good functional outcomes. Of relevance, some patients reported higher level of satisfaction and quality of life. AIM: We investigated the profile of the patients who may benefit the most from penile prosthesis implantation. MATERIALS AND METHODS: Data from a national multi-institutional registry of penile prostheses including patients treated from 2014 to 2017 in Italy (Italian Nationwide Systematic Inventarization of Surgical Treatment for Erectile Dysfunction) were analyzed. All data have been prospectively recorded by 45 surgeons on a dedicated website (www.registro.andrologiaitaliana.it) and revised by a single data manager. Patients' baseline characteristics were recorded. In order to simultaneously evaluate perceived penile prosthesis function and quality of life, all patients were re-assessed at 1-year follow-up using the validated questionnaire Quality of Life and Sexuality with Penile Prosthesis. High quality of life after surgery was defined as a score higher than the 75th percentile in each of the subdomains of the Quality of Life and Sexuality with Penile Prosthesis questionnaire. Logistic regression analysis tested the association between clinical characteristics and high quality of life after penile prosthesis implantation. RESULTS: Follow-up data were available for 285 patients (median age 60 years; interquartile range: 56-67) who underwent penile prosthesis implantation. Erectile dysfunction etiology was organic in 40% (114), pelvic surgery/radiotherapy in 39% (111), and Peyronie's disease in 21% (60) of the cases. Patients showed good overall Quality of Life and Sexuality with Penile Prosthesis scores at 1-year follow-up for functional (22/25), personal (13/15), relational (17/20), and social (13/15) domains. Overall, 27.0% (77) of patients achieved scores consistent with the high quality of life definition. These patients did not differ in terms of median age (60 vs. 62), type of prosthesis (inflatable penile prostheses: 95% in both of the cases), and post-operative complications (10% vs. 14%) than those with lower quality of life score (all p > 0.1). At logistic regression analysis, erectile dysfunction etiology was the only factor independently associated with high quality of life at 1 year after surgery (p = 0.02). Patients treated for Peyronie's disease (odds ratio: 2.62; p = 0.01; 95% confidence interval: 1.20-5.74) were more likely to report better outcomes after accounting for age, post-operative complications, and surgical volume. CONCLUSION: Penile prosthesis implantation is associated with an overall good quality of life. The subset of patients affected by erectile dysfunction secondary to Peyronie's disease seemed to benefit the most from penile prosthesis implantation in terms of functional outcomes, relationship with their partners and the outside world, and perceived self-image. The systematic use of validated questionnaires specifically addressed at evaluating quality of life and satisfaction after penile prosthesis implantation should be further implemented in future studies to better define the predictors of optimal satisfaction after penile prosthesis implantation.

Post-Operative Acute Urinary Retention After Greenlight Laser. Analysis of Risk Factors from A Multicentric Database.

PURPOSE: Greenlight laser is a mini-invasive technique used to treat Benign Prostatic Obstruction (BPO). Some of the advantages of GreenLight photoselective vaporization (PVP) are shorter catheterization time and hospital stay compared to TURP. Post-operative acute urinary retention (pAUR) leads to patients' discomfort, prolonged hospital stay and increased health care costs. We analyzed risk factors for urinary retention after GreenLight laser PVP. MATERIALS AND METHODS: In a multicenter experience, we retrospectively analyzed the onset of early and late post-operative acute urinary retention in patients undergoing standard or anatomical PVP. The pre-, intra- and post-operative characteristics were compared betweene patients who started to void and the patients who developed post-operative urinary retention. RESULTS: The study included 434 patients suitable for the study. Post-operative acute urinary retention occurred in 39 (9%). Patients with a lower prostate volume (P < .001), an adenoma volume lower than 40 mL (P < .001), and lower lasing time (P = .013) had a higher probability to develop pAUR at the univariate analysis. The multivariate logistic regression confirmed that lower lasing time (95% CI: 0.86-0.99, OR = 0.93, P = .046) and adenoma volume (95% CI: 0.89-0.98, OR = 0.94, P = .006) are correlated to pAUR. Furthermore IPSS ≥ 19 (95% CI: 1.19- 10.75, OR = 2.27, P = .023) and treatment with 5-ARI (95% CI: 1.05-15.03, OR = 3.98, P = .042) are risk factors for pAUR. CONCLUSION: In our series, post-operative acute urinary retention was related to low adenoma volume and lasing time, pre-operative IPSS ≥ 19 and 5-ARI intake. These data should be considered in deciding the best timing for urethral catheters removal.

