Analysis of Health-Related Quality of Life Reporting in Phase III RCTs of Advanced Genitourinary Tumors.

BACKGROUND: As recommended in the European Society for Medical Oncology (ESMO) guidelines, assessment of health-related quality of life (HRQoL) should be a relevant endpoint in randomized controlled trials (RCTs) testing new anticancer therapies. However, previous publications by our group and others revealed a frequent underestimation and underreporting of HRQoL results in publication of RCTs in oncology. Herein, we systematically reviewed HRQoL reporting in RCTs testing new treatments in advanced prostate, kidney and urothelial cancers and published between 2010 and 2022. METHODS: We searched PubMed RCTs testing novel therapies in genitourinary (GU) cancers and published in fifteen selected journals (Annals of Oncology, BMC Cancer, British Journal of Cancer, Cancer Discovery, Clinical Cancer Research, Clinical Genitourinary cancer, European Journal of Cancer, European Urology, European Urology Oncology, JAMA, JAMA Oncology, Journal of clinical Oncology, Lancet, Lancet Oncology and The New England Journal of Medicine). We excluded trials investigating exclusively best supportive care or behavioral intervention, as well as subgroup or post hoc analyses of previously published trials. For each RCT, we investigated whether HRQoL assessment was performed by protocol and if results were reported in the primary manuscript or in a secondary publication. RESULTS: We found 85 eligible trials published between 2010 and 2022. Only 1/85 RCTs (1.2%) included HRQoL among primary endpoints. Of note, 25/85 (29.4%) RCTs did not include HRQoL among study endpoints. HRQoL results were non-disclosed in 56/85 (65.9%) primary publications. Only 18/85 (21.2%) publications fulfilled at least one item of the CONSORT-PRO checklist. Furthermore, 14/46 (30.4%) RCTs in prostate cancer, 12/25 (48%) in kidney cancer and 3/14 (21.4%) in urothelial cancer reported HRQoL data in primary publications. Next, HRQoL data were disclosed in primary manuscripts of 12/32 (37.5%), 5/13 (38.5%), 5/16 (31.3%) and 5/15 (33.3%) trials evaluating target therapies, chemotherapy, immunotherapy and new hormonal agents, respectively. Next, we found that HRQoL data were reported in 16/42 (38%) and in 13/43 (30.2%) positive and negative trials, respectively. Finally, the rate of RCTs reporting HRQoL results in primary or secondary publications was 55.3% (n = 47/85). CONCLUSIONS: Our analysis revealed a relevant underreporting of HRQoL in RCTs in advanced GU cancers. These results highlight the need to dedicate more attention to HRQoL in RCTs to fully assess the value of new anticancer treatments.

Use of penile shear wave elastosonography for the diagnosis of Peyronie's Disease: a prospective case-control study.

BACKGROUND: To evaluate the stiffness of the tunica albuginea (TA), we used a new noninvasive diagnostic technique called shear wave elastography (SWE). We determined whether SWE values are correlated with the degree of penile curvature, the time of disease onset, and pain severity experienced by patients during erection. This study analyzed the elasticity of the TA of patients with Peyronie's disease compared to that of the control group. We also analyzed any correlations between the stiffness of the cavernous bodies and the degree of curvature, time from diagnosis to curvature onset, and erectile pain severity. This was a prospective case-control study involving 100 men enrolled from September 2020 to August 2021. Participants were divided into group A (case group, n = 50), which included men with PD, with or without pain, and with penile curvature, or group B (control group, n = 50), which included healthy patients older than 18 years who visited the urology clinic for reasons other than PD. The medical history was collected for all patients who also underwent objective examination, B-mode ultrasound evaluation, and SWE. The International Index of Erectile Function (IIEF-15) visual analog scale (VAS) questionnaire was administered to all participants. RESULTS: There were no significant between-group differences regarding age, weight, and height (p > 0.05); however, there was a significant difference in the stiffness values (p < 0.05). An inverse correlation was observed between stiffness and the VAS score (p < 0.0001). A positive correlation was observed between the degree of curvature (p < 0.0001) and the time of curvature onset (p < 0.0001). The IIEF-15 scores were poorer in group A than in group B (p < 0.0001). CONCLUSION: SWE is an inexpensive, noninvasive method that can be used to measure the stiffness of PD patients.

