Treatment Of Erectile Dysfunction Research Articles

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-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.

Evaluation of tadalafil supplementation on the neutrophil/lymphocyte and the platelet/lymphocyte ratios in patients with erectile dysfunction: A prospective study.

We aimed to evaluate the effect of daily 5 mg tadalafil on the neutrophil/lymphocyte ratio (NLR) and the platelet/lymphocyte ratio (PLR) in patients with erectile dysfunction (ED). 30 subjects with ED were given tadalafil as well as 30 subjects with ED who were not receiving tadalafil were recruited. 30 healthy individuals served as controls. Receiver operating characteristic curve (ROC) showed that the best cut off point of pre-treatment and post treatment NLR in the ED treatment group was found <1.51, <1.51, sensitivity of 68.3%, 58.3%, specificity of 53.3%, 53.3%, lower bound of 0.558, 0.517, upper bound of 0.789, 0.757, total accuracy of 67.4%, 63.7% and p 0.003, 0.0025, respectively. Additionally, the best cut off point of pre-treatment and post treatment PLR in the ED treatment group was found <5.89, <5.99, sensitivity of 65%, 63.3%, specificity of 63.3%, 53.3%, lower bound of 0.515, 0.435, upper bound of 0.755, 0.687, total accuracy of 63.5%, 56.1% and p 0.027, 0.341, respectively. Daily 5 mg Tadalafil supplementation significantly improves erectile function through decreasing these markers as well as depression and anxiety.

Recovery of the hibernating cavernosum by penile revascularization

ABSTRACT Objective Chronic ischemia-related cavernous dysfunction is considered irreversible. However, in certain patients, cavernous function appears to recover with penile revascularization. In this study, we investigated a potential cavernous dysfunction reversibility from a clinical perspective. Patients and Methods We involved 93 young patients in the study with arterial erectile dysfunction (ED) (median age: 30 years). Erectile function tests were performed according to the standard operating procedures of the International Society of Sexual Medicine. Among the participants, 63 and 30 displayed pure arteriogenic and mixed vasculogenic (due to both arterial insufficiency and cavernous dysfunction) ED, respectively. Penile revascularization was performed by anastomosing the inferior epigastric artery to the dorsal artery. The ED treatment success was considered from a score of at least 24 on the International Index of Erectile Function-6. Results Our results proved that penile revascularization cured 92.1% and 73.8% of the patients with pure arteriogenic and mixed vasculogenic ED, respectively (Kaplan-Meier method, log-rank test: no significant difference). The required time for curing 50% of the patients was 10.5 and 10.0 months for pure arteriogenic and mixed vasculogenic ED, respectively, indicating no recovery delay in patients with mixed vascular ED. Furthermore, the cavernous dysfunction degree did not influence cavernous function recovery. Conclusion Penile revascularization cured ED in 73.8% of the patients with mixed vasculogenic ED. Cavernous dysfunction appears to be reversible in certain cases. Furthermore, we observed no delay in functional recovery compared to participants with healthy cavernous function. These two discoveries suggest that cavernous function recovery after penile revascularization is similar to the concept of hibernating myocardium in ischemic myocardium. Although cavernous dysfunction is considered irreversible, it could be reversed in multiple cases with blood flow restoration to the cavernous tissue.

Research Advances in Stem Cell Therapy for Erectile Dysfunction.

Erectile dysfunction (ED) is a common clinical condition that mainly affects men aged over 40 years. Various causes contribute to the progression of ED, including pelvic nerve injury, diabetes, metabolic syndrome, age, Peyronie's disease, smoking, and psychological disorders. Current treatments for ED are limited to symptom relief and do not address the root cause. Stem cells, with their powerful ability to proliferate and differentiate, are a promising approach for the treatment of male ED and are gradually gaining widespread attention. Current uses for treating ED have been studied primarily in experimental animals, with most studies observing improvements in erectile quality as well as improvements in erectile tissue. However, research on stem cell therapy for human ED is still limited. This article summarizes the recent literature on basic stem cell research on ED, including cavernous nerve injury, aging, diabetes, and sclerosing penile disease, and describes mechanisms of action and therapeutic effects of various stem cell therapies in experimental animals. Stem cells are also believed to interact with host tissue in a paracrine manner, and improved function can be supported through both implantation and paracrine factors. To date, stem cells have shown some preliminary promising results in animal and human models of ED.

A primer on the restorative therapies for erectile dysfunction: a narrative review.