Impact of systemic inflammatory markers on the response to Hyperthermic IntraVEsical Chemotherapy (HIVEC) in patients with non-muscle-invasive bladder cancer after bacillus Calmette-Guérin failure.

Objectives: To evaluate the impact of pre- and post-treatment systemic inflammatory markers on the response to Hyperthermic IntraVEsical Chemotherapy (HIVEC) treatment in a cohort of patients with high-grade non-muscle-invasive bladder cancer with bacillus Calmette-Guérin (BCG) failure or intolerance who were unsuitable or unwilling to undergo early radical cystectomy. As a secondary endpoint, we assessed the influence of some demographic, clinical and pathological factors on the response to chemo-hyperthermia. Patients and methods: Between March 2017 and December 2019, 72 consecutive patients were retrospectively analysed. Patients with diseases or conditions that could interfere with systemic inflammatory status or full blood count were excluded. The HIVEC protocol consisted of six weekly intravesical treatments with 40 mg Mitomycin-C diluted in 50 mL distilled water. The drug was heated to a temperature of 43°C. Association of categorical variables with response to HIVEC was evaluated using Yates' chi-squared test and differences in continuous variable were analysed using the Mann-Whitney test. Logistic regression analysis was performed to define independent predictors of response to HIVEC. Results: Patients who failed HIVEC were more likely to have multiple tumours (P = 0.039) at transurethral resection of bladder and a recurrence rate of >1/year (P = 0.046). Lower post-HIVEC inflammatory indices [C-reactive protein (P = 0.021), erythrocyte sedimentation rate (P = 0.027)] and lower pre- (P = 0.014) and post-treatment (P = 0.004) neutrophil-to-lymphocyte ratio (NLR) values were significantly associated with the response to the HIVEC regimen (no bladder cancer recurrence or progression). In the multivariate analysis, patients with a recurrence rate of >1/year were eight-times more likely to experience failure of HIVEC (P = 0.007). Higher pre- (P = 0.023) and post-treatment NLR values (P = 0.046) were associated with a worse response to the HIVEC regimen. Conclusions: The recurrence rate and systemic inflammatory response markers could be useful tools to predict the likelihood of obtaining a response with the HIVEC regimen. These markers might help to guide patients about the behaviour of the tumour after BCG failure, predicting failure or success of a conservative treatment. Abbreviations: CHT: chemo-hyperthermia; CIS: carcinoma in situ; CRP: C-reactive protein; EAU: European Association of Urology; ESR: erythrocyte sedimentation rate; HG: high grade; HIVEC: Hyperthermic IntraVEsical Chemotherapy; ICD: immunogenic cell death; IL: interleukin; MMC: Mitomycin-C; NK: natural killer; NLR: neutrophil-to-lymphocyte ratio; NMIBC: non-muscle-invasive bladder cancer; PLR: platelet-to-lymphocyte ratio; RC: radical cystectomy; SIR: systemic inflammatory response; TURB: transurethral resection of bladder.

Preliminary evidence of the impact of social distancing on psychological status and functional outcomes of patients who underwent robot-assisted radical prostatectomy.

INTRODUCTION: Social distancing is considered the best strategy to prevent the spread of COVID-19 (COronaVIrus Disease 19). We aimed to analyse the effect of 'social distancing' on the emotional state, post-operative pain and functional outcomes of patients undergoing robot-assisted radical prostatectomy (RARP). MATERIAL AND METHODS: We retrospectively reviewed data of male patients who underwent RARP within the study period (from March to April 2019 [Group A = 27 patients] and from March to April 2020 [Group B = 29 patients]). Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) results were collected on the first day of hospitalization. Post-operative pain was assessed using the numerical rating scale (NRS) and visual analogic scale (VAS) after surgery in the post-anesthesia care unit (PACU) and at 24 hours. Functional outcomes were evaluated at the one-month follow-up. Demographic, pathological and peri-operative data were collected for all patients. RESULTS: There were no significant differences in demographics and pathological characteristics amongst the groups. We observed that patients in Group A had a statistically lower value on the PHQ-9 and GAD-7 questionnaires than patients of Group B. Moreover, Group A showed statistically significant better post-operative pain control in PACU and at 24 hours. At one-month follow-up, patients in Group B required more diapers for incontinence than Group A, showing poor early continence. Patients in Group A showed interest in sexual rehabilitation after 1.11 ±.320 months while patients in Group B after 2.59 ±.712 months (p <.001). Moreover, 17 out of 29 patients (58.62%) in Group B were referred to an andrologist, compared to 100% of patients from Group A (p = 0.0006). CONCLUSIONS: Social distancing during the COVID-19 pandemic is associated with a poor pre-operative emotional state, as well as influencing post-operative pain, early urinary continence and desire for sexual rehabilitation.

