Improvement In Erectile Function Research Articles

Heparin-binding epidermal growth factor-like growth factor improves erectile function in streptozotocin-induced diabetic mice.

Heparin-binding epidermal growth factor-like growth factor (HB-EGF) serves as a pro-angiogenic factor; however, there is to our knowledge currently no reported research on the relationship between HB-EGF and diabetic erectile dysfunction (ED). In this study we aimed to determine whether HB-EGF can improve the erectile function of streptozotocin-induced diabetic mice and to explore the related mechanisms. Eight-week-old male C57BL/6 mice were used for diabetes induction. Diabetes mellitus (DM) was induced by low-dose injections of streptozotocin (50mg/kg) for 5 consecutive days. Eight weeks after streptozotocin injections, DM was determined by measuring blood glucose and body weight. Diabetic mice were treated with two intracavernous administrations of phosphate-buffered saline (20μL) or various doses of HB-EGF (days -3 and 0; 1, 5, and 10μg in 20μL of phosphate-buffered saline). The angiogenesis effect of HB-EGF was confirmed by tube formation and migration assays in mouse cavernous endothelial cells and mouse cavernous pericytes under high-glucose conditions. Erectile function was measured by electrical stimulation of the cavernous nerve, as well as histological examination and Western blot analysis for mechanism assessment. In vitro angiogenesis, cell proliferation, in vivo intracavernous pressure, neurovascular regeneration, cavernous permeability, and survival signaling were the outcomes measured. Expression of HB-EGF was reduced under diabetic conditions. Exogenous HB-EGF induced angiogenesis in mouse cavernous endothelial cells and mouse cavernous pericytes under high-glucose conditions. Erectile function was decreased in the DM group, whereas administration of HB-EGF resulted in a significant improvement of erectile function (91% of the age-matched control group) in association with increased neurovascular content, including cavernous endothelial cells, pericytes, and neuronal cells. Histological and Western blot analyses revealed a significant increase in the permeability of the corpus cavernosum in DM mice, which was attenuated by HB-EGF treatment. The protein expression of phospho-Akt Ser473 and phosphorylated endothelial nitric oxide synthase Ser1177 increased after HB-EGF treatment. The use of HB-EGF may be an effective strategy to treat ED associated with DM or other neurovascular diseases. Similarly to other pro-angiogenic factors, HB-EGF has dual roles in vascular and neuronal development. Our study focused on broadly evaluating the role of HB-EGF in diabetic ED. In view of the properties of HB-EGF as an angiogenic factor, its dose concentration should be strictly controlled to avoid potential side effects. In the diabetic ED mouse model in this study erectile function was improved by HB-EGF, which may provide new treatment strategies for patients with ED who do not respond to phosphodiesterase 5 Inhibitors.

THE ANALYSIS STUDY OF RENAL TRANSPLANTATION BENEFITS PATIENTS WITH END-STAGE RENAL DISEASE BY IMPROVING ERECTILE FUNCTION: A COMPREHENSIVE SYSTEMATIC REVIEW

Background: Renal transplantation is a highly effective treatment for end-stage renal disease (ESRD), addressing the impact of erectile dysfunction on quality of life. Erectile dysfunction, characterized by the inability to achieve and sustain an erection for good sexual activity, affects the physical and psychological well-being of individuals and their partners. However, research on the impact of renal transplantation on erectile dysfunction has yielded conflicting results. Understanding the beneficial impacts of renal transplantation on erectile dysfunction could potentially lead to more successful outcomes. Methods: Adhering to the PRISMA 2020 standards, this systematic investigation sought to examine complete English literature texts published from 2004 until 2024. Only editorials and review articles that had a Digital Object Identifier (DOI) and were published in the same magazine as the submission were considered for acceptance. We utilized many sources, such as ScienceDirect, PubMed, and SagePub, to acquire the literature. Result: The study examined over 40 papers sourced from reliable venues like Science Direct, SagePub, and PubMed. After selecting eight papers for further scrutiny, a comprehensive analysis of the complete corpus of literature was conducted. Conclusion: Renal transplantation has shown significant improvement in erectile function in patients with end-stage renal disease (ESRD), with a lower prevalence of erectile dysfunction and higher function scores. Factors such as pretransplantation IIEF-5 score, age, and anastomosis to the common iliac artery have significant associations with improved erectile function. However, the exact mechanism behind this effect remains unclear.

