Treatment Of Erectile Dysfunction Research Articles

Prevalence and trends in physical therapy interventions for erectile dysfunction: A Scopus-based bibliometric analysis (1989-2022).

Erectile dysfunction (ED) is a condition that affects many males. Physical therapy (PT) is the one potential treatment for ED that may improve blood flow, muscle strength, and other factors that may contribute to the issue. Data on the prevalence and trends of research on PT for ED are lacking. This study aimed to evaluate the literature trends in PT for ED via bibliometric and visualized analysis. Data on publications were collected from Scopus covering the period between 1989 and 2022. To refine the data, bibliometric analyses were conducted using Microsoft Access, Microsoft Excel, an online visualization platform, and BiblioAnalytics. Power BI and Bibliomaster were used to generate figures and tables, while Biblioshiny and VOSviewer were used for visualization. A total of 494 documents were identified. The year 2019 generated the largest number of publications, with a total of 54. These studies have received 12,917 citations related to PT for ED. The most common document type was the original article with 283 publications. The University of California, USA, was the most productive institution on this topic, with 21 publications and 2,035 citations. The USA led all countries with 114 publications on the topic. The Journal of Sexual Medicine secured the top ranking with an h-index of 18. The main topics studied were erectile dysfunction, shockwave therapy, and physiotherapy. The number of publications on PT for ED has demonstrated an upward trend over the last three decades.

Androgens and erectile dysfunction: from androgen deficiency to treatment.

Androgens play important roles in regulating the growth and development of the male reproductive system and maintaining libido and erectile function. The specific mechanisms by which androgen deficiency leads to erectile dysfunction (ED) are not yet fully understood. To understand the mechanisms and treatment of androgen deficiency-related ED. A literature search in the past 10years was conducted in PubMed and Google Scholar to determine the effects of androgen deficiency on erectile function and the treatment of androgen deficiency. Androgen deficiency can be caused by hypothalamic-pituitary lesions and injuries, testicular-related diseases and injuries, endocrine and metabolic disorders, the side effects of medication, and age. Androgen deficiency can lead to ED by inhibiting the NOS/NO/cGMP pathway (nitric oxide synthase/nitric oxide/cyclic guanosine monophosphate) and altering the expression of ion channel proteins, as well as by inducing oxidative stress, death, and fibrosis in penile corpus cavernosum cells. Testosterone replacement therapy is effective at improving the serum testosterone levels and erectile function in patients with androgen deficiency. For patients who need to maintain a low androgenic state, erectile function can be improved by lifestyle changes, treatment with phosphodiesterase type 5 inhibitors, low-intensity extracorporeal shock wave therapy, and stem cell therapy. Androgen deficiency can affect the structure and function of the penile corpus cavernosum, leading to ED. Areas of further study include how androgen replacement therapy can improve erectile function and how to improve the maintenance of erectile function in patients with hypoandrogenic status.