Outcomes and complications of Hyperthermic IntraVesical Chemotherapy using mitomycin C or epirubicin for patients with non-muscle invasive bladder cancer after bacillus Calmette-Guérin treatment failure.

INTRODUCTION: Chemohyperthermia is a feasible option in BCG (bacillus Calmette-Guérin) failure patients who desire bladder preservation. We aimed to assess outcomes and complications of chemohyperthermia using mitomycin C (MMC) or epirubicin (EPI). MATERIAL AND METHODS: From March 2017 to February 2020, 103 BCG failure or intolerance patients with high-risk NMIBC (non-muscle invasive bladder cancer) underwent a hyperthermic intravesical chemotherapy (HIVEC) regimen. Five patients did not complete at least 5 instillations and were excluded from analysis. MMC was used in 72 out of 98 patients (Group A) while EPI was used in 26 patients (Group B). Response to HIVEC, predictive factors for treatment outcome and the disease-free survival (DFS) were defined as primary endpoints. The complications of chemohyperthermia were assessed as a secondary endpoint. RESULTS: No significant differences were found in recurrence and progression after induction course between Groups A and B. Kaplan-Meier disease-free survival was 22.61 months in Group A and 21.93 in Group B. The log-rank test showed no statistically significant difference between the two curves (p = .627). In the multivariate analysis, patients with tumor size ≥3 cm (p = .029), recurrence rate >1/year (p = .034), concomitant carcinoma in situ (CIS) during transurethral resection of bladder (TURB) (p = .039) and BCG-unresponsive status (p = .048) were associated with a worse response to chemohyperthermia. The use of MMC or EPI did not influence the response to treatment (p = .157). A slightly significant higher rate of overall complications (p = .0488) was observed in Group B. A significantly higher rate of Grade 3 frequency/urgency (p = .0064) contributed to this difference. The use of EPI was the only independent factor associated with severe urinary frequency/urgency (p = .017). No patients experienced Grade 4/5 adverse events. CONCLUSIONS: HIVEC can be considered a feasible option in BCG failure/intolerant NMIBC patients, avoiding or postponing radical cystectomy in some particular subclasses of patients.

The role of Protopine associated with Nuciferine in controlling adverse events during hyperthermic intravesical chemotherapy instillations. A nutraceutical approach to control adverse event during intravesical instillations.

OBJECTIVES: The aim of this study was to analyse the role of two alkaloid, Protopine and Nuciferine, in the prevention and the treatment of the low and mild grade adverse events related to the use of HIVEC® (Hyperthermic IntraVEsical Chemotherapy) instillations. MATERIALS AND METHODS: From September 2017 to September 2019, 100 patients were prospectively randomized into two groups: Group A = Protopine and Nuciferine syrup, 10 ml, once a day, for 8 weeks; Group B = placebo (flavoured coloured water), 10 ml, once a day, for 8 weeks. The primary endpoint was the evaluation of the efficacy of the therapy with Protopine and Nuciferine in controlling of the irritative symptoms. The secondary endpoint was the evaluation of the influences of the treatment on the uroflowmetric parameters. RESULTS: The patients of Group A showed a better International Prostatic Symptoms Score (IPSS) score, a better control of urgency symptoms (PPIUS) and tolerate well the pain (VAS score). The treatment doesn't modify Uroflow-Qmax and seems to improve the Uroflow-Voided Volume (ml) without influencing the Uroflow-Post Void Residual volume (PVR). Moreover, the treatment with Protopine and Nuciferine has been proven to be effective in the treatment of overactive bladder (OAB) symptoms. Patients' evaluation of the two different treatments assessed with Patient Global Impression of Improvement questionnaire (PGI-I), demonstrated improvements in the Group A, while the Group B showed a lower satisfaction. CONCLUSIONS: Protopine and Nuciferine can be interesting nutraceutical compounds useful to control irritative and pain related symptoms of intravesical chemo/immunotherapy.