Stem cell therapy in diabetic men with erectile dysfunction: a 24-month follow-up of safety and efficacy of two intracavernous autologous bone marrow derived mesenchymal stem cells injections, an open label phase 2 clinical trial

BackgroundRecently we reported results of phase 1 pilot clinical trial of 2 consecutive intracavernous (IC) injection of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) for the first time in the treatment of diabetic patients with erectile dysfunction (DM-ED). In phase 2 of this study our aim is to evaluate long term safety and efficacy of IC injections of BM-MSC on additional eight patients with DM-ED.ResultsEach patient received 2 consecutive IC injections of BM-MSC and evaluated at 1, 3, 6, 12, and 24-month time points. Primary outcome was the tolerability and safety of stem cells therapy (SCT), while the secondary outcome was improvement of erectile function (EF) as assessed using the International Index of Erectile Function-5 (IIEF-5), Erection Hardness Score (EHS) questionnaires, and Color Duplex Doppler Ultrasound (CDDU). IC injections of BM-MSCs was safe and well-tolerated. Minor local and short-term adverse events related to the bone marrow aspiration and IC injections were observed and treated conservatively. There were significant improvement in mean IIEF-5, EHS, all over the follow-up time points in comparison to the baseline. At 24-month follow up there were significant decline in the mean IIEF-5, and EHS compared to the baseline. The mean basal and 20-min peak systolic velocity was significantly higher at 3-month after the IC injections compared to baseline.ConclusionsThis phase 2 clinical trial confirmed that IC injections of BM-MSC are safe and improve EF. The decline in EF over time suggests a need for assessing repeated injections.Clinical trial registrationNCT02945462

Efficacy of Aphrodisiac Drugs Combination with Phosphodiesterase-5 (PDE5) Inhibitors in Patients with Erectile Dysfunction (Pilot Study)

Abstract Background Erectile dysfunction is a common medical disorder that primarily affects men older than 40 years of age. Many lines of treatments are used. An aphrodisiac is defined as any food or drug that arouses the sexual instinct, induces sexual desire and increases pleasure and performance. Aim of the Work The aim of this study to assess the efficacy of aphrodisiac drugs (Cavigen), in combination with Phosphodiesterase-5 (PDE5)”Sildenafil” Inhibitors in management of erectile dysfunction in men responding to Phosphodiesterase-5 (PDE5) inhibitors in patients with (IIEF) score: Mild (22-25), mild to moderate (17-21). Patients and Methods This study was a prospective, double-blind, case control placebo (pilot study) performed at the outpatient clinic of the Department of Urology and Andrology, Ain Shams University hospitals. The number of patients after the dropouts and exclusion were 40 patients, twenty in each group one group was administrated gingko biloba capsules(Cavigen) twice daily combined with phosphodiesterase 5 inhibitor (Viagra) on demand and the other one administrated placebo capsules similar to the ginkgo biloba twice daily combined with phosphodiesterase 5 inhibitor (Viagra) on demand. The study protocol was approved by our institutional review board. This study was performed in accordance with the Consolidated Standards of Reporting Trials (CONSORT) statement and all participants provided written informed consent before nrolment. Patients were recruited from February 2020 to August 2020 and the final results were obtained in August 2020. Results The present study enrolled two well matched groups, twenty patients in each group as regard base line characteristics including demographic data, pretreatment IIEF total score and pretreatment type of ED. The present study enrolled two well matched groups and both groups showed improvement but there was no significant difference between the studied groups as regard IIEF total score and type of ED at one- and three- months posttreatment. After 6 months posttreatment there was significant difference between the studied groups as regard IIEF total score and type of ED with superiority of combined treatment group. The amount of increase in total score of IIEF after 6 months was found significantly higher in study group (6.35±3.38) than control group (2.15 ± 2.13) with p-value <0.001. In both of studied groups, we found that there was statistically significant increase in the total score of IIEF after 1 month, 3 months and 6 months than pre study and also increase in the percentage of no ED cases after 1 month, 3 months and 6 months than pre study. Conclusion Our findings demonstrate that two Ginkgo Biloba capsules oral intake per day combined with PDE-5 inhibitors on demand were safe and effective for the improvement of erectile function in patients with mild and mild to moderate ED. Overall, Aphrodisiacs drugs seem to be a promising cure for ED and improvement of sexual health.

Endovascular penile revascularization improves erectile dysfunction in patients with penile arterial insufficiency

In most institutions, patients with erectile dysfunction due to penile arterial insufficiency are offered palliative treatments like vacuum constrictor devices, intraurethral alprostadil, intracavernosal injection of prostaglandins, and/or implantation of penile prosthesis when these patients can be treated by endovascular penile revascularization. 50% of patients with erectile dysfunction are non-responders to phosphodiesterase-5 inhibitors. 70% of non-responders to phosphodiesterase-5 inhibitors have penile arterial insufficiency that can be treated with endovascular penile revascularization. Patients who are non-responders to phosphodiesterase-5 inhibitors should be screened for penile arterial insufficiency using penile duplex scan. If penile artery peak systolic velocity is <35 cm/s, then arterial insufficiency is suspected, and computed tomography (CT) angiogram is obtained to confirm presence of significant stenosis in iliac-pedundle-penile arterial system. Patients with penile arterial insufficiency should be offered endovascular penile revascularization. This minimally invasive procedure has minimal perioperative complications (<1%) and has significant clinical improvement in erectile function in >60% of patients at 12 months. Endovascular penile revascularization is safe and has long term clinical improvement in erectile function. This minimally invasive procedure can result in improved erectile function and preserves penile size and shape in most non-responders to phosphodiesterase-5 inhibitors.