Characterization of Ano1 expressing cells in the mouse corpus cavernosum

Background/objectives: Highly coordinated contraction and relaxation of smooth muscle cells (SMCs) is critical to penile function. The Ca2+-activated Cl− channel, Anoctamin-1 (Ano1) plays a role in this as antagonists of this channel inhibit contractile, electrical and intracellular Ca2+ activity. mRNA encoding Ano1 is highly expressed in whole rabbit corpus cavernosum (CC). Despite its significant contribution to erectile function, the specific cell type that expresses Ano1 has not been determined, with previous studies relying on morphological identification of cells alone. Atypical SMCs (ASMCs) expressing platelet derived growth factor receptor-a (PDGFRa; Pdgfra), myosin heavy chain ( Myh11) and Ano1 have been observed in the renal pelvis where they are thought to drive the activity in adjacent SMCs (Grainger et al. 2020; PMID: 32415739). Therefore, the objective of this study is to identify the cell type that expresses Ano1 in the CC. Methods: Cells were isolated from the CC of mice selectively expressing eGFP in PDGFRa+ cells (PDGFRa+-eGFP mice) and SMCs ( Myh11-eGFP mice). Cell suspensions were sorted using fluorescence activated cell sorting (FACS) and evaluated for expression of cell specific markers ( Pdgfra and Myh11) by qPCR. Enriched PDGFRa+ cells and SMCs were examined with ddPCR to determine the expression of Ano1. Protein expression was evaluated using immunofluorescent labeling of frozen CC sections with an antibody targeting Ano1. Results: FACS sorted Myh11-eGFP+ cells expressed Myh11 and Pdgfra. Sorting of PDGFRa-eGFP+ cells revealed two subpopulations, bright and dim. Examination of these two PDGFRa-eGFP+ subpopulations revealed that while both expressed similar levels of Pdgfra, the dim population also expressed Myh11 suggesting that these cells may be similar to ASMCs of the renal pelvis. ddPCR revealed that the PDGFRa-eGFP+ dim population had higher gene copy numbers of Ano1 compared to Myh11-eGFP+ cells. Immunofluorescent labeling of CC sections revealed that Ano1 protein was present in a subpopulation of PDGFRa+ cells. Conclusion: The data presented in this study demonstrates that Ano1 is expressed in mouse CC PDGFRa-eGFP+ dim populations that also express Pdgfra and Myh11; this is similar to ASMCs in the renal pelvis. Future directions include examining the relationship of PDGFRa-eGFP+ dim cells to SMCs and nerve terminals in the CC and to determine if these cells are also present in human CC. This cell population could represent a novel target for the treatment of erectile dysfunction in patients who do not respond to phosphodiesterase inhibitors. Funding: AUA Research Scholar Award to KIH, NIH DK129528 to CAC, NIH P20GM130459 for imaging and molecular cores. This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

A contemporary systematic review of penile lengthening procedures with penile prosthesis.

Penile prosthetic devices are the standard treatment for erectile dysfunction (ED) after failure of maximum medical therapy and conservative options. Several penile lengthening procedures (PLPs) can be performed concurrently with penile prosthesis (PP) insertion in patients with severe ED, penile shortening, and/or Peyronie's disease to help combat negative emotional and psychological concerns from penile length loss with penile prosthetic device placement. An extensive, systematic literature review of the various pre-, intra-, and post-operative techniques that can be applied to preserve, restore or enhance penile length at the time of penile prosthetic implantation. Numerous pre-operative and post-operative inflation protocols exists with vacuum erection devices and penile traction therapy. Intraoperative surgical techniques include cavernosal sparing and channeling without dilatation, subcoronal incision with circumferential penile degloving and grafting, the sliding technique, the modified sliding technique, the multiple-slit technique, the tunical expansion procedure (TEP), modified TEP, and the auxetic expansion procedure. These approaches can be meaningful to restore and/or preserve length for patients undergoing PP insertion. PLPs can be performed by surgeons who have extensive penile reconstruction experience and have been trained to do these procedures, as there is significant risk to the patient and limitations to what can be expected. Each patient must be counseled in detail about the risks and benefits of these procedures and have their expectations managed as the average postoperative penile length recovery is around 3 cm and can range from 0-4.0 cm. Future research is needed to identify the appropriate candidate for each approach, and how much length gain the patient can expect.

Azulene and Its Derivatives as Potential Compounds in the Therapy of Dermatological and Anticancer Diseases: New Perspectives against the Backdrop of Current Research.

The scientific article focuses on the role of azulene and its derivatives in the therapy of dermatological diseases, presenting the latest laboratory and clinical research as well as prospects for further studies. In a synthetic literature review, various databases such as PubMed, Scopus, Web of Science, and the Database of Polish Scientific Journals were queried to select relevant articles concerning azulene. The conclusions drawn from the thematic analysis of the studies emphasize the multifaceted pharmacological actions of azulene and its derivatives including their anti-inflammatory properties, potential anticancer effects, photoprotective abilities, alleviation of itching, management of atopic dermatitis, and treatment of erectile dysfunction. However, there are certain limitations associated with the application of unmodified azulene on the skin, particularly related to photodecomposition and the generation of reactive oxygen species under UV radiation. These effects, in turn, necessitate further research on the safety of azulene and azulene-derived substances, especially regarding their long-term use and potential application in phototherapy. The authors of this work emphasize the necessity of conducting further preclinical and clinical studies to fully understand the mechanisms of action. Incorporating azulene and its derivatives into the therapy of dermatological disorders may represent an innovative approach, thereby opening new treatment avenues for patients.

