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Despite theoretical benefits of intermittent as compared with continuous androgen-deprivation therapy in patients with metastatic prostate cancer, intermittent therapy did not result in longer survival or long-term improvement in quality of life. Prostate cancer is an androgen-dependent disease, and continuous androgen deprivation has been the standard therapy for metastatic hormone-sensitive disease. Despite a high response rate, resistance to androgen-deprivation therapy occurs in most patients, resulting in a median survival of 2.5 to 3 years. 1 , 2 There is evidence suggesting that progression to castration resistance is adaptive in part, and pathways involving the androgen receptor, as well as cell-survival pathways independent of the androgen receptor, have been implicated. 3 , 4 Data from an androgen-dependent tumor model have suggested that androgen withdrawal alters the ratio of putative stem cells in the tumor-cell population. 5 Initially, differentiated . . .

Peyronie’s Disease (PD) is characterized by fibrotic plaques in the penile tunica albuginea, causing curvature and painful erections. Current treatments have limited established efficacy. Platelet-Rich Plasma (PRP), known for modulating inflammation, offers a potential alternative. This randomized, placebo-controlled, crossover study at the University of Miami assesses PRP’s safety and efficacy for PD. Forty-one PD patients were randomized into PRP-placebo (Group A) and placebo-PRP (Group B) sequences, receiving two injections of each treatment over three months, with a crossover to receive two injections of alternate treatment over the next three months. Assessments include pain scale, goniometry, questionnaires, and curvature evaluations. Preliminary analysis of 28 patients shows that PRP is safe. There were no adverse events, including penile complications, during follow-up. Pain scores during treatments showed no significant difference between PRP and placebo ( p  = 0.52). Over six months, the PRP-Placebo group’s median PDQ score decreased from 1.9 (IQR: 1.7–2.9) to 1.4 (IQR: 0.7–2.1). This change was not statistically significant ( p  = 0.098). In contrast, the Placebo-PRP group showed a significant reduction from 1.8 (IQR: 1.4–2.6) to 1.2 (IQR: 1.0–2.0) ( p  = 0.020). No significant changes in IIEF scores were observed. Both groups initially had a median penile curvature of 40 degrees. At 3 months, the PRP-Placebo group’s curvature decreased to 38 degrees (IQR: 35–47.5), while the Placebo-PRP group decreased to 35 degrees (IQR: 30–60). At 6 months, the PRP-Placebo group showed a significant reduction to 25 degrees (IQR: 20–40, p  = 0.047), while the Placebo-PRP group’s reduction to 32.5 degrees (IQR: 20–50) was not significant ( p  = 0.490). These early results indicate a delayed PRP effect, prompting further investigation into its long-term impacts. Although limited by sample size, this study suggests PRP injections as a safe treatment for PD, with ongoing research aiming to clarify its therapeutic value.

Abstract Context Most labs set the lower limit of normal for testosterone at the 2.5th percentile of values in young or age-matched men, an approach that does not consider the physiologic changes associated with various testosterone concentrations. Objective To characterize the dose-response relationships between gonadal steroid concentrations and measures regulated by gonadal steroids in older men. Design, Participants, and Intervention 177 men aged 60 to 80 were randomly assigned to receive goserelin acetate plus either 0 (placebo), 1.25, 2.5, 5, or 10 grams of a 1% testosterone gel daily for 16 weeks or placebos for both medications (controls). Primary Outcomes Changes in serum C-telopeptide (CTX), total body fat by dual energy X-ray absorptiometry, and self-reported sexual desire. Results Clear relationships between the testosterone dosage (or the resulting testosterone levels) and a variety of outcome measures were observed. Changes in serum CTX exceeded changes in the controls in men whose testosterone levels were 0 to 99, 100 to 199, 200 to 299, or 300 to 499 ng/dL, whereas increases in total body fat, subcutaneous fat, and thigh fat exceeded controls when testosterone levels were 0 to 99 or 100 to 199 ng/dL. Sexual desire and erectile function were indistinguishable from controls until testosterone levels were <100 ng/dL. Conclusion Changes in measures of bone resorption, body fat, and sexual function begin at a variety of testosterone concentrations with many outcome measures remaining stable until testosterone levels are well below the stated normal ranges. In light of this variation, novel approaches for establishing the normal range for testosterone are needed.