The effect of combination treatment with low-intensity shockwave therapy and daily tadalafil on severe erectile dysfunction: a double-blind, randomized, sham-controlled clinical trial.

Patients with severe erectile dysfunction (ED) remain the most challenging group in terms of available noninvasive treatment modalities. The study sought to assess the role of combination therapy with low-intensity shockwave therapy (LiST) and daily tadalafil 5mg in a highly select group of patients with severe vasculogenic ED through a double-blind, randomized trial. Forty-eight sexually active men were randomly assigned to 12 sessions of LiST 3 times weekly and tadalafil 5mg once daily (n = 34) or sham therapy and tadalafil (n = 17) for 4 weeks. Patients were assessed at 1 and 3 months after completion of treatment. Improvement of erectile function was evaluated through the International Index of Erectile Function-Erectile Function domain (IIEF-EF) or 6-item IIEF and the Sexual Encounter Profile (SEP) diary. The primary outcome was the difference between the groups in the IIEF-EF at 3 months after completion of treatment. Secondary outcomes comprised (1) the difference between the groups in the IIEF-EF at 1 month after completion of treatment, (2) the difference between the groups in the "yes" responses to question 3 of the SEP diary at 1 and 3 months, and (3) the treatment-related adverse events. The number of patients attaining a minimal clinically important difference in the IIEF-EF (improvement of at least 7 points) was also assessed. After treatment, the absolute scores in the IIEF-EF were higher in patients receiving LiST and tadalafil vs sham therapy and tadalafil both at the 1-month (12.1 ± 2.4 vs 10.2 ± 1.7; P = .002) and at the 3-month (12.9 ± 2.1 vs 10.8 ± 1.8; P < .001) evaluation. Between the 2 groups, the proportion of "yes" responses to question 3 of the SEP diary was not statistically significant, whereas the number of patients attaining a minimal clinically important difference in the IIEF-EF was statistically significant only at the 3-month evaluation. No adverse events occurred. Application of LiST in patients with severe vasculogenic ED receiving daily dose tadalafil may further improve erectile function compared with tadalafil as a stand-alone treatment on the short term. Although we provided the first study in the field, severe vasculogenic ED was defined based on medical history and clinical examination and not based on penile ultrasound measures. The combination of 12 sessions LiST 3 times weekly and daily tadalafil for 4 weeks led to a 2-point difference in the IIEF-EF compared with sham therapy and daily tadalafil among patients with severe vasculogenic ED after 1 and 3 months from completion of treatment.

Pudendal Nerve Neurolysis in Patients Afflicted With Pudendal Nerve Entrapment: A Systematic Review of Surgical Techniques and Their Efficacy.

To assess the effectiveness and safety of various techniques of pudendal nerve neurolysis (PNN) in patients with pudendal nerve entrapment (PNE). A comprehensive literature search was conducted on May 20th, 2023, using Scopus, PubMed, and Embase databases. Only studies in English involving adults were accepted, while meeting abstracts and preclinical studies were excluded. A total of 34 papers were included. Transperineal PNN emerged as a promising technique, demonstrating significant potential in alleviating pain, restoring erectile function in males, and improving the resolution of urinary stress incontinence in females. Furthermore, the bilateral approach consistently yielded positive outcomes in addressing urinary symptoms. The transgluteal technique appeared particularly suitable for cases of posterior PNE, situated between the sacrospinous ligament and the lesser sciatic foramen. A progressive amelioration of painful symptoms was observed during follow-up. Minimally invasive PNN is evolving and enables decompression along the entire proximal tract up to the Alcock canal, minimizing the risk of comorbidities. In addition to reducing pudendal neuralgia, robot-assisted and laparoscopic approaches determined a reduction in lower urinary tract symptoms and an improvement in erectile function, though further studies are required to corroborate these findings. PNN emerges as an effective treatment for PNE with minimal morbidity. Therefore, PNN should be tailored according to the site of PNE to enhance functional outcomes and improve patient quality of life.

