Treatment Of Erectile Dysfunction Research Articles

3D human foreskin model for testing topical formulations of sildenafil citrate

Sildenafil citrate is an approved drug used for the treatment of erectile dysfunction and premature ejaculation. Despite a widespread application, sildenafil citrate shows numerous adverse cardiovascular effects in high-risk patients. Local transdermal drug delivery of this drug is therefore being explored as an interesting and noninvasive alternative administration method that avoids adverse effects arised from peak plasma drug concentrations. Although human and animal skin represents the most reliable models to perform penetration studies, they involve a series of ethical issues and restrictions. For these reasons new in vitro approaches based on artificially reconstructed human skin or “human skin equivalents” are being developed as possible alternatives for transdermal testing. There is little information, however, on the efficiency of such new in vitro methods on cutaneous penetration of active ingredients. The objective of the current study was to investigate the sildenafil citrate loaded in three commercial transdermal vehicles using 3D full-thickness skin equivalent and compare the results with the permeability experiments using porcine skin. Our results demonstrated that, while the formulation plays an imperative role in an appropriate dermal uptake of sildenafil citrate, the D coefficient results obtained by using the 3D skin equivalent are comparable to those obtained by using the porcine skin when a simple drug suspension is applied (1.17 × 10-10 ± 0.92 × 10-10 cm2/s vs 3.5 × 102 ± 3.3 × 102 cm2/s), suggesting that in such case, this 3D skin model can be a valid alternative for ex-vivo skin absorption experiments.

Post-infection erectile dysfunction risk - comparing COVID-19 with other common acute viral infections: a large national claims database analysis.

It is unknown if the risk of erectile dysfunction (ED) following Coronavirus-19 (COVID-19) infection is virus-specific. Our study assessed the risk of ED in COVID-19 patients as compared to patients with other common viral infections. The TriNetX COVID-19 Research Network was queried. We examined cohorts of men aged ≥18 years infected with: COVID-19, influenza, respiratory syncytial virus, enterovirus, acute viral hepatitis, mononucleosis, and herpes zoster. Men were included if they had at least one outpatient follow-up visit within 18 months and excluded if they had one of the other viruses of interest or a prior ED diagnosis or treatment, prostatectomy, pelvis radiation, or chronic hepatitis infection. Cohorts were propensity score matched and compared for differences in new ED diagnosis and/or prescription of phosphodiesterase-5 inhibitors (PDE5i). COVID-19 positive men were less likely to develop ED or have a PDE5i prescription than men with infected with herpes zoster [Relative Risk(RR): 0.37, 95% Confidence Interval (CI) 0.27-0.49] and more likely to develop ED or have a PDE5i prescription than men with no acute viral illness (RR: 1.33, 95% CI 1.25-1.42). In this national propensity-matched cohort study comparing post-infection ED risk and PDE5i prescriptions, we found that COVID-19 was no more likely to result in a diagnosis of ED or prescription of PDE5i when compared to all acute viral illnesses except herpes zoster, which was more likely to result in a diagnosis of ED or prescription of PDE5i when compared to COVID-19. These findings suggest an inflammatory etiology (perhaps due to cytokine release, endothelial dysfunction, or blunted hormone signaling) behind any acute infection can result in a heightened ED risk; however, further studies are required to investigate the connection between other viral infections and ED.

Patients' attitude with surgery for Peyronie's disease: results from a multicentric European study.

