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.

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.

Fournier's gangrene: Clinical case and review of the literature.

Fournier's gangrene is a life-threatening acute necrotizing fasciitis of perianal,genitourinary and perineal areas. Nowadays, is well known that Fournier gangrene is almost never an idiopathic disease. In this article we report a case of a 70-year-old patient that initially was not treated properly. The gold standard therapy of the Fournier's gangrene remains today a complete, early and extended surgical debridement.

Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial).

BACKGROUND: Phytotherapy has been used to treat patients with lower urinary tract symptoms (LUTS). We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens (SeR), Lycopene (Ly), and Selenium (Se) + tamsulosin versus single therapies. METHODS: PROCOMB trial (ISRCTN78639965) was a randomized double-blinded, double-dummy multicenter study of 225 patients between 55 and 80 years old, PSA ≤ 4 ng/ml, IPSS ≥12, prostate volume ≤60 cc, Qmax ≤15 ml/sec, postvoid residual urine (PVR) <150 ml. Participants were randomized group A (SeR-Se-Ly), group B (tamsulosin 0.4 mg), group C (SeR-Se-Ly + tamsulosin 0.4 mg). The primary endpoints of the study were the reduction of IPSS, PVR, and increase of Qmax in group C versus monotherapy groups. RESULTS: The decrease for combination therapy was significantly greater versus group A (P < 0.05) and group B (P < 0.01) for IPSS and versus group A (P < 0.01) for PVR from baseline to 6 months. A greater decrease in IPSS was observed for Group C versus group A (P < 0.01) and increase in Qmax versus group B (P < 0.01), from 6 months to 12 months. At one year, the changes of IPSS and Qmax were greater for Group C versus monotherapies (each comparison <0.05). The proportions of men with a decrease of at least three points (each comparison P < 0.05) and decrease of 25% for IPSS (each comparison P < 0.01) were greater for Group C. CONCLUSION: SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS.

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.

Can Urinary Stones Change History?

Urolithiasis is a common disorder born with the first hominids and the earliest texts describing symptoms date back to 3200 BC in Mesopotamia. The symptoms have always been the same, whereas the possibility of treatment has changed throughout the history. Gaius Plinius Secondus, known as Pliny the Elder, in his work "Naturalis Historia," described the pain produced by a urinary stone as an excruciating torment. When there was not an effective remedy, could this atrocious torment change the lives and choices of men? When the affected people were kings, powerful, or artists, could renal colic affect their political decisions or their artistic works? I answer positively to these questions. I will set some historical facts to demonstrate this. We will see how the surgical treatment of urolithiasis contributed to separating medicine from surgery in medieval Europe. I will tell how an archer's life was saved by perineal lithotomy surgery. I will try to prove that Michelangelo Buonarroti left traces of his stone disease in the Sistine Ceiling. Finally, I will connect the foundation of Rome, capital of the Kingdom of Italy, to bladder stones. A cultural-scientific game, not a historical treatise, in which I will try to connect some important events to urinary calculi.

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.

Effect of body mass and physical activity at younger age on the risk of prostatic enlargement and erectile dysfunction: Results from the 2018 #Controllati survey.