Differential inhibition of sildenafil and macitentan on saxagliptin metabolism

The development of diabetes mellitus (DM) is generally accompanied by erectile dysfunction (ED) and pulmonary arterial hypertension (PAH), which increases the use of combination drug therapy and the risk of drug-drug interactions. Saxagliptin for the treatment of DM, sildenafil for the treatment of ED and PAH, and macitentan for the treatment of PAH are all substrates of CYP3A4, which indicates their potential involvement in drug-drug interactions. Therefore, we investigated potential pharmacokinetic interactions between saxagliptin and sildenafil/macitentan. We investigated this speculation both in vitro and in vivo, and explored the underlying mechanism using in vitro hepatic metabolic models and molecular docking assays. The results showed that sildenafil substantially inhibited the metabolism of saxagliptin by occupying the catalytic site of CYP3A4 in a competitive manner, leading to the alterations in the pharmacokinetic properties of saxagliptin in terms of increased maximum plasma concentration (Cmax), area under the plasma concentration–time curve from time 0 to 24 h (AUC(0-t)), area under the plasma concentration–time curve from time 0 extrapolated to infinite time (AUC(0-∞)), decreased clearance rate (CLz/F), and prolonged terminal half-life (t1/2). In contrast, a slight inhibition was observed in saxagliptin metabolism when concomitantly used with macitentan, as no pharmacokinetic parameters were altered, except for CLz/F. Thus, dosage adjustment of saxagliptin may be required in combination with sildenafil to achieve safe therapeutic plasma concentrations and reduce the risk of potential toxicity, but it is not necessary for co-administration with macitentan.

The Management of Inflatable Penile Prosthesis Erosion and Infection following Iatrogenic Aspiration

The Management of Inflatable Penile Prosthesis Erosion and Infection following Iatrogenic Aspiration

An Acupuncture Protocol for the Treatment of Erectile Dysfunction: A Delphi Process

Plain Language SummaryAs many as 322 million men may be afflicted by erectile dysfunction (ED) (impotence) by 2025. The health consequences are substantial with an increased risk of cardiovascular diseases and higher mortality in addition to reduced quality of life. Acupuncture may be a potential treatment option with a low side-effect profile; however, a standardised treatment protocol has been lacking for the use in the clinic and in clinical trials. This study aimed to develop a best-practice acupuncture treatment protocol for the treatment of ED. Eleven acupuncture experts have by the means of a Delphi process reached tool consensus on a diagnostic and a treatment protocol for men suffering from ED. This is the first attempt in modern times and in the West to provide clinical acupuncturists and researchers with a treatment protocol for this common health issue.

Utilization Trends of Phosphodiesterase Type-5 Inhibitors for Erectile Dysfunction Between 2019 and 2023 in Tanzania.

Introduction Erectile dysfunction (ED) profoundly affects millions of people globally, including interfering with mental health and quality of life. Phosphodiesterase type-5 inhibitors (PDE5Is) such as sildenafil are pivotal in ED treatment. This study aimed to examine the utilization patterns ofPDE5Is in Tanzania. Materials and methods In this retrospective longitudinal study, data on sildenafil and other similar PDE5Is imported between 2019 and 2023 were sourced from the Tanzania Medicines and Medical Devices Authority (TMDA). Pre-processing and visualization were performed using Microsoft Power BI Desktop, and further analysis was performed using IBM SPSS Statistics for Windows, Version 26 (Released 2019; IBM Corp., Armonk, New York, United States). Utilization trends were ascertained through curve fitting, Holt's linear trend model, and autoregressive integrated moving average (ARIMA) models. The defined daily doses (DDDS) per 1000 inhabitants (DID) were calculated using the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) Classification System and the DDD methodology endorsed by the WHO Collaborating Centre for Drug Statistics Methodology. Results Between 2019 and 2023, there was a pronounced increase in the importation of approximately 587 consignments of PDE5Is. Employing the Holt model (R-square = 0.843), a substantial increase from 0.220910 DID in 2019 to 0.534272 DID by 2025 was observed and anticipated. The period witnessed sildenafil dominating 75.5% of the total use, with Erecto being the most consumed brand (37.6% of totalDID). Notably, 2022 had the highest surge (27.2% of the total), albeit a slight decline was observed in 2023 (20.5%). This trend was supported by a linear regression model (R-square = 0.889). Conclusion We found increasing annual trends of PDE5Is of utilization. This requires critical oversight and effective policies to ensure appropriate use and risk minimization.