RéSUMé: CONTEXTE: Pour évaluer la rigidité de la tunique albuginée (TA), nous avons utilisé une nouvelle technique de diagnostic non invasive, appelée élastographie par ondes de cisaillement (EOC). Nous avons déterminé si les valeurs de EOC étaient corrélées avec le degré de courbure du pénis, le moment d'apparition de la maladie de Lapeyronie (MP) et la gravité de la douleur ressentie par les patients pendant l'érection. Cette étude a analysé l'élasticité de la TA des patients atteints de MP par rapport à celle d'un groupe témoin. Nous avons également recherché toute corrélation entre la rigidité des corps caverneux et le degré de courbure, le temps écoulé entre le diagnostic et l'apparition de la courbure, et la gravité de la douleur érectile. Il s'agit d'une étude cas-témoins prospective impliquant 100 hommes enrôlés de septembre 2020 à août 2021. Les participants ont été assignés au groupe A (cas, n = 50), qui comprenait des hommes atteints de MP, avec ou sans douleur, et présentant une courbure du pénis, ou au groupe B (témoins, n = 50), qui comprenait des patients en bonne santé âgés de plus de 18 ans qui venaient à la clinique d'urologie pour des raisons autres que la MP. Les antécédents médicaux ont été recueillis pour tous les patients qui ont également subi un examen objectif, une évaluation échographique en mode B et une EOC. Le questionnaire de l'échelle visuelle analogique (EVA) de l'Indice international de la fonction érectile (IIEF-15) a été administré à tous les participants. RéSULTATS: Il n'y avait pas de différences significatives entre les groupes en ce qui concerne l'âge, le poids et la taille ; toutefois, il y avait une différence significative dans les valeurs de rigidité (p<0,05). Une corrélation inverse a été observée entre la rigidité et le score EVA (p<0,0001). Une corrélation positive a été observée entre le degré de courbure (p<0,0001) et le moment de l'apparition de la courbure (p<0,0001). Les scores IIEF-15 étaient plus faibles dans le groupe A que dans le groupe B (p<0,0001). CONCLUSIONS: L'élastographie par ondes de cisaillement (EOC) est une méthode peu coûteuse et non invasive qui peut être utilisée pour mesurer la rigidité des patients atteints de MP.

Testicular shear wave elastography in oligo-astheno-teratozoospermic individuals: a prospective case-control study.

PURPOSE: The primary objective of this study was to evaluate the testicular stiffness by ultrasound shear wave elastography (SWE) both in men with oligo-astheno-teratozospermia (OAT) and in control group. The secondary objective was to identify a possible correlation between semen quality with testicular stiffness. METHODS: This was a prospective case-control study. We divided the sample in two groups; Group A (case group) included men with OAT, and Group B (control group) men with normal sperm parameters. All participants had at last two semen analysis in the past 180 days (at last 90 days apart), using performed ultrasound and SWE elastography. RESULTS: We analyzed 100 participants, 50 patients in Group A and 50 controls in Group B. There were statistically significant differences in term of testicular volume and testicular stiffness between two groups. Men with OAT had the testicular stiffness value higher than the controls in both sides (left testicular stiffness 21.4 ± 5.4 kPa vs 9.9 ± 1.6 kPa, p < 0.0001; right testicular stiffness 22.9 ± 4.8 kPa vs 9.5 ± 2.4 kPa, p < 0.0001). Men with abnormal semen parameters showed an inverse correlation between the mean value of testicular stiffness and total sperm count (22.15 ± 3.38 kPa, r = - 0.387, p = 0.005), sperm concentration (22.15 ± 3.38 kPa, r = - 0.244, p = 0.04), and progressive motility (22.15 ± 3.38 kPa, r = - 0.336, p = 0.01), while the correlation was not evident in controls group. CONCLUSION: SWE is able to differentiate between testicles with spermatogenic changes from a healthy testicle. For this reason, it could be used to evaluate, in a non-invasive way, the tissue alterations of the organ.

Shear wave elastography as a new, non-invasive diagnostic modality for the diagnosis of penile elasticity: a prospective multicenter study.