Despite the existence of conservative therapies for Peyronie's disease (PD), surgery is commonly utilized for the treatment of bothersome curvatures due to its potential effectiveness, although it carries intrinsic risks and may not universally lead to satisfactory outcomes. To explore the rate and factors influencing patients' willingness to undergo surgery for PD. Data were prospectively collected in 5 European academic centers between 2016 and 2020. Data included age, time from PD onset, penile pain, curvature degree, difficulty at penetration, hourglass deformity, erectile dysfunction (ED), and previous treatments. All patients were offered conservative treatments, either medications or injections. Tunical shortening or lengthening procedures were offered as an alternative to conservative treatments, when indicated. Penile prosthesis was offered to those with concomitant ED. Patients' attitudes with surgery were recorded. Logistic regression analyses tested the profile of patients who were more likely to be willing to undergo surgery. Patients' willingness to undergo surgery for PD. This study included 343 patients with a median age of 57.3years (IQR, 49.8-63.6) and a median penile curvature of 40.0° (IQR, 30.0°-65.0°). Overall, 161 (47%) experienced penetration difficulties and 134 (39%) reported ED. Additionally, hourglass deformity and penile shortening were reported by 48 (14%) and 157 (46%), respectively. As for previous treatments, 128 (37%) received tadalafil once daily; 54 (16%) and 44 (13%), intraplaque verapamil and collagenase injections; and 30 (9%), low-intensity shock wave therapy. Significant curvature reduction (≥20°) was observed in 69 (20%) cases. Only 126 (37%) patients were open to surgery for PD when suggested. At logistic regression analysis after adjusting for confounders, younger age (odds ratio [OR], 0.97; 95% CI, 0.95-1.00; P = .02), more severe curvatures (OR, 1.04; 95% CI, 1.03-1.06; P < .0001), and difficulty in penetration (OR, 1.88; 95% CI, 1.04-3.41; P = .03) were associated with a greater attitude to consider surgical treatment. The need for effective nonsurgical treatments for PD is crucial, as is comprehensive patient counseling regarding surgical risks and benefits, particularly to younger males with severe curvatures. Main limitations are the cross-sectional design and the potential neglect of confounding factors. Patients with PD, having a lower inclination toward surgery, emphasize the need for effective nonsurgical alternatives and accurate counseling on the risks and benefits of PD surgery, particularly for younger men with severe curvatures.

Non-invasive alternative for phosphodiesterase inhibitor-refractory erectile dysfunction: Real-life experience with low-intensity extracorporeal shockwave therapy.

This retrospective study assessed the efficacy of low-intensity extracorporeal shockwave therapy (Li-ESWT) in the treatment of erectile dysfunction (ED) in patients unresponsive to phosphodiesterase inhibitors (PDE5is). Between May 2020 and December 2022, we retrospectively analyzed the records of 126 ED patients who underwent Li-ESWT post unsuccessful PDE5is trials, defined as inadequate response following at least 6 consistent trials with correct dosage (preference given to 20 mg tadalafil). Patients with neurogenic disorders were excluded. Patients' ED severity was determined using the IIEF-5 score and further categorized into 2 groups. The Li-ESWT treatment protocol consisted of 12 weeks. Data was analyzed using descriptive statistics and paired t-tests. In the cohort of 126 patients, the mean age was 50.5 ± 12.4 years, with a BMI of 29.18 ± 3.49. Notably, 74.6% had ED for more than 12 months. Before Li-ESWT, 55.6% used sildenafil and 44.4% used tadalafil. Post 3 months of Li-ESWT, the average IIEF score rose significantly from 10.19 ± 7.71 to 14.29 ± 0.92 (P < .01). Particularly, Group 2 exhibited a significant improvement in their mean IIEF score from 13.78 ± 1.38 pretreatment to 21 ± 2.31 post-treatment. However, Group 1 (with higher diabetes prevalence) showed a marginal rise from 5.8 ± 1.47 to 6.1 ± 3.2 (P = .14). Similarly, the overall EHS score progressed significantly from 1.34 ± 0.8 to 2.3 ± 1.17 post-treatment. Post-treatment, while Group 1 showed no changes in successful vaginal penetration, Group 2 reported a dramatic increase in successes, from 16 before treatment to 68 after. This study demonstrated the efficacy of Li-ESWT for PDE5is-refractory ED, particularly in patients with moderate to mild ED. However, patients with severe ED and comorbidities did not show significant improvement. Further research with larger sample sizes, control groups, longer follow-up periods, and standardized protocols is required to confirm the effectiveness and limitations of Li-ESWT in ED treatment.

Hyperbaric oxygen therapy as a treatment for erectile dysfunction: a meta-analysis.