Inflammatory cytokine profiles in erectile dysfunction: a bidirectional Mendelian randomization.

Inflammatory cytokines (ICs) play an important role in erectile dysfunction (ED). Previous studies have demonstrated that most ED patients have high levels of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6) and interleukin-8 (IL-8). The causality between 41 ICs and ED is investigated using the Mendelian randomization (MR) approach. Single nucleotide polymorphisms (SNPs) exposure data of 41 ICs came from a genome-wide association study (GWAS) of 8293 subjects. At the same time, the FINNGEN R9 database provided the ED outcome data containing 2205 ED patients and 164104 controls. MR-Egger (ME), inverse variance weighting (IVW), and weighted median (WM) were applied to conduct the MR study and IVW was taken as the main criterion. From a genetic perspective, the increase of interferon-inducible protein-10 (IP-10) level significantly increased the risk of ED (P=0.043, odds ratio (OR)=1.269, 95% confidence interval (95%CI): 1.007-1.600), while the increase of interleukin-1 receptor antagonist (IL-1RA) markedly decreased the risk of ED (P=0.037, OR=0.768, 95%CI: 0.600-0.984). Meanwhile, IP-10 (p=0.099) and IL-1RA (p=0.135) failed to demonstrate causality in reverse MR analysis. Changes in ICs levels will significantly affect the risk of ED, especially IP-10 as a risk component for ED and IL-1RA as a protective component for ED. In the future, we can achieve targeted treatment and prevention of ED by intervening with specific inflammatory factors.

Responses of Five Different Artificial Intelligence Chatbots to the Top Searched Queries About Erectile Dysfunction: A Comparative Analysis

The aim of the study is to evaluate and compare the quality and readability of responses generated by five different artificial intelligence (AI) chatbots—ChatGPT, Bard, Bing, Ernie, and Copilot—to the top searched queries of erectile dysfunction (ED). Google Trends was used to identify ED-related relevant phrases. Each AI chatbot received a specific sequence of 25 frequently searched terms as input. Responses were evaluated using DISCERN, Ensuring Quality Information for Patients (EQIP), and Flesch-Kincaid Grade Level (FKGL) and Reading Ease (FKRE) metrics. The top three most frequently searched phrases were “erectile dysfunction cause”, “how to erectile dysfunction,” and “erectile dysfunction treatment.” Zimbabwe, Zambia, and Ghana exhibited the highest level of interest in ED. None of the AI chatbots achieved the necessary degree of readability. However, Bard exhibited significantly higher FKRE and FKGL ratings (p = 0.001), and Copilot achieved better EQIP and DISCERN ratings than the other chatbots (p = 0.001). Bard exhibited the simplest linguistic framework and posed the least challenge in terms of readability and comprehension, and Copilot’s text quality on ED was superior to the other chatbots. As new chatbots are introduced, their understandability and text quality increase, providing better guidance to patients.

Androgenic Properties and Subchronic Toxicity of the Aqueous Extract of Pycnanthus angolensis (Welw.) Warb. Wood (Myristicaceae)

