IIEF-EF Score Research Articles

The Intra-Meatal Application of Tadalafil Cream Versus Oral Administration Efficacy and Safety: Results from a Randomized, Two-Administration Route, Cross-Over Clinical Trial.

Background: Tadalafil cream, a topically administered phosphodiesterase-5 inhibitor (PDE5), presents a potential alternative to oral PDE5 inhibitors like tadalafil for the treatment of erectile dysfunction (ED). This study evaluates the non-inferiority and potential superiority of tadalafil cream compared to oral tadalafil. Methods: This randomized controlled trial employed a cross-over design with two treatment periods of two weeks each, separated by a one-week washout phase. Thirty-five male participants aged 18-75 with diagnosed ED (International Index of Erectile Function-Erectile function: IIEF-EF score < 26) were randomized to receive either tadalafil cream or oral tadalafil. Tadalafil cream was applied topically, while tadalafil was taken orally. The primary endpoint was IIEF-EF, and secondary endpoints were measured using the International Index of Erectile Function (IIEF) domain scores. Adverse events and treatment preferences were also assessed. Results: Tadalafil cream showed a higher increase in sexual function across all IIEF domains compared to oral tadalafil. The lower bounds of the confidence interval [improvement: final-baseline scores between tadalafil cream and oral tadalafil 0.72 (95% CI -2.72-4.15)] were above the non-inferiority margin of -3.22, confirming tadalafil cream's non-inferiority in the erectile function domain. In the intercourse satisfaction domain, tadalafil cream was superior to oral tadalafil. At the end of the trial, 88.57% of participants preferred tadalafil cream (95% CI 73.26%-96.79%), a result significantly above the non-inferiority margin that indicated superiority (p < 0.001). No systemic adverse events were reported for tadalafil cream, and significant differences in dizziness, headache, nasal congestion, and erythema were observed between the two treatments. Conclusions: Tadalafil cream is a safe and effective treatment for erectile dysfunction, demonstrating non-inferiority and potential superiority over oral tadalafil, with a high patient preference. Its topical administration offers a promising alternative for patients, particularly those with cardiovascular diseases where oral PDE5 inhibitors are contraindicated or less well tolerated.

The potential role of intracavernosal injection of platelet-rich plasma for treating patients with mild to moderate erectile dysfunction: A GRADE-Assessed systematic review and meta-analysis of randomized controlled trials.

Platelet-rich plasma (PRP) has shown positive effects on enhancing erectile function in animal studies. Human clinical trials are limited and provide contradictory results. This review aims to conduct a meta-analysis of the available Randomized controlled trials (RCT) to assess the efficacy of PRP in males with ED. A systematic review was carried out following the Cochrane Handbook of Intervention and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and registered in PROSPERO (CRD42023441655). A total of three RCTs were included in the analysis for a total of 221 patients with mild to moderate ED. The patients receiving PRP reported significantly better improvement of IIEFEF score during 1,3- and 6-months follow-up compared to the placebo group (mean difference [MD] 2.66, 95% confidence interval [CI] 1.48 to 3.83, p < 0.01; MD 2.11, 95%CI 0.13 to 4.09, p = 0.04; MD 2.99, 95%CI 1.79 to 4.19, p < 0.01). The pooled analysis indicated that attainment of minimally clinical important difference (MCID) was significantly higher in patients receiving PRP compared to the placebo group during one and 6-month follow-up (odds ratio [OR] 5.51, 95%CI 1.2 to 254, p = 0.03; OR 5.64, 95%CI 2.05 to 15.55, p < 0.01; respectively). Encouragingly, no major AEs were reported in all three trials in the PRP and placebo groups (p = 0.99). This review highlights the potential role of PRP in providing short-term improvement of erectile function parameters for up to 6 months in mild to moderate ED patients. Future RCTs with longer-duration follow-ups and more standardized treatment protocols are necessary to gain sufficient details on PRP's long-term effectiveness and safety.

Randomized trial of low intensity shockwave therapy for erectile dysfunction utilizing grayscale ultrasound for analysis of erectile tissue homogeneity/inhomogeneity.

