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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.

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.

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.

A key barrier to the consistent use of condoms is their negative effect on sexual pleasure. Although sexual pleasure is a primary motivation for engaging in sex and is an integral part of overall sexual health, most programs to improve sexual health operate within a pregnancy and disease-prevention paradigm. A new condom, CSD500 (Futura Medical Developments; Surrey, UK), containing an erectogenic drug was developed for use among healthy couples to improve sexual pleasure by increasing penile firmness, size and erection duration. We conducted a randomized controlled trial to test whether promoting the novel condom CSD500 for improved sexual pleasure is effective in reducing condomless sex compared to the provision of standard condoms with counseling for pregnancy and disease prevention. We randomized 500 adult, heterosexual, monogamous couples in Thanh Hoa province, Vietnam to receive either CSD500 (n = 248) or standard condoms (n = 252). At enrollment and after 2, 4, and 6 months, we interviewed women and sampled vaginal fluid to test for the presence of prostate-specific antigen (PSA), an objective, biological marker of recent semen exposure. We registered the protocol before trial initiation at ClinicalTrials.gov (identifier: NCT02934620). Overall, 11.0% of women were PSA positive at enrollment. The proportion of follow-up visits with PSA-positivity did not differ between the intervention (6.8%) and control arms (6.7%; relative risk, 1.01; 95% confidence interval, 0.66–1.54). Thus, we found no evidence that promoting an erectogenic condom to women in a monogamous, heterosexual relationship in Vietnam reduced their exposure to their partner’s semen. These findings might not hold for other populations, especially those with a higher frequency of condomless sex.

Hydrogen sulfide (H₂S) is synthesized by 2 enzymes, cystathionine β-synthase (CBS) and cystathionine γ-lyase (CSE). L-Cysteine (L-Cys) acts as a natural substrate for the synthesis of H₂S. Human penile tissue possesses both CBS and CSE, and tissue homogenates efficiently convert L-Cys to H₂S. CBS and CSE are localized in the muscular trabeculae and the smooth-muscle component of the penile artery, whereas CSE but not CBS is also expressed in peripheral nerves. Exogenous H₂S [sodium hydrogen sulfide (NaHS)] or L-Cys causes a concentration-dependent relaxation of strips of human corpus cavernosum. L-Cys relaxation is inhibited by the CBS inhibitor, aminoxyacetic acid (AOAA). Electrical field stimulation of human penile tissue, under resting conditions, causes an increase in tension that is significantly potentiated by either propargylglycine (PAG; CSE inhibitor) or AOAA. In rats, NaHS and L-Cys promote penile erection, and the response to L-Cys is blocked by PAG. Our data demonstrate that the L-Cys/H₂S pathway mediates human corpus cavernosum smooth-muscle relaxation.

Nitric oxide (NO) generated by neuronal NO synthase (nNOS) initiates penile erection, but has not been thought to participate in the sustained erection required for normal sexual performance. We now show that cAMP-dependent phosphorylation of nNOS mediates erectile physiology, including sustained erection. nNOS is phosphorylated by cAMP-dependent protein kinase (PKA) at serine(S) 1412. Electrical stimulation of the penile innervation increases S1412 phosphorylation that is blocked by PKA inhibitors but not by PI3-kinase/Akt inhibitors. Stimulation of cAMP formation by forskolin also activates nNOS phosphorylation. Sustained penile erection elicited by either intracavernous forskolin injection, or augmented by forskolin during cavernous nerve electrical stimulation, is prevented by the NOS inhibitor L-NAME or in nNOS-deleted mice. Thus, nNOS mediates both initiation and maintenance of penile erection, implying unique approaches for treating erectile dysfunction.