Aims: Pycnanthus angolensis (Welw.) Warb. also known as “Etengué” in the Baka language, is a medicinal plant used by the Baka Pygmies of Cameroon to treat erectile dysfunction. This study aimed to evaluate the androgenic activity and subchronic toxicity of the aqueous extract of Pycnanthus angolensis wood.
 Study Design: Experimental design.
 Place and Duration of Study: Laboratory of Biochemistry, Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, between November 2022 and October 2023.
 Methodology: Twenty-five male Wistar strain rats were divided into 5 groups of 5 rats each including a positive control group that received testosterone enanthate (5 mg/kg) intramuscularly once a week; a normal control group that received distilled water (10 ml/kg) and three test groups which received 134 and 267 and 533 mg/kg of the aqueous extract of Pycnanthus angolensis daily per os. On the 29th day, the animals were killed, and several biochemical parameters were assessed for androgenic properties.
 Results: At a dose of 134 mg/kg, the extract significantly increased (p<0.05) the levels of testicular cholesterol, testosterone and serum prostatic acid phosphatase activity compared to those of the normal control. A toxicity study showed that at doses of 134 and 267 mg/kg, the extract did not induce any significant variation (p>0.05) in the creatinine level, but a significant reduction (p<0.05) in of aspartate and alanine aminotransferase activities was recorded. Histopathology revealed destruction of testicular spermatozoa at a dose of 533 mg/kg compared to that of the controls.
 Conclusion: These results showed that at a dose of 134 mg/kg, the aqueous extract of Pycnanthus angolensis (Welw.) Warb. wood is capable of stimulating the production of androgens and is tolerated by the rat's body. Our results justified the traditional use of this plant for the treatment of male infertility and erectile dysfunction.

Downstream Revenue Realized by Facilities Placing Inflatable Penile Prosthesis in Medicare Beneficiaries to Treat Erectile Dysfunction

ObjectivesTo quantify the incremental downstream revenue generated from subsequent treatment of men who received an inflatable penile prosthesis (IPP) to treat erectile dysfunction (ED), compared to men without ED. MethodsThe 100% Medicare Standard Analytic Files were used to conduct a retrospective claims analysis of the 5-year revenue generated by patients receiving IPP to treat their ED, compared to a propensity-matched cohort of men without ED. Men aged 65 years or older with ED who underwent IPP implantation (Current Procedural Terminology® 54405) in a hospital outpatient setting between January 1, 2016 and December 31, 2021, and who had continuous Medicare Parts A and B enrollment for 12 months pre-index IPP and five years post-index IPP discharge date were included in the study. Men without ED but with comparable characteristics were identified and used as a comparator group. Revenue received by hospitals from Medicare was defined as the sum of payments for patient services, other payor-paid amounts, patient deductibles, copayments, and coinsurance. Revenue was inflated to 2022 US dollars. The mean values and their corresponding standard deviations (SD) are reported. ResultsAfter matching, there were 2,905 men with ED who received an IPP and 7,462 men without ED. The IPP cohort showed a significantly higher 5-year cumulative revenue (mean=$34,571 [SD=$50,234]) compared to the men without ED (mean=$3,189 [SD=$11,527]). When stratified by diagnosis type, the differences in revenue were $10,258 for circulatory disease, $2,646 for diabetes, $2,013 for urology, and $1,043 for prostate cancer. Significantly more IPP patients had at least one health encounter for these conditions over the 5-year follow-up period than their matched controls (55.0% versus 7.8% for circulatory, 46.7% versus 16.8% for urology, 19.3% versus 3.6% for diabetes, and 19.0% versus 3.0% for prostate cancer). ConclusionsMen with ED who received IPP generated substantially higher revenue for the healthcare system over a 5-year period, nearly ten times as much, compared to men without ED, excluding the initial cost of the IPP procedure. The presence of ED, coupled with IPP usage, is associated with significantly increased healthcare revenue across a range of medical conditions compared to men without ED. These findings emphasize the financial implications for advanced ED programs to improve access to necessary care for these patients. Healthcare facilities may leverage these insights to effectively allocate resources to deliver critical healthcare to men with ED.

Which PDE5 inhibitor is the most effective in the treatment of erectile dysfunction in men with spinal cord injury? A systematic review and network meta-analysis.