Hyperbaric oxygen therapy (HBOT) is a medical treatment in which the patient is exposed to 100% oxygen at a higher than atmospheric pressure. Over the past few decades, HBOT has been used to treat a variety of medical conditions. In recent times, there has been a rising curiosity regarding the potential therapeutic benefits of HBOT in the treatment of erectile dysfunction (ED). The study sought to review and meta-analyze available data regarding the use of HBOT for ED, including its potential mechanisms of action and effectiveness. We included only articles that evaluated the impact of HBOT on ED symptoms using the International Index of Erectile Function score. Prospective nonrandomized studies or randomized controlled clinical trials were included. Data extraction was performed in duplicate. Data analysis was conducted using Review Manager 5.41, and the presence of heterogeneity between studies was evaluated. The results were presented as the mean difference (MD) with 95% confidence interval (CI). A total of 5 studies that reported outcomes using the International Index of Erectile Function scores were included in this analysis. In patients with post-robotic-assisted laparoscopic prostatectomy-induced ED, the analysis showed a significant MD of -4.13 (95% CI, -6.08 to -2.18; P < .0001) in favor of the control group. Conversely, patients who received HBOT for reasons other than ED exhibited an MD of 4.58 (95% CI, 2.63 to 6.52; P < .00001). In the group that received HBOT for pure vasculogenic ED, the MD was 10.50 (95% CI, 9.92 to 11.08) in favor of HBOT. A meta-analysis of these data revealed a nonsignificant difference in erectile function scores, with an MD of 3.86 (95% CI, -2.13 to 9.86; P = .21). The use of HBOT in the treatment of ED appears to be a promising approach. While further research is needed to establish the efficacy and long-term effects of this treatment, preliminary studies have shown encouraging results in terms of improving erectile function in men with vasculogenic ED.

Efficacy of Chinese Herbal Medicine Formula in the Treatment of Mild to Moderate Erectile Dysfunction: Study Protocol for a Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

Erectile dysfunction (ED) is a prevalent condition in urology, primarily managed with PDE5 inhibitors (PDE5Is). However, approximately 20% of patients do not experience improvement in overall sexual satisfaction (OS) after taking PDE5Is. Among these, traditional Chinese medicine (TCM) has emerged as a complementary approach, with formulas like Hongjing I granules (HJIG) showing promise in preliminary studies. This study aims to rigorously evaluate the effectiveness and safety of HJIG in mild to moderate ED cases, assessing improvement in both sexual function and TCM pattern alignment. This study is a randomized, double-blind, placebo-controlled multicentre trial. Recruitment will be conducted from patients who have a strong willingness to try using only traditional Chinese medicine treatment (This is very common in traditional Chinese medicine hospitals.). A total of 100 patients diagnosed with mild to moderate ED caused by qi deficiency and blood stasis will be recruited and randomly assigned to receive one of two treatments: HJIG (N = 50) or placebo (N = 50). Patients will receive 8 weeks of treatment and a 16-week follow-up starting from the fourth week of treatment. Outcome measures, including the International Index of Erectile Function-Erectile Function domain (IIEF-EF) score, Sexual Encounter Profile (SEP), and Traditional Chinese Medicine symptom score, will be evaluated. The expected outcome of this trial is that the use of the herbal formula HIJG alone can improve overall sexual satisfaction (OS) in patients with mild to moderate ED, while also improving their traditional Chinese medicine symptom scores. This will provide evidence-based support for the use of Chinese medicine in the treatment of ED in China. Chinese Clinical Trial Registry, ChiCTR2000041127, Registered on 19 December 2020, https://www.chictr.org.cn/showproj.html?proj=46469. Recruitment began in March 2021, therefore 80 patients have been recruited. It is expected to finish recruiting in December 2023.

Novel Method for Identifying and Treating Erectile Dysfunction

Sexual or erectile dysfunction (ED) is the ineptitude to get or keep a hard penile erection. ED can have a detrimentaleffect on physical and psychological health. This review helps in understanding the detailed etiology of ED and variousapproaches for the management of ED. The occurrence and incidence of erectile dysfunction are on the rise among men.Various other factors greatly impact the progression of ED, including individual general health and physiological conditions suchas psychiatric or psychological problems, diabetes mellitus, genitourinary disease, cardiovascular disease, and chronic diseases.Erectile dysfunction occurs when the release of nitric oxide (NO) triggers the activation of the guanylate cyclase enzyme in thespongiosum and corpora cavernosa, leading to relaxation of the vascular smooth muscle and an increase in cyclic guanosinemonophosphate (cGMP) levels. This physiological process is essential for achieving and maintaining a firm penile erection. Somecommon and advanced methods, such as the physical method, sexual history, laboratory testing, apomorphine test, NPTR test,and color duplex Doppler ultrasound test, are used to diagnose erectile dysfunction. This review also focuses on emergingtreatments that address the medical need for effective ED management. This comprehensive review bridges gaps in the currentliterature, offering superior insights into ED management and improving the quality of life for individuals with ED.