Erectile Dysfunction (ED) is a problem of achieving or maintaining a firm erection for satisfactory sexual intercourse. To compare the efficacy of polyherbal oral and topical Unani formulations (Majoon/Electuary and Tila/liniment) versus Tentex Forte and Himcolin in Erectile dysfunction. This study was a comparative clinical trial conducted on 36 patients, with n = 18 in each test and control group. The test group was treated with polyherbal oral formulation (Majoon) 1 tsp twice daily and few drops of Tila locally. The control group received two capsules of Tentex Forte twice daily, with a few drops of Himcolin gel locally. Likewise, both groups were treated for 28 days. Study outcomes viz. difficulty in achieving and maintaining penile erections, and International Index of Erectile Function-15 score were assessed before and at the end of the study. Student t tests, Mc Nemars, and chi-square tests were used for data analysis. The findings of this study suggest that there is a highly significant effect of either intervention on difficulty in achieving and maintaining penile erection (P < .001) and IIEF-15 scores (P < .001). However, no significant difference was observed between the two groups (P = .15), which signifies that both interventions have a comparable effect on erectile dysfunction. It can be concluded that polyherbal Unani formulation Majoon 7g twice orally and a few drops of Tila locally are equally effective as Tentex Forte and Himcolin in managing erectile dysfunction.

Background Erectile dysfunction (ED) is characterized by a persistent inability to achieve and maintain sufficient penile erection for satisfactory sexual performance persisting for at least six months. Low-intensity pulsed ultrasound (LIPUS), a noninvasive therapy, has shown potential in improving ED by promoting the regeneration of connective tissue, blood vessels, and cavernous nerves, as well as reducing inflammation. This study aims to evaluate the clinical efficacy and histological changes in the corpus cavernosum of patients with ED treated with tadalafil combined with LIPUS through a randomized controlled trial. Methods This study will enroll 114 patients diagnosed with ED who will be randomly assigned to either the treatment group or the control group in a 1:1 ratio using simple random sampling. The treatment group will first receive 5 mg of tadalafil daily combined with twice-weekly LIPUS therapy for 4 weeks. Following a 4-week interval with daily 5 mg tadalafil alone (no LIPUS treatment), the same combined treatment regimen will be repeated. The control group will receive only 5 mg of tadalafil daily. The primary outcome will be assessed using the minimal clinically important difference (MCID) based on the International Index of Erectile Function-5 (IIEF-5) at each follow-up visit. Additional assessments will include the Erection Hardness Score (EHS), penile blood flow parameters, and elasticity values for a comprehensive evaluation. Discussion The study aims to evaluate the efficacy of tadalafil combined with LIPUS for treating ED and to improve the evaluation of treatment response in erectile dysfunction by integrating blood flow parameters and two-dimensional shear wave elastography. Trial registration Trial registration: ClinicalTrials.gov, NCT06543628. Registered 5th August 2024, https://clinicaltrials.gov/study/NCT06543628 .

Abstract OBJECTIVE: The objective is to evaluate the efficacy of coadministration of garlic (as a hydrogen sulfide [H2S] donor) and tadalafil for patients with ED using a placebo-controlled, prospective, randomized, two-arm pilot study in patients responding poorly to tadalafil alone. MATERIALS AND METHODS: The patients with complaints of ED (with normal penile Doppler) who failed to maintain sustained improvement in erectile function with tadalafil were recruited after excluding those with comorbidities. The study sample was randomized into two groups. Group A received garlic 5 g twice a day orally and Group B received a placebo twice daily orally for 4 weeks. Both groups continued tadalafil 5 mg in the night for 4 weeks. Their erectile function was assessed at the beginning and at the end of 4 weeks using the International Index of Erectile Function (IIEF-EF), erectile function domain and compared. A value of P ≤ 0.05 was considered statistically significant. RESULTS: Nineteen patients in Group A (mean age 37.5 ± 10.6 years) and 16 patients in Group B (mean age 39.6 ± 9.6 years) participated in the pilot study conducted from May 2022 to August 2022. The participants treated with garlic (as an H2S donor) as a coadministrant had statistically significant improvement in IIEF-EF score (P ≤ 0.0001) at the end of 4 weeks compared to placebo. CONCLUSIONS: Garlic (as an H2S donor) as adjunctive therapy was beneficial in our study participants responding poorly to tadalafil alone.