Phosphodiesterase 5 inhibitors (PDE5i) are the first-line drugs for erectile dysfunction (ED) but differences among available molecules should drive therapy personalization. Choosing one PDE5i over another is a challenge in men with spinal cord injury (SCI), as the evidence of efficacy for each molecule is derived from few studies and comparative "head-to-head" trials are lacking. To assess the efficacy of the different PDE5i for SCI-related ED with a network meta-analysis (NMA) approach. Databases from PubMed, Web of Science, Scopus, and Cochrane Library were checked for randomized controlled trials (RCTs) comparing any PDE5i to each other or placebo in men with traumatic SCI lasting ≥6 months. Data were incorporated in a random-effect NMA, where treatments' efficacy was ranked using the surface under the cumulative ranking curve (SUCRA). The 10 RCTs included provided information about 1,492 men with ED due to traumatic SCI. Intervention arms included sildenafil, tadalafil, and/or vardenafil. Overall, at the pairwise meta-analysis, PDE5i were four times more effective than placebo in improving erectile function (risk ratio: 4.13, 95% CI: 2.76, 6.19). The comparative analysis from NMA revealed that tadalafil was associated with the highest SUCRA value (81%), followed by vardenafil (68%) and sildenafil (49%). Within the grading of comparison network, tadalafil appeared to be the best PDE5i in the treatment of SCI-related ED. Further focused studies are warranted to confirm these findings and define optimal doses and duration of therapy.

Age-related pharmacokinetics differences were observed between young and elderly populations of a novel PDE5 inhibitor, youkenafil, and its metabolite M459

PurposeYoukenafil is a novel oral selective PDE5 inhibitor for treating Erectile Dysfunction. This investigation assessed pharmacokinetics (PK), safety, and tolerability of youkenafil and its main metabolite (M459) after taking 100 mg youkenafil hydrochloride tablets in elderly and young subjects. MethodsThis Phase I, single-center, open-label, parallel-group, single-dose study was conducted on 24 individuals (12 elders and 12 youngsters). Each subject received a single oral 100 mg youkenafil hydrochloride tablets. Blood samples were collected before medication and up to 48 h after medication for PK analysis. Safety and tolerability were also assessed, including treatment-emergent adverse events (TEAEs), laboratory tests, 12-lead ECG, vital sign inspections, color vision examinations, and physical examinations. ResultsPlasma concentrations of youkenafil and M459 were quantified. PK parameters were determined by non-compartmental analysis. Median Tmax of elderly and young groups were both 0.733 h. However, Cmax, AUC0-t, and AUC0-∞ of youkenafil were separately 16.8 %, 37.2 %, and 37.5 % higher in elders and t1/2 of youkenafil was 2.1 h longer in elders. More great differences were observed for M459. T1/2 values were 4.05 h longer in elders, with Cmax, AUC0-t and AUC0-∞ 73.7 %, 81.1 %, and 81.4 % higher in elders. Two (8.3 %) elderly subjects reported TEAEs (all grade Ⅰ in severity) and both recovered without any treatment. No serious adverse reactions (SAEs) or serious unexpected suspected adverse reactions (SUSARs) occurred in this study. ConclusionsThis was the first PK research of youkenafil and M459 in elderly men. PK parameters differences between youkenafil and M459 were comparable between elderly and young groups. Moreover, safety and tolerability of youkenafil were favorable in both groups.

Monocyte-to-high-density lipoprotein cholesterol ratio and the risk of erectile dysfunction: a study from NHANES 2001-2004.

The monocyte-to-high-density lipoprotein cholesterol ratio (MHR) has become a novel inflammation marker with a possible association with erectile dysfunction (ED); however, there are fewer studies exploring the association between MHR and ED. This study sought to explore the association between MHR and ED. This study population was drawn from participants in two 2-year cycles of the National Health and Nutrition Examination Survey (2001-2002 and 2003-2004). MHR was calculated as the ratio of monocyte count (103 cells/μL) to high-density lipoprotein cholesterol (mg/dL). The relationship between MHR and ED was explored using survey-weighted logistic regression models with MHR as a continuous variable and divided into tertiles (tertile 1 [T1]: <0.01; T2: 0.01-0.014; T3: >0.014). We also used a smooth curve fit (penalized spline method) to characterize the dose-response relationship between MHR and ED. In addition, subgroup analyses based on age, body mass index, smoking, hypertension, diabetes mellitus, and cardiovascular disease were performed to further analyze the data. Sensitivity analyses were also conducted to further assess the stability of the results. The main outcome measure was the difference in ED prevalence between MHR levels. A total of 1361 participants were enrolled, with 513 (T1), 438 (T2), and 410 (T3) participants in the 3 MHR groups. After adjusting for all potential covariates, survey-weighted logistic regression analyses showed a significant association between MHR and ED (odds ratio [OR], 1.96; 95% confidence interval [CI], 1.26-3.05). When MHR was used as a categorical variable, the adjusted OR for ED prevalence increased significantly with increasing MHR after adjusting for all potential covariates (T3 vs T1: OR, 2.14; 95% CI, 1.29-3.55). The dose-response curves showed that the prevalence of ED increased with increasing MHR. Easy to access and low cost, MHR is a convenient clinical tool that helps clinicians in the prevention and treatment of ED. The present study is the first to examine the association between MHR and ED nationally representative data. However, the study population was derived from a U.S. database, so the findings are limited to the U.S. population. Our study demonstrated that MHR levels were independently associated with ED and that ED patients had higher MHR levels, suggesting that MHR may be a valuable predictor for identifying people at higher risk for ED.