Erectile dysfunction (ED) is a common condition that affects millions worldwide. Patients and urologists alike are seeking alternative therapies that can provide long-lasting results in the treatment of ED. This review provides a comprehensive overview of restorative treatments available for ED, such as platelet-rich plasma, stem cell therapy, and shockwave therapy. The aim of this narrative review is to provide a primer for urologists and general practitioners on the basics of implementing ED restorative therapies in their practice. The PubMed, MEDLINE, and Google Scholar databases were searched for articles in the English language through August 31, 2023, that included key terms such as "erectile dysfunction," "restorative therapy," "shockwave therapy," "platelet-rich plasma," "stem cell therapy," and "stromal vascular fraction." Reference lists of selected studies were manually reviewed to find articles not identified by the initial database search. Shockwave therapy has demonstrated effectiveness in treating ED, with devices like the Medispec ED1000 and Storz Duolith showing statistically significant improvements in patient scores for International Index of Erectile Function (IIEF)-Erectile Function scores in clinical trials. In reported studies of platelet-rich plasma injections, a substantial percentage of patients reached a minimal clinically important difference in the IIEF-Erectile Function scale after treatment. Studies of ED treatment with stem cell therapy, while limited and with small sample sizes, have demonstrated encouraging improvements in patient scores for the abridged 5-item version of the IIEF after treatment. Shockwave, platelet-rich plasma, and stem cell therapies are important, novel, noninvasive restorative treatments for ED that can provide relief for patients wishing to avoid a more invasive approach. While these therapies have shown promising results in clinical trials, more research is required to establish them as standardized and efficacious options in the management of ED.

Intracerebral Haemorrhage after Illicit Use of Sildenafil: A Case Report

Sildenafil(viagra) has become one of the top selling over the counter product for the treatment of male erectile dysfunction.(1) We report a case of 34year male patient admitted in our ICU with history of severe headache followed by sudden loss of consciousness after ingestion of two tablets of sildenafil(50mg) land up intracerebral bleed and died. There are many cases in the literature reporting intracerebral or subarachnoid haemorrhage associated with use of sildenafil while sexual contact.

PDE5 inhibitors against cancer via mediating immune cells in tumor microenvironment: AI‐based approach for future drug repurposing exploration

AbstractPhosphodiesterase‐5 (PDE5) inhibitors are used clinically for the treatment of erectile dysfunction, pulmonary arterial hypertension, and other urological diseases. Emerging evidences have suggested the therapeutic capacity of PDE5 inhibitors as the repurposed drugs in oncology. However, the essential immune function of PDE5 inhibitors against cancer in tumor microenvironment (TME) remains unclear. This review aimed to summarize the recent advances regarding the repurposing of PDE5 inhibitors as anti‐cancer agents for cancer management to enhance the anti‐tumor immune response by mediating various immune cells, which included the myeloid‐derived suppressor cells, macrophages, T cells, fibroblasts, and natural killer cells in TME. Moreover, artificial intelligence (AI), as a new approach, is composed of traditional machine learning and deep learning methods and could be potentially used to identify the targets of immune cells in TME and predict the efficacy for repurposed drug toward malignancies. In summary, these endeavors provide novel insights into the comprehensive strategies for PDE5 inhibitors mediating immune cells against cancer and AI‐based approach for future drug repurposing exploration.

Cldn4 overexpression promotes penile cavernous smooth muscle cell fibrotic response via the JNK signaling pathway.

Erectile dysfunction (ED), defined as the inability to achieve or maintain a penile erection sufficient to satisfy sexual behavior, is prevalent worldwide. Using previous research, bioinformatics, and experimental confirmation, we aimed to discover genes that contribute to ED through regulating hypoxia in corpus cavernosum smooth muscle cells (CCSMCs). We used the Gene Expression Omnibus to acquire the sequencing data of the corpus cavernosum transcriptome for diabetic ED and nerve injury type ED rats. We intersected the common differentially expressed genes. Further verification was performed using single cell sequencing. Real-time quantitative polymerase chain reaction and immunofluorescence were used to investigate whether the differentially expressed genes are found in the corpus cavernosum. We used induced hypoxia to assess cell viability changes, and we developed a lentivirus overexpressing Cldn4 for in vitro and in vivo experiments to measure changes in JNK signaling, fibrosis, hypoxia, and erectile function. Our results indicate that targeting the JNK pathway and decreasing local hypoxia may be better options for therapeutic intervention to improve erectile function. We identified Cldn4 and found its expression increased in the corpora cavernosa of the 2 datasets. In addition, we found that hypoxia can increase the expression of Cldn4, activate the JNK signaling pathway, and exacerbate fibrosis in CCSMCs. Cldn4 overexpression in CCSMCs activated the JNK signaling pathway and increased fibrotic protein expression. Last, rat corpus cavernosum overexpressing Cldn4 activated the JNK signaling pathway, increased local fibrosis, and impaired erectile function. Through bioinformatics and in vitro and in vivo experiments, we found that Cldn4 has a negative effect on ED, and targeting Cldn4 may provide new ideas for ED treatment. Although we have identified Cldn4 as a potential target for ED treatment, we have only conducted preliminary validation on CCMSCs, and we still need to further validate in other cell lines. CCSMC hypoxia leads to increased Cldn4, in both nerve injury and diabetic ED rat models, and promotes fibrosis by activating the JNK signaling pathway.