OBJECTIVE: Shear wave elastosonography (SWE) could be used to evaluate the elasticity of penile tissue. Few studies in the literature, however, have investigated its use in patients with erectile dysfunction (ED) or have attempted to correlate findings with International Index of Erectile Function (IIEF-5) scores. The primary aim of this study was to evaluate the characteristics of erectile tissue using SWE and to determine possible relationships with IIEF-5 and Erection Hardness Scale (EHS) scores. The secondary aim was to establish a cut-off SWE examination value over which cavernous tissue stiffness could contribute to a subsequent organic alteration. METHODS: This prospective study included male patients 18-80 years of age who attended two general andrology clinics and underwent SWE. Subjects were divided into groups according to IIEF-5 score, and correlations between SWE and IIEF-5 and EHS questionnaire scores were explored. RESULTS: A total of 270 subjects (mean age 46.7 ± 16.9 years) were included. ED was reflected by low IIEF-5 and EHS scores and a decrease in the mean elasticity of the corpora cavernosa according to SWE, although the difference between the left and right corpora cavernosa was not statistically significant. No statistically significant correlation was found between measurements of the corpora cavernosa (in kPa) and age. The optimal cut-off identified was 24.75 kPa. CONCLUSION: Results demonstrated that the mean elasticity of the corpora cavernosa according to SWE was correlated with IIEF-5 score and EHS score.

Peyronie's disease may negatively impact the sexual experience of a couple and female sexual function: a single center study.

BACKGROUND: Peyonie's disease (PD) mostly affects males in the fifth decade of life, with a prevalence in the general population ranging between 0.5% and 20.3%. The pathology of PD is characterized by fibrosis of the tunic albuginea of the cavernous bodies of the penis, with the presence of pain in the erection and penile deformity. This is associated with decreased sexual function for both participants. The objective of the study was to investigate the influence of PD pathology on both male patients' and their female partners' sexual spheres, and analyze changes in sexual function and perception following penile correction surgery. METHODS: Prospective study, we included male patients with PD and their female partner sexually active. Patients underwent corporoplasty with multiple plications. The male and female sexuality was evaluated before surgery and three months after male treatment by the Female sexual Function Index (FSFI); International Index of Erectile Function (IIEF); Visual Analogical Scale (VAS). RESULTS: From January 2018 to November 2019 we included 35 couple. The female subjects before partner's surgery presented dyspareunia, loss of sexual desire, inability to achieve orgasm, and sexual dissatisfaction. At three months after surgical treatment there was an improvement of sexual function in both male patients and female partners (desire P<0.0001, arousal P<0.0001, lubrification P<0.0001, orgasm P<0.0001, satisfaction P<0.0001, pain P<0.0001). As regarding male patients the pain decreased significantly (VAS score from 6 to 2.5), while there was no statistically significant improvement in erectile function (P=0.05). CONCLUSIONS: Our findings suggest that a viable approach to treatment of PD patients that involves their partners could lead to better functional and psychological results.

Topical alprostadil (Vitaros©) in the treatment of erectile dysfunction after non-nerve-sparing robot-assisted radical prostatectomy.

OBJECTIVE: The aim of the study is the evaluation of the efficacy and safety of the treatment with topical alprostadil (Vitaros©) in post-robot assisted radical prostatectomy (RARP) rehabilitation therapy of patients with erectile dysfunction (ED). METHODS: Seventy-four patients were enrolled and underwent non-nerve-sparing RARP. INCLUSION CRITERIA: age <75, preoperatively International Index of Erectile Function (IIEF-5) >16, erection hardness score (EHS) ⩾2, weekly sexual intercourse ⩾1, affirmative answers to Sexual Encounter Profile Question (SEP-Q) 2 and SEP-Q3, Charlson Comorbidity Index (CCI) ⩽5, Eastern Cooperative Oncology Group (ECOG) performance status ⩽1, no moderate/severe cardiovascular disease. RESULTS: Vitaros was administered ⩾2 twice a week. At month 6, the IIEF-5 decreased from 20.5 preoperative to 18.1 post-treatment. EHS score decreased from a mean of 3.3 to a mean of 3.0. The quality of life score decreased from an average of 5.1 to 2.3. Weekly sexual intercourse decreased from an average of 2.1 to 1.7. Six patients dropped out; 89.7% patients showed a positive SEP-Q2 and 77.8% a positive SEP-Q3. All patients responded positively to Global Assessment Questions (GAQ)-1 and 97% to GAQ-2. Of all 68 analyzed patients, 13 (17.6%) switched to intracavernous injection therapy. CONCLUSIONS: In conclusion, Vitaros may become a viable alternative to common injective therapies in well-selected patients after RARP.