(O-01) PREDICTORS OF INTRACAVERNOSAL INJECTION THERAPY IN MEN WITH ERECTILE DYSFUNCTION

Abstract Introduction &amp; Objective Oral phosphodiesterase type 5 inhibitors (PDE5i) and intracavernosal injections (ICI) are effective treatments for erectile dysfunction (ED). However, the risk factors associated with the transition from oral therapy to ICI use remain less established. We aimed to identify predictive factors contributing to the progression from oral PDE5i to ICI therapy. Methods Retrospective chart review was conducted on patients presenting with erectile dysfunction at our clinic. Patients initiating therapy before clinical documentation or without follow-up were excluded. Statistical analysis utilized chi-square test, two-tailed student's t-test, and multivariable logistic regression performed in R. Results Among 259 men treated for ED, 61% (158) reported subjective improvement with oral PDE5i therapy alone, while 18% (46) initiated ICI therapy. Table 1 summarizes demographic information and cardiovascular risk factors. Men progressing to ICI had higher rates of hypertension (54.3% vs. 28.4%, p=0.0015), type 2 diabetes mellitus (32.6% vs. 11.4%, p=0.0013), and a history of radical prostatectomy (26.1% vs. 3.8%, p&amp;lt;0.001) compared to those satisfied with oral therapy. Significant predictors for ICI progression on multivariate analysis were history of radical prostatectomy (OR 19.4, [95% CI, 1.42-678.88]) and diabetes mellitus (OR 8.6, [95% CI, 1.36-76.49]). Two patients (4.3%) experienced priapism as a complication of ICI use. Among the patients using ICI, 54% (25/46) reported satisfaction with their erections. Conclusions Cardiovascular risk factors and a history of radical prostatectomy were more prevalent among patients progressing from oral therapy to ICI in our cohort. These findings may guide early counseling on ED treatment progression for patients with these predictive factors. Financing No conflict.

Bioavailability enhancement of sildenafil citrate via hydrogel-forming microneedle strategy in combination with cyclodextrin complexation

Sildenafil citrate (SIL) as a first-line treatment for erectile dysfunction is currently reported to have poor solubility and bioavailability. Moreover, SIL undergoes first-pass metabolism when taken orally and its injection can lead to discomfort. In this study, we introduce a novel transdermal delivery system that integrates hydrogel-forming microneedles with the inclusion complex tablet reservoir. The hydrogel-forming microneedle was prepared from a mixture of polymers and crosslinkers through a crosslinking process. Importantly, the formulations showed high swelling capacity (>400 %) and exhibited adequate mechanical and penetration properties (needle height reduction < 10 %), penetrating up to five layers of Parafilm® M (assessed to reach the dermis layer). Furthermore, to improve the solubility of SIL in the reservoir, the SIL was pre-complexed with β-cyclodextrin. Molecular docking analysis showed that SIL was successfully encapsulated into the β-cyclodextrin cavity and was the most suitable conformation compared to other CD derivatives. Moreover, to maximize SIL delivery, sodium starch glycolate was also added to the reservoir formulation. As a proof of concept, in vivo studies demonstrated the effectiveness of this concept, resulting in a significant increase in AUC (area under the curve) compared to that obtained after administration of pure SIL oral suspension, inclusion complex, and Viagra® with relative bioavailability > 100 %. Therefore, the approach developed in this study could potentially increase the efficacy of SIL in treating erectile dysfunction by being non-invasive, safe, avoiding first-pass metabolism, and increasing drug bioavailability.