(014) Safety and Efficacy of Platelet-Rich Plasma Injection for the Treatment of Erectile Dysfunction; A Randomized Prospective Study

Abstract Introduction Platelet-rich plasma (PRP) intracorporeal injection is one of the popular regenerative therapies that has been gaining much interest in recent years as an adjunct or alternative treatment for erectile dysfunction (ED). Nevertheless, scientific evidence to support its clinical efficacy remains controversial. Objective The aim of this study was to evaluate the safety and efficacy of PRP injections for the treatment of ED. Methods A prospective, randomized, double-blinded, placebo-controlled, interventional clinical study was conducted on 52 subjects at the Department of Urology, Faculty of Medicine, Beni-Suef University. Patients were randomized into two groups: the PRP group (n=26) and the placebo (saline) group (n=26). Each participant received three sessions (at two-week intervals) of PRP or saline injections according to his assigned group. International index of erectile function-5 (IIEF-5) scores and safety-related observations were collected at the 1st, 3rd, and 6th months of follow-up. Results The median age and ED duration were statistically comparable for both groups, 52.2 versus 52.5 years and 12.87 versus 11.8, respectively (P = 0.285). With regards to the efficacy of PRP, there were no statistically significant differences between both groups after 1, 3, and 6 months of treatment. After 1 month of treatment, the mean IIEF-5 score for the PRP group was 16.12 ± 1.25 versus 15.99 ± 1.21 for the placebo group (P = 0.683). After 3 months, the IIEF-5 score for the PRP group was 16.44 ± 1.17 compared to 16.31 ± 1.06 for the placebo group (P = 0.653). Also after 6 months, the IIEF-5 score for the PRP group was 16.35 ± 1.45 close to 16.23 ± 1.19 for the placebo group (P = 0.727). No transient hemorrhagic adverse events (hematuria, local petechial bleeding, or ecchymosis) or other side effects were reported during the injection and follow-up period for both groups. Conclusions The results of this trial suggest that although the treatment of ED with 3 injections of intracavernosal PRP separated by two-week intervals may be safe, it is not more effective than a placebo injection. Disclosure No.

(121) Acceptant and Commitment Therapy to Increase Compliance to Sexual Dysfunction Treatments in Men with Prostate Cancer: 6- and 12-Month Data from a Randomized Controlled Trial

Abstract Introduction For many men with prostate cancer, difficulty with sexual dysfunction, in particular erectile dysfunction (ED), can trigger a psychological process which leads to avoidance of utilizing sexual dysfunction treatments. Objective This study tests a novel psychological intervention based on Acceptance and Commitment Therapy (ACT) concepts to help men utilize these treatments. Methods This ongoing study recruited men with prostate cancer starting intracavernosal injection therapy (ICIT) for the treatment of ED. The recruitment goal is N=220. Subjects are randomized to ICIT + ACT (ACT), which focuses on reducing avoidance, or ICIT + Enhanced Monitoring and Education (EME), which includes enhanced follow-up. Both groups receive ICIT plus 3 sessions (30–45 min) and 10 booster sessions (10 min). The interventions are delivered over the course of a year. Subjects are assessed at entry and every 6 months (m) for two years. The primary outcomes are the number of penile injections/week (verified by syringe count), and compliance (defined as ≥2 injections/week). Secondary outcomes assess psychosexual variables. Preliminary 6m and 12m data is presented. Since these are preliminary analyses, effect sizes (d) are reported for secondary variables (d=0.2, small effect; d=0.5, medium effect; d=0.8, large effect). Results To date, 191 subjects have been randomized; 112 have completed the 6m assessment (ACT n=57, EME n=55) and 97 completed the 12m assessment (ACT n=48, EME n=49). Mean age at baseline was 60±7 years. At 6m and 12m, the ACT group utilized more injections/week vs. the EME group (6m: median 1.8 vs. 1.2, p=0.01; 12m: median 2.0 vs. 1.4, p=0.01) and were more compliant with ICI vs. the EME group (6m: 65% vs. 35%, p=0.01, RR=1.86; 12m: 79% vs. 41%, p=0.01, RR=1.93). At 6m and 12m, the ACT group reported greater: satisfaction with ED treatment (d=0.6) and overall sexual relationship (d=0.2). The ACT group also reported lower: sexual bother (d=0.2), prostate cancer treatment regret (d=0.3), negative psychological impact of cancer (d=0.3), and depressive symptoms (d=0.4). Conclusions Preliminary analysis suggests ACT significantly increases ICI use. Data also indicate that ACT helps increase men’s satisfaction with injections and sexual relationship, while reducing sexual bother, prostate cancer treatment regret, the psychological impact of cancer, and depressive symptoms. Disclosure No.

