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The aim of the study was to assess safety and efficacy of botulinum-A toxin (BTX) injection into the bulbospongiosus muscle versus hyaluronic acid (HA) gel injection in glans penis for treatment of premature ejaculation (PE). The patients were randomly divided into 2 groups. Group a (n = 30) were injected with botulinum toxin type a injection in bulbospongiosus (BS) muscle at the perineum (25 units on each side). Group b (n = 30) were injected with 2 ml hyaluronic acid along the corona (proximal part) of the glans penis and frenulum. The mean IELT significantly increased from 1.78 min to 3.87 min after the BTX injection while the mean IELT was significantly increased to 7.3 min from 1.23 min before injection among the hyaluronic acid injected group (p < 0.001). The improvement of IELT was more significantly noted in the HA group than BTX group by the end of treatment. Both modalities provided a well- tolerated potential treatment in the management of PE with, HA demonstrating a higher efficacy than BTX. More high-quality, randomized prospective studies and the standardization of the inclusion criteria and the outcome assessment methods are needed in order to confirm these findings.

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.

A multicenter, open-label, randomized, controlled superiority trial with 18 months of follow-up was conducted to investigate whether oral zinc supplementation could further promote spermatogenesis in males with isolated hypogonadotropic hypogonadism （IHH） receiving sequential purified urinary follicular-stimulating hormone/human chorionic gonadotropin （uFSH/hCG） replacement. Sixty-seven Chinese male IHH patients were recruited from the Departments of Endocrinology in eight tertiary hospitals and randomly allocated into the sequential uFSH/hCG group （Group A, n = 34） or the sequential uFSH plus zinc supplementation group （Group B, n = 33）. In Group A, patients received sequential uFSH （75 U, three times a week every other 3 months） and hCG （2000 U, twice a week） treatments. In Group B, patients received oral zinc supplementation （40 mg day-1） in addition to the sequential uFSH/hCG treatment given to patients in Group A. The primary outcome was the proportion of patients with a sperm concentration 〉1.0 × 106 ml-1 during the 18 months. The comparison of efficacy between Groups A and B was analyzed. Nineteen of 34 （55.9%） patients receiving sequential uFSH/hCG and 20 of 33 （60.6%） patients receiving sequential uFSH/hCG plus zinc supplementation achieved sperm concentrations ≥1.0 × 106 ml-1 by intention to treat analyses. No differences between Group A and Group B were observed as far as the efficacy of inducing spermatogenesis （P = 0.69）. We concluded that the sequential uFSH/hCG plus zinc supplementation regimen had a similar efficacy to the sequential uFSH/hCG treatment alone. The additional improvement of 40 mg day-1 oral zinc supplementation on spermatogenesis and masculinization in male IHH patients is very subtle.

Men with erectile dysfunction (ED) frequently have a disproportionate burden of comorbid vascular disorders including atherosclerotic disease. We investigated whether scheduled tadalafil is better than on-demand (OD) in improving endothelium-dependent vasodilatation of cavernous arteries in men with ED and whether this effect is also exerted on markers of endothelial function. We did an open-label, randomized, crossover study including 20 male outclinic patients aged 18 years or older (mean age 54 years) who had at least a 3-month history of ED of any severity or etiology. Tadalafil (20 mg) on alternate days (ADs) or OD was administered for 4 weeks. Primary end points were variations of basal inflow (peak systolic velocity (PSV)) and flow-mediated dilatation (FMD) of cavernous arteries compared with baseline at penile Duplex ultrasound. Secondary end points were variations of Q13-SIEDY scores regarding morning erections and of markers of endothelial function, that is, vascular cell adhesion molecule (VCAM), intercellular cell adhesion molecule, endothelin-1 (ET-1), insulin and C-reactive protein (CRP). PSVs and FMD were higher after AD treatment when compared with OD and baseline, respectively ( P =0.0001), and improvements were maintained from 2 weeks after discontinuation ( P <0.005). Patients receiving tadalafil AD experienced a significant improvement of morning erections as compared to AD treatment ( P <0.0001); ET1, VCAM and CRP showed a robust decrease after chronic vs OD regimes ( P <0.05), with concomitant increase in insulin levels ( P <0.05), without any variation in blood pressure and other laboratory parameters. Chronic but not OD tadalafil improves endothelial function with sustained effects from its discontinuation. Chronic treatment also produces a dramatic increase in morning erections, which determines better oxygenation to the penis, thus providing a rationale for vascular rehabilitation.