Summary Introduction:  Erectile dysfunction (ED) is a highly prevalent condition affecting nearly one in five men worldwide. The advent of phosphodiesterase type 5 inhibitors (PDE5i) has revolutionised the ED treatment landscape and provided effective, minimally invasive therapies to restore male sexual function. Materials and methods:  A pubmed search was performed of all English language articles from 1996 to present reviewing PDE5i, including pharmacokinetics, efficacy profiles and comparisons, where available. Results:  Currently available PDE5i in the United States include sildenafil, vardenafil, tadalafil and avanafil, each of which has unique side effect, pharmacokinetic and outcome profiles. Sildenafil is associated with increased rate of visual changes, vardenafil with QT prolongation and tadalafil with lower back pain. Avanafil and vardenafil orodispersible tablet rapidly achieve peak plasma concentration, which results in faster onset of action, whereas tadalafil exhibits the longest half‐life. First time response to PDE5i is approximately 60–70%, with no significant differences in efficacy noted among therapies. The literature does not clearly demonstrate a preference for one drug. High‐treatment success rates (89%) were reported when patients were prescribed all available PDE5i. Daily dosing with tadalafil is associated with improved erectile function (EF) over time. Finally, novel modes of patient–provider interaction, including internet‐based education, communication and prescribing, may also improve long‐term adherence. Conclusions:  PDE5i represent first line therapy for ED with excellent overall efficacy and satisfactory side effect profiles. Enhanced communciation, coupled with increased knowledge of drug characteristics, comparative treatment regimens and optimal prescribing patterns, offer compelling tools to improve long‐term treatment success.

Majority of current treatment strategies against erectile dysfunction (ED) has been consisted of only a supportive care to sustain enough erection during a sexual intercourse. In this study, we investigated whether the cultured conditioned medium of human exfoliated deciduous dental pulp stem cells (SHED‐CM) had an ability to treat ED through fundamentally repairing the pathological damage of vascular endothelial cells of the corpus cavernosum. An open‐label pilot study was performed from April 2016 to October 2020. SHED‐CM was injected directly into the corpus cavernosum of penis of 38 ED patients who visited our clinic and fulfilled the inclusion criteria. Efficacy was assessed using the simplified International Index of Erectile Function (IIEF‐5) questionnaire. The average age and initial IIEF‐5 score of the patients enrolled in this study was 56 (31–79) years old and 13.1 (5–20) points, respectively. Medical history revealed 7 patients with diabetes, 7 patients with hypertension and 1 patient with priapism undergone shunt operation. Of these, 37 patients (97.4%) showed an improvement in IIEF‐5 of an average of 19.3 (7–25) points or 64.4 (10–300) % increase after three injections of SHED‐CM. Eighteen patients (47.4%) achieved more than 21 points (no ED) in IIEF‐5. No adverse events were encountered. This is the first clinical report of ED treatment in the literatures evaluating the efficacy of SHED‐CM. Treatment with SHED‐CM is expected to repair vascular damages of the corpus cavernosum, which are the main cause of ED, and to be widely spread as a fundamental clinical application for ED.

Summary The aim of this study was to evaluate the impact of group psychotherapy and the use of a phosphodiesterase‐5 inhibitor (PDE‐5i) in the early rehabilitation stage of patients with prostate cancer undergoing radical prostatectomy (RP). Fifty‐six patients undergoing RP for prostate cancer were randomised into four groups, and 53 completed the protocol: Group 1 – control (n = 11), Group 2 – group psychotherapy (n = 16), Group 3 – lodenafil 80 mg/one tablet per week (n = 12) and Group 4 – group psychotherapy + lodenafil 80 mg/one tablet per week (n = 14). The groups were individually evaluated for erectile function (IIEF‐5) and quality of life – QoL (SF‐36) weekly, with two meetings held a week apart before the RP and 12 weekly meetings after surgery. The ages ranged from 39 to 76 years, average 61.84. There were no significant medication side effects. Only Group 4 showed improvement in intimacy with a partner and satisfaction with their sex life (P = 0.045 and P = 0.013 respectively), and with no significant worsening of the IIEF‐5 (P = 0.250) reported. All groups showed worsening in the final result of the role limitations caused by physical problems (P = 0.009) and role limitations caused by emotional problems (P = 0.002) of the SF‐36, but Group 4 had a significantly higher score for the role limitations caused by physical problems (P = 0.009) than the other groups. In conclusion, precocious integral treatment involving group psychotherapy and PDE‐5i before and after RP led to less deterioration of erectile function and other domains related to physical aspects (SF‐36), with improvement in intimacy with their partner and satisfaction in their sex life, being superior to single treatments.