A phytotherapic approach to reduce sperm DNA fragmentation in patients with male infertility.

INTRODUCTION: Infertility affects 50 to 80 million (between 8 and 12% of couples). Male factor is a cause of infertility in almost half of the cases, mainly due to oligoasthenoteratozoospermia. DNA fragmentation is now considered an important factor in the aetiology of male infertility. We studied the effects on semen analysis and on DNA fragmentation of in vivo admnistration of Myo-Inositol and Tribulus Terrestris plus Alga Ecklonia plus Biovis (Tradafertil; Tradapharma Sagl, Swizerland) in men with previously diagnosed male infertility. MATERIALS AND METHODS: Sixty patients were enrolled in the present study and were randomized into two subgroups: the group A who received Myo-inositol 1000 mg, Tribulus Terrestris 300 mg, Alga Ecklonia Bicyclis 200 mg and Biovis one tablet a day for 90 days, and the group B (placebo group) who received one placebo tablet a day for 90 days. The primary efficacy outcome was the improvement of semen characteristics after 3 months' therapy and the secondary outcome was the reduction of the DNA fragmentation after treatment. RESULTS: The groups were homogenous for age, hormonal levels, sperm concentration and all parameters of sperm analysis. Sperm concentration and progressive motility improved after treatment with Tradafertil (3.82 Mil/ml vs. 1.71 Mil/ml; p<0.05; 4.86% vs. 1.00%; p<0.05) as well as the DNA fragmentation (-1.64% vs -0.39%, p<0.001). No side effects were revealed. CONCLUSIONS: In conclusion, we can affirm that Tradafertil is safe and tolerable. It is a new phytotherapic approach to Oligoasthenoteratospermia (OAT) syndrome that could lead to good results without interacting with hypothalamic-pituitary-gonadal axis.

Evaluation of penile cavernosal artery intima-media thickness in patients with erectile dysfunction. A new parameter in the diagnosis of vascular erectile dysfunction. Our experience on 59 cases.

OBJECTIVE: A precise characterization of erectile dysfunction (ED) of vascular origin has not yet been achieved, although cavernous peak systolic velocity (PSV) is generally considered a major parameter. Nevertheless the penile dynamic color Doppler is invasive and linked to several complications. The intima-media thicknesses (IMT) of cavernosal artery would add to the predictive value of vasculogenic ED risk and outcomes. We also hypothesized the existence of a correlation between IMT cavernosal artery and IMT carotid arteries. This study seeks to evaluate these hypotheses with our experience, investigating the predictive accuracy of carotid and cavernosal Doppler ultrasound findings for discriminating patients with vasculogenic ED. MATERIAL AND METHODS: A total of 59 subjects (32 vasculogenic ED patients - group A - and 27 no vasculogenic ED patients - group B) were evaluated in our andrological center from September 2012 to June 2013 and enrolled in the study. All subjects underwent medical history, erectile function domain of the International Index of Erectile Function, physical examination, routine and sex hormone blood tests, and high resolution dynamic color Doppler ultrasound evaluation of carotid and penile districts and valuation of IMT in both districts. RESULTS: The values of cavernosal artery IMT in group A were higher than in group B (0,28 ± 0,06 mm vs 0,17 ± 0,07 mm). Even the values of carotid artery IMT in vasculogenic ED group were higher than in no vasculogenic ED group (0,74 ± 0,14 mm vs 0,59 ± 0,11 mm). The cavernosal IMT showed a moderate (r = 0.61) positive linear correlation (p < 0.001) with the carotid artery IMT. CONCLUSIONS: An increased cavernous IMT might predict ED of vascular origin with more accuracy than PSV and could be a sensitive predictor also for systemic atherosclerosis at an earlier phase.

Early versus delayed hormonal treatment in locally advanced or asymptomatic metastatic prostatic cancer patient dilemma.