Electrohydraulic shockwave devices have been Food and Drug Administration-cleared for improved blood flow and connective tissue activation and have been used to treat erectile dysfunction (ED). In this study, the main focus was to evaluate improvement in erectile tissue quality after low intensity shockwave therapy (LiSWT). A single-blind, sham-controlled, randomized, prospective study, was performed in men with ED naïve to shockwave or radial ballistic pressure wave therapy. Participants were randomized 1:2 to simulated (sham) or active LiSWT treatment. After simulated treatments, participants in the Sham Arm were converted to active LiSWT, while participants initially in the Active Treatment Arm received no further treatment. Assessments were performed at baseline and two follow-up visits. Subjective parameters of erectile function (EF) were assessed by total and EF domain scores of the International Index of Erectile Function (IIEF) and sexual encounter profile (SEP). Objective parameters of penile erection were measurements of hypoechoic areas in images obtained by grayscale ultrasound (GUS) with high resolution 15.4 MHz probe and cavernosal artery peak systolic velocity (PSV) and end diastolic velocity (EDV) by color duplex Doppler ultrasound (DUS). Outcome measures for erectile and urinary function were also obtained. Simulated LiSWT did not significantly change any assessment parameter. Sham Arm participants who converted to active LiSWT had significantly increased mean IIEF total (P=0.02) and IIEF-EF scores that approached statistical significance (P=0.06), relative to baseline. Similarly, at the end of the study, Active Treatment Arm participants had significantly increased mean IIEF total (P=0.02) and IIEF-EF scores that approached statistical significance (P=0.07), relative to baseline. Additionally, at the end of the study, SEP3 success rates (erection lasting long enough for successful intercourse) approached statistical significance when Sham Arm participants were converted to active LiSWT (P=0.08) and reached statistical significance in the Active Treatment Arm (P=0.049). GUS assessments by visual grading were significantly correlated to IIEF-EF score (P=0.002) and were significantly increased relative to baseline in the Active Treatment Arm at follow-up Assessment 1 (P=0.03) and Assessment 2 (P=0.04). The greatest reduction in hypoechoic area after LiSWT occurred in the proximal penile shaft. EDV was also significantly reduced in the Active Treatment Arm at follow-up Assessment 1 (P=0.04) and Assessment 2 (P=0.04). LiSWT also resulted in improved prostate symptom scores, approaching significance in the Active Treatment Arm (P=0.055) with no changes in prostate-specific antigen. Treatment-related adverse events were limited and transient. In this prospective trial, LiSWT was safe and efficacious for erectile symptoms using GUS imaging as a novel, non-invasive method to assess improvements in corporal veno-occlusive function. Improved veno-occlusion and reduced hypoechoic area demonstrated by GUS imaging suggest that LiSWT decreases connective tissue content in penile erectile tissue. Lower urinary tract symptoms also improved with LiSWT. NCT06600893 on clinicaltrials.gov.

Efficacy and safety of low-intensity pulsed ultrasound (LIPUS) combined with tadalafil in the treatment of severe erectile dysfunction: a retrospective cohort study.

Low-intensity pulsed ultrasound (LIPUS) is an effective and safe treatment for mild to moderate erectile dysfunction (ED). This study aimed to investigate the efficacy and safety of combining LIPUS with tadalafil in treating severe ED. The data from 27 patients treated with LIPUS alone (group A) and 21 patients treated with a combination of LIPUS and daily 10 mg tadalafil (group B) were retrospectively analyzed. The LIPUS regimen consisted of twice-weekly treatments for 4 consecutive weeks. The treatment was considered effective if the change in International Index of Erectile Function-Erectile Function Domain (IIEF-EF) score after treatment was greater than or equal to the minimal clinically important difference (MCID) (the MCID for severe ED is 7 points). The effectiveness, IIEF-EF score, erectile hardness score (EHS), peak systolic velocity (PSV), end diastolic velocity (EDV), and adverse events were evaluated before treatment, 4 weeks after treatment, and 12 weeks after treatment. Compared to pre-treatment, both groups showed significant improvement in IIEF-EF score and EHS at 4 and 12 weeks after treatment (P<0.001), with no statistically significant difference between the two time points (P>0.05). The effective rate did not significantly differ between group A (9/27, 33.3%) and group B (10/21, 47.62%) at 4 weeks or between group A (9/27, 33.3%) and group B (12/21, 57.14%) at 12 weeks after treatment (P=0.32, P=0.10). However, in patients without comorbidities, the effective rate of group B (12/18, 66.67%) was higher than that of group A (9/25, 36.00%) at 12 weeks after treatment (P=0.047). After LIPUS treatment, the PSV level significantly increased and the EDV level significantly decreased compared with before treatment (P<0.05). No adverse events were reported. The study suggests that LIPUS has a therapeutic effect on severe ED patients, especially those without comorbidities. It may have a synergistic or overlapping effect with phosphodiesterase type 5 inhibitors (PDE5Is) on severe ED patients without comorbidities.

Gout and erectile dysfunction: Increased carotid intima-media thickness is independently associated with greater likelihood for erectile dysfunction.