(063) Effect of Phosphodiesterase Type 4 Inhibitor on Erectile Function Recovery and Nerve Regeneration After Cavernous Nerve Injury in Rats

Abstract Introduction There is no consensus on the best treatment regimen for recovery of erectile function (EF) after radical prostatectomy (RP). Although many pharmacological interventions can improve EF in rats, there is still a lack of studies evaluating strategies that promote nerve regeneration of the cavernous nerve (CN). Phosphodiesterase type 4 inhibitors (PDE4Is), such as rolipram, have shown a neuroprotective effect after spinal cord injury in mice, facilitating functional recovery. It has also been suggested that the neuroprotective property of sildenafil is probably attributed to its effect on phosphodiesterase type 4. Objective Our aim was to evaluate the role of rolipram and its association with tadalafil in EF recovery and nerve regeneration after bilateral CN crush injury (BCNI) in rats. Methods Thirty-five male Wistar rats were randomly divided into four groups: (i) sham (no CN lesion); (ii) control (no treatment after BCNI); (iii) BCNI + tadalafil; (iv) BCNI + rolipram and (v) BCNI + tadalafil + rolipram. The initial laparotomy was performed and the CN were crushed with a hemostatic clamp. The animals in groups (iii) and (iv) received tadalafil (5mg/kg/d) or rolipram (1mg/kg/d) orally for 14 days, respectively. The animals in group (v) received tadalafil + rolipram at the same doses. Then, the animals were submitted to CN stimulation at frequencies 4, 8 and 16 Hz, with recording of mean arterial pressure (MAP) and intracavernosal pressure (ICP). EF was represented by the measurement of maximum ICP normalized to MAP (ICP/MAP ratio) and total normalized area under the curve (AUC) of ICP. The penises and CN of the animals were sent for structural evaluation with the immunohistochemical markers S100 and Ki-67. Results In the functional analysis, BCNI resulted in worse EF when compared to sham. This was observed when considering the maximum ICP/MAP and when analyzing normalized AUC of ICP for 4Hz and 8Hz. The different treatments were able to increase the ICP/MAP ratio after stimulation with 4Hz (p = 0.04) and 8Hz (p = 0.01). When considering normalized AUC of ICP, the different drugs (tadalafil, rolipram or tadalafil + rolipram) showed a significant improvement in EF in two of the three frequencies analyzed (4Hz and 8Hz) (figure 1). For 16hz, although it did not reach a statistical difference, a trend of improvement was observed after the different treatments (p = 0.08). With regard to immunohistochemical analysis, the tadalafil group had a higher expression of S100 in the dorsal penile nerve compared to the control group (p = 0.01). The rolipram group had a lower expression of Ki-67 in the CN compared to the control group (p = 0.03). Conclusions The combination of tadalafil and rolipram was associated with a functional improvement in EF in the experimental model with rats. The present study also suggests that rolipram may have a neuroprotective effect according to the structural evaluation of the CN. 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.

(118) Treatment Postcovid Hypogonadism with Autologous Stem Cells and PRP

Abstract Introduction COVID-19 affects ACE receptors, causing autoimmune processes that damage testicular tissue, disrupting the processes of spermatogenesis and testosterone production. Recently, we have seen an increasing number of patients with erectile dysfunction ED appearing 3–6 month safter COVID-19 and prolonging for years. Objective The aim of our study was to determine effectiveness of hormone stimulating and replacement therapy, possibility of restorative therapy with autologous stem cells (ASC) and Plasma rich Platelets (PRP) –therapy in patients with hypogonadism. Methods 117 patients with ED, which appeared 3–6 months after COVID-19. All patients except ED had clinical signs of decreased testosterone: decreased libido, mental and cognitive functions, decreased performance, fatigue. Testosterone fractions (total and free), LH, Estradiol, FSH before, during and after rehabilitation therapy were studied. Patients were divided into 2 groups: 1st- 68 patients with real hypogonadism (Tm = 7.43 + 2.1 below 12 nmol / l), and 2nd - 49 patients with relative hypogonadism (Tm = 14.1 + 1.8 above 12 nmol / l). l), they were studied the sensitivity of tissue receptors to testosterone. Results First group - patients were prescribed Tribulus terrestris extract 45% - 750 mg, Fenugreek extract 50% - 25 mg twice a day for 2 months. 37 patients (54.4%), group 1a (mean age 41.6 + 4.3) responded to therapy by normalizing the level of T (more than 12 nmol/l) and improving erectile function, 31 patients (45.6%), group 1b (average age 47.3 + 5.2) without the effect of herbal medicine prescribed testosterone Omnadren 250 1 time in 3 weeks. After 2 months of hormone replacement therapy, 28 patients were diagnosed with normal T levels, but only 19 patients (61.2%) in group 1b improved their erectile function. Second group - 49 patients were also prescribed Tribulus terrestris extract 45% - 750 mg, Fenugreek extract 50% - 25 mg twice a day for 2 months and PRP therapy (intracavernous injections of 2 ml of autoplasma with a platelet concentration greater than 1 million/ml) 1 time in 10 days 8 times. 23 patients - group 2a responded to therapy with the disappearance of symptoms of hypogonadism and improvement of ED. 26 patients - group 2b – did not have significant improvements, so they received 2 courses of 5 intravenous injections of 5 million autologous stem cells (50 millionin total). 17 patients (65.4% of group 2b) improved their mental health, reduction of symptoms of hypogonadism, improvement of erectile function to normal values (IIEF -5 increased to 19.4 + 2.2). Conclusions 1. Multicenter studies of the effect of COVID-19 on fertile and androgenic function in men and the possibility of their recovery in postpartum pathology are still needed and should be prolonged. 2. A significant proportion of men with postcovid hypogonadism and ED are men with normal levels of T, but reduced sensitivity of tissue receptors to T (relative hypogonadism). 3. In the treatment of relative postcovid hypogonadism, intracavernous PRP therapy and intravenous stem cell therapy have a clinical effect and can be considered as promising treatments for this pathology. Disclosure No.

