1.Evaluation of an alternative dosing regimen with tadalafil, three times per week, for men with erectile dysfunction: SURE study in Italy.
Vincenzo MIRONE ; Ciro IMBIMBO ; Andrea ROSSI ; Riccardo SICUTERI ; Domenico VALLE ; Nicola LONGO ; Ferdinando FUSCO ; null
Asian Journal of Andrology 2007;9(3):395-402
AIMTo examine the preference for two dosing regimens of 20 mg of tadalafil, on demand or three times per week, in men affected with erectile dysfunction (ED) in Italy.
METHODSScheduled Use versus on demand Regimen Evaluation (SURE) is a multicenter, crossover and open-label study, involving 94 urology centers in Italy. Patients aged 18 years or older affected with ED for at least 3 months were enrolled and randomized to 20 mg of tadalafil treatment on demand or three times per week for 5-6 weeks. After a 1-week washout, patients were crossed over to the alternate regimen for 5-6 weeks. A treatment preference question was used to determine the preferred treatment regimen. International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP) questionnaire were used as efficacy measures.
RESULTSA total of 1 058 men (mean age 54.8 years), were randomized to treatment. Overall, 59.1% of patients preferred the on-demand regimen and 41.9% preferred the three times per week dosing. Both regimens were efficacious and well tolerated. Although a statistically higher improvement of the IIEF erectile function (IIEF-EF) domain score and the SEP questionnaire was reported for the three times per week compared to the on-demand treatment regimen, this difference was numerically minimal and lacking in clinical significance.
CONCLUSIONTadalafil is effective and well tolerated whether used on demand or three times per week. Patients should be given the option to choose the best treatment regimen according to personal needs and preferences.
Carbolines ; administration & dosage ; therapeutic use ; Cross-Over Studies ; Drug Administration Schedule ; Erectile Dysfunction ; drug therapy ; Humans ; Italy ; Male ; Middle Aged ; Phosphodiesterase Inhibitors ; administration & dosage ; therapeutic use ; Tadalafil ; Treatment Outcome
2.The Clinical Efficacy of Pollen Extract and Vitamins on Chronic Prostatitis/Chronic Pelvic Pain Syndrome Is Linked to a Decrease in the Pro-Inflammatory Cytokine Interleukin-8.
Tommaso CAI ; Paolo VERZE ; Roberto LA ROCCA ; Alessandro PALMIERI ; Daniele TISCIONE ; Lorenzo Giuseppe LUCIANI ; Sandra MAZZOLI ; Vincenzo MIRONE ; Gianni MALOSSINI
The World Journal of Men's Health 2017;35(2):120-128
PURPOSE: We aim to evaluate the efficacy of pollen extract in association with vitamins in patients affected by chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and to evaluate the level of the pro-inflammatory mediators interleukin (IL)-6, IL-8, and IL-10. MATERIALS AND METHODS: Patients diagnosed with CP/CPPS between January and December 2015 were enrolled in this study. Participants were randomly assigned to receive oral capsules of pollen extract and vitamins (group A) or bromelain (group B) for 3 months. At the enrolment time and 3 months after enrolment, all patients completed questionnaires (the National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI] and the Short Form-36 and underwent urological examinations and microbiological evaluation. Levels of IL-6, IL-8, and IL-10 were evaluated in seminal plasma. RESULTS: Sixty-five male patients (mean age of 32.7±4.7 years) were analysed (group A, n=32; group B, n=33). At the follow-up examination, 24 of the 32 patients in group A showed a significant reduction in the NIH-CPSI total score compared with 8 of the 33 patients in the bromelain group (p<0.001). Moreover, the mean level of IL-8 was significantly lower in the pollen extract and vitamins group when compared with the bromelain group (298 pg/mL vs. 736 pg/mL, respectively; p<0.001). In group A we found a statistically significant reduction in the levels of IL-8 between enrolment and the follow-up visit (878 pg/mL vs. 298 pg/mL, respectively; p<0.001). CONCLUSIONS: Treatment with pollen extract and vitamins improved the quality of life in CP/CPPS patients by reducing the levels of pro-inflammatory IL-8.
Bromelains
;
Capsules
;
Follow-Up Studies
;
Humans
;
Interleukin-10
;
Interleukin-6
;
Interleukin-8*
;
Interleukins
;
Male
;
National Institutes of Health (U.S.)
;
Pelvic Pain*
;
Pollen*
;
Prostatitis
;
Quality of Life
;
Semen
;
Treatment Outcome*
;
Vitamins*
3.A comprehensive evaluation of sexual and reproductive outcomes following robot-assisted retroperitoneal lymph node dissection for nonseminomatous germ cell tumor.
Francesco A MISTRETTA ; Ottavio DE COBELLI ; Paolo VERZE ; Francesco BOTTICELLI ; Letizia JANNELLO ; Stefano LUZZAGO ; Gabriele COZZI ; Roberto BIANCHI ; Ettore DI TRAPANI ; Matteo FERRO ; Giovanni CORDIMA ; Danilo BOTTERO ; Deliu Victor MATEI ; Vincenzo MIRONE ; Gennaro MUSI
Asian Journal of Andrology 2022;24(6):579-583
Sexual disorders following retroperitoneal pelvic lymph node dissection (RPLND) for testis tumor can affect the quality of life of patients. The aim of the current study was to investigate several different andrological outcomes, which may be influenced by robot-assisted (RA) RPLND. From January 2012 to March 2020, 32 patients underwent RA-RPLND for stage I nonseminomatous testis cancer or postchemotherapy (PC) residual mass. Modified unilateral RPLND nerve-sparing template was always used. Major variables of interest were erectile dysfunction (ED), premature ejaculation (PE), dry ejaculation (DE), or orgasm alteration. Finally, fertility as well as the fecundation process (sexual intercourse or medically assisted procreation [MAP]) was investigated. Ten patients (31.3%) presented an andrological disorder of any type after RA-RPLND. Hypospermia was present in 4 (12.5%) patients, DE (International Index of Erectile Function-5 [IIEF-5] <25) in 3 (9.4%) patients, and ED in 3 (9.4%) patients. No PE or orgasmic alterations were described. Similar median age at surgery, body mass index (BMI), number of nodes removed, scholar status, and preoperative risk factor rates were identified between groups. Of all these 10 patients, 6 (60.0%) were treated at the beginning of our robotic experience (2012-2016). Of all 32 patients, 5 (15.6%) attempted to have a child after RA-RPLND. All of these 5 patients have successfully fathered children, but 2 (40.0%) required a MAP. In conclusion, a nonnegligible number of andrological complications occurred after RA-RPLND, mainly represented by ejaculation disorders, but ED occurrence and overall sexual satisfaction deficit should be definitely considered. No negative impact on fertility was described after RA-RPLND.
Male
;
Child
;
Humans
;
Robotics
;
Quality of Life
;
Retrospective Studies
;
Neoplasms, Germ Cell and Embryonal/surgery*
;
Testicular Neoplasms/pathology*
;
Lymph Node Excision/adverse effects*
;
Retroperitoneal Space/surgery*
;
Erectile Dysfunction/surgery*
;
Treatment Outcome