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Objectives: To determine the optimum combination therapy of Silodosin-Tadalafil versus Silodosin-Vardenafil in terms of both tolerability and efficacy for the management of distal ureteric stones., Methods: This prospective, double blinded, randomized clinical trial included 140 patients with distal ureteric stones, randomized into two groups: Group I (n = 67) received Silodosin 8 mg once daily combined with Tadalafil 5 mg once daily, and Group II (n = 68) received Silodosin 8 mg once daily combined with Vardenafil 10 mg once daily. The primary outcome was the tolerability of the combination therapies, assessed through the incidence of adverse events. Secondary outcomes included stone expulsion rate, expulsion time, and the need for analgesics., Results: Both combination therapies demonstrated similar efficacy, with no significant differences in stone expulsion rate (70.1% vs. 67.6%, P = 0.754), expulsion time (19 ± 3 days for both groups, P = 0.793), and analgesic requirements (P > 0.05). However, the Silodosin-Tadalafil combination showed a significantly lower occurrence of adverse events, with notable differences in headache (23.9% vs. 57.4%, P < 0.001), dizziness (32.8% vs. 60.3%, P = 0.001), and gastrointestinal upset (9% vs. 66.2%, P < 0.001), and other adverse effects. The overall occurrence of any adverse event was significantly lower in the Silodosin-Tadalafil group (88.1% vs. 98.5%, P = 0.017)., Conclusions: Both Silodosin-Tadalafil and Silodosin-Vardenafil therapies are effective in managing distal ureteric stones. However, the Silodosin-Tadalafil combination is associated with a significantly lower incidence of adverse events, making it a more tolerable option for patients., Competing Interests: Declarations. Conflict of interest: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Ethics approval: The study was approved by the Research Ethics Committee, Faculty of Medicine, Benha University, Egypt (Approval code: RC 24-2-2023). Informed consent: Informed consent was obtained from all individual participants included in the study., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

Purpose: We aimed to compare the efficacy, safety, and compliance of tadalafil 5 mg daily dose in the tablet form versus oral dispersible film (ODF) in men with mild-to-moderate erectile dysfunction (ED)., Methods: One hundred thirty-five randomized patients were equally divided into three groups according to age where each group included forty-five patients. Within each group, 15 patients received oral tadalafil 5 mg, 15 patients received ODF tadalafil 5 mg and 15 patients received a placebo once daily for 1 month. All participants were assessed by the validated Arabic version of the international index of erectile function (ArIIEF-5) at baseline and after 1 month. Also, the efficacy of different forms of tadalafil 5 mg was assessed by responding affirmatively to a questionnaire., Results: Patients aged > 25 to < 40 years and 40-55 years and > 55 years showed a statistically significant improvement of ArIIEF-5 scores after tadalafil 5 mg tablet and ODF tadalafil 5 mg compared to placebo ODF (23 ± 1.4; 22.7 ± 0.9; 20 ± 0.9; 20.4 ± 1.3; 20.2 ± 1.2; 16.6 ± 1.2; 18.5 ± 1.7; 19.6 ± 1.4; 16.3 ± 1.4; p < 0.001, respectively). Three patients (> 25 to < 40 years) who received tadalafil 5 mg tablet showed muscle and back pain. Gastrointestinal (GIT) upset (eight patients) followed by headache (seven patients) were the main side effects reported in patients (40-55 years) who received tadalafil 5 mg tablet. While GIT upset was the main side effect reported in patients (> 55 years) who received tadalafil 5 mg tablet., Conclusion: ODF tadalafil 5 mg is an effective, tolerable, and safe formulation that can be used in patients with mild-to-moderate ED., (© 2024. The Author(s).)