(105) Arab Patient and Partner Satisfaction Following Malleable Penile Prosthesis Implantation in North Africa and the Middle East

Abstract Introduction Due to the sensitivity of the topic of penile implants for the treatment of refractory erectile dysfunction (ED) in the Middle East and North Africa region, a scarce body of related research is available. Objective We aimed at investigating the levels of patient and partner satisfaction after malleable penile prosthesis implantation among the Arab population and its dynamics during and after the first 6 months of surgery. Methods This was a prospective 6-month follow-up study of 120 patients undergoing malleable penile prosthesis implantation at our unit by a single surgeon. Three telephone encounters were conducted for each couple at 1 month, 3 months, and 6 months postoperative (PO). We utilized our validated Arabic version of the Modified Erectile Dysfunction Inventory of Treatment Satisfaction (AM-EDITS). During the 1st first encounter, we inquired about the general patient perioperative experience, starting from preoperative counseling till the first month after surgery. The 2nd and 3rd encounters focused on patient and partner satisfaction after implant utilization. Results The average ages of the men and their partners were 54.7±8.4 and 32.9±4.6 years, respectively. Levels of anxiety decreased in over 82% of the men in our study upon receiving proper preoperative counseling. Almost all of the patients were happy (96%) with their early PO days with over 50% of them exceeding their expectations. After 3 months, 82.5% of the men were satisfied, describing their erections to be 80% close to natural. Of the 92.5% satisfied partners at 3 months, nearly 80% were highly satisfied. Over 93% of them reported feeling sexually desirable by their husbands. As opposed to the significant rise in men’s overall satisfaction and AM-EDITS index by 11.6% and 5.2 ± 0.8% (P &amp;lt; 0.001), respectively after 6 months PO, partners demonstrated a 12.4% and 5.9 ± 0.8 decline (P &amp;lt; 0.001), respectively, compared to the 3 months follow up. Conclusions Malleable penile implants still represent a good quality-of-life treatment option for middle to low-income countries. Time has a positive effect on Arab men’s PO satisfaction as opposed to their partners’. The explanation behind these findings should be investigated in further studies. A proper understanding of the dynamics of patient and partner satisfaction over time may be useful for proper perioperative counseling of both parties to ensure their sustainable satisfaction. Disclosure No.

(144) The Use of Virtual Reality Systematic Desensitization for the Treatment of Psychogenic Erectile Dysfunction: A Pilot Study