Purpose We studied the effect of a platelet-rich fibrin matrix (PRFM) combined with prostaglandin E-1 (PGE-1) injection on erectile function in patients refractory to response for phosphodiesterase type 5 inhibitors (PDE5-Is). Methods This randomized, double-blind, placebo-controlled study included 80 patients. The patients were randomly assigned to four groups and blinded together with the administrating physicians to the nature of the intracorporeal injection (ICI) therapies. Group (1) received saline, group (2) received platelet-rich fibrin matrix (PRFM), group (3) received prostaglandin E-1 (PGE-1), and group (4) received a combination of PRFM + PGE-1. The patients received ICI therapy weekly for 8 consecutive weeks. Clinical information and follow-up data were obtained at 1, 2, 3, and 6 months. Results A significant increase occurred in the validated Arabic version of the International Index of Erectile Function (ArIIEF-5) score in group (4) compared to the other three groups ( p value = 0.037). There was a significant difference in erection hardness scale (EHS) scores among all groups after receiving the different treatments ( p  = 0.004). A significant increase was seen in the ArIIEF-5 score in groups 4 and 3 compared to that in groups 1 and 2 ( p  < 0.001). There was also a significant increase in the arterial dilatation % in groups 4 and 3 compared to that in groups 1 and 2 ( p  = 0.019). Conclusion The combination of PRFM plus PGE-1 had shown significant improvement in the ArIIEF-5 score, yet the patients still had mild to moderate ED.

To prospectively assess the safety and effectiveness of the investigational phosphodiesterase 5 inhibitor avanafil to treat erectile dysfunction in men with diabetes mellitus. This 12-week, multicenter, double-blind, placebo-controlled study conducted between December 15, 2008, and February 11, 2010, randomized 390 men with diabetes and erectile dysfunction 1:1:1 to receive avanafil, 100 mg (n=129), avanafil, 200 mg (n=131), or placebo (n=130). Coprimary end points assessed changes in the percentage of sexual attempts in which men were able to maintain an erection of sufficient duration to have successful intercourse (Sexual Encounter Profile [SEP] 3), percentage of sexual attempts in which men were able to insert the penis into the partner's vagina (SEP 2), and International Index of Erectile Function erectile function domain score. Compared with placebo, least-squares mean change from baseline to study end in SEP 3, SEP 2, and International Index of Erectile Function erectile function domain score were significantly improved with both avanafil, 100 mg (P≤.002), and avanafil, 200 mg (P<.001). Additional analyses indicated that successful intercourse could be initiated in 15 minutes or less through more than 6 hours after avanafil dosing. Adverse events most commonly reported with avanafil treatment were headache, nasopharyngitis, flushing, and sinus congestion. Avanafil was safe and effective for treating erectile dysfunction in men with diabetes and was effective as early as 15 minutes and more than 6 hours after dosing. The adverse events seen with avanafil were similar to those seen with other phosphodiesterase 5 inhibitors. clinicaltrials.gov Identifier NCT00809471.

To investigate the efficacy, tolerability, and patient’s preference of alprostadil cream for topical use administered within the urethral meatus versus the standard administration route, in erectile dysfunction (ED) treatment. Seventy-one patients (mean age 59.7 ± 9.0 years) affected by ED were analyzed in this multicenter, randomized, two-administration routes, cross-over trial. All patients received a single dose of alprostadil cream applying the dispenser to the tip of the penis (without contacting the urethral meatus) (Standard administration route or ST.AR) alternating with a single dose of alprostadil cream applying the dispenser within the urethral meatus (New administration route or NEW.AR) separated by a one-week washout period, according to randomization. The primary objective of the study was to evaluate the change in International Index of Erectile Function (IIEF-5) total score from baseline to the control visit by comparing the ST.AR and NEW.AR. Secondary objectives of the study were to compare the different methods of administration by evaluating the change in the Sexual Encounter Profile (SEP-2 and SEP-3) questionnaire score and the Patient Reported Outcomes (PROs) by scoring the Patient Self-Assessment of Erection (PSAE) questionnaire. The treatment safety profile was assessed by analysis of adverse events (AEs). Based on the study findings it is evident that the NEW.AR is more efficacious than the ST.AR in improving IIEF-5 and SEP scores from baseline to control visit (IIEF-5: +3.8 vs +6.3; p < 0.001; positive response to SEP-2: 10 vs 27; p = 0.002) and in terms of PSAE (a significant improvement from the baseline in 31% of patients; p < 0.001). As regards the safety profile, no difference in terms of local and systemic side effects was found.