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Introduction The effectiveness of phosphodiesterase type 5 (PDE5) inhibitors over the conservative management of Peyronie’s disease (PD) has been widely questioned. Aim To determine the role of sildenafil 25 mg film formulation twice a day (S25 b.i.d.) in the improvement of curvature after treatment of collagenase of Clostridium hystoliticum (CCH) in penile curvature owing to PD. Methods From April 2017 to April 2018, 161 consecutive patients were treated with S25 b.i.d. + CCH or CCH alone. Adjustment variables consisted of age, penile curvature, and the 15-question International Index of Erectile Function (IIEF-15) questionnaire at baseline using 1:1 propensity-score matching. Overall, 50 patients were considered subdivided into the following: 25 patients who received S25 b.i.d. + CCH (group A) and 25 who received CCH alone (group B). Patients received CCH injection using a shortened protocol and vacuum device in both groups. Main Outcome Measure The primary outcome of the study was the change in penile curvature after treatment, and secondary outcomes were the change in sexual function (IIEF-15) and in the Peyronie’s Disease Questionnaire (PDQ) and its subscores, PDQ-PS (psychosexual symptoms), PDQ-PP (penile pain), and PDQ-SB (symptom bother). Results Overall, mean penile curvature was 47.0° (SD 21.88), the mean IIEF-EF (erectile function) was 23.56 (SD 4.10), and the mean PDQ was 27.06 (SD 13.55). After the treatment, we observed a mean change for penile curvature of 25.6 (SD 9.05) in group A and –25.6 (SD 9.7) in group B (P < .01), for IIEF-EF of 2.28 (SD 2.33) in group A and 1.36 (SD 1.77) in group B (P = .03), for PDQ-PS of –3.04 (SD 2.95) in group A and of –2.12 (SD 2.06) in group B (P = .11), for PDQ-PP of –1.0 (SD 4.48) in group A and of –0.88 (SD 2.04) in group B (P = .60), for PDQ-SB of –5.84 (SD 4.58) in group A and of –4.16 (SD 4.45) in group B (P = .60), and for Female Sexual Function Index of 3.8 (SD 2.45) in group A and of 2.72 (SD 2.28) in group B (P = .14). We found a rate of global satisfaction of 70.83% in group A and of 84.0% in group B (P = .27). Clinical Implications Addition of S25 b.i.d. to CCH is superior to CCH alone for improving penile curvature and erectile function. Strength & Limitations This is the first study comparing sildenafil + CCH vs CCH alone for the treatment of PD. Lack of randomization and direct verification of appropriate use of penile modeling could be considered limitations. Conclusion In this study, combination therapy was superior in terms of penile curvature and erectile dysfunction improvement.

Introduction: Recent evidences demonstrated that male factor alone is responsible for about 30% cases of infertility. Human follicle-stimulating hormone (hFSH) has been introduced to increase sperm concentration, spermatogonial population, or both natural or assisted pregnancy rates (PRs) in oligozoospermic subjects with normal concentrations of gonadotropins. Methods: Fifty infertile men affected by idiopathic azoospermia were enrolled in this study, after undergoing medical history, physical and clinical examination, baseline semen parameters and hormonal plasma concentrations. Inclusion criteria were infertility for at least 2 years, idiopathic azoospermia, FSH Results: We observed a PR of 15% (3/25) and 28% (7/25) in control and treated group, respectively. SRR after medical treatment and ART was 24% (6/25), while in the control group was 12.5% (2/25). The sperm in the ejaculate of five patients (20%) after medical treatment exhibited a mean concentration of 0.9 million/ml and a mean motility of 12%. The FR was significantly greater in the treatment group with respect to the control group, 30% and 20%, respectively. Conclusions: FSH treatment showed greater efficacy rather than control by increasing the rate of PR and FR in azoospermic patients who underwent TESE.