The study aimed to compare gout patients and healthy subjects in terms of erectile dysfunction, carotid intima-media thickness (CIMT), and other variables and to investigate the relationship between CIMT and erectile dysfunction. This cross-sectional study was conducted with 134 male gout patients (median age: 56 years; range, 48 to 62 years) and 104 healthy males (median age: 47 years; range, 40.5 to 54.5 years) between September 2022 and June 2023. Age, comorbidities, height, weight, laboratory results, gout treatment data, insulin resistance evaluated by the homeostatic model assessment for insulin resistance, presence and severity of erectile dysfunction evaluated by the six-item International Index of Erectile Function erectile function domain (IIEF-EF), and CIMT measured by ultrasound were assessed. Hypertension, hyperlipidemia, greater insulin resistance, erectile dysfunction, and bilaterally increased CIMT were significantly more common in the gout group. The mean IIEF-EF score of gout patients was significantly lower than that of controls. Multivariable logistic regression revealed increased CIMT as the sole parameter independently associated with erectile dysfunction (p=0.010). When both groups were categorized into CIMT-based subsets, erectile dysfunction was present in 97.9% of patients with coexistence of gout and increased CIMT (≥0.9 mm), a significantly higher proportion compared to the other three subsets (p<0.001). Increased CIMT was the only factor independently associated with a greater likelihood of erectile dysfunction in patients with and without gout; however, coexistence of gout and increased CIMT appears to result in a significantly elevated risk for erectile dysfunction.

Retrospective analysis of the efficacy of low-intensity extracorporeal shock wave therapy on young and middle-aged patients with erectile dysfunction responsive to PDE5Is: reducing the use of PDE5Is.

Low-intensity extracorporeal shock wave therapy (Li-ESWT) is a new method for treating erectile dysfunction (ED), but there are no standards yet for its indications. The study aimed to suggest the early clinical efficacy of Li-ESWT and explore its related factors in young and middle-aged patients with ED who responded to phosphodiesterase type 5 Inhibitors (PDE5Is). Data from 61 patients with ED who had previously responded to oral PDE5Is and subsequently underwent Li-ESWT were collected. This included information on age, body mass index, total testicular volume, sex hormones, as well as IIEF-EF scores before treatment and at 1, 3, and 6months after treatment. The treatment regimen involves a weekly session for four consecutive weeks, with each session administering 5000 shock wave pulses. Linear regression analysis was utilized to identify factors associated with the efficacy of Li-ESWT treatment. Additionally, the improvement in different severity groups of ED before and after treatment, along with their IIEF-EF scores, was compared. Li-ESWT was more targeted and effective for young and middle-aged patients with erectile dysfunction who responded to PDE5Is. The age of enrolled patients ranges from 22 to 53years old, and the IIEF-EF scores at 1month, 3months, and 6months after treatment were compared to baseline for efficacy assessment, showing significant improvements (P < .0001) in all instances. Linear regression analysis using baseline data revealed predictive factors associated with treatment efficacy: treatment efficacy was negatively correlated with baseline IIEF-EF scores (t = -2.599, P = .013) and positively correlated with baseline LH levels (t = 2.170, P = .036). Given the considerable cost of Li-ESWT treatment and the emphasis on treatment continuity, we hope to identify the most suitable candidates for Li-ESWT therapy, thereby optimizing its application. Our findings provide a better solution for nonelderly ED patients who are responsive to PDE5Is. This study was limited by our sample size and follow-up time. After 3months of Li-ESWT, the IIEF-EF score gradually stabilizes and short-term maintenance of PDE5Is medication increases the responsiveness to shock wave therapy.

PDE5is-naïve versus non-naïve patients at first investigation for erectile dysfunction-findings from a long-term, real-life cross-sectional study.