Operative profile, safety and functional outcomes after GreenLight laser prostate surgery: results from a 12 months follow-up multicenter Italian cohort analyses.

BACKGROUND: Over the two past decades, GreenLight laser therapy has been considered a valid alternative for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia/benign prostatic obstruction (BPH/BPO). However, the debate on the effectiveness of laser therapy compared to conventional techniques is still open. The aim of our study is to analyze and describe the use of GreenLight laser prostate surgery in Italy, with regard to the surgical techniques performed and the surgical and functional outcomes at mid-term follow-up. METHODS: From March 2012 to July 2018, patients who underwent GreenLight laser prostate surgery for LUTS due to BPH/BPO from 19 Italian centers were included. The following parameters were evaluated in the population: age, prostate volume, prostate adenoma volume, PSA tot, Qmax at uroflowmetry (UFM), International Prostatic Symptoms Score (IPSS), previous therapy for LUTS, use of anticoagulants and antiplatelet drugs. We recorded also the kind of anesthesia, mean laser time (min), mean irradiation time (min), TURP conversion/completion rate, postoperative day of catheter removal, postoperative acute urinary retention (AUR), hospital stay, variation of hematocrit (Ht) and hemoglobin levels (Hb). Early complications were classified according to the Clavien-Dindo classification, the re-operation rate within 30 days and after 30 days, the late complications and the Patient Global Impression of Improvement were also collected. Changes over time in terms of blood loss and functional outcomes (IPSS and Qmax at the UFM at 6 and 12 months) were tested with Student's test for paired samples. We assumed P≤0.05 as level of statistical significance. RESULTS: Overall, 1077 were enrolled in the study, 554 (56.4%) were treated with standard vaporization and 523 (48.6%) with anatomical vaporization. Student's t-test for paired samples showed no statistically significant differences in terms of reduction of Ht preoperative vs. Ht postoperative (42.80±3.91 vs. 39.93±5.35 95% CI P=0.3) and preintervention and postintervention Hb levels (14.28±1.46 vs. 13.72 P=0.35). Compared with the preoperative Qmax (8.60±2.64), the 6- and 12-month UFM showed a significant improvement [19.56±6.29, P<0.01 and 19.99±5.92 P<0.01]. In terms of IPSS variation, compared to the baseline level (22±5.51) the 6- and 12-month follow-up confirmed a significant reduction (8.01±4.41 P<0.01 and 5.81±4.12 P<0.01 respectively). Postoperative complications were CD0, CD1, CD2, CD3, CD4 in 33.0%,35.3%, 2.9%, 0.3%, and 0.6%. CONCLUSIONS: To the best of our knowledge, this is one of the most numerous surgical series of GreenLight laser vaporization and with the longest follow-up. This technique should be considered as a safe and effective alternative in the treatment of secondary LUTS to BPH.

An outcomes analysis of penile prosthesis implantation following radical cystoprostatectomy and urinary diversion: a multicentric retrospective cohort study.

There is limited scientific literature regarding the management outcomes for end-stage erectile dysfunction (ED) following radical cystoprostatectomy (RCP). This study aims to evaluate the surgical outcomes of penile prosthesis (PP) implantation. A retrospective analysis over 17 years (2004-2017) was performed from the clinical records of patients in four tertiary referral centres, whom previously had undergone RCP, followed by PP implantation for end-stage ED. Outcome measures include both intra and postoperative complications, operative duration, a 5-point Likert hematoma scale as well as length of hospital stay. Additionally, a matched-pair cohort analysis was performed, dividing patients in 2 groups according to the type of urinary diversion (neobladder versus ileal conduit/cutaneous ureterostomy). The median time elapsed between RCP and PP implantation was 38 months (IQR 20-56). The median follow-up was 18 months (IQR 12-156). A 3-piece inflatable PP was implanted in 43 patients (91.5%) whereas a semirigid device was implanted in the remainder. Reservoir position was extra-peritoneal (utilising a separate abdominal incision) in 24 patients (54.8%), while an ectopic high-submuscular placement was preferred in the remainder. PP infection and mechanical failure occurred in 1 (2.1%) and 3 cases (6.3%) respectively. The comparative analysis of surgical outcomes did not show any statistically significant difference between the two groups. Our evidence suggests that PP implantation in patients with refractory ED following RCP may represent a safe and effective procedure associated with a low incidence of complications. The main limitation of this study is represented by the non-randomised, retrospective nature as well as the lack of patients' functional outcomes and the limited follow-up.