Improving Erectile Dysfunction Management Among Asian Men With Diabetes Using the Knowledge Translation Intervention.

Erectile dysfunction (ED) is frequently undermanaged due to communication barriers, particularly among Asian men. We looked at how ED discussion and treatment were affected by the patient's prompt sheet and the Knowledge Translation Tools in the Management of Erectile Dysfunction (LASTED). We conducted a quasi-experimental study in a primary care clinic in Kedah, Malaysia involving 120 Asian men with diabetes. In the intervention group, patients were given a prompt sheet to indicate their intention to discuss or receive ED treatment, and physicians were provided with LASTED to assist with ED consultation. The control group patients received standard care from their physicians. The intervention increased the initiation of ED discussion up to 66.7% compared with 8.3% in the control group. In the intervention group, 57.5% of patients were prescribed phosphodiesterase-5 inhibitors and men with ED of moderate severity were more likely to be prescribed oral ED medication. Use of the LASTED flipchart was associated with prescription of phosphodiesterase-5 inhibitors (P = .011) and patient satisfaction with ED consultation (P <.001). Our study suggests that using the LASTED flipchart and patient's prompt sheet together may encourage ED conversation and medication prescription particularly when working with Asian men who frequently view ED as a taboo subject.

Multi-incision technique and cavernous xenografting with penile prosthesis implant: Alternative solution for combined treatment of erectile dysfunction and Peyronie’s disease

Multi-incision technique and cavernous xenografting with penile prosthesis implant: Alternative solution for combined treatment of erectile dysfunction and Peyronie’s disease

COUNTERFEIT AND ILLEGAL MEDICINAL PRODUCTS AS AN EXAMPLE OF DRUGS THAT DO NOT MEET THE BASIC QUAITY REQUIREMENTS

Falsification or counterfeiting of medicinal products is a severe pharmaceutical crime. According to the World Health Organization, about 10% of medicinal products in developing countries are falsified. In the case of medicines sold over the Internet, the figure is as high as 50%, and this phenomenon's scale is increasing yearly. The illegally sourced preparations are not manufactured in accordance with Good Manufacturing Practice (GMP). Among the most frequently falsified medicinal products are preparations used for erectile dysfunction, weight loss aids, or anabolic-androgenic steroids. The presence of undeclared active ingredients and impurities, incorrect dosage due to different than declared contents, and the sourcing of over-the-counter medicines from unknown sources can lead to serious side effects that threaten patients' lives and health. In addition, inaccurate or incomplete descriptions of product formulation can additionally cause the risk of drug interactions, which can consequently lead to serious medical incidents.&#x0D; The purpose of this paper is to discuss the requirements for medicinal products and to present the problem of the quality of counterfeit and illegal medicinal products. This issue is discussed using phosphodiesterase type 5 inhibitors (applied to the treatment of erectile dysfunction) as an example.&#x0D; KEYWORDS: falsified medicinal products, quality of medicinal products, PDE-5 inhibitors

Use of phosphodiesterase 5 inhibitors is not associated with ocular adverse events.