AYURVEDIC MANAGEMENT OF TERATOZOOSPERMIA: A SINGLE CASE STUDY

Male infertility is a significant factor in over 40% of infertility cases. This research paper presents a case study of a 35-year-old Indian labourer working in a steel factory who reported symptoms of Mlan-Shishnata (loss of erection during intercourse), Alpaharsha (reduced sexual desire) along with a history of 4 years without a child. The patient was diagnosed as Klaibya, a condition characterised by male sexual dysfunction, with teratozoospermia, a condition involving abnormal sperm morphology. Ayurvedic therapy, specifically Vajikaran chikitsa, was administered to the patient following an Abhyantar Shodhana (bio-cleansing) procedure. The treatment protocol included Koshtha-Shuddhi (purgation) with the decoction of herbal medicines and Yogbasti. Additionally, the patient received Bastand Vrushya Basti for two months and oral intake of specific Ayurvedic formulations for three months. The patient's progress was evaluated using the International Index of Erectile Function and semen analysis before and after three months of treatment. Semen analysis after treatment revealed that 63% of the patient's sperm exhibited normal morphology, indicating a substantial enhancement compared to the initial Teratozoospermia condition, along with significant improvement in erectile function, orgasmic function, Sexual desire, Intercourse satisfaction and Overall satisfaction of the individual demonstrating the successful use of Ayurvedic formulations in treating Klaibya w.s.r.t. teratozoospermia without any reported adverse side effects. This case study underscores the diverse range of Ayurvedic therapy options available for addressing male infertility disorders.

(231) Low-Intensity Extracorporeal Shockwave Therapy Twice Per Week for Six Weeks May Result in Transient Subjective Improvements in Erectile Function

Abstract Introduction Low-intensity extracorporeal shockwave therapy (LiESWT) has been reported to result in subjective improvements in erectile function, but the ideal patient population and treatment protocol have not yet been established. Objective We aimed to assess improvements in International Index of Erectile Function – Erectile Function domain (IIEF-EF) scores following treatment with LiESWT of 1500 shocks of 0.2mJ/mm2 per treatment, twice a week for six weeks. We hypothesized that LiESWT results in subjective improvements of erectile function. Methods Patients were prospectively enrolled in a clinical trial examining changes in erectile function following LiESWT. The study was powered to detect a change in IIEF-EF scores of 5 points. Patients received 12 bi-weekly LiESWT treatments of 0.2mJ/mm2 at 5Hz, 1500 shocks delivered per treatment using the Storz Duolith T-Top Ultra shockwave device. Patients completed IIEF-EF, Sexual Encounter Profile (SEP) questions two and three, Global Assessment Questions (GAQ), and Erection Hardness Score (EHS) questionnaires prior to initiation of treatments and following completion of treatments at 1-2 weeks, 4-6 weeks, 3 months and 6 months post-treatment. Changes in questionnaire responses were compared to baseline responses. Data were analyzed using single variant one-tailed T-tests and one-tailed Fisher’s exact test. Values are reported as means ± standard error. Results Twenty-five patients completed all five study visits. Mean pre-treatment IIEF-EF score was 14.24 ± 1.21. Mean IIEF-EF scores increased to 15.80 ± 1.46 1-2 weeks following treatment (Study Time #2), 16.12 ± 1.46 4-6 weeks following treatment (Study Time #3), 18.12 ± 1.57 3 months following treatment (Study Time #4), and 16.36 ± 1.86 6 months following treatment (Study Time #5), though results only reached significance at Study Time #4 (p=0.016) and results were not sustained. Changes in IIEF-EF scores following treatment were evaluated by baseline ED severity (normal IIEF-EF 26-30, N=1; mild IIEF-EF 22-25, N=2; mild-moderate IIEF-EF 17-21, N=7; moderate IIEF-EF 11-16, N=10; severe IIEF-EF 6-10, N=5. Patients with IIEF-EF scores 11-21 reported significant improvements in IIEF-EF scores at all time points (Figure 1). Mean pre-treatment EHS score was 2.1±0.14. There was no significant improvement in EHS score following treatment at any time point, and no differences when analyzed based on pre-treatment ED severity. Similarly, no changes in SEP or GAQ positive response rates were noted following treatment. Conclusions Our results suggest that LiESWT using 1500 shocks per treatment with energy of 0.2mJ/mm2 twice per week for 6 weeks may transiently improve subjective erectile function as measured using IIEF-EF questionnaires, particularly for patients with mild-moderate to moderately severe ED, consistent with other studies. However, improvements may not be sustained 6 months following treatment. Disclosure No.