Phosphodiesterase 5 inhibitors (PDE5is) represent a first-line pharmacological therapy for erectile dysfunction (ED). Men could obtain PDE5is for recreational purposes without any proper medical prescription. We aimed to analyze clinical characteristics of patients who already used any PDE5i for ED without previous formal medical prescription. Data from 2012 heterosexual, sexually active men seeking first medical help for ED at our outpatient clinic between 2005 and 2022 were analyzed. All patients were assessed with a comprehensive sexual and medical history and completed the International Index of Erectile Function (IIEF) at baseline. Comorbidities were scored with the Charlson comorbidity index (CCI). Thereof, according to exposure to any PDE5i before their first visit, patients were subdivided into: PDE5i-naïve and non-PDE5i-naïve patients. Descriptive statistics tested the sociodemographic and clinical characteristics of both groups. A logistic regression model predicted the likelihood of being PDE5i-naïve at the baseline. Linear regression analysis (LRA) estimated the likelihood of being PDE5i-naïve versus non-PDE5i-naïve over the analyzed timeframe. Lastly, local polynomial regression models graphically explored the likelihood of being PDE5i-naïve at the first clinical assessment over the analyzed timeframe, and the sensitivity analyses tested the probability of being PDE5i-naïve at baseline. Overall, 1,491 (70.9%) patients were PDE5i-naïve and 611 (29.1%) were non-PDE5i-naïve at the first assessment. PDE5is-naïve patients were younger, with a lower prevalence of CCI ≥ 1 and of normal erectile function (EF) than non-PDE5i-naïve men (all p<0.05). Multivariable logistic regression found that patients with lower BMI (OR: 0.99), higher IIEF-EF scores (OR: 1.02), lower rates of severe ED (OR: 0.94), and who had been assessed earlier throughout the study timeframe (OR: 1.27) were less likely to be PDE5i-naïve at baseline. Univariate LRA revealed that younger patients (Coeff: -0.02), with lower CCI (Coeff: -0.29) and higher alcohol intake per week (Coeff: 0.52) were more likely to be PDE5i-naïve over the analyzed timeframe. Moreover, for the same IIEF-EF score, patients with higher CCI had lower probability of being PDE5i-naïve. Self-prescription of PDE5is is an attitude presents in the general population, despite this phenomenon has decreased overtime. Current data outline the importance to keep promoting educational campaigns to promote PDE5is as effective and safe medicinal products, while avoiding their improper use.

(O-23) EFFECTIVENESS OF COMPREHENSIVE TREATMENT FOR ERECTILE DYSFUNCTION WITH MEDICATION AND SHOCKWAVE THERAPY: A REAL-LIFE STUDY

Abstract Objective To evaluate the effectiveness of adding shockwave therapy to pharmacological treatment in a cohort of men with erectile dysfunction in Colombia and Peru. Methods Observational cohort study. Patient records from those treated for erectile dysfunction in 2022 were reviewed. Patients over 18 years old, without other sexual dysfunctions were included. Changes in the IIEF-EF questionnaire score and the proportion of patients achieving penetration capability (EHS &amp;gt;2) after treatment were assessed. Results 317 patients met the criteria and were included in the analysis. 150 received medication only (group 1) and 167 received shockwave therapy + medication (group 2). The median duration of treatment was 4.8 months for group 1 and 5.6 months for group 2. The initial IIEF-EF score for group 1 was 15.8 (+/-5.4) and the average increase at the end of treatment was 7.35 (+/-5.4) points. In group 2, the initial IIEF-EF was 14.7 (+/-4.9) and the average increase was 7.47 (+/-5.8). At the end of treatment, 39.3% of patients in group 1 and 42.5% in group 2 reported no ED according to the IIEF-EF score. The proportion of patients who could not achieve penetration (EHS &amp;lt;=2) before treatment and achieved sufficient rigidity for penetration (EHS &amp;gt;2) after treatment was 85% in group 1 and 94% in group 2. Conclusions The additional use of shockwave therapy improves the outcomes of pharmacological treatment in patients with ED. Financing Boston Medical Group.

(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.

(202) Comparative Study of the Efficacy of Avanafil and Atorvastatin Daily Dose in Management of Vasculogenic Erectile Dysfunction