Phosphodiesterase 5 inhibitor (PDE5i) use has been linked to a number of ocular side effects, such as serous retinal detachment (SRD), retinal vascular occlusion (RVO), and ischemic optic neuropathy (ION). We investigated the risk for SRD, RVO, and ION in patients using PDE5is. We utilized the IBM MarketScan (2007-2021) Commercial and Medicare Supplemental Databases (version 2.0) for this analysis. To estimate overall events risk, Cox proportional hazard models were applied to calculate the hazard ratios (HRs) for erectile dysfunction (ED) diagnosis and the different treatments, adjusting for region, median age, obesity, diabetes mellitus, hyperlipidemia, smoking, hypertension, coronary artery disease, and sleep apnea. Additionally, the same analyses were performed to calculate the HRs for benign prostatic hyperplasia (BPH) diagnosis and the different treatments. HRs for SRD, RVO, and ION. In total, 1 938 262 men with an ED diagnosis were observed during the study period. Among them, 615 838 (31.8%) were treated with PDE5is. In total, 2 175 439 men with a BPH diagnosis were observed during the study period. Among them, 175 725 (8.1%) were treated with PDE5is. On adjusted Cox regression analysis, PDE5i use was not associated with SRD, RVO, ION, and any ocular event when compared with ED diagnosis and other ED treatments. Importantly, as the intensity of ED treatment increased, so did the risk of ocular events. In addition, PDE5i use was not associated with SRD and ION when compared with BPH diagnosis and other BPH treatments. In contrast, in patients with BPH, PDE5i use was associated with RVO (HR, 1.14; 95% CI, 1.06-1.23). Importantly, patients with BPH receiving other medical treatment (ie, 5a reductase/alpha blocker; HR, 1.11; 95% CI, 1.06-1.16) or surgical treatment (HR, 1.10; 95% CI, 1.02-1.19) had a higher risk of RVO. We did not observe any consistent association between PDE5i use and any ocular adverse events (SRD, RVO, and ION). Because we did not have access to the patients' medical records, we recorded outcome definitions using ICD-9 and ICD-10 coding. Patients using PDE5is for ED or BPH indications did not have an increased risk of ocular events, even when compared with other treatments for ED or BPH.

Causal effects of gut microbiota on erectile dysfunction: a two-sample Mendelian randomization study.

Several observational studies have reported the correlation between gut microbiota and the risk of erectile dysfunction (ED). However, the causal association between them remained unestablished owing to intrinsic limitations, confounding factors, and reverse causality. Therefore, the two-sample Mendelian randomization (MR) study was performed to determine the causal effect of gut microbiota on the risk of ED. The MR analysis utilized the publicly available genome-wide association study (GWAS) summary-level data to explore the causal associations between gut microbiota and ED. The gut microbiota data were extracted from the MiBioGen study (N = 18,340), and the ED data were extracted from the IEU Open GWAS (6,175 ED cases and 217,630 controls). The single nucleotide polymorphisms (SNPs) served as instrumental variables (IVs) by two thresholds of P-values, the first P-value setting as <1e-05 (locus-wide significance level) and the second P-value setting as <5e-08 (genome-wide significance level). The inverse variance weighted approach was used as the primary approach for MR analysis, supplemented with the other methods. In addition, sensitivity analyses were performed to evaluate the robustness of the MR results, including Cochran's Q test for heterogeneity, the MR-Egger intercept test for horizontal pleiotropy, the Mendelian randomization pleiotropy residual sum, and outlier (MR-PRESSO) global test for outliers, and the forest test and leave-one-out test for strong influence SNPs. Our results presented that the increased abundance of Lachnospiraceae at family level (OR: 1.265, 95% CI: 1.054-1.519), Senegalimassilia (OR: 1.320, 95% CI: 1.064-1.638), Lachnospiraceae NC2004 group (OR: 1.197, 95% CI: 1.018-1.407), Tyzzerella3 (OR: 1.138, 95% CI: 1.017-1.273), and Oscillibacter (OR: 1.201, 95% CI: 1.035-1.393) at genus level may be risk factors for ED, while the increased abundance of Ruminococcaceae UCG013 (OR: 0.770, 95% CI: 0.615-0.965) at genus level may have a protective effect on ED. No heterogeneity or pleiotropy was found based on the previously described set of sensitivity analyses. Our MR analysis demonstrated that the gut microbiota had inducing and protective effects on the risk of ED. The results provide clinicians with novel insights into the treatment and prevention of ED in the future. Furthermore, our study also displays novel insights into the pathogenesis of microbiota-mediated ED.

Maximizing outcomes in penile prosthetic surgery: exploring strategies to prevent and manage infectious and non-infectious complications.

