Li-Eswt improves hemodynamic parameters thus suggesting neoangiogenesis in patients with vascular erectile dysfunction

Extracorporeal treatment with low intensity shock-wave therapy (LI-ESWT) is a recently introduced non-invasive method which purposes the restoration of the pathophysiological alterations at the base of vasculogenic ED in male patients. The evidence in favour of the neoangiogenic potential of this treatment derived from in vitro studies and on animal models. The purpose of this study, in which the Power Doppler method was applied, is to demonstrate \u2018objectively\u2019 the real efficacy of LI-ESWT at the level of the microcirculation of the corpora cavernosa (neoangiogenesis) in patients affected by vasculogenic ED. Data from this study show, for the first time, that LI-ESWT treatment promotes neovascularisation of the functional arteries in patients affected by vasculogenic ED

Prospective Cross-Sectional Evaluation of Penile Helicine Circulation by Power Doppler During Dynamic Ultrasound in Veno-Occlusive Erectile Dysfunction

Objective: To evaluate the usefulness of Power Doppler to improve the diagnostic work up of veno-occlusive erectile dysfunction patients. Materials and Methods: Patients affected by erectile dysfunction, mean IIEF 5 = 13.5 (12-17) for at least 6 months, were enrolled in a prospective cross-sectional study. All patients underwent Dynamic Power Doppler after intracavernous injection of vasoactive drugs (PGE1 20 mcg and Papaverine 6 mg). Poor responders’ patients subsequently underwent to cavernosometry to get a full assessment of the vascular framework. Results: 202 patients (mean age 46 years), were included in the study. 96 subjects (47.5%) who did not adequately respond to the intracavernous injection -test, subsequently underwent to cavernosometry. In 42 of 96 patients (43.7%) cavernosometry was positive for veno-occlusive dysfunction. In a total of 160 patients who did not have veno-occlusive dysfunction (54 with negative cavernosometry + 106 intracavernous injection-test responders), the Power Doppler was normal in 126 (78.8%) and pathological in 34 (21.3%) in terms of steric conformation of “low flow” vessels corresponding to the Cavernosal Terminal Unit. The diagnostic sensitivity of Power Doppler towards veno-occlusive dysfunction was found to be 52.4% (Positive Predictive Value: 39.3%), the specificity was 78.8% (Negative Predictive Value: 86.3%) and the total diagnostic accuracy was equal to 73.3%. Conclusion: Collected data evidenced that patients who reported altered morphological features of the Cavernosal Terminal Unit had an approximately 4-fold greater risk of having veno-occlusive dysfunction compared to patients who had normal Power Doppler features (OR = 4.076; 95% CI: 1.996-8.327)

Evaluation of SARS-CoV-2 and semen quality in COVID-19 patients

Author of the Study: The aim of this studywas to evaluate the possible presence of SARS-CoV-2 in semen samples collected by young men with COVID-19 and their semen quality looking for a possible relationship between the infectious disease and fertility. Materials and Methods: In this prospective study we enrolled 15 consecutive men (age 18–50 ys) with positive oropharyngeal swab to SARS-CoV 2 and mild to moderate disease according to NCPPCP (7th edition) classification. Exclusion criteria were the presence of coomorbidities potentially related to infertility.Blood samples for the assay of FSH, LH, testosterone, procalcitonin, interleukin 6, C reactive protein was obtained. A semen sample was collected to detect SARSCoV viral RNA by the automated Real- Time PCR ELITe InGenius® system and the GeneFinderTM COVID-19 Plus RealAmp Kit assay (ELITechGroup, France). Moreover sperm examinations were performed according to WHO criteria. Results: SARS-CoV-2 RNA has not been detected in semen samples from none of the subjects analysed. sperm analysis exhibited abnormal seminal parameters in 13 out of 15 patients (87%). The inflammatory indices showed no differences in patients with abnormal semen compared to patients with normal semen. Conclusions: SARS-CoV-2 was not present in the semen while semen quality is altered in an high percentage of cases in this population