INTRODUCTION: The objective of this work is to compare the effectiveness of hormonal treatment (luteinizing hormone-releasing hormone agonists and/or antiandrogens) as an early or as a deferred intervention for patients with locally advanced prostate cancer (LAPC) and/or asymptomatic metastasis. MATERIALS AND METHODS: Systematic review of trials published in 1950-2007. Sources included MEDLINE and bibliographies of retrieved articles. Eligible trials included adults with a history of LAPC who are not suitable for curative local treatment of prostate cancer. We retrieved 22 articles for detailed review, of which 8 met inclusion criteria. The Veterans Administration Cooperative Urological Research Group suggested that delaying hormonal therapy did not compromise overall survival and that many of the patients died of causes other than prostate cancer. In European Organisation for Research and Treatment of Cancer (EORTC) 30846 trial, the median survival for delayed endocrine treatment was 6.1 year, and for immediate treatment 7.6 year, the HR for survival on delayed versus immediate treatment was 1.23 (95 % CI 0.88-1.71), indicating a 23 % nonsignificant trend in favour of early treatment. In EORTC 30891, the immediate androgen deprivation resulted in a modest but statistically significant increase in overall survival. The protocol SAKK 08/88 showed the lack of any major advantage of immediate compared with deferred hormonal treatment regarding quality of life or overall survival. CONCLUSIONS: The early intervention with hormonal treatment for patients with LAPC provides important reductions in all-cause mortality, prostate cancer-specific mortality, overall progression, and distant progression compared with deferring their use until standard care has failed to halt the disease.

Risk of acute myocardial infarction after transurethral resection of prostate in elderly.

BACKGROUND: Benign prostatic hyperplasia is a frequent disease among elderly, and is responsible for considerable disability. Benign prostatic hyperplasia can be clinically significant due to lower urinary tract symptoms that take place because the gland is enlarged and obstructs urine flow. Transurethral resection of the prostate remains the gold standard treatment for patients with moderate or severe symptoms who need active treatment or who either fail or do not want medical therapy. Moreover, perioperative and postoperative surgery complications as cardiovascular ones still occur. The incidence of acute myocardial infarction in patients undergoing transurethral resection of the prostate is controversial. The first studies showed an increase in mortality and relative risk of death from myocardial infarction in transurethral resection of the prostate group vs open prostatectomy but these results are in contrast with more recent data. DISCUSSION: Given the conflicting evidence of the studies in the literature, in this review we are going to discuss the factors that may influence the risk of myocardial infarction in elderly patients undergoing prostate surgery. We analyzed the possible common factors that lead to the development of myocardial infarction and benign prostatic hyperplasia (cardiovascular and metabolic), the stressor factors related to prostatectomy (surgical and haemodynamic) and the risk factors specific of the elderly population (comorbidity and therapies). SUMMARY: Although transurethral resection of the prostate is considered at low risk for severe complications, there are several reports indicating that cardiovascular events in elderly patients undergoing this surgical operation are more common than in the general population. Several cardio-metabolic, surgical and aging-related factors may help explain this observation but results in literature are not concord, especially due to the fact that most data derive from retrospective studies in which selection bias cannot be excluded. Subsequently, further studies are necessary to clarify the incidence of acute myocardial infarction in old people.

Presenting a case of a mucinous adenocarcinoma of an exstrophic bladder in an adult patient and a review of literature.

BACKGROUND: Bladder exstrophy occurs in approximately 1 in 35,000 live births and is associated with an increased incidence of bladder cancer. CASE PRESENTATION: A 55-year old male patient was diagnosed with a primary mucinous adenocarcinoma of an unreconstructed exstrophic bladder. Examination of the entire gastrointestinal tract shown there were not other primary cites. Immunohistochemistry confirmed the nature of the tumour. The patient underwent a radical cystoprostatectomy with en block bilateral pelvic lymphadenectomy, urinary diversion with a cutaneous ureterostomy and epidpadias repair. CONCLUSION: Adult bladder exstrophy and epispadia correction is a very rare practice in urology due the fact that this congenital disease is diagnosed and corrected in neonates. We advocate the radical surgical management, after exclusion of any primary malignant sites related to the gastrointestinal tract.

Stress urinary incontinence: long-term results of laparoscopic Burch colposuspension.