Inflatable Penile Prostheses (IPP) implantation is a surgical treatment for patients desiring definitive treatment for erectile dysfunction. While this procedure has proven to be effective, it also carries its own set of unique risks that need to be carefully considered. The article reviews the current understanding of complications associated with penile prosthetic surgery and provides strategies to mitigate these adverse events. This article covers various aspects of IPP implantation, including the risks of infection, bleeding, injury to nearby structures, glans ischemia, and device malfunction. It also discusses the importance of careful preoperative screening to identify risk factors and the implementation of infection reduction strategies such as antimicrobial prophylaxis, skin prep, and operative techniques. In addition, it emphasizes the need for postoperative vigilance and prompt management of any complications that may arise. Overall, the article provides a comprehensive overview of the risks and strategies for mitigating complications associated with IPP implantation. Our recommendations are given based on the current consensus in the field and highlight the importance of careful planning, attention to detail, and effective communication between healthcare providers and patients. Despite the potential risks, this review underscores the fact that complications following penile prosthesis implantation are relatively rare.

Evidence for benefits and risks of tadalafil as a non-prescription medicine: review and evaluation using the Group Delphi technique to achieve consensus amongst clinical experts.

An evidence-based consensus meeting was held with urologists, a pharmacist and a cardiologist to perform a structured benefit-risk analysis of reclassifying tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor for treatment of erectile dysfunction (ED), to be available without prescription in Germany. As per the Brass process endorsed by regulatory authorities, an evidence-based Brass value tree was developed, which identified the incremental benefits and risks that should be considered above the safety and efficacy evidence required for prescription medicines. During the Group Delphi consensus meeting, the expert panel rated the likelihood and clinical impact of each benefit and risk on a scale of 0 (none) to 3 (high). Overall attribute scores were calculated from the product of the mean likelihood and mean clinical impact scores giving a possible score of 0-9. The overall benefit attribute scores ranged from 2.8 to 5.4. The overall risk attribute scores ranged from 0.2 to 2.2 though most were 1.0 or less (3 or more is generally considered to be of concern). On balance, the independent meeting scored the benefits of reclassification of tadalafil higher than the risks and considered the risk mitigation strategies of the packaging label and patient information leaflet (PIL) sufficient.

Fluorescence “turn-on” sensing for five PDE5 inhibitors in functional food based on bimetallic nanoclusters

Some phosphodiesterase type-5 (PDE5) inhibitors are active ingredients of prescription drugs that are widely used in the treatment of erectile dysfunction (ED). Recently, a large number of substances with this activity have been developed. Illegal addition of PDE5 inhibitors to foods could lead to cardiovascular diseases and even death, which poses a serious threat to food safety, therefore an on-site rapid screening method is urgently needed. Herein, a host functionalized bimetallic nanoclusters, CD/Au Ag NCs, were synthesized through self-assembly of 6-Aza-2-thiothymine gold nanoclusters (ATT-Au NCs), Arginine silver nanoclusters (Arg-Ag NCs) and carboxymethyl β-cyclodextrin (β-CMCD). The introduction of Rhodamine 6G (R6G) could quench the fluorescence of CD/Au Ag NCs based on the inner filter effect (IFE) and fluorescence resonance energy transfer effect (FRET). Importantly, it was discovered that several PDE5 inhibitors exhibited a higher binding affinity to β-CMCD and could displace R6G binding with CD cavity, which disrupted the fluorescence quenching effects and resulted in the fluorescence recovery of CD/Au Ag NCs. This fluorescence turn-on signal could be utilized for the detection of PDE5 inhibitors. At present, emerging PDE5 inhibitor analogues pose a great challenge to food safety due to their unknown efficacy and safety. The proposed method holds the advantages of high sensitivity, simple probe synthesis, easy operation, and simultaneous detection of multiple PDE5 inhibitors. Meanwhile, the successful application in functional food sample demonstrated its high application potential in multiple PDE5 inhibitors screening.