COVID-19 disease in clinical setting: Impact on gonadal function, transmission risk, and sperm quality in young males

Objectives: We want to evaluate the possible presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in semen samples and semen quality, looking for a possible relationship between the infectious disease and fertility. Methods: In this prospective study, we enrolled 15 consecutive men (age 18-50 years) with positive oropharyngeal swab to SARS-CoV-2 and classified, according to WHO criteria, in mild to moderate disease. A semen sample was collected to detect SARS-CoV viral RNA by the automated Real-Time PCR ELITe InGenius\uae system and the GeneFinderTM COVID-19 Plus RealAmp Kit assay (ELITechGroup, France). Analysis of semen characteristics was performed according to WHO laboratory manual 5th ed. for the examination and processing of human semen. Blood samples for the dosage of hormonal assay, procalcitonin, interleukin 6, C-reactive protein were obtained. Results: SARS-CoV-2 RNA has not been detected in semen samples from any of the subjects analysed. Sperm analysis exhibited abnormal seminal values in 14 out of 15 patients (93.3%). Furthermore, no difference was detected regarding sperm quality between mild and moderate SARS-CoV-2 patients. No alteration in the inflammatory indices was observed in the studied population, as well gonadotropins and testosterone levels. Conclusions: COVID patients studied exhibits alteration of the seminal fluid both in microscopic and macroscopic characteristics such as hypoposia and increased viscosity, which have not been detected in previous studies. The presence of viral RNA within the seminal fluid was excluded

The first-generation phosphodiesterase 5 inhibitors and their pharmacokinetic issue

Background: Erectile dysfunction (ED) is a relatively frequent disease that negatively impacts the overall quality of life, well-being, and relationships. Although the use of phosphodiesterase 5 inhibitors (PDE5is) has revolutionized the treatment of ED, a high percentage of ED patients discontinue PDE5i treatment. Objectives: (i) To analyze the reasons for patient dissatisfaction leading to PDE5i discontinuation; (ii) analyze the pharmacokinetics of new formulations focusing on the time needed to reach an effective plasma concentration of PDE5is (Tonset) following drug intake; and (iii) summarize the physicochemical properties of sildenafil to understand which excipients may increase the absorption rate. Material and methods: An online PubMed literature search was conducted to identify English language publications from inception to January 2019. Results: The main reasons for patient dissatisfaction when using PDE5is on demand are the relatively long Tonset after taking vardenafil and sildenafil, including formulations such as film-coated tablets, fine granules, orally disintegrating tablets (ODTs), and oral thin films (ODFs). The relatively long Tonset, further worsened when accompanied by eating, highlights the following: (i) the need for planning intercourse, determining partner-related issues; (ii) issues when having sex before the maximum effect of the drug; and (iii) lower drug-related placebo effects. Some data suggest that sildenafil is a ‘difficult’ molecule, but Tonset can be improved following absorption by buccal mucosa using appropriate excipients. Conclusions: We conclude that several ODT and ODF formulations can improve the ‘discretion’ issue because they are taken without water, but they have similar pharmacokinetics to corresponding film-coated tablet formulations. One ODF formulation of sildenafil was characterized by a shorter Tonset and could potentially increase patient satisfaction following treatment. However, more clinical studies are needed to confirm the findings. Surfactants and ascorbic acid appear to be crucial excipients for achieving a high absorption rate, but more studies are needed

The intra-meatal application of alprostadil cream (Vitaros®) improves drug efficacy and patient’s satisfaction: results from a randomized, two-administration route, cross-over clinical trial