Abstract Introduction Erectile dysfunction (ED) is a sexual dysfunction that affects the sexual health of millions of men around the world. In recent years, the evidence indicates an increase in cases of ED among individuals under 40 years old. In most cases, the etiology is of psychogenic origin. Cognitive-behavioral therapy (CBT) has been proven effective and remains one of the most widely used treatments for ED in these cases although controlled studies are lacking. One of the most effective CBT techniques is a set of activities performed by a couple, known as systematic desensitization (SD). SD involves gradually exposing the patient to feared intimacy-related activities with their partner. However, many patients do not have a stable partner or do not want their partner to participate in the treatment. Technological advances are helping to create virtual SD programs which are able to reproduce the sights, sounds, and other sensations of the feared situation. Objective Our goal is to determine the potential usefulness of a new virtual reality-based SD program for the treatment of psychogenic ED (pED). Methods Six sexually active men diagnosed with pED based on criteria for Erectile Disorder from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) completed virtual SD over 8 weeks. The program consisted of one educational session and five different virtual reality audio exercises which were completed at home using a masturbation aid device called Myhixel ED01, that is connected to a smartphone. The five-item Spanish version of the International Index of Erectile Function (IIEF-5) questionnaire was used to assess symptoms before and after the treatment and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire was used for evaluating satisfaction with treatment. Results Patients enrolled had a mean age of 34.83 years (range 27–39) and experienced an improvement in erectile function, mean IIEF-5 score pretreatment was 11(range 9–13) mean posttreatment IIEF score was 18 (range 14–21). The mean EDITS index score at the end of the treatment was 64.70 (range 59–70.25). No adverse effects were reported during the treatment. Conclusions This case series suggests that the use of a virtual reality-based SD could be a potentially effective and safe therapeutic option for men with pED. This new treatment would facilitate greater access of men with pED to one of the most commonly used strategies of sexual therapy, as it would no longer require the participation of a partner. Studies with adequate sample sizes, control groups, randomization, and follow-up are needed to determine the effectiveness of this new treatment. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: NEW WELLNESS CONCEPT SL.

(108) Evaluation the Efficacy and Safety of Hyperbaric Oxygen Therapy in Sildenafil Citrate Non Responder Organic Erectile Dysfunction Patients: a Randomized Double Blinded Controlled Clinical Trial

Abstract Introduction Although the phosphodiesterase 5 inhibitors (PDE5i) are the first-line oral agents for erectile dysfunction (ED) treatment, there is growing number of PDE5i- non responder patients. Management of those patients is challenging and one of the new suggested regenerative therapies is the hyperbaric oxygen therapy (HBOT). HBOT is the application of oxygen under pressure to increase tissue oxygen levels. Few clinical reports were published about HBOT and ED. Objective To evaluate the efficacy and safety of HBOT in sildenafil citrate non- responder organic ED patients. Methods The current study included 30 sildenafil citrate non-responder ED patients. Patients were divided into two groups (randomly assigned and comparably cross-matched for age). Both patients and the investigators were blinded as regards the treatment until the end of the study. Group 1: Patients assigned to the HBOT group (20 patients) were treated with (30) sessions in 5 days/week (90 minutes of 100% oxygen at 2.2 ATA); Group 2: Patients assigned to the control group (10 patients) were exposed to (30) sessions of air oxygen tension at 1 ATA with room oxygen. Baseline laboratory investigations were done (random blood sugar, lipid profile, total &amp; free testosterone). All patients were evaluated with the sexual health inventory for men (SHIM), erection hardness score (EHS), the sexual health encounter profile (SEP), and penile color Doppler initially, at 1 &amp; 3 months after the end of treatment. Results The age mean ± SD in the HBOT group was 56.35±7.43 years and in the control group was 61.7±7.14 years. The current study showed that sildenafil citrate non-responders ED patients with 30 sessions of HBOT in 5 days/week, demonstrated a significant improvement of the total SHIM score, EHS, and SEP after 1 month of stoppage of treatment as compared to the control group. Also, penile color Doppler evaluation showed a significant improvement of 10 &amp;20 minutes peak systolic velocity (PSV) between patients receiving HBOT compared to the control after 1 month of stoppage of treatment. More interestingly, the improvement of the total SHIM score, EHS, and SEP continued after 3 months of stoppage of the HBOT treatment as compared to the baseline evaluation. In addition, 10 &amp;20 minutes PSV with penile color Doppler evaluation demonstrated maintained improvement after 3 months of stoppage of the HBOT treatment as compared to the baseline evaluation. In addition, the linear regression analysis was done for factors affecting SHIM score improvement (1 month/baseline) in the HBOT treatment group, revealing that hypertension was an independent predictor for SHIM score improvement. Hypertensive patients showed 4.6 times more SHIM score improvement as compared to non-hypertensive patients. As regards HBOT safety, there was no significant difference in adverse effects between the HBOT treatment group and the control group. Conclusions HBOT might be a potential therapeutic modality for sildenafil citrate non-responder ED patients especially in hypertensive patients with good safety profile. Further a multi-centric trial with a larger sample size and a longer follow-up period is recommended. Disclosure No.

