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.

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.

Health sciences are steadily developing apps to help people to adopt correct lifestyles and to help physicians to monitor patients with chronic diseases. However, a properly validated tool that can evaluate patients' perception of apps is still lacking in many languages. In English, a validated questionnaire, called User Version of the Mobile Application Rating Scale (uMARS), is currently available. We translated the uMARS into Italian and validated our version. The uMARS questionnaire was translated from English to Italian by an official translator, and then administered to 100 smartphone users in order to evaluate the same app at times 1 and 2 (after 2 weeks). Paired t-test, Pearson Correlation Coefficient, Intraclass Correlation Coefficient (ICCs) and Cronbach's Alpha were used to evaluate the reliability and validity of the Italian uMARS. We recruited 100 subjects, 52 males (52%) and 48 females (48%), with a mean age of 22.8 (SD: 3.4). All subjects answered all questions both at time 1 and at time 2. Paired t-test showed no statistically significant difference in each answer or group of answers between times 1 and 2 (P > 0.05). Cronbach's alpha was 0.945, as all subjects answered all questions. Each question was further assessed through the Pearson correlation coefficient, which demonstrated high reliability, with significant P (< 0.05) and Pearson Coefficients higher than 0.7. Similarly, ICCs were always higher than 0.750. Our results validated the Italian version of uMARS, which may become a reliable and useful tool for evaluating health apps.

The aim of the study was to describe the surgical outcomes of a series of consecutive patients treated with robot-assisted pyeloplasty (RAP) for ureteropelvic junction obstruction in a single tertiary referral center. We prospectively collected and retrospectively analyzed data of 292 patients submitted to RAP performed from September 2011 to December 2016 by four experienced surgeons. The stenotic ureteropelvic junction was resected according to the Anderson-Hynes technique. Complications' severity was recorded and graded according to the modified Clavien classification system. The mean age was 40.6 years (SD15.5). Median Charlson Comorbidity Index was 0 (IQR 0-1). All interventions were performed with a transperitoneal access and a ureteral stent was always positioned. The mean operative time was 112.8 minutes (SD 48.7). Overall postoperative complications were 29 (9.9%): 24 (8.2%) surgical complications (7.2% Clavien 1, 0.7% Clavien 2 and 0.3% Clavien 3) and 5 (1.7%) medical complications (1% Clavien 1, 0.7% Clavien 2). The mean length of stay (LOS) was 4 days (SD 2.0). Median follow-up was 21 months (range 14-62). Six (2%) patients presented a recurrent obstruction with persistent hydronephrosis with or without symptoms or they had persistent symptoms. They were all submitted to retrograde holmium laser endopyelotomy. One (0.3%) of them required redo RAP for persistence of symptoms 8 months after the endoscopic treatment. In our experience, RAP with Anderson-Hynes technique performed in a tertiary referral center by expert surgeons represent a safe and feasible procedure with an overall low rate of postoperative complications.

Article: One-year outcomes after water vapor thermal therapy for symptomatic benign prostatic hyperplasia in an unselected Italian multicenter cohort - Minerva Urology and Nephrology 2023 Jan 19 - Minerva Medica - Journals