To investigate the efficacy, tolerability, and patient’s preference of alprostadil cream for topical use administered within the urethral meatus versus the standard administration route, in erectile dysfunction (ED) treatment. Seventy-one patients (mean age 59.7 ± 9.0 years) affected by ED were analyzed in this multicenter, randomized, two-administration routes, cross-over trial. All patients received a single dose of alprostadil cream applying the dispenser to the tip of the penis (without contacting the urethral meatus) (Standard administration route or ST.AR) alternating with a single dose of alprostadil cream applying the dispenser within the urethral meatus (New administration route or NEW.AR) separated by a one-week washout period, according to randomization. The primary objective of the study was to evaluate the change in International Index of Erectile Function (IIEF-5) total score from baseline to the control visit by comparing the ST.AR and NEW.AR. Secondary objectives of the study were to compare the different methods of administration by evaluating the change in the Sexual Encounter Profile (SEP-2 and SEP-3) questionnaire score and the Patient Reported Outcomes (PROs) by scoring the Patient Self-Assessment of Erection (PSAE) questionnaire. The treatment safety profile was assessed by analysis of adverse events (AEs). Based on the study findings it is evident that the NEW.AR is more efficacious than the ST.AR in improving IIEF-5 and SEP scores from baseline to control visit (IIEF-5: +3.8 vs +6.3; p < 0.001; positive response to SEP-2: 10 vs 27; p = 0.002) and in terms of PSAE (a significant improvement from the baseline in 31% of patients; p < 0.001). As regards the safety profile, no difference in terms of local and systemic side effects was found

A “real life” investigation on the prescriptive habits among Italian andrologists: The “CONSER” survey from Italian Society of Andrology (SIA) on Sildenafil oral film

Even if oral type 5 phosphodiesterase inhibitors (PDE5i) seem an effective treatment for erectile dysfunction (ED), the drop-out is high among patients. For this reason, pharmaceutical companies are encouraged to develop new administration routes, such as the orally disintegrating film. The aim of this study was to analyse the prescription habit of Italian andrologists affiliated to Italian Society of Andrology (SIA) in the era of new oro-dispersible formulation of sildenafil. A 12-items dedicated questionnaire has been distributed to 77 urologists andrologists. As a result of the questionnaire, sildenafil is still the preferred drug of Italian andrologists as it is considered the safest and the most effective. It combines the speed of action and the discretion of the intake that are very important issues for the adherence to the treatment according to the Italian sample. Physicians have also reported the positive feedback of the patients taking sildenafil film as they consider the oro-dispersible formulation either comparable or superior to the old tablet. In conclusion this new formulation has given a new life to an old molecule like sildenafil, and Italian andrologists considered this new pharmaceutical formulation as a good tool to improve the patient’s adherence to the treatment and quality of life

A \u201creal life\u201d investigation on the prescriptive habits among Italian andrologists: The \u201cCONSER\u201d survey from Italian Society of Andrology (SIA) on Sildenafil oral film

Even if oral type 5 phosphodiesterase inhibitors (PDE5i) seem an effective treatment for erectile dysfunction (ED), the drop-out is high among patients. For this reason, pharmaceutical companies are encouraged to develop new administration routes, such as the orally disintegrating film. The aim of this study was to analyse the prescription habit of Italian andrologists affiliated to Italian Society of Andrology (SIA) in the era of new oro-dispersible formulation of sildenafil. A 12-items dedicated questionnaire has been distributed to 77 urologists andrologists. As a result of the questionnaire, sildenafil is still the preferred drug of Italian andrologists as it is considered the safest and the most effective. It combines the speed of action and the discretion of the intake that are very important issues for the adherence to the treatment according to the Italian sample. Physicians have also reported the positive feedback of the patients taking sildenafil film as they consider the oro-dispersible formulation either comparable or superior to the old tablet. In conclusion this new formulation has given a new life to an old molecule like sildenafil, and Italian andrologists considered this new pharmaceutical formulation as a good tool to improve the patient\u2019s adherence to the treatment and quality of life

Low intensity shockwave therapy in combination with phosphodiesterase-5 inhibitors is an effective and safe treatment option in patients with vasculogenic ED who are PDE5i non-responders: a multicenter single-arm clinical trial