Purpose We sought to evaluate the effects of oral testosterone undecanoate treatment based on the temporary growth of penis and the complications of surgery in children with microphallic hypospadias. Materials and methods A total of 72 randomized consecutive children with microphallic hypospadias were included in the study from March 2011 to September 2013. While 34 children were treated with oral testosterone undecanoate treatment prior to surgery on time (group 1), 36 children did not receive any treatment preoperatively (group 2). All children underwent hypospadias repair using transverse preputial island flap (Duckett technique) urethroplasty or combination of Duckett and Thiersch–Duplay techniques. Penile length, diameter, serum testosterone level, and secondary effects were recorded before and after therapy in group 1. Postoperative complications were assessed with respect to fistulas, urethral strictures, diverticula, meatal stenosis, and glanular dehiscence in both groups. Results Mean penile length and diameter increased significantly by 1.06 ± 0.53 cm ( P  < 0.05) and 0.30 ± 0.09 cm ( P  < 0.05). Postoperative complications included urethrocutaneous fistulas in nine patients (25 %) in group 2 compared to two patients (5.9 %) in group 1 ( P  < 0.05). While three patients (8.3 %) in group 2 had urethral strictures, no patient in the testosterone group had this complication ( P  > 0.05). There were three patients (8.3 %) with diverticula in group 2 and three patients (8.9 %) with this complication in group 1 ( P  > 0.05). None of our patients had signs or symptoms of meatal stenosis, glanular dehiscence, or residual chordee in both groups. Finally, there was a significant difference between the overall reoperation rates of group 2 (14 patients, 38.9 %) and group 1 (five patients, 14.7 %, P  < 0.05). Conclusions Pretreatment with oral testosterone undecanoate was effective in improving the temporary penile growth and decreasing the surgical complications in children with microphallic hypospadias.

Introduction Surgical correction of genital defects was formerly proposed when the size of the penis was sufficient to permit easy surgical repair. To enlarge penile size, temporary stimulation with testosterone either topical or parenteral has been reported. Parenteral testosterone has been found to be effective; however, variable results have been reported with topical testosterone. This study was taken up as an attempt to compare the efficacy of parenteral versus topical testosterone application. Materials and methods Twenty-one consecutive children with microphallic hypospadias were randomized to receive either topical or parenteral testosterone prior to surgery. Penile length, glans circumference and secondary effects were recorded before and after therapy by the same observer. Results Significant penile growth was noticed in both the groups of children when compared with pre-therapy size. Conclusions The desired therapeutic effect of significant penile growth following testosterone was achieved in both the groups of children. There was no significant difference between the two routes of administration.

Abstract Background Considerable attention has been paid to perfluoroalkyl compounds (PFCs) because of their worldwide presence in humans, wildlife, and environment. A wide variety of toxicological effects is well supported in animals, including testicular toxicity and male infertility. For these reasons, the understanding of epidemiological associations and of the molecular mechanisms involved in the endocrine-disrupting properties of PFCs on human reproductive health is a major concern. Objective To investigate the relationship between PFC exposure and male reproductive health. Design This study was performed within a screening protocol to evaluate male reproductive health in high schools. Patients This is a cross-sectional study on 212 exposed males from the Veneto region, one of the four areas worldwide heavily polluted with PFCs, and 171 nonexposed controls. Main Outcome Measures Anthropometrics, seminal parameters, and sex hormones were measured in young males from exposed areas compared with age-matched controls. We also performed biochemical studies in established experimental models. Results We found that increased levels of PFCs in plasma and seminal fluid positively correlate with circulating testosterone (T) and with a reduction of semen quality, testicular volume, penile length, and anogenital distance. Experimental evidence points toward an antagonistic action of perfluorooctanoic acid on the binding of T to androgen receptor (AR) in a gene reporter assay, a competition assay on an AR-coated surface plasmon resonance chip, and an AR nuclear translocation assay. Discussion This study documents that PFCs have a substantial impact on human health as they interfere with hormonal pathways, potentially leading to male infertility. PFC exposure leads to impairment of the male reproductive system, which is supported by experimental evidence showing an interference of these chemicals on the binding of testosterone to its receptor.