GreenLight Photoselective Vaporization of the Prostate: One Laser for Different Prostate Sizes.

Introduction: GreenLight laser vaporization of the prostate (photoselective vaporization of the prostate [PVP]) is a safe and effective procedure for Benign Prostatic Hyperplasia. Long-term results and advantages of PVP in patients with large and symptomatic prostate are still under evaluation. Materials and Methods: In a multicenter experience, patients who underwent standard or anatomical PVP were retrospectively reviewed. Patients with follow-up >12 months were divided into two groups based on prostate volume (<100 cc vs ≥100 cc). Pre- and perioperative data, as well as postoperative results and complications, were recorded after 3, 6, and 12 months and then annually. Results: One thousand and thirty-one patients were eligible, 916 of these had a prostate volume of <100 cc and 115 ≥ 100 cc. Median follow-up period was 25.0 months (interquartile range [IQR] 16.5-35.0) and 16.0 months (IQR 12.0-24.0) in ≥100 and <100 groups, respectively. No difference was found in terms of catheterization time, postoperative stay, and postoperative acute urine retention. Patients with prostate ≥100 required longer operative time (75 vs 55 minutes), lasing time (41.7 vs 24.9 minutes), and higher energy used but lower energy density. Patients with prostate ≥100 had a higher incidence of early (50.4% vs 35.7%) and late complications (21.7% vs 12.8%) and early urge/incontinence symptoms (40.9% vs 29.3%). No statistically significant differences were found for the maximum urinary flow (Qmax) and International Prostate Symptom Score (IPSS) results between the two groups. The reintervention rate in ≥100 group was 3.5% vs 2.3% in <100. Conclusions: In the midterm follow-up, GreenLight PVP guarantees the same results in different prostate volume groups. Early and late complications are more frequent in large prostates.

The Use of a Combination of Vaccinium Macracarpon, Lycium barbarum L. and Probiotics (Bifiprost®) for the Prevention of Chronic Bacterial Prostatitis: A Double-Blind Randomized Study.

INTRODUCTION: To evaluate the efficacy of Bifiprost® + Serenoa Repens 320 mg versus Serenoa Repens 320 mg alone for the prevention of chronic bacterial prostatitis (CBP) due to enterobacteriaceae. METHODS: Between September 2016 and September 2018, 120 patients with CBP at the National Institutes of Health (NIH type II) with recurrent infections due to enterobacteriaceae (Escherichia Coli and Enterococcus faecalis) were enrolled and randomized into 2 groups each to receive Bifiprost® + Serenoa Repens 320 mg (Group A) or Serenoa Repens 320 mg alone (Group B) daily for 24 weeks (after receiving a proper antibiotic treatment with subsequent culture negativization). The primary endpoint was the reduction in the episodes of prostatitis. The secondary endpoint evaluated was the score of the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI). Evaluation was performed at baseline and at 12, 24, and 36 weeks. RESULTS: The patients of the Group A experienced a significantly larger reduction in the prostatitis episodes than the Group B at 24 and 36 weeks, but they did not experience a significantly larger reduction at 12 weeks. After 12 weeks of treatment, the mean NIH-CPSI score was reduced in both groups compared with baselines, but no significant differences were seen between the Group A and Group B. On the contrary, we observed a significant difference in the mean NIH-CPSI score between the 2 groups at 24 and 36 weeks. CONCLUSION: The association of Bifiprost® and Serenoa Repens 320 mg improves the prevention of the episodes of CBP due to enterobacteriaceae and ameliorates prostatitis-related symptoms after 6 months of therapy. The long-term impact on the entero-urinary route was also seen 3 months after the end of the treatment.

The role of diallyl thiosulfinate associated with nuciferine and diosgenin in the treatment of premature ejaculation: A pilot study.