Low-intensity shockwave therapy (Li-ESWT) has been shown to be an effective and safe treatment for vasculogenic erectile dysfunction (ED). We aim to evaluate the effectiveness and safety of LiESWT in treating patients affected from vasculogenic ED who did not respond to oral treatment with Phosphodiesterase 5 inhibitors (PDE5-i). It is a multicentric open-label prospective study, in a cohort of patients non-responders to PDE-5i. Li-ESWT was performed in an outpatient setting by using the following schedule: 3000 shockwaves with an energy of 0.25 mJ/mm2 and a frequency of 4–6 Hz, twice a week for 3 weeks. International Index of Erectile Function, Erection Hardness Score and Sexual Quality of Life-Male questionnaires, and penile doppler ultrasound (PDU) are the outcome measurements. The Student t-test or Wilcoxon signed-rank test were applied to compare variables, with results considered statistically significant at p &lt; 0.05. 106 (97.2%) completed treatment and performed follow-up visit after 4 weeks. At follow up visit, the mean IIEF-EF increased by 8.6 points (13.47 ± 4.61 vs 22.07 ± 5.27; p &lt; 0.0001). A clinically significant improvement of IIEF-EF was achieved in 75 patients (70.7%). An EHS score ≥ 3, sufficient for a full intercourse, was reported by 72 patients (67.9%) at follow-up visit. 37 (34.9%) patients reported a full rigid penis (EHS = 4) after treatment. Li-ESWT treatment was also able to improve quality of life (SQOL-M: 45.56 ± 8.00 vs 55.31 ± 9.56; p &lt; 0.0001). Li-ESWT significantly increased mean PSV (27.79 ± 5.50 vs 41.66 ± 8.59; p &lt; 0.0001) and decreased mean EDV (5.66 ± 2.03 vs 1.93 ± 2.11; p &lt; 0.0001) in PDU. Combination of Li-ESWT and PDE5-i represents an effective and safe treatment for patients affected from ED who do not respond to first line oral therapy

Outcomes and predictive factors of successful salvage microdissection testicular sperm extraction (mTESE) after failed classic TESE: results from a multicenter cross-sectional study

Microdissection testicular sperm extraction (mTESE) has been proposed as a salvage treatment option for men with a previously failed classic TESE (cTESE), but data are scarce. We aimed to assess the outcome of and potential predictors of successful salvage mTESE in a cohort of men previously submitted to unfruitful cTESE. Data from 61 men who underwent mTESE after a failed cTESE between 01/2014 and 10/2020, at 6 tertiary-referral centres in Italy were analysed. All men were investigated with semen analyses, testicular ultrasound, hormonal and genetic blood testing. Pathological diagnosis from TESE was collected in every man. Descriptive statistics and logistic regression models were used to investigate potential predictors of positive sperm retrieval (SR+) after salvage mTESE. Baseline serum Follicle-Stimulating hormone (FSH) and total testosterone levels were 17.2 (8.6\u201330.1) mUI/mL and 4.7 (3.5-6.4) ng/mL, respectively. Sertoli-cell-only syndrome (SCOS), maturation arrest (MA) and hypospermatogenesis were found in 24 (39.3%), 21 (34.4%) and 16 (26.2%) men after cTESE, respectively. At mTESE, SR+ was found in 30 (49.2%) men. Patients with a diagnosis of hypospermatogenesis had a higher rate of SR+ (12/16 (75%)) compared to MA (12/21 (57.1%)) and SCOS (6/24 (25%)) patients at mTESE (p &lt; 0.01). No clinical and laboratory differences were observed between SR+ and SR- patients at mTESE. There were no significant complications after mTESE. At multivariable logistic regression analysis, only hypospermatogenesis (OR 9.5; p &lt; 0.01) was independently associated with SR+ at mTESE, after accounting for age and FSH. In conclusion, salvage mTESE in NOA men with previous negative cTESE was safe and promoted SR+ in almost 50%. A baseline pathology of hypospermatogenesis at cTESE emerged as the only independent predictor of positive outcomes at salvage mTESE