(228) Cell-Based Therapy Can Restore Erectile Function in Men with Type 2 Diabetes and Metabolic Syndrome by Promoting Angiogenesis and Endothelial Repair

Abstract Introduction Although there has been a growing interest in restorative therapies for erectile dysfunction (ED) in recent years, there is still limited mechanistic evidence to support their effectiveness in the clinical setting. Objective The goal of this research was to investigate the mechanistic impact of cell-based therapy in men with ED secondary to Type 2 Diabetes Mellitus (DM2) and Metabolic Syndrome (MetS) through analysis of plasma biomarkers. Methods International Index of Erectile Function (IIEF) was completed by all men in the ACESO (NCT02886884) and CERES (NCT03059355) clinical trials. ACESO and CERES were both randomized, blinded, pilot phase clinical trials in which all participants received cellular therapy at varying doses and sources to treat endothelial dysfunction secondary to either DM2 or MetS, respectively. The intervention in both trials was peripheral intravenous infusion of allogeneic Mesenchymal Stem Cells (MSCs) of either 20 or 100 million cells derived from either bone marrow (BM) or umbilical cord tissue (UC). Follow-up was for 1 year. Endothelial function was measured via Brachial Artery Flow Mediated Vasodilation (FMD) and Endothelial Progenitor Cell-Colony Forming Units (EPC-CFU) assay. Plasma aliquots were isolated from blood samples and subjected to multiplex ELISA assay for analysis of angiogenic biomarkers. Results Data was pooled from all 20 men in the ACESO and CERES clinical trials. Overall, 7 received 20 million BM-MSCs, 9 received 100 million BM-MSCs, 2 received 20 million UC-MSCs, and 2 received 100 million UC-MSCs. There were no treatment emergent serious adverse effects (TE-SAEs) within 30 days following infusion in any of the participants. Among men with ED (IIEF-EF&amp;lt;25), 31.25% achieved MCID in erectile function. Participants with mild or moderate ED at baseline showed greater improvements in erectile function and endothelial function compared to those with severe ED. Participants who achieved MCID following cell therapy also experienced statistically significant improvements in FMD (P=0.05), whereas those who did not achieve MCID or had normal erectile function at baseline did not experience an improvement in FMD. Furthermore, men with Metabolic Syndrome who met MCID criteria were found to have increased Angiopoietin 1 and decreased Angiopoietin 2 following cell therapy. Conclusions The findings of this study demonstrate the potential of cell-based therapies in improving erectile function, angiogenic, and endothelial function. Future studies should aim to identify the causative mechanisms underlying these restorative effects in humans, paving the way for enhanced understanding and optimization of such therapies. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Longeveron LLC.

(366) Potential Effectiveness of Focused Vibration Treatment for Psychogenic Erectile Dysfunction: A Case Series

Abstract Introduction The current non-pharmacological treatment of psychogenic erectile dysfunction (pED) is based on cognitive-behavioral interventions that often involve the participation of the partner, such as desensitization procedures, sensory focusing, and couples counseling. However, it is important to note that in many cases, patients may not have a stable partner or their partner cannot participate in the treatment. The application of local mechanical vibration has shown promising results in increasing skin blood flow and nitric oxide production in healthy young adults. The relaxation of smooth muscle in the penis initiates and maintains an erection. The local release of nitric oxide from autonomic dilator nerves and vascular endothelium is crucial in initiating and sustaining this process. Technological advances have allowed the design of vibrating devices that men can use during sexual encounters. Objective To determine if the on-demand use of a focused vibration device can increase blood flow and promote relaxation of erectile tissue to improve erectile function in patients with pED. Methods Seven 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) and without a stable partner, were instructed to use a vibrating device called TENUTO II during their sexual encounters for duration of 8 weeks. This device generates focal vibrations on the penis and the perineal area in intervals of 10 seconds of vibration followed by 10 seconds of pause, with a frequency of 50Hz and an amplitude of 2mm. The five-item Spanish version of the International Index of Erectile Function (IIEF-5) questionnaire was used to assess symptoms before and after the procedure and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire was used for evaluating satisfaction with treatment. Results After the using the device, all patients enrolled with a mean age of 36.1 years (range 28-45) experienced an improvement in erectile function, mean IIEF-5 score pretreatment was 11(range 5–13) mean posttreatment IIEF score was 20 (range 18-27). No adverse effects were reported during the treatment. Conclusions This case series suggests that use of an on-demand focused vibration device could be a potentially effective and safe therapeutic option for men with pED. However, further studies with a larger number of participants and a more rigorous research design are needed to confirm these preliminary findings. Disclosure Yes, this is sponsored by industry/sponsor: MysteryVibe. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Mysteryvibe.