Objectives To evaluate the efficacy and safety of collagenase clostridium histolyticum (CCH) (Xiapex®, Xiaflex®) in the treatment of Peyronie's disease (PD) using a new modified treatment protocol which aims at reducing the number of injections needed and reducing patient visits, thus reducing the cost and duration of treatment. Patients and Methods A prospective study of 53 patients with PD who had treatment with CCH at a single center using a new modified protocol. The angle of curvature assessment after an intra-cavernosal injection of PGE1, IIEF and Peyronie's disease questionnaires (PDQ) were performed at baseline and at week 12 (4 weeks after the last injection). The global assessment of PD questionnaire was performed at week 12. Under a penile block of 10ml of plain lignocaine 1%, a total of 3 intra-lesional injections of CCH (0.9mg) were given at 4 weekly intervals using a new modified injection technique. In between injections patients used a combination of home modelling, stretching and a vacuum device on a daily basis in order to mechanically stretch the plaque. Investigator modelling was not performed. Results The mean penile curvature at baseline was 54° (30 - 90°). Of the 53 patients in the study, 51 patients (96.2%) had an improvement in the angel of curvature with a mean value of 17.36° (0°- 40°) or 31.4% from baseline (0 - 57%) after 3 CCH injections. The end mean curvature was 36.9° (12 °- 75°; p

Introduction Peyronie's disease (PD) is a common condition that results in penile deformity, which makes sexual intercourse difficult or impossible, and causes psychological, emotional, and relationship difficulties for the man affected and his partner. Collagenase Clostridium histolyticum (CCH; Xiapex, Xiaflex) is the first licensed non-surgical treatment option for PD. The safety and efficacy have been demonstrated in two large phase III randomized controlled trials (IMPRESS I and IMPRESS II). Aim To review the safety and efficacy of CCH and to introduce a new shortened modified protocol for CCH that was developed by the authors to decrease the cost and duration of treatment. Methods A review of the medical literature on CCH for inclusion in this review was obtained by searching the PubMed (from 1946) and Medline (from 1946) medical databases and from the screening of relevant bibliographies. The search terms Xiapex, Xiaflex, collagenase Clostridial histolyticum, and Peyronie's disease were used. Clinical trials in men with PD and scientific articles relating to pharmacologic data were included in the review. When possible, large, randomized, and well-designed trials were selected. Main Outcome Measures Changes in the angle of penile curvature and in the Peyronie's Disease Questionnaire domains. Results The clinical trials demonstrate the safety and efficacy of CCH in the treatment of PD. The new modified protocol developed by the authors is as safe and effective as the protocol used in the clinical trials. Conclusion CCH is the first licensed non-surgical treatment for PD. Its safety and efficacy have been demonstrated in large well-designed clinical trials. The new shortened modified protocol decreases the cost and duration of the treatment without compromising the safety and efficacy of the drug. This alteration will allow more patients to benefit from CCH. Abdel Raheem A, Johnson M, Abdel-Raheem T, et al. Collagenase Clostridium histolyticum in the Treatment of Peyronie's Disease—A Review of the Literature and a New Modified Protocol. Sex Med Rev 2017;5:529–535.

Background A new oro-dispersible film (ODF) formulation of sildenafil has been developed for the treatment of erectile dysfunction (ED) to overcome the drawbacks that some patients experience when taking the conventional film-coated tablet (FCT). Aim To assess the effectiveness and safety of sildenafil ODF formulation in patients with ED who were using the conventional FCT. Methods From May 2017 through July 2017, 139 patients with ED were enrolled. Data from penile color-duplex ultrasound, medical history, hormonal evaluation, and patient self-administered questionnaires were collected. All patients were administered sildenafil 100-mg FCT for 4 weeks. Thereafter, they underwent a 2-week washout period and subsequently took sildenafil 75-mg ODF for 4 weeks. Outcomes The International Index of Erectile Function (IIEF-15), Hospital Anxiety and Depression Scale (HADS), Patient Global Impressions of Improvement (PGI-I), and Clinician Global Impressions of Improvement (CGI-I) questionnaires were administered and severity of ED was classified as severe (IIEF-15 score ≤ 10), moderate (IIEF-15 score 11–16), or mild (IIEF-15 score = 17–25). Results All patients completed the final protocol. Differences in mean IIEF scores for erectile function, orgasmic function, sexual desire, and intercourse satisfaction were significantly in favor of sildenafil 100-mg FCT, whereas the mean score for overall satisfaction was in favor of sildenafil 75-mg ODF. A significant difference in changes in HADS score was found from washout to final follow-up (mean difference = −0.19; P < .01). For the ODF formulation, the median CGI-I score was 3.5 (interquartile range [IQR] = 2.5–4.5) and the median PGI-I score was 3.0 (IQR = 2.0–4.0). The median action time was 20.0 minutes (IQR = 15.0–30.0) and the median mouth time was 60.0 seconds (IQR = 30.0–120.0). Clinical Implications The ODF formulation of a widely known drug, with the same safety and effectiveness of the FCT, was better appreciated by patients in overall satisfaction. Strengths and Limitations This is the first clinical trial to assess the efficacy of a new formulation of sildenafil in patients with ED. The limitations of the study are related to the methodology used: it was not a case-control study and the patients were not drug-naïve for ED treatment. Therefore, only the “additional” side effects of the ODF formulation compared with FCT are reported. Conclusion The new ODF formulation is as efficient and safe as the FCT formulation and offers a new choice of treatment to specialists for more precisely tailored therapy.