(139) Efficacy of a New Vacuum Erection Device (Vigor 2020) for Erectile Dysfunction in a Retrospective Study in Japan

Abstract Introduction Phosphodiesterase 5 inhibitors (PDE5i) are the first-line treatment for erectile dysfunction (ED), but there is in approximately 30% of ineffective patients or contraindicated in patients taking nitrate medications. Although vacuum erection device (VED) is the second line in ED guidelines, they have long been unavailable in Japan, due to the withdrawal of their manufacturers. Objective A new VED, Vigor 2020, has now been manufactured and received medical approval by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. It is very important to be able to sexual intercourse with VED, recommended in the ED guidelines. We conducted a retrospective observational study of patients with Vigor 2020 in clinical practice. Methods We analyzed male patients aged 20 years or older who presented to an outpatient clinic with ED and were treated with Vigor 2020 as a second-line treatment, because PDE5i was ineffective or contraindicated. Sexual and ejaculatory function were assessed using questionnaires [Erection Hardness Score (EHS), International Index of Erectile Function (IIEF), Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ-EjD), the numerical rating scale (NRS)]. Results There were 34 participants who could be evaluated before and after the use of Vigor 2020, with a mean age of 57.85 (27–86) years. Significant improvement in EHS and IIEF total score were observed with the use of Vigor 2020 in all participants. There was a significant improvement in MSHQ-EjD and NRS for participants who had an EHS of 3 or higher after the use of Vigor 2020. But no significant improvement in MSHQ-EjD and NRS for participants who had an EHS of 2 or lower after the use of Vigor 2020. The participants experienced no significant adverse events. Conclusions Vigor 2020 may be one treatment tool for ED, as defined in the ED guidelines. There is not only significant improvement of erection with Vigor 2020 but also improvement of ejaculation in cases of significant erectile efficacy. Disclosure No.

(031) Bioequivalence Studies of Sildenafil Citrate Orodispersible Film Administered With and Without Water versus Viagra Film-Coated Tablets in Healthy Adult Male Volunteers

Abstract Introduction Orodispersible film (ODF) formulation offers ease of use, convenience of administration, and other advantages, especially for patients who have difficulty in swallowing or are on liquid restriction compared with conventional oral formulations for the treatment of erectile dysfunction. Objective These studies compared the bioequivalence of 50 mg sildenafil citrate ODF formulation (test drug) with the marketed 50 mg sildenafil citrate film-coated tablet (FCT) (Viagra; Pfizer, New York, NY) (reference drug), with and without water in 2 randomized cross-over studies. Methods Two randomized cross-over studies were conducted. The first study explored the bioequivalence of test drug administered with and without water compared with the reference drug with water. The second study investigated the bioequivalence of test drug, without water, compared with the reference drug with water. 42 healthy adult male volunteers started the first study and only 40 completed. While 80 subjects who were enrolled completed the second study. All the 120 subjects from both the studies were included for pharmacokinetic and bioequivalence analysis. All volunteers fasted for 10 hours pre-dose. A 1-day washout period between doses was observed. Blood samples were collected at regular intervals both before (up to 120 minutes before dosing) and after dosing (at different intervals up to 14 hours) dosing stages. Statistical analyses on pharmacokinetic parameters were performed. Safety and tolerability for both the formulations were evaluated. Results In the first study, bioequivalence was demonstrated for sildenafil citrate ODF administered with water when compared with the Viagra FCT. The ratios of adjusted geometric means (90% confidence interval (CI)) were maximum plasma concentration: 1.02 (94.91–108.78) and area under the plasma concentration-time curve: 1.09 (104.49–113.21) for sildenafil citrate ODF administered with water vs Viagra FCT. These ratios were within the bioequivalence acceptance range of 80% to 125%, indicating that the bioequivalence criteria were met. The pharmacokinetic parameters for the second study also demonstrated bioequivalence for sildenafil citrate ODF when administered without water compared with Viagra FCT. The ratios of adjusted geometric means (90% CI) were maximum plasma concentration: 1.02 (95.47–109.36) and area under the plasma concentration-time curve: 1.06 (103.42–108.40) for sildenafil citrate ODF administered without water vs Viagra FCT. Adverse events in both the studies occurred at similar rates for the 2 formulations and were mild in intensity and were expected from the known safety profile. Conclusions Sildenafil citrate ODF administered with and without water met bioequivalence criteria compared with Viagra FCT administered with water under fasted conditions in healthy adult male volunteers. These results suggest that the new ODF formulation can be used interchangeably with the marketed FCT formulation. Therefore, the new ODF formulation can be used as a suitable alternative to the conventional oral solid dosage form for the treatment of ED. Disclosure Yes, this is sponsored by industry/sponsor: Viatris Inc. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Viatris Inc.