(162) Evaluating the Effectiveness of Testosterone Therapy Combined with PDE5 Inhibitors in Enhancing Erectile Function in Eugonadal Men

Abstract Introduction Historically, testosterone therapy (TTh) is not indicated in eugonadal men with erectile dysfunction (ED). Moreover, the 2018 AUA Guidelines state that TTh is not indicated as monotherapy for men suffering from ED but should be considered as combination therapy with PDE5i, as TTh may increase the efficacy of PDE5i therapy. Objective We investigated the benefits of providing TTh in combination with PDE5i therapy in marginally eugonadal men to determine its efficacy in improving erectile function. Methods A retrospective chart review was performed on men presenting with ED to an academic institution’s Men’s Health Clinic from 2010 to 2022. Objective data was gathered on key variables that affected patient-reported outcomes of ED, including age at presentation and comorbidities, as well as use of TTh and use of oral PDE5i. 177 eugonadal men were selected with the criteria of testosterone levels &amp;gt;300 ng/dL on initial presentation. Results were then statistically analyzed using a two-tailed student’s T test in R and p-values to determine the significance between variables and outcomes in ED. Results Out of our cohort of 179 eugonadal men presenting with ED, 42 patients were continued or started on concurrent TTh with oral PDE5i therapy added, and 83 were started on PDE5i monotherapy. Men in the dual-therapy group excluding those already on TTh began with a pre-therapy testosterone mean of 412.3 ng/dL compared to 443.0 ng/dL which was insignificant (p=0.22). There were no significant differences in presenting age (p=0.61) or comorbidities including hypertension (p=0.89) and diabetes (p=0.63) between the two groups. Additionally, there were no significant differences in lab values of HgA1c (p=0.34), cholesterol (p=0.80), triglycerides (p=0.27), or LDL (p=0.89). However, there was a lower initial HDL in the combination group of 45.1 mg/dL compared to 55.8 mg/dL (p = 0.036). Men in the dual-therapy group were more likely to report subjective improvement in ED symptoms compared to men taking PDE5is alone. This was supported by 33/42 (78.6%) of men in the dual therapy group reporting improved erectile function compared to 49/83 (59.0%) of men in the PDE5i only group (p = 0.029). Conclusions In conclusion, these results demonstrate that treatment of eugonadal men with concurrent TTh and PDE5i therapy demonstrated a significant improvement in erectile function as compared to PDE5i therapy alone. These findings suggest consideration of testosterone therapy in addition to PDE5i in clinical practice when treating marginally eugonadal men presenting with ED. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Consultant for AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast Investor: Sprout.

(126) Application of HIFEM Therapy Improves Orgasmic, Urinary and Erectile Function by Stimulation of Pelvic Floor Muscles