ItalyPurpose: In this study, we aimed to determine the role of extracorporeal shockwave therapy (ESWT) in the management of Peyronie’s disease (PD). Materials and Methods: A total of 325 patients suffering from PD were enrolled in this single-arm clinical study. All patients were received ESWT using a schedule of 1 treatment/wk. Penile curvature was measured by a goniometer after intracavernosal drug-induced erection using Alprostadil. Plaque size was measured with a ruler and sexual function assessed by the international index of erectile function (IIEF)-15 score. Severity of erectile dysfunction was classified as severe (IIEF-15 ≤10), moderate (IIEF-15 between 11 and 16), or mild (IIEF-15 between 17 and 25). Results were evaluated at baseline and 3 months after the treatment.Results: All the patients completed the study protocol. Median age was 59.0 years (55.0–64.0 years). After treatment, the median (interquartile range, IQR) plaque size reduced from 1.78 cm2 (1.43–2.17 cm2) to 1.53 cm2 (1.31–1.96 cm2) (p

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; pConclusions 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.

Introduction and Aim This article reviews the current literature on common physiopathogenetic factors and pharmacological pathways of lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) in men and their implications for diagnosis and treatment. Main Outcome Measures and Methods A literature search was conducted to identify original articles, reviews, editorials, and international scientific congress abstracts by combining the following terms: lower urinary tract symptoms, erectile dysfunction and phosphodiesterase type 5 inhibitors (and their abbreviations LUTS, ED and PDE5‐Is). Results We identified manuscripts presenting: (i) The existence of several newly discovered common pathophysiological mechanisms of LUTS and ED indicating that PDE5‐Is might represent an alternative to current treatments of men with LUTS (e.g., α1‐adrenergic blockers and 5α‐reductase inhibitors); (ii) Randomized controlled clinical trials have shown that treatment with PDE5‐Is is associated with improvements in both LUTS and ED in men with significant problems in both areas. Conclusion The presence of common pathophysiological mechanisms between LUTS and ED seems well recognized and needs further exploration. Further comparisons between different PDE5‐Is would be useful to determine the most appropriate regimen and their efficacy to safety ratio. Fusco F, D'Anzeo G, Sessa A, Pace G, Rossi A, Capece M, and d'Emmanuele di Villa Bianca R. BPH/LUTS and ED: Common pharmacological pathways for a common treatment. J Sex Med 2013;10:2382–2393.

Benign prostatic hyperplasia is considered a progressive disease intimately linked with aging. The long-term use of combination therapy with a 5-alpha-reductase inhibitor, together with an alpha blocker in men with moderate-severe symptoms, reduces the risk of clinical progression and BPH-related surgery. It is unclear what the impact is of preoperative therapy with 5-ARI in patients that undergo surgery. The aim of our study was to evaluate the impact of preoperative therapy with 5-alpha-reductase inhibitors on: a) indication on the type of surgery; b) surgical and functional outcomes; c) surgical complications. This is a prospective observational study. It will include all patients undergoing surgery by TURP or Open Prostatectomy in a period of 24 months. We expect results that demonstrate significant and favorable influence of pretreatment with 5-alpha-reductase inhibitors on certain outcomes. Therefore, therapy with 5-ARI could be considered as neoadjuvant to surgery, whatever this is.