(138) Efficacy and Patient Satisfaction of Low-Intensity Shockwave Treatment for Erectile Dysfunction in a Retrospective Real-World Study in Japan

Abstract Introduction In Japan, the treatment options for erectile dysfunction (ED) are very restricted, if phosphodiesterase type 5 inhibitors (PDE5Is) are not effective. In this situation, low-intensity extracorporeal shockwave therapy (LiESWT) has gained increased attention as a new option for ED treatment in Japan. Objective To clarify the efficacy of low-intensity extracorporeal shockwave therapy for patients with erectile dysfunction, compare the efficacy between two types of lithotripters (ED1000 [focused type] and Renova [linear type]), and detect factors indicative of therapeutic gain with the treatment. Methods This retrospective study included 76 patients (52.8 +/- 11.7 years) treated by ED1000 (12 times over 9 weeks) and 484 patients (52.5 +/- 11.6 years) treated by Renova (4 times over 4 weeks). Age, sexual symptoms scores, and blood examinations were assessed. Efficacy was judged by improvement of the scores and patient satisfaction and compared between patients at 1 month after treatment with the lithotripters. Independent factors influencing efficacy by Renova were also assessed. Results Sexual symptom scores were improved significantly by both lithotripters, although the changes in the scores did not differ significantly between them. Efficacy rate as judged by patient satisfaction was 65.8% with the ED1000 and 71.1% with Renova, also without significant difference. Among several factors including age, sexual symptoms scores, endocrinological factors, metabolic factors, and the rate of phosphodiesterase type 5 inhibitor use, only age was found to be an independent factor influencing the efficacy of Renova. Conclusions We clearly showed the high efficacy of both lithotripters. Although the efficacy rate did not differ between them, we speculated that the fewer treatment sessions needed with the Renova versus the ED1000 would be a great advantage for patients. We also suggest that Renova should be recommended for patients younger than 70 years of age. Disclosure No.

(262) Salvage Penile Prosthetic Surgery, Unique Surgical Technique. Institutional Experience

Abstract Introduction `-Penile prosthesis surgery represents the end-stage treatment for erectile dysfunction. It is conventionally used only in cases of erectile dysfunction refractory to pharmacological treatments. -Penile prothesis surgery is associated with a high satisfaction rate and a low complication profile. However, it must be appreciated that the complications of surgery can have devastating consequences on a patient's quality of life and satisfaction and include infection, prosthesis malfunction, penile corporal perforation and penile length loss. -This study discusses the diagnosis and management of infected penile prosthesis with highlighting special intra-operative surgical technique that might be a valuable step in Salvage penile prosthetic surgery Objective Since its introduction in 1996 Mulcahy salvage has significantly improved outcomes for the removal and replacement of infected penile prostheses. Long-term follow up data of Mulcahy salvage show an infection-free rate of 82%. In our study we evaluated the Salvage Penile Prosthetic Surgery Cases done in our tertiary institution since (2000 up to date) and introduce the unique surgical technique that resulted in reduction the re-infetion rate. Methods This is a retrospective, institutional review Results total of 13 Salvage penile prosthetic surgeries done in our tertiary center since between 2000 and 2023 out of them only one case developed reinfection and ended with penile prosthesis removal. Therefor, the rate of re-infection is 8% comparing with latest successe rate of Mulcahy technique (18%) We applied surgical step intra- operative that might be the underling reason of decreasing the the reinfection rate that will be presented in details. Conclusions This retrospective analysis of salvage procedures and replacement of infected penile prosthesis with malleable prosthesis shows a high infection-free rate. Disclosure No.

(028) Intracavernosal Injection of Platelet-Rich Plasma for the Treatment of Erectile Dysfunction: A Meta-Analysis of Randomized Placebo-Controlled Trials

