Effectiveness and Safety of Oro-Dispersible Sildenafil in a New Film Formulation for the Treatment of Erectile Dysfunction: Comparison Between Sildenafil 100-mg Film-Coated Tablet and 75-mg Oro-Dispersible Film.

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. Cocci A, Capece M, Cito G, et al. Effectiveness and Safety of Oro-Dispersible Sildenafil in a New Film Formulation for the Treatment of Erectile Dysfunction: Comparison Between Sildenafil 100-mg Film-Coated Tablet and 75-mg Oro-Dispersible Film. J Sex Med 2017;14:1606-1611.

Clinical and penile Doppler outcomes using a modified, tourniquet free, Nesbit plication for severe Peyronie's disease.

BACKGROUND: Penile curvature (PC) can be surgically corrected by plication techniques or Nesbit corporoplasty. These shortening techniques can be complicated by post-operative: penile shortening, recurrent PC, palpable suture knots and erectile dysfunction. Furthermore, Nesbit procedures require the use of a penile tourniquet to avoid intraoperative bleeding. This observational study aims to assess the results of Nesbit modified corporoplasty, avoiding intraoperative use of tourniquet without risk of bleeding. The objective is to reduce penile ischemic anatomical and functional damages such as long-term erectile dysfunction. METHODS: Between January 2010 and March 2019, a total of 64 patients with congenital penile curvature (CPC) and Peyronie's disease (PD) underwent surgical correction with a Nesbit modified technique first time described by Rolle et al., with minimal technical differences. The operation notes were retrospectively reviewed. In particular, we evaluated pre- and post-operative erectile functions using IIEF-5 score, penile Doppler ultrasonography and overall patient satisfaction. RESULTS: During operations, no intraoperative bleeding was noted, and no short-term complications such as hematomas or neurovascular bundle lesions were reported. At 6 months, no palpable subcutaneous indurations and no sensory change were detected. Post-operative penile shortening was reported in 38 (59.4%) patients (mean 0.83±0.79 cm), but it did not influence the high overall satisfaction rate of 91.4%. Only 2 patients reported a slightly partial recurrence of curvature (<15%) with no need for a redo surgery. Mean IIEF-5 score increased from 17.1±5.2 to 20.8±3.9 at 6 months and 21.8±3.4 at 12 months (P<0.001 in both cases). Mean PSV also significantly increased at the end of follow-up (28.5±6.1 at baseline vs. 31.0±7.1 at 12 months, P=0.03). CONCLUSIONS: Considering the optimal results in terms of erectile functions increasing and absence of PC recurrence (>15°), we think that Nesbit modified corporoplasty without tourniquet application during reconstruction is a safe and effective surgical procedure for all kind of shortening corporoplasty to reduce the time of penile ischemia, preventing even serious consequences for the normal physiology of erection.

Efficacy and safety of avanafil 200 mg versus sildenafil 100 mg in the treatment of erectile dysfunction after robot-assisted unilateral nerve-sparing prostatectomy: A prospective multicentre study.

Phosphodiesterase type 5 inhibitors represent the standard treatment of erectile dysfunction after nerve-sparing prostatectomy. Avanafil is a second-generation phosphodiesterase type 5 inhibitor with a high selectivity for phosphodiesterase type 5 isoform. To date, there are no studies comparing the outcomes of avanafil versus sildenafil in this scenario. In this study, we evaluated the efficacy and safety of avanafil versus sildenafil as a drug for post-prostatectomy rehabilitation. Overall, 160 patients submitted to robot-assisted nerve-sparing prostatectomy for localized prostate cancer at three hospitals were enrolled for the present study. After 6 months of treatment, patients in the two groups showed no significantly different sexual function scores, except for the Erection Hardness Score and Sexual Encounter Profile-Q2 that were higher in the Sildenafil group. Adverse events in the Avanafil group occurred in four (5%) patients and in 16 (20%) patients in the Sildenafil group. According to our experience, in patients undergoing nerve-sparing prostatectomy, penile rehabilitation with avanafil compared to sildenafil showed a lower ability to produce a valid erection in the initial phase of sexual intercourse, a difference that disappears in the continuation of the same. Avanafil showed a greater tolerance profile with a lower rate of AEs and discontinuation of therapy due to AEs.

Extracorporeal Shock Wave Therapy in Peyronie's Disease: Clinical Efficacy and Safety from a Single-Arm Observational Study.

PURPOSE: 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<0.001); the median (IQR) penile length in erection increased from 13.0 cm (12.0-14.0 cm) to 14 cm (13.0-15.0 cm) (p<0.001) and the median (IQR) penile curvature from 30.4° (22.2°-35.4°) to 25.0° (20.2°-30.4°) (p<0.001). We also observed a decrease in pain assessed by visual analogue scale (7 vs. 3; p<0.001), an improvement in each of the IIEF sub-domains (p<0.001) and an improvement in all three PD questionnaire domains (p<0.001). CONCLUSIONS: Based on our findings, ESWT could be considered a safe and efficient minimally invasive option for the management of the patients suffering from PD.

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.

Effectiveness of highly purified urofollitropin treatment in patients with idiopathic azoospermia before testicular sperm extraction.

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 <12 mIU/ml. Twenty-five patients were allocated to treatment with hFSH three times/week per 3 months (Fostimon), and 25 patients underwent just testicular sperm extraction (TESE) without medical treatment. All patients underwent, after 3 months, assisted reproduction techniques (ARTs) with TESE. The primary outcome was represented by the differences in the sperm retrieval rate (SRR) between groups, while the secondary outcomes were the differences in PR and fertilization rate (FR). 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.

Bladder Instillation Therapy With Hyaluronic Acid and Chondroitin Sulfate Improves Symptoms of Postradiation Cystitis: Prospective Pilot Study.

BACKGROUND: After radiotherapy (RT) for prostate cancer (PCa), several patients reported lower urinary tract symptoms (LUTS) due to damage and discontinuation of the glycosaminoglycan layer of the bladder. Instillation of hyaluronic acid and chondroitin sulfate (HA-CS) represents replenishment therapy of the glycosaminoglycan layer. The aim of the study is to evaluate the efficacy and safety of HA-CS in men with symptomatic cystitis after RT for PCa. MATERIALS AND METHODS: Eighty consecutive men were treated with RT for PCa; 30 of these (37.5%) reported clinically relevant LUTS and associated bother as measured by the Interstitial Cystitis Symptom Index and Problem Index (ICSI/ICPI) Questionnaire 3 months after RT. Symptomatic patients received instillation therapy with HA-CS weekly for the first month and then at weeks 6, 8, and 12. All patients completed the ICSI/ICPI questionnaire before and after RT and at the end of HA-CS treatment. RESULTS: HA-CS significantly reduced postradiation LUTS (P < .001) and bother (P = .006). Age, Gleason score, and radiation dose were the main determinants of worsening of LUTS after radiation (ICSI score baseline vs. postradiation: P = .047, .043, and .023). In multivariate analysis, only age influenced LUTS worsening after RT (P = .01). Age, radiation dose, and radiation toxicity were related to recovery of LUTS (ICSI score postradiation vs. post-HA-CS P = .041, P = .050, and P = .046). In multivariate analysis, no factor was statistically significant. CONCLUSIONS: A remarkable worsening of symptoms and bother was observed after RT. HA-CS instillation is a safe treatment and resulted in an improvement of LUTS irrespective of age and clinical features, with full recovery of urinary bother.