OBJECTIVE: To assess the efficacy and safety of an association of diallyl thiosulfinate with nuciferine and diosgenin in the treatment of a group of patients suffering from premature ejaculation (PE), primary or secondary to erectile dysfunction (ED). MATERIALS AND METHODS: From July 2015 to October 2016, 143 patients (mean age 25.3; range 18-39) affected by PE completed the study and were finally analyzed in this phase I study. All patients, after clinical assessment and laboratory evaluation were asked to take an association of diallyl thiosulfinate with nuciferine and diosgenin as oral tablet, once a day, on alternate days, for three months. At the baseline and after three months of treatment, each patient was asked to complete the following questionnaires: International Index of Erectile Function (IIEF-5), Premature Ejaculation Diagnostic Tool (PEDT), Male Sexual Health Questionnaire (MSHQ). RESULTS: A statistical significant improvement in terms of erectile function, comparing the IIEF-5 value at baseline and follow- up visit was found (respectively IIEF-5: 8.7 vs 14.01; p < 0.001). Moreover, at follow-up visit, 97/143 men (67.8%) referred a subjective improvement of the erection quality and a better control of the ejaculation (PROs). The IELT improved too between the baseline evaluation and the follow-up visit (p < 0.001). CONCLUSION: In conclusion, our study, even if supported by preliminary results, showed how Diallyl Thiosulfinate, Nuciferine and Diosgenin is able to improve the control of ejaculation in patients suffering from PE, primary or secondary to ED without any significant adverse effects.

Serenoa repens + selenium + lycopene vs tadalafil 5 mg for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction: a Phase IV, non-inferiority, open-label, clinical study (SPRITE study).

OBJECTIVE: To compare in a randomised, open-label, non-inferiority clinical study, the efficacy and tolerability of Serenoa repens (SeR) + selenium (Se) + lycopene (Ly) (SeR-Se-Ly) therapy vs tadalafil 5 mg in men with lower urinary tract symptoms (LUTS). PATIENTS AND METHODS: From May 2015 to January 2017, 427 patients were enrolled in 21 different centres (International Standard Randomised Controlled Trial Number Register [ISRCTN] 73316039). Inclusion criteria included: age between 50 and 80 years, International Prostate Symptom Score (IPSS) ≥12, maximum urinary flow rate (Qmax ) ≤ 15 mL/s, and post-void residual (PVR) <100 mL. Patients were randomised into two groups in a 2:1 ratio: Group A (SeR-Se-Ly, 1 tablet daily for 6 months) and Group B (tadalafil 5 mg, 1 tablet daily for 6 months). The primary endpoint of the study was the non-inferior variation in the IPSS and Qmax in Group A vs Group B after 6 months of treatment. RESULTS: In all, 404 patients completed the full protocol. When comparing both therapies, Group A was statistically not inferior to Group B considering the median change in IPSS (-3.0 vs -3.0; P < 0.01), IPSS quality of life (-2.0 vs -2.0; P < 0.05), and Qmax (2.0 vs 2.0 mL/s; P < 0.01). We found statistically significant differences in the increase of at least 3 points in Qmax (38.2% vs 28.1%; P = 0.04) and of at least 30% of Qmax (39.2% vs 27.3%; P < 0.01) in Group A compared to Group B. The percentage of patients with an increase of at least 3 points in the IPSS and a decrease of at least 25% of the IPSS was not statistically different between the two groups. For adverse events, four patients in Group A (1.44%) and 10 in Group B (7.81%) (P < 0.05) reported side-effects. CONCLUSION: We have shown that treatment with SeR-Se-Ly was not inferior to tadalafil 5 mg for improving IPSS and Qmax in men with LUTS.

Distal corporoplasty for distal cylinders extrusion after penile prosthesis implantation.