Abstract Introduction Erectile dysfunction (ED) affects 3 to 76.5% of men globally. Appropriate treatments for ED patients are vital to ensure their quality of life. However, the present conservative ED treatments cannot reverse the underlying pathology and often lead to discontinuation due to the lack of efficacy. Regenerative therapies, including platelet-rich plasma (PRP), have been gaining increasing interest for the last few years. Preclinical studies suggest that growth factors in PRP may be beneficial in ED. With the increasing evidence of PRP, a meta-analysis has yet to be conducted to determine its efficacy and safety compared to a placebo. Objective To systematically evaluate PRP's efficacy and safety for treating ED based on randomized placebo-controlled trials (RCTs) results. Methods A comprehensive search on PubMed, Scopus, and EMBASE databases was conducted on June 2023 to find relevant articles following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. RCTs in English evaluating PRP's efficacy and safety in treating ED were included. The primary outcomes were the International Index of Erectile Function-Erectile Function (IIEF-EF) score at 1-, 3-, and 6-months post-treatment. The secondary analysis includes the proportion of patients who met the minimal clinically important difference (MCID) of IIEF-EF score, IIEF score for sexual satisfaction and overall satisfaction, peak systolic velocity (PSV) in the cavernousal artery, and the complication rate after treatment. Quality of included studies was assessed using JADAD Score and Cochrane RoB2 tools. Meta-analysis with a random or fixed effects model based on the heterogeneity was performed using Revman 5.4. Results From 183 articles in initial research, three RCTs with low risk of bias were reviewed. We included 103 patients in the PRP group and 106 in the placebo group. The baseline of the evaluated score from both groups was comparable despite variable PRP protocol being used. The pooled analysis showed that PRP is associated with higher IIEF-EF scores at 1, 3, and 6 months follow up compared to placebo with a mean difference (MD) of 2.85 (95% CI, 1.68 – 4.03, p: &amp;lt;0.00001), 2.81 (95% CI, 1.57 – 4.05, p: &amp;lt;0.00001), 3.11 (95% CI, 1.96 – 4.27, p: &amp;lt;0.00001). Similarly, the proportion of patients who met MCID and PSV at follow-up also favoured the PRP group. On contrary, the IIEF score for sexual satisfaction and overall satisfaction domain, as well as VAS score post-injection were comparable between groups. No significant adverse event was reported in any study during follow-up. Conclusions The present meta-analysis suggests that PRP is effective and tolerable as a restorative therapy for managing ED patients compared to a placebo. Nevertheless, additional RCTs with more robust data from larger sample sizes and longer-term follow-ups are required to corroborate the findings. Disclosure No.

(030) Hand Held, Self-Applicable Radio Frequency Device for the Treatment of Erectile Dysfunction. A Pilot Study with 6 Months Follow-Up

Abstract Introduction Collagen is an essential component of the structures involved in the erectile mechanism. Radiofrequency (RF) energy has been shown to renew and restore the spatial structural arrangement of collagen fibers and may improve erectile function of men suffering from erectile dysfunction (ED). Objective To assess the feasibility, safety, and efficacy of low-intensity radiofrequency (RF) therapy in men with ED. Methods Men with moderate &amp; mild to moderate ED, with or without the use of PDE5-inhibitors were included. After instructions, each patient treated himself with the radiofrequency device (Vertica®), applying his selected individual RF intensity. Patients underwent, according to the protocol, 12 sessions of 30-minute treatments over 2 months. Patients were evaluated at baseline, 1, 3 and 6 months after treatment using validated questionnaires; International Index of Erectile Function (Full IIEF), IIEF-EF, and erection Hardness score (EHS), satisfaction (EDITS, BSW), and disease-specific quality and quality of life (QEQ, SQOL). In each session, patients filled safety and side-effect questions (pain, fever, burning, discomfort, urinary disorders). The Wilcoxon signed ranks test and the Marginal Homogeneity test were used for statistical processing. Results Twenty-seven out of 28 men treated, were available for 6 months follow-up, mean age 59.2±9.7. The mean ED duration was 41.2±29 months. Mean baseline IIEF-EF was 16.8±1 and improved significantly to 24.8±1.6, 24.3±1.8, and 24.2±2.08 at 1, 3 and 6 months respectively (p&amp;lt;0.001). The Minimal Clinical Important Difference (MCID) criteria were met by 25/28 (89%) at 1-month follow-up and 20/27(74%) at 6-month follow-up (p&amp;lt;0.001). A statistically and clinically significant improvement was demonstrated in the Full IIEF and EHS scores at baseline and during follow-up. No correlation was found between IIEF improvement and the age of the patients. Borderline significance (p=0.05) was found between the duration of ED and IIEF-EF improvement. No side effects were reported and participants rated the device as very comfortable and easy to operate. Conclusions The novel radiofrequency, home-use device for the treatment of ED shows promising results and the potential to improve erectile function. In this study, it was feasible and safe. Further high-quality randomized controlled trials are needed to determine the long-term efficacy of the treatment. Disclosure Yes, this is sponsored by industry/sponsor: Ohhmed, Israel. Clarification: No industry support in study design or execution. Any of the authors act as a consultant, employee or shareholder of an industry for: Ohhmed, Freya, Besins, Verility.