To prospectively compare the clinical responses and penile color-duplex ultrasound (PCDU) results of oral PDE5 inhibitors (PDE5-Is) with papaverine intracavernosal injection (ICI) and to evaluate whether PDE5-Is could be used as alternatives to vasoactive agent injections, 25 ED patients underwent PCDU three times with an interval of at least 1 week, using different pharmacological induction: ICI mode (30–60 mg papaverine), sildenafil mode (100 mg sildenafil) and tadalafil mode (20 mg tadalafil). The preference of the patients was collected when all tests were completed. No significant differences were found in peak systolic velocity and acceleration time among all three modes. However for the ICI mode, end diastolic velocity of the right cavernosal artery was significantly higher than those of the sildenafil and tadalafil modes 5 min after erection induction, and at 15 min it became lower than those of two PDE5-I modes. Consequently, resistance index of the right cavernosal artery in ICI mode was reversed at 5 and 15 min. In all, 60.0 and 56.0% patients managed to reach full erection in PDE5-Is modes, which was significantly lower than in ICI mode (80.0%). Therefore, although PDE5-Is and papaverine ICI showed similar effects on PCDU parameters in detecting arterial ED, more patients had better clinical responses to ICI, and oral PDE5-Is administration still showed some pitfalls in practical use.

The primary objective of this work was to delve into the potential therapeutic advantages and dissect the molecular mechanisms of salidroside in enhancing erectile function in rats afflicted with diabetic microvascular erectile dysfunction (DMED), addressing both the whole-animal and cellular dimensions.We established a DMED model in Sprague‒Dawley (SD) rats and conducted in vivo experiments. The DMED rats were administered varying doses of salidroside, the effects of which on DMED were compared. Erectile function was evaluated by applying electrical stimulation to the cavernous nerves and measuring intracavernous pressure in real time. The penile tissue underwent histological examination and Western blotting. Hydrogen peroxide (H2O2) was employed in the in vitro trial to induce an oxidative stress for the purpose of identifying alterations in cell viability. The CCK-8 assay was used to measure the viability of corpus cavernous smooth muscle cells (CCSMCs) treated with vs. without salidroside. Flow cytometry was utilized to detect alterations in intracellular reactive oxygen species (ROS). Apoptosis was assessed through Western blotting and TdT-mediated dUTP nick-end labelling (TUNEL). Animal and cellular experiments indicate that the Nrf2/HO-1 signalling pathway may be upregulated by salidroside, leading to the improvement of erectile function in diabetic male rats by alleviating oxidative stress and reducing apoptosis in corpus cavernosum tissue.

Background Phthalates are endocrine-disrupting chemicals with anti-androgenic qualities and studies reported associations between prenatal phthalate exposure and infant genitalia. This study investigated whether increased prenatal phthalate exposure is associated with decreased fetal penile measures. Methods Data was from the New York University Children’s Health and Environment Study (2016–2019). Maternal urinary concentrations of 16 phthalate metabolites were quantified at <18 weeks gestation as a proxy for fetal exposure ( n  = 334 male pregnancies). We retrospectively measured penile length and width using ultrasounds conducted 18–24 weeks gestation ( n  = 173 fetuses). Associations of maternal urinary levels of phthalates with fetal penile length and width were determined using linear regression models. Results 57.2% of women were Hispanic, 31.8% Non-Hispanic White, 6.4% Asian, 2.3% Non-Hispanic Black, and 2.3% multiple races. Mean maternal age was 32 years (standard deviation [SD] = 5.7). Mean penile length was 7.13 mm (SD = 1.47) and width was 6.16 mm (SD = 0.87). An inverse relationship was observed between maternal levels of mono-ethyl phthalate and fetal penile length, and mono-(7-carboxy-n-heptyl) phthalate and penile width, though estimates were small and not significant when considering correction for multiple comparisons. Conclusions In our cohort we found no clinically meaningful associations between early pregnancy phthalate exposure and fetal penile length or width. Impact First-trimester phthalate metabolites were assessed in pregnant women in New York City. Penile length and width were retrospectively measured on clinically assessed ultrasounds conducted ≥18 weeks and <24 weeks of gestation. In this cohort, no clinically meaningful associations were observed between first-trimester prenatal phthalate exposure and fetal penile length. This study contributes to the limited but growing research on the impact of prenatal phthalate exposure on male fetal genital development. The results emphasize that there may not be a clear association between prenatal phthalate exposure and fetal penile length and width, and further research on this topic may be required.