Purpose: Few data exist on dihydrotestosterone (DHT) adaptation to exercise-related stress. The aim of the study was to investigate on serum DHT and other androgens' responses to acute aerobic exercises, and to verify if a long-acting phosphodiesterase's type 5 inhibitors could influence these responses, as previously observed for salivary testosterone., Methods: In a double-blind cross over study, 12 healthy trained male volunteers were submitted to both an acute sub-maximal and maximal exercise tests on cycle ergometer, after randomly receiving a two days placebo or tadalafil administration (20 mg, Cialis ® , Ely-Lilly, Indianapolis, IN, USA). Blood sample collections were performed at different time points before and after exercise. Serum DHT, total testosterone (TT), dehydroepiandrosterone sulfate (DHEAS) and luteinizing hormone (LH), were assayed., Results: Serum DHT increase in placebo treatment immediately post maximal aerobic exercise and return to basal values at 60 min of recovery whereas tadalafil administration significantly reduced the DHT increase after exercise. The values of areas under curves showed the increase of TT after acute sub-maximal and maximal exercise and of DHEAS only after acute maximal aerobic exercise independently from treatment., Conclusions: In addition to testosterone, also DHT plays an exercise-related adaptive role during high intensity aerobic exercise, but its rapid useful effects during exercise have to be determined. We hypothesized that the increased androgens secretion during exercise could be mainly related to steroidogenic enzymes modifications in peripheral tissues (i.e., muscles). Moreover, the blunting effect of tadalafil on DHT increase support a possible role of peripheral nitric oxide/GMPc related pathways in influencing physical-stress related DHT metabolism.

Purpose: We aimed to investigate the efficacy and safety of tadalafil, aspirin, and tadalafil + aspirin combination therapy in vascular erectile dysfunction (VED)., Methods: A total of 336 patients were randomly divided into four groups (group 1, aspirin 100 mg/day, 126 patients; group 2, tadalafil 5 mg/day, 72 patients; group 3, tadalafil 5 mg + aspirin 100 mg, 72 patients; group 4, placebo, 66 patients). In all groups, the changes from baseline to end point in erectile function scores on the International Index of Erectile Function (IIEF-EF) and the number of patients who answered "yes" to questions 2 and 3 of the sexual encounter profile(SEP) were compared statistically., Results: The changes in IIEF-EF scores after treatment were 7.2 ± 4.4, 7.3 ± 4.3, 7.5 ± 4.4, and 2.0 ± 4.6 for group 1 (p < 0.0001), group 2 (p < 0.0001), group 3 (p < 0.0001), and group 4 (p = 0.0204), respectively. The change in SEP-2 ratios after treatment were 36.6%, 36.9%, 41.7%, and 9.4% for group 1 (p < 0.0001), group 2 (p < 0.0001), group 3 (p < 0.0001), and group 4 (p = 0.2925), respectively. The change in SEP-3 ratios after treatment was 46.6%, 49.2%, 53.7%, and 12.5% for group 1 (p < 0.0001), group 2 (p < 0.0001), group 3 (p < 0.0001), and group 4 (p = 0.1456), respectively. In group 2, both the number of patients who reported side effects (p < 0.0001) and stopped using the drug due to side effects (p < 0.05) were significantly higher than the control and others groups., Conclusions: Successful results were obtained by tadalafil and aspirin monotherapy and tadalafil + aspirin combination therapy in patients with VED. However, the least side effect was observed in the tadalafil + aspirin group. Aspirin can be used alone in the treatment of patients with VED, or combined with tadalafil to reduce side effects and increase success.

Pharmacological advances in erectile dysfunction (ED) treatment have aroused growing interest among health professionals towards sexual dysfunction, generating an increasing demand for dosage forms and drug delivery systems, including tadalafil. This study aimed to develop a device to generate patches that would enable drug dosage individualization and transdermal administration. To create such a mechanical device, technical drawings were made using the CAD software. A functional prototype was built, and a pharmaceutical formulation containing tadalafil (10 mg cm -2 ) was prepared. An analytical method (HPLC) was developed and validated. The average weight of adhesives (n = 10) was 241.01 mg; the content uniformity for preparations in unit doses (n = 10) was 108.93%, and a CV <2% for intraadhesive tadalafil content (n = 40) was observed. The ex vivo permeation of patches containing tadalafil was determined in Franz cells (n = 6), equipped with human skin and kept for 12 h in contact with the patch, by using the tape stripping method. The optimized method showed acceptable confidence limits within the range recommended by regulatory agencies, being validated for use in this ex vivo permeation study. Tadalafil could permeate to the viable epidermis and dermis (5.7%). The created device produced homogeneous patches of tadalafil, showing such technological innovation as to be feasible in individualized therapy for the treatment of ED.