Physiotherapeutic approaches for the erectile dysfunction management: basic principles and an efficacy evaluation of the current technologies

Physiotherapy is a treatment method for a wide range of diseases of various organs and systems. Its efficacy and practicability are of the great discussions during the past few decades. In urology, this method is used for treatment of erectile dysfunction (ED) caused by a violation of the trophism of genitalia due to radical prostatectomy, atherosclerosis, diabetes mellitus, Peyronie's disease. Shock wave therapy based on the remote action of a low-intensity focused acoustic wave is one of the widely used effective physiotherapeutic methods for the treatment of vasculogenic ED. The main effects of shock waves are neoangiogenesis, nerve fibers regeneration, deceleration of the cavernous fibrosis and reduction of the sympathetic outflow. Some technologies (e.g. radio waves) in addition to those effects also warm the tissues, what accelerates metabolism and improves regenerative processes. All shockwave and radiowave technologies have already demonstrated their efficacy compared with sham control. However, in the few comparative studies, no significant difference was found in efficacy between different technologies. Clinical guidelines consider physiotherapy only as an alternative treatment for patients with mild vasculogenic ED who are refractory or unresponsive to oral vasoactive therapy. Nevertheless, some studies make it possible to judge the efficacy of physiotherapy for treatment of patients with either etiology of the ED. The result of the ED treatment does not depend on the number of treatment courses, their duration, the number of pulses per course and the periodicity of therapy sessions. Also, the original studies have some major shortcomings (i.e. a large percentage of patients dropping out of follow-up). These factors cast doubt on the organotropism of physiotherapy. So, additional comparative studies are required to determine the optimal dosing regimen and to explore the influence of physiotherapy organotropic and psychological components on the results of the treatment. The study aimed to summarize the currently available data evaluating the efficacy of different physiotherapeutic technologies, to compare the efficacy of different technologies for ED treatment.

Low-intensity shockwave therapy improves baseline erectile function: a randomized sham-controlled crossover trial

Abstract Background Low-intensity shockwave therapy for erectile dysfunction is emerging as a promising treatment option. Aim This randomized sham-controlled crossover trial assessed the efficacy of low-intensity shockwave therapy in the treatment of erectile dysfunction. Methods Thirty-three participants with organic erectile dysfunction were enrolled and randomized to shockwave therapy (n = 17) or sham (n = 16). The sham group was allowed to cross over to receive shockwave therapy after 1 month. Outcomes Primary outcomes were the changes in Sexual Health Inventory for Men (SHIM) score and Erection Hardness Score at 1 month following shockwave therapy vs sham, and secondary outcomes were erectile function measurements at 1, 3, and 6 months following shockwave therapy. Results At 1 month, mean SHIM scores were significantly increased in the shockwave therapy arm as compared with the sham arm (+3.0 vs −0.7, P = .024). Participants at 6 months posttreatment (n = 33) showed a mean increase of 5.5 points vs baseline (P &amp;lt; .001), with 20 (54.6%) having an increase ≥5. Of the 25 men with an initial Erection Hardness Score &amp;lt;3, 68% improved to a score ≥3 at 6 months. When compared with baseline, the entire cohort demonstrated significant increases in erectile function outcomes at 1, 3, and 6 months after treatment. Clinical Implications In this randomized sham-controlled crossover trial, we showed that 54.6% of participants with organic erectile dysfunction met the minimal clinically important difference in SHIM scores after treatment with low-intensity shockwave therapy. Strengths and Limitations Strengths of this study include a sham-controlled group that crossed over to treatment. Limitations include a modest sample size at a single institution. Conclusions Low-intensity shockwave therapy improves erectile function in men with erectile dysfunction as compared with sham treatment, which persists even 6 months after treatment. Clinical Trial Registration ClinicalTrials.gov NCT04434352.

Symptomatic benefits of testosterone treatment in patient subgroups: a systematic review, individual participant data meta-analysis, and aggregate data meta-analysis