INTRODUCTION: Distal extrusion of cylinders is a potential complication of the penile prosthesis implantation. Several methods have been proposed for repairing a distal penile erosion. We present our preliminary experience in "Distal corporoplasty" technique. METHODS: We enrolled 18 consecutive patients whose underwent a distal corporoplasty with simultaneous reimplantation of an "AMS 700 inflatable penile prosthesis (LGX)" from January 2013 to November 2015 at our hospital. All procedures were performed by a single surgical team. Intraoperative and postoperative complications have been classified and reported according to Satava6 and Clavien-Dindo (CD) system.7 Mean values with standard deviations (±SD) were computed and reported for all items. RESULTS: Mean age of the patients was 53.61 (±11.90) years. Mean body max index (BMI) was 24.22 (±2.51). Mean operative time was 85.2 (±13.1) minutes. Blood losses were minimal. No intraoperative complications are reported according to Satava classification. Four out of 18 patients (22.22%) experienced postoperative complications according to CD system. All patients had sexual intercourse for the first time postsurgery after a mean of 59.11 ± 2.08 days. Mean follow-up was 22.11 (±9.95). DISCUSSIONS: Distal extrusion of cylinders is a potential complication of the penile prosthesis implantation. Distal corporoplasty was first described by Mulcahy. He reported a series of 14 patients with a follow-up of about 2 years with optimal functional outcomes. Moreover, distal corporoplasty resulted in shorter operative time, better function, less pain, and fewer recurrences than Gortex windsock repair.10 In our experience, distal corporoplasty is a simple and safe procedure in the treatment of distal cylinders extrusion when the prosthetic material is not exposed to the exterior.

INSIST-ED: Italian Society of Andrology registry on penile prosthesis surgery. First data analysis.

OBJECTIVES: The Italian Society of Andrology, i.e. "Società Italiana di Andrologia" (S.I.A.), launched on December 2014 a prospective, multicenter, monitored and internal review board approved Registry for penile implants, the "INSIST-ED" (Italian Nationwide Systematic Inventarisation of Surgical Treatment for ED) Registry. Purpose of this first report is to present a baseline data analysis of the characteristics of penile implant surgery in Italy. MATERIAL AND METHODS: The INSIST-ED Registry is open to all surgeons implanting penile prostheses (all brands, all models) in Italy, providing anonymous patient, device, surgical procedure, outcome, follow-up data, for both first and revision surgeries. A Registry project Board overviews all the steps of the project, and a Registry Monitor interacts with the Registry implanting surgeons. RESULTS: As by April 8, 2016, 31 implanting surgeons actively joined the Registry, entering 367 surgical procedures in its database, that comprise: 310 first implants, 43 prosthesis substitutions, 14 device explants without substitution. Implanted devices account for: 288 three-component devices (81,3%), 20 two-component devices (5,4%), 45 non-hydraulic devices (12,3%). Leading primary ED etiologies in first implant surgeries resulted: former radical pelvic surgery in 111 cases (35,8%), Peyronie's disease in 66 cases (21,3%), diabetes in 39 cases (12,6%). Two intraoperative complications have been recorded. Main reasons for 57 revision surgeries were: device failure (52,6%), erosion (19,3%), infection (12,3%), patient dissatisfaction (10,5%). Surgical settings for patients undergoing a first penile implant were: public hospitals in 251 cases (81%), private environments in 59 cases (19%). CONCLUSIONS: The INSIST-ED Registry represents the first European experience of penile prosthesis Registry. This baseline data analysis shows that: three-pieces inflatable prosthesis is the most implanted device, leading etiology of erectile dysfunction (ED) in patient receiving a prosthesis is former radical pelvic surgery, primary reason for revision surgery is device failure, primary settings for first penile implant surgery are public hospitals. Evaluation of penile implant impact on recipients quality of life is presently ongoing.

Rare complication after a transrectal ultrasound guided prostate biopsy: a giant retroperitoneal hematoma.

Common complications related to transrectal ultrasound (TRUS) guided prostatic needle biopsy are hematuria, hematospermia, and hematochezia. To the best of our knowledge, we report the second case of a very large hematoma extending from the pelvis into the retroperitoneal space in literature.A 66-year-old man with a serum prostate-specific antigen (PSA) of 5.4 ng/ml was admitted to our department for a TRUS-guided prostatic needle biopsy. Laboratory values on the day before biopsy, including coagulation studies, were all normal. The patients did not take any anticoagulant drugs. No immediate complications were encountered. Nevertheless, 7 hours after the biopsy, the patient reached our emergency department with severe diffuse abdominal pain, hypotension, tachycardia, and confusional state. He underwent an ultrasonography and then a computed tomography (CT) scan that showed "a blood collection in the pelvis that extending to the lower pole of left kidney associated with a focus of active contrast extravasation, indicating active ongoing prostate bleeding." Consequently, he underwent a diagnostic angiography that showed no more contrast extravasation, without the need of embolization. Management of hematoma has been conservative and hematoma was completely reabsorbed 4 months later.