Abstract Introduction The weak pelvic floor in men contributes to various urological disorders. Treatment can be accomplished by strengthening the pelvic floor muscles (PFM) through pelvic floor muscle training. Nevertheless, such development of PFM is time-consuming and heavily dependent on the subject's ability to perform selective muscle contractions. An advantageous approach is the targeted stimulation of PFM which can be accomplished via electromagnetic stimulation. Particularly, the pelvic floor muscles can be non-invasively and selectively stimulated via the HIFEM field. This results in the natural development and rehabilitation of PFM, which, among other functions, plays a vital role in facilitating orgasmic, urinary and erectile function. Objective The aim of this study is to assess the safety and efficacy of the HIFEM pelvic procedure for the treatment of erectile dysfunction. Methods In this study, 28 males with a median age of 56 (30-72 years) were enrolled. The treatment was composed of ten weekly 28-minute sessions. Outcome measurements were collected via questionnaires and ultrasound imaging prior to and after the last treatment. To assess changes in erectile and sexual function, and prostate-related symptoms, the International Index of Erectile Function (IIEF) and International Prostate Symptom Score (IPSS) were used. Transverse B-Mode ultrasound video scans were recorded along the long axis of the penile shaft from the tip to the base with the penis in a flaccid state. A linear transducer was used, the depth was set at 2 cm, and the frame rate was approximately 30 frames per second. Separate video recordings of the left and right cavernosum were taken. The ultrasound scans were processed by the Morphometrix cloud-based algorithm. Adverse events were monitored during the study. Results All evaluation methods proved the efficiency of treatment on a statistically significant level. A significant improvement was detected in the majority (4 of 5) of the domains of IIEF, with the overall score improvement from a baseline value of 45.14±2.42 to 48.75±2.86 (+3.61 points). The most exceptional improvement was found in Sexual desire (+18.78%; p=1.06x10-3), Erectile dysfunction (+13.03%; p=5.7x10-4), and Orgasmic function (+10.69%; p=7.04x10-5) domains. The mean difference in the total score of the IPSS questionnaire reached -3.04 points (p=5.1x10-6), exceeding the corresponding minimal clinical difference (MIC=3 points). Overall, subjects, on average, shifted from moderately symptomatic (9.57±1.37 points) to mildly symptomatic (6.54±0.91 points). An increase in vascularity of both cavernosal was measured within 57% of patients who underwent ultrasound examination; specifically, a significant improvement was recorded in tissue segment count (TSC; +104%; p=1.17x10-4) and density (TSD; +81% p=2.20x10-3), pointing to better blood flow and delivery in examined tissues. No adverse event was observed. Conclusions The therapy administering HIFEM technology of the pelvic floor for selective PFM stimulation demonstrated significant improvement of erectile and orgasmic function and urinary symptoms. The questionnaire results corresponded with ultrasound measurements using a novel algorithm, identifying positive changes in the penile vascular system. Overall, the treatment may be considered a safe and a possible first-line solution for male patients suffering from dysfunctions linked to weakened pelvic floor muscles. Further investigation is needed. Disclosure Yes, this is sponsored by industry/sponsor: BTL. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: AFFIRM Science.

Effectiveness of Low-Intensity Extracorporeal Shock Wave Therapy in Erectile Dysfunction: An Analysis of Sexual Function and Penile Hardness at Erection: An Umbrella Review.

The present umbrella review of five systematic reviews and meta-analyses was conducted to investigate the effectiveness of Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) in the treatment of vascular origin Erectile Dysfunction (ED). A search was carried out in the databases of Pubmed, Scopus, Medline, Scielo and Embase. Participants were divided into two groups: an experimental group receiving Li-ESWT and a control group receiving simulated shock waves. The main variable of this study is ED, measured using the International Index of Erectile Function-Erectile Function (IIEF-EF) and the Erection Hardness Score (EHS) scale. The results showed a statistically significant increase in the mean IIEF-EF score in the experimental group. Overall, four out of five articles reported an increase in the EHS score in the Li-ESWT group compared to the placebo. Concerning the treatment parameters, better outcomes were observed with an energy density of 0.09 mJ/mm2 and the application of 1500-2000 pulses. Additionally, a follow-up of 6-12 months resulted in greater improvement in ED compared to 3 months, although more studies investigating follow-ups beyond 12 months are needed. Obtaining conclusive and clear results is challenging; however, everything indicates that Li-ESWT is an innovative therapeutic alternative for vascular-origin ED due to its low risk and improvement in erectile function.

Nanotechnology in sexual medicine.

Statement of Significance: There is significant potential for improvement in erectile function and prevention of erectile dysfunction if these diverse and novel nanotherapies can be translated to the clinic.

Pragmatic Approaches to Scalable Prehabilitation

Patients with cancer should ideally undergo proactive screening for muscle wasting, dietary deficiencies, functional changes, and/or psychological needs. Alternatively, a cross-referral strategy may be useful. A multimodal prehabilitation approach can address impairments and optimize function before treatment. Urological prehabilitation has led to improvements in lean body mass, bone density, erectile function, and urinary continence.

Assessment of the treatment effectiveness of men with mild and medium degree of erectile dysfunction.

. Aim: To assess the effectiveness of monotherapy and complex treatment of patients with erectile dysfunction depending on its severity. Materials and Methods: Men with moderate and mild erectile dysfunction took part in the study, who, in turn, were divided into groups, depending on the treatment, with the evaluation of the results of the International Index of Erectile Function (MIEF-15), the state of cavernous hemodynamics and the function of the vascular endothelium before and after treatment. Results: In patients with an average degree of severity, who received complex treatment including a course of low-energy shock wave therapy, against the background of taking sildenafil and L-arginine, the best results were obtained in the quality of erection and increased cavernous blood flow, which positively affected satisfaction with sexual intercourse and overall satisfaction. It has also been proven that the function of the endothelium was improved in patients receiving L-arginine, due to which there was a probable decrease in endothelin-1. A probable improvement of erectile function was obtained in the group of patients with a mild degree who received L-arginine, and there was no statistical difference from the indicators in the group who received sildenafil, which was confirmed by the data of dopplerography. Conclusions: Patients with an average degree of erectile dysfunction require comprehensive treatment. The use of L-arginine can be an alternative to phosphodiesterase type 5 inhibitors in the treatment of mild erectile dysfunction.