(O-26) INITIAL EXPERIENCE IN IMPLEMENTING AN INTRACAVERNOSAL INJECTABLE THERAPY PROGRAM FOR THE TREATMENT OF ERECTILE DYSFUNCTION IN PATIENTS AT A PUBLIC HOSPITAL

Abstract Introduction Intracavernous injectable therapy (IIT) has been considered a second-line therapy for the treatment of erectile dysfunction (ED) since the emergence of phosphodiesterase type 5 inhibitors (IPDE-5) for oral use in the late 1990s. The ease of access to IPDE-5, with increasingly accessible costs, in addition to the safety and efficacy with the use of these medications, caused IIT to fall into disuse for a good period. In turn, about 30% of men with ED do not respond satisfactorily to the oral use of IPDE-5, needing to resort to some other form of treatment. Materials and Method Patients with ED unresponsive to oral IPDE-5 were referred for IIT. Subsequently, they were submitted to a questionnaire to evaluate the results. Results Eight men answered the applied questionnaire. The mean age of patients was 61 years (44-75 years). All patients reported that their partner was aware of the treatment used, and 75% of patients reported the presence of some comorbidity. The response to the test was considered satisfactory in 75% of the patients, with full erection (EHS 4) in 37.5%, and partial erection with penetration (EHS 3) in 37.5%. Only one patient (12.5%) reported not having adapted to the proposed treatment, despite having a satisfactory erection. After a 12-month follow-up, only one patient (12.5%) continues to use IIT, 3 (37.5%) opted for penile prosthesis implantation, while the others chose not to adhere to any subsequent treatment. In 62.5% of patients there was no report of any side effect. Conclusion Despite high rates of efficacy and satisfaction reported in the literature, our initial experience showed a low rate of adherence to IIT. The team's lack of experience and difficulty in following up patients probably contributed to these results, revealing a need for better team training and patient guidance. Financing No conflict.

(O-20) COMPARISON OF THREE SHOCKWAVE THERAPY PROTOCOLS FOR THE TREATMENT OF ERECTILE DYSFUNCTION

Abstract Introduction Multiple treatment modalities have been used to treat erectile dysfunction (ED), including focal shock waves. This therapy has demonstrated a short-term positive effect in patients who respond or not to PDE-5i, with variability in therapeutic protocols. Aim To evaluate the effectiveness of 3 shock wave protocols for the treatment of ED. Methods Randomized, multicenter clinical trial. 277 men with non-psychological ED, over 18 years of age, without cancer or major surgeries in the pelvic area or any neurological disease that affected their erectile function, were randomized to one of three groups: weekly (6 wave sessions (WS), 1 x wk), monthly (6 WS 1 x month) or reinforcement (6 WS, 1 x week + 5 sessions, 1 x month). The wave parameters were the same in all groups, no patient received medication. The primary outcome was the change in IIEF-EF score at 6 months of follow-up. The change in the IIEF at the end of therapy and at 3 months of follow-up, erection hardness with the EHS, self-esteem with the SEAR questionnaire, and side effects were also evaluated. Results 222 patients completed the study. In the 6-month evaluation, the average change in the IIEF-EF in the monthly schedule was 4.3 (+/-6.7), 1.9 (+/-6.5) in the weekly schedule, and 5.0 (+/-6.1) in the reinforcement schedule ( p=0.0086). At the end of therapy and at 3 months the change in the IIEF-EF was 3.2 (+/-5.8) and 2.9 (+/-5.5) in the monthly group, 2.7 (+/-4.5) and 3.0 (+/-5.3) in the weekly one, and 4.2 (+/-6.4) and 4.4 (+/-6.5) in the reinforcement one. No differences were found between the groups in the proportion of patients who increased at least one point in erection hardness, nor in the average in the SEAR questionnaire in the evaluations carried out. No patient reported adverse effects to the therapy. Conclusions The results suggest that monthly and reinforcement wave schemes present good results for the treatment of ED. Financing Boston Medical Group.