Testosterone replacement therapy is known to improve sexual function in men younger than 40 years with pathological hypogonadism. However, the extent to which testosterone alleviates sexual dysfunction in older men and men with obesity is unclear, despite the fact that testosterone is being increasingly prescribed to these patient populations. We aimed to evaluate whether subgroups of men with low testosterone derive any symptomatic benefit from testosterone treatment. We did a systematic review and meta-analysis to evaluate characteristics associated with symptomatic benefit of testosterone treatment versus placebo in men aged 18 years and older with a baseline serum total testosterone concentration of less than 12 nmol/L. We searched major electronic databases (MEDLINE, Embase, Science Citation Index, and the Cochrane Central Register of Controlled Trials) and clinical trial registries for reports published in English between Jan 1, 1992, and Aug 27, 2018. Anonymised individual participant data were requested from the investigators of all identified trials. Primary (cardiovascular) outcomes from this analysis have been published previously. In this report, we present the secondary outcomes of sexual function, quality of life, and psychological outcomes at 12 months. We did a one-stage individual participant data meta-analysis with a random-effects linear regression model, and a two-stage meta-analysis integrating individual participant data with aggregated data from studies that did not provide individual participant data. This study is registered with PROSPERO, CRD42018111005. 9871 citations were identified through database searches. After exclusion of duplicates and publications not meeting inclusion criteria, 225 full texts were assessed for inclusion, of which 109 publications reporting 35 primary studies (with a total 5601 participants) were included. Of these, 17 trials provided individual participant data (3431 participants; median age 67 years [IQR 60-72]; 3281 [97%] of 3380 aged ≥40 years) Compared with placebo, testosterone treatment increased 15-item International Index of Erectile Function (IIEF-15) total score (mean difference 5·52 [95% CI 3·95-7·10]; τ2=1·17; n=1412) and IIEF-15 erectile function subscore (2·14 [1·40-2·89]; τ2=0·64; n=1436), reaching the minimal clinically important difference for mild erectile dysfunction. These effects were not found to be dependent on participant age, obesity, presence of diabetes, or baseline serum total testosterone. However, absolute IIEF-15 scores reached during testosterone treatment were subject to thresholds in patient age and baseline serum total testosterone. Testosterone significantly improved Aging Males' Symptoms score, and some 12-item or 36-item Short Form Survey quality of life subscores compared with placebo, but it did not significantly improve psychological symptoms (measured by Beck Depression Inventory). In men aged 40 years or older with baseline serum testosterone of less than 12 nmol/L, short-to-medium-term testosterone treatment could provide clinically meaningful treatment for mild erectile dysfunction, irrespective of patient age, obesity, or degree of low testosterone. However, due to more severe baseline symptoms, the absolute level of sexual function reached during testosterone treatment might be lower in older men and men with obesity. National Institute for Health and Care Research Health Technology Assessment Programme.

Development of in silico models to guide the experimental characterisation of penile tissue and inform surgical treatment of erectile dysfunction

This paper presents a computational study to investigate the mechanical properties of human penile tissues. Different experimental testing regimes, namely indentation and plate-compression tests, are compared to establish the most suitable testing regime for establishing the mechanical properties of the different penile tissues. An idealised MRI-based geometry of the penis, containing different tissue layers, is simulated using the finite element (FE) method to enable realistic predictions of the deformation of the penis. Unlike the linear elastic models used in the literature to-date, hyperelastic isotropic/anisotropic material models are used to capture material nonlinearity and anisotropy. The influence of material properties, morphological variations, material nonlinearity and anisotropy are investigated. Moreover, the implantation of an inflatable penile prosthesis (IPP) is simulated to assess the effects of the implantation procedure, material nonlinearity, and anisotropy on tissue stresses. The results indicate that the interior layers of the penis do not affect the overall stiffness of the penis in the indentation test, while the plate-compression test is able to capture the effects of these layers. Tunica Albuginea (TA) is found to have the most significant contribution to the total stiffness of the penis under load. It can also be observed that buckling occurs in the septum of the penis during the compression tests, and different morphologies dictate different compressive behaviours. There is a clear need for future experimental studies on penile tissues given the lack of relevant test data in the literature. Based on this study, plate-compression testing would offer the most insightful experimental data for such tissue characterisation.

Postmortem Toxicology of Tadalafil in a Forensic Case

Tadalafil is an inhibitor of the human enzyme cyclic guanosine monophosphate–specific phosphodiesterase, type 5 (PDE-5). As a mild vasodilator, it is primarily used for the treatment of erectile dysfunction, an increasingly common condition in men. It is also used for treatment of benign prostatic hyperplasia and pulmonary arterial hypertension. Adverse events of this drug are rare. Absolute contraindications include serious cardiac disease. Despite the widespread use of tadalafil, very little is known about its toxicology in forensic pathology and its association with post-mortem redistribution. This study presents a forensic case with possible contribution of tadalafil. The administration of tadalafil might act as a concurrent cause or contributing factor for lethal cardiogenic shock in people with cardiac disease.