BACKGROUND: The open Burch colposuspension, first described in 1961 had been widely employed for the surgical treatment of women with stress urinary incontinence (SUI) caused by urethral hypermobility. We evaluated the long-term efficacy of laparoscopic Burch colposuspension (LBC) for SUI in women. METHODS: A randomized prospective trial was conducted from September 2010 to January 2013. The extraperitoneal laparoscopic Burch colposuspension was performed by an operator on 96 women, mean age was 54,3 ± 3,7 years all of whom suffered from SUI or mixed urinary incontinence. Patients completed a self-administered the Short Form-36 (SF-36), the Physical Component Summary (PCS) and Mental Component Summary (MCS), the Short Urinary Distress Inventory (SUDI) and Short Incontinence Impact Questionnaire (SIIQ). at both baseline and follow up(6 weeks, 6 months, 18 months postoperatively). The Genito-Urinary Treatment Satisfaction Scale (GUTSS) was used to assess satisfaction with surgery. RESULTS: After follow up was recorded an improvement of questionnaries scores. The general health score is improved after surgery (2,60 ± 1.02 versus 2,76 ± 1.06) with p = 0.09. The PCS baseline score is 46.29 ± 10.95 versus 49.54 ± 10.41 after treatment with p = 0.01, so there was a significant baseline to follow up improvement. The MCS improved also, infact baseline score is 42.19 ± 12.57 versus 42.70 ± 13.03 with p = 0.87. The SUDI baseline score is 50.22 ± 20.73 versus 23.92 ± 17.90, while SIIQ score is 49.98 ± 23.90 versus 31.40 ± 23.83 with p < 0.01. In both questionnaires there is an improvement. Satisfaction with treatment outcomes from the GUTSS at 6-month follow up is 29.5 ± 6.3 with p = 0.46. CONCLUSION: The LBC has significant advantages, without any apparent compromise in short-term and long term outcomes.

Efficacy and safety profile of a novel technique, ThuLEP (Thulium laser enucleation of the prostate) for the treatment of benign prostate hypertrophy. Our experience on 148 patients.

BACKGROUND: Over the past years laser technology has played a predominant role in prostate surgery, for the treatment of benign prostate hypertrophy (BPH). Various laser devices have been introduced in clinical practice, showing good results in terms of complications and urodynamic outcomes efficacy compared with TURP and Open Prostatectomy.In this study we describe the efficacy and the safety profile of a novel laser technique, ThuLEP (Thulium Laser Enucleation of Prostate) that permits a complete anatomical endoscopic enucleation of prostatic adenoma independently to prostate size. METHODS: 148 patients with a mean age of 68.2 years were enrolled between September 2009 and March 2012 (36 months), and treated for BPH with ThuLEP. Every patient was evaluated at base line according to: Digital Rectal Examination (DRE), prostate volume, Post-Voided volume (PVR), International Prostate Symptoms Score (I-PSS), International Index of Erectile Function-5 (IIEF-5), Quality of Life (QoL), PSA values, urine analysis and urine culture, uroflowmetry. The same evaluation was conducted after a 12 month follow-up. ThuLEP was performed by 2 expert surgeons. RESULTS: Our data showed a better post-operative outcome in terms of catheter removal, blood loss, TURP syndrome, clot retention and residual tissue compared to large series of TURP and OP. Only 1.3% of patients had bladder wall injury during morcellation. I-PSS, Qmax, Prostate Volume, QoL and PVR showed a highly significant improvement at 12 month follow-up in comparison to preoperative assessment. CONCLUSION: ThuLEP represent an innovative option in patients with BPH. It is a size independent surgical endoscopic technique and it can be considered the real alternative, at this time, to TURP and even more to Open Prostatectomy for large prostate, with a complete removal of adenoma and with a low complication rate.

Observational study: daily treatment with a new compound "Tradamixina" plus serenoa repens for two months improved the lower urinary tract symptoms.