OBJECTIVE: Overweight and low physical activity (PA) increase the risk of prostatic enlargement and erectile dysfunction (ED). Less clear is the role of these factors at young age on the lifelong risk. MATERIALS AND METHODS: During June 2018 the Italian Society of Urologists organized the month of Male Urologic Prevention "#Controllati". Men aged 18 years or more were invited to attend urologic centers for a visit and counselling about urologic/ andrologic conditions. Each participating man underwent a physical examination and was asked about urologic symptoms, sexual activity and possible related problems. RESULTS: We analyzed data from 2786 men, aged 55.1 years (SD 10.9, range 19-97). A total of 710 (25.5%) subjects had a diagnosis of prostatic enlargement and 632 (22.7%) of DE. Overweight/obese men were at increased risk of prostatic enlargement and ED with corresponding odds ratio (0R) in comparison with normal or underweight men, being respectively 1.18 (95% Confidence Interval (CI) 1.00-1.44) and 1.69 (95% CI 1.39-2.05). The OR of prostatic enlargement in comparison with men reporting at age 25 a BMI < 25.0 was 1.22 (95% CI 1.01-1.51) for men with a BMI at 25 years of age ≥ 25; the corresponding OR value for ED was 1.17 (0.92- 1.48). Considering total PA at diagnosis, the OR of prostatic enlargement in comparison with no or low PA, was 0.69 (95%CI 0.55-0.86) for men reporting moderate PA and 0.75 (95%CI 0.58-0.98) for those reporting intense PA. When we considered PA at 25 years of age, the OR of subsequent diagnosis of prostatic enlargement, in comparison with men reporting no/low PA at 25 years of age was 0.81 (95%CI 0.63-1.04) for men reporting moderate PA and 0.70 (95%CI 0.52-0.99) for those reporting intense PA. CONCLUSIONS: These findings underline the utility of encouraging healthy lifestyle habits among young men in order to reduce the subsequent risk of prostatic enlargement and ED.

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.

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.

"Aquabeam® System" for benign prostatic hyperplasia and LUTS: birth of a new era. A systematic review of functional and sexual outcome and adverse events of the technique.

PURPOSE: Aim of this systematic review is to evaluate functional outcomes (Qmax, QoL, IPSS, PVR), sexual outcome (erectile dysfunction and anejaculation rate), and adverse events evaluated according to the Clavien-Dindo classification. METHODS: The bibliographic search with the included terms (prostate, benign prostatic hyperplasia, benign prostatic enlargement, lower urinary tract symptoms, water jet dissection, aquablation, Aquabeam®) produced a literature of 32 articles altogether. After removing papers of not interest or articles which the outcomes could not be deduced, nine studies were examined for a total of 664 patients screened. RESULTS: The functional outcomes, evaluated after water jet dissection, have shown improvement with respect to the baseline in all the selected articles. In the comparison papers with the TURP, the Aquablation has been statistically not inferior regarding functional outcomes. The sexual outcomes have highlighted a better ejaculation rate for water jet dissection than TURP. Regarding the adverse events, water jet dissection documented low rates of adverse events and, in comparison studies, were not statistically superior than TURP. CONCLUSIONS: In our systematic review, the Aquabeam® System for the treatment of LUTS/BPH has proven to be a safe technique that provides functional outcomes comparable to TURP. About sexual outcomes, the most important data is certainly the low rate of retrograde ejaculation. However, other multicenter randomized trials with larger cohorts and longer follow-up are still needed.

Association between selenium and lycopene supplementation and incidence of prostate cancer: Results from the post-hoc analysis of the procomb trial.

BACKGROUND: Many potential chemopreventive agents have been used in PCa prevention, including selenium (Se) and lycopene (Ly). However, their role has been matter of debate over the years, due to potential of promotion of PCa. PURPOSE: In this study we aimed at evaluating the incidence risk of prostate cancer (PCa) in a cohort of patients treated with Se and Ly. METHODS: The Procomb trial design has been previously published (ISRCTN78639965). From April 2012 to April 2014 209 patients were followed and underwent prostate biopsy when PSA ≥4 ng/ml and/or suspicion of PCa. The all cohort was composed by patients treated with Se and Ly (Group A = 134 patients) and control (Group B = 75 patients). RESULTS: During the follow-up time of 2 years, a total of 24 patients (11.5%) underwent prostate biopsy, of which 9 (4.3%) where diagnosed with PCa and 15 (7.2%) where diagnosed with benign prostatic hyperplasia. We did not observe statistical differences in terms of mean changes of PSA between the two groups (p-value for trend = 0.33). The relative risk (RR) for PCa was 1.07 and 0.89 in group A and B, respectively (p = 0.95). At the multivariate Cox regression analysis supplementation with Se and Ly was not associated with greater risk of PCa (hazard ratio: 1.38; p = 0.67). CONCLUSION: In this analysis we did not show evidences supporting a detrimental role of Selenium and Lycopene supplementation in increasing PCa after 2 years of therapy, nor supporting a protective role.