The primary goal in the management strategy of a patient with ED would be to determine its etiology and cure it when possible, and not just to treat the symptoms alone. One of the new therapeutic strategies is the use of low intensity extracorporeal shockwave (LISW) therapy. The mechanism of shockwave therapy is not completely clear. It is suggested that LISW induces neovascularization and improvement of cavernosal arterial flow which can lead to an improvement of erectile function by releasing NO, VEGF and PCNA. Materials and Methods: 31 patients between February and June 2013 with mild to severe ED and non-Phosphodiesterase 5 inhibitors responders were enrolled. Patients underwent four weekly treatment sessions. During each session 3600 shocks at 0.09mJ/ mm2 were given, 900 shocks at each anatomical area (right and left corpus cavernosum, right and left crus). Improvement of the erectile function was evaluated using the International Index of Erectile Function (IIEF-EF), the Sexual Encounter Profile (SEP) diaries (SEP-Questions 2 and 3) and Global Assessment Questions (GAQ-Q1 and GAQ-Q2). Results: At 3-month follow-up IIEF-EF scores improved from 16.54±6.35 at baseline to 21.03±6.38. Patients answering ‘yes’ to the SEP-Q2 elevated from 61% to 89% and from 32% to 62% in the SEP-Q3. A statistically significant improvement was reported to the Global Assessment Questions (GAQ-Q1 and GAQ-Q2). Conclusion: In conclusion, we can affirm that LISW is a confirmed therapeutic approach to erectile dysfunction that definitely needs more long-term trials to be clarified and further verified.

Varicocele is present in 15% to 20% of the general population, but in approximately 35% to 40% of males presenting for an evaluation of their infertility. Indeed it is well known that varicocele can cause testicular damage and infertility. No evidence indicates a varicocele treatment in infertile men who have normal semen analysis or in men with subclinical varicocele. In this situation, varicocelectomy cannot be recommended. Varicocele repair may be effective in men with subnormal semen analysis, a clinical varicocele and otherwise unexplained infertility, but we need further randomized studies to confirm that this subgroup of infertile couples will benefit from treatment. There is no doubt about the standard indications of varicocelectomy, but recent literature seems to go towards new indications of varicocele repair. The aim of this review is to give a look at the literature to analyze the proper indications to varicocelectomy for the proper patient.

Recently, many studies explored the role of inflammation parameters in the prognosis of urinary cancers, but the results were not consistent. The modified Glasgow Prognostic Score (mGPS), a systemic inflammation marker, is a prognostic marker in various types of cancers. The aim of the present study was to investigate the usefulness of the preoperative mGPS as predictor of recurrence-free (RFS), overall (OS), and cancer-specific (CSS) survivals in a large cohort of urothelial bladder cancer (UBC) patients.A total of 1037 patients with UBC were included in this study with a median follow-up of 22 months (range 3-60 months). An mGPS = 0 was observed in 646 patients (62.3%), mGPS = 1 in 297 patients (28.6 %), and mGPS = 2 in 94 patients (9.1%).In our study cohort, subjects with an mGPS equal to 2 had a significantly shorter median RFS compared with subjects with mGPS equal to 1 (16 vs 19 months, hazard ratio [HR] 1.54, 95% CI 1.31-1.81, P < 0.001) or with subjects with mGPS equal to 0 (16 vs 29 months, HR 2.38, 95% CI 1.86-3.05, P < 0.001). The association between mGPS and RFS was confirmed by weighted multivariate Cox model. Although in univariate analysis higher mGPS was associated with lower OS and CSS, this association disappeared in multivariate analysis where only the presence of lymph node-positive bladder cancer and T4 stage were predictors of worse prognosis for OS and CSS.In conclusion, the mGPS is an easily measured and inexpensive prognostic marker that was significantly associated with RFS in UBC patients.