BACKGROUND: Lower urinary tract symptoms (LUTS) are associated with great emotional costs to individuals and substantial economic costs to society. This study seeks to evaluate the effect of a new natural compound "Tradamixina plus Serenoa Repens" in order to improve lower urinary tract symptoms. METHODS: 100 patients (≥ 45 years) who had had LUTS/BPH for >6 mo at screening and with IPSS -The international Prostate symptom scores- ≥ 13 and maximum urinary flow rate (Qmax) ≥ 4 to ≤ 15 ml/s. were recruited. The compound "Tradamixina plus Serenoa Repens" (80 mg of Alga Ecklonia Bicyclis, 100 mg of Tribulus Terrestris and 100 mg of D-Glucosamine and N-Acetyl-D-Glucosamine plus 320 mg of Serenoa Repens) was administered daily for 2 months. At visit and after 60 days of treatment patients were evaluated by means of detailed medical urological history, clinical examination, laboratory investigations (total PSA), and instrumental examination like urolfowmetry. Efficacy measures included IPSS-International Prostate Sympto, BPH Impact Index (BII), Quality-of-Life (QoL) Index. Measures were assessed at baseline and end point (12 wk or end of therapy) and also at screening, 1 and 4 wk for IPSS, and 4 wk for BII. Statistical significance was interpreted only if the results of the preceding analysis were significant at the 0.05 level. RESULTS: After 2 months of treatment the change from baseline to week 12 relative to "Tradamixina plus Seronea Repens" in total IPSS and Qol was statistically significant. Differences from baseline in BII were statistically significant for "Tradamixina plus Seronea Repens" above all differences in BII were also significant at 4 wk (LSmean ± SE: -0.8 ± 0.2). In the distribution of subjects over the PGI-I and CGI-I response categories were significant for"Tradamixina plus Seronea Repens" (PGI-I: p = 0.001; CGI-I). We also observed a decrease of total PSA. CONCLUSION: The daily treatment with a new compound "Tradamixina plus Serenoa Repens" for 2 months improved the male sexual function , it improved the bother symptoms which affect the patient's quality of life , improved uroflowmetric parameters, and we also observed a decrease of serum PSA level.

Sexual asthenia: Tradamixina versus Tadalafil 5 mg daily.

BACKGROUND: Reduced libido is widely considered the most prominent symptomatic reflection of low testosterone (T) levels in men. Testosterone deficiency (TD) afflicts approximately 30% of men aged 40-79 years. This study seeks to evaluate the effect of a new natural compound "tradamixina "in order to improve male sexual function in elderly men, particularly libido and possible erectile dysfunction, versus administration of tadalafil 5 mg daily. METHODS: Seventy patients (67.3 ± 3.7 years) with stable marital relations and affected by reduced libido, with or without erectile dysfunction were recruited. They were randomly separated in 2 groups A-B of 35. Group A was administered twice a day a new compound "Tradamixina" (150 mg of Alga Ecklonia Bicyclis, 396 mg of Tribulus Terrestris and 144 mg of D-Glucosamine and N-Acetyl-D-Glucosamine) for two months, while Group B was administered tadalafil 5 mg daily, for two months. At visit and after 60 days of treatment patients were evaluated by means of detailed medical and sexual history, clinical examination, laboratory investigations (Total and Free T), instrumental examination (NPTR- nocturnal penile tumescence and rigidity test- with Rigiscan). Patients completed a self-administered IIEF questionnaire (The international index of erectile function) and SQoLM questionnaire (Sexual quality of life Questionnarie-Male). The results pre and post treatment were compared by Student t test (p<0.005). RESULTS: After 2 months of treatment in group A serum TT levels (230 ± 18 ng/dl vs 671 ± 14 ng/dl ) and FT levels(56 ± 2.4 pg/ml vs 120 ± 3.9 pg/ml) increased, while in group B serum TT levels (245 ± 12 ng/dl vs 247 ± 15 ng/dl ) and FT levels(53 ± 0.3 pg/ml vs 55 ± 0.5 pg/ml) increased not statistically significant. The patient's numbers with negative NPTR improved after treatment in group A and B (15 vs 18 and 13 vs 25 respectively). The IIEF total score in group A increased after treatment with tradamixina (15 ± 1.5 vs 29.77 ± 1.2); the IIEF total score in group B increased slightly (12 ± 1.3 vs 23.40 ± 1.2). The SQoLM total score improved in both groups (A:16 ± 2,3 vs 33 ± 4,1 and B: 16 ± 3,4 vs 31 ± 2,1). CONCLUSION: The treatment twice a day with "Tradamixina" for 2 months improved libido in elderly men without side effects of Tadalafil.

Testosterone deficiency causes penile fibrosis and organic erectile dysfunction in aging men. Evaluating association among Age, TDS and ED.

INTRODUCTION: We studied the possible correlation between age, testosterone deficiency, cavernosal fibrosis and erectile dysfunction (ED). METHODS: 47 patients with ED were enrolled between September 2010 and October 2011. IIEF-EF score, NPTR test using the Rigiscan method, total and free testosterone levels, and cavernosum biopsy were carried out on all patients. Patients aged 65 or over were defined as Old Age (OA) while patients under 65 were defined Young age (YA). The strength of the relationships found was estimated by Odds Ratio. RESULTS: 74% of patients with values of over 52% collagen fibers in the corpora cavernosa were found to have organic ED. A significant difference was found in age, percentage of collagen fibers, testosterone levels between patients with Positive Rigiscan (PR) and Negative Rigiscan (NR). Hypotestosteronaemia increased the risk of ED with PR (OR: 21.4, 95% CI: 20.2-22.6) and in both young age patients (OR: 4.3, 95% CI: 2.4-6.2) and old age patients (OR: 15.5, 95% CI: 13.4-17.6). Moreover cavernosal fibrosis increased the risk of ED with PR in both young age patients (OR: 8.2, 95% CI: 6.4-10.0 and old age patients (OR: 24.6, 95% CI: 20.8-28.4). CONCLUSIONS: This study demonstrates a strong association among age, testosterone deficiency, cavernosal fibrosis and ED with PR. Age, testosterone deficiency and cavernosal fibrosis are potentially correctable factors of cavernosal fibrosis and organic ED. Further, prospective studies are needed to evaluate if testosterone treatment, alone or in association with PDE5 inhibitors, may lower the risk of cavernosal fibrosis or decrease the severity the fibrosis in ED patients.

Tunical plication in the management of penile curvature due La Peyronie's disease. Our experience on 47 cases.

BACKGROUND: Peyronie's disease is an acquired connective tissue disorder of the penile tunica albuginea with fibrosis and inflammation. The disease produces palpable plaques, penile curvature and pain during erections. Patients report negative effects in four major domains: physical appearance and self-image, sexual function and performance. These changes damage sexual life and compromise the quality of life. Our objective is to review the patient's sexual life after penile tunical plicature using the International Index of Erectile Function (IIEF) and the Sexual Encounter Profile (SEP) questionnaires. METHODS: A total of 47 patients with Peyronie's disease (PD) were enrolled at our urology department and they underwent correction of penile deviation between February 2009 and March 2010. Mean patient age was 56 years and mean follow-up was 24 months. Patients with painless PD plaque with no progression in angulation for at least 12 months were chosen for surgery. They underwent a penile tunical plication.IIEF and SEP questionnaire were administered to all patients. RESULTS: Of all treated patients, 94% were able to insert their penis in the partner's vagina (p<0.01; SEP question 2), compared with 62% preoperatively and 90% of them was satisfied overall with the sexual intercourse (p<0.01; SEP question 5) .Patients had a significantly higher endpoint and a greater change from baseline for the remaining SEP questions related to achievement of an erection, satisfaction of erection hardness (SEP questions 1 and 4; p < 0:001).We reported a significant improvement in the IIEF scores (from a baseline total score of 25.2 +/- 3.2 to a final score of 38.3 +/- 5.2; P<0.01). It resulted in significantly higher endpoint IIEF scores across all five IIEF domains: Erectile Function, Intercourse Satisfaction, Orgasmic Function, Sexual Desire and Overall Satisfaction. The main complaint was penile shortening (28 patients, 60%), feeling of the suture during flaccidity and tumescence (37 patients, 80%). CONCLUSION: Patient quality of life improved after surgery thanks to the improvement of their sexual life. The complications are unimportant and few bother symptoms are reported. The significant improvement in erectile function was also supported by IIEF and SEP questionnaire data. Nowadays tunical plication is a safe, advantageous and useful technique to treat patients suffering of Peyronie's disease.

A case of giant cell tumor of the hipbone invading the bladder.

Giant cell tumor of bone (GCTB) is a very rare neoplasm of the skeleton (about one new case per million population per year). In literature there is a great confusion about GCTB. The majority of authors think that GCTB is a benign locally aggressive tumor, others think that this is a malignant neoplasm and some authors think that GCTB is a reactive condition. This is the first case in literature of GCTB of the hipbone invading the bladder.