Abstract Introduction Erectile dysfunction (ED) is defined as the “consistent inability to attain or maintain a penile erection, or both, sufficient for adequate sexual relations”. ED is not only a medical problem but affects the marital relations and patient's self-esteem and causes the quality of life to decrease. which in turn causes the patient to go into depression or develop anxiety. In the past, erectile dysfunction was considered, in most cases, to be a purely psychogenic disorder, but current evidence suggests that more than 80% of cases have an organic aetiology. Causes of organic erectile dysfunction can now be broadly divided into nonendocrine and endocrine. Of the nonendocrine aetiologies, vasculogenic (affecting blood supply) is the most common and can involve arterial inflow disorders and abnormalities of venous outflow (corporeal veno-occlusion). Avanafil is a second-generation phosphodiesterase type 5 inhibitor approved for erectile dysfunction by the FDA on 2012 and by EMA in 2013. With a high selectivity for phosphodiesterase type 5 isoform AND faster onset of action compared with other PDE5 inhibitors, it offers more tolerability and less adverse events. Atorvastatin is 3-hydroxy-methylglutaryl (HMG)-CoA reductase inhibitor act on the rate-limiting step in cholesterol biosynthesis (the conversion of HMG-CoA to mevalonate) and are effective in treating dyslipidemia. statins reverse endothelial dysfunction by decreasing the action of oxidized low-density lipoprotein (LDL) on endothelial cells, resulting in an increase of NO activity. Objective is to evaluate and compare the efficacy of avanafil and atorvastatin daily dose in management of patients with vasculogenic erectile dysfunction. Methods A 60 adult heterosexual males complaining of vasculogenic erectile dysfunction proven by penile duplex were collected from outpatient andrology clinics of Al-Azhar University Hospitals. The patients were divided into two treatment groups: (Group A): 30 patients received daily dose of 100 mg avanafil. (Group B): 30 patients received daily dose of 40 mg atorvastatin, The main outcome measures and the difference in penile duplex ultrasound results and IIEF-EF scores between the two groups are evaluated and compared at the end of the study, Age of patients between 20 and 50 years, established diagnoses of Vasculogenic erectile dysfunction, Normal lipid profile, Normal Total and Free testosterone levels and No contraindications to the study medications were included criteria. However patients who failed to fulfill any of the inclusion criteria, psychogenic or neurogenic erectile dysfunction, dyslipidemia Patients with Renal or Hepatic insufficiency and Patients with advanced cardiovascular diseases such as heart failure and coronary artery disease on antianginal drugs especially nitrates were excluded. Results Our study revealed statistically significant improvement in Penile Doppler ultrasonography parameters (PSV, EDV&amp; RI) and IIEF-EF scores in avanafil group compared to atorvastatin group. Conclusions avanafil 100 mg daily dose leads to significant improvement in men with vasculogenic erectile, while atorvastatin 40 mg caused no significant differences, neither positively nor adversely. In summary, avanafil at dose of 100 mg can be a therapeutic appropriate choice in cases of vasculogenic ED. Disclosure No.

(012) Sexual Dysfunction in Men After Failed Hypospadias Repair

Abstract Introduction Hypospadias is commonly treated in childhood, and future sexual function of such patients is sometimes overlooked. Some published reports reveal excellent sexual function following hypospadias repair at long term, while other authors state high prevalence of sexual dysfunction which depends on original position of urethral meatus. Patients with complications of primary hypospadias repair are one of the most difficult subpopulations to evaluate. This is a unique subset of patients who should be described separately from men who underwent successful hypospadias repair. Objective To describe the spectrum of sexual dysfunction in patients with sequelae of failed hypospadias repair and our experience in its management. Methods We evaluated 112 patients with a history of failed hypospadias repair, defined as presence of voiding symptoms or cosmetic problems remaining despite previous surgery or caused by it. Patients’ median age was 29.5 years (range: 18–62). There were no intersex cases. Only 9.8% (11/112) underwent single attempt at surgical reconstruction, the median number of attempts was 3.5 (range: 1–9). Patients with IIEF-EF score ≤ 25 were considered to have erectile dysfunction; those with IIEF-EF ≤ 16 underwent penile doppler ultrasound, penile electromyography and endocrine assessment. Results 64.2% of patients (72/112) were dissatisfied with penile appearance, 40.2% (45/112) had ED, 71.4% (80/112) had ejaculation disorders. Psychogenic ED was diagnosed in 21 patients with preserved non-coital erections and no evidence of organic ED. Median IIEF-EF in ED patients was 20 (range: 8–25). Asthenic ejaculation, delayed ejaculation and anejaculation were present in 63.4% (71/112), 7.1% (8/112) and 3.5% (4/112) patients, respectively. Premature ejaculation was present in 28.6% (32/112) patients, but its association with hypospadias or previous surgery is unlikely. On univariate analysis only the number of previous attempts at surgical repair was a significant predictor of sexual dysfunction following definitive surgery (p = 0.033). Rate of normal sexual function was 37.5%, 23.5% and 9.1% among patients with history of ≤ 3, 4–6 and ≥ 7 procedures, respectively. Conclusions Failed hypospadias repair may lead to a wide spectrum of sexual dysfunction, involving sexual desire, erection and ejaculation. Repeated surgery leads to increased risk of sexual dysfunction which may be devastating for patient’s quality of life. 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.

(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.

(069) Markers of Neovascularization and Neurogenesis May Change After Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction

Abstract Introduction Low-intensity extracorporeal shockwave therapy (LiESWT) is thought to treat erectile dysfunction (ED) but the mechanism remains elusive. It is believed that LiESWT may work by stimulating neovascularization and nerve regeneration as demonstrated in animal models by histologically increased angiogenesis-related growth factors and neuronal factors including vascular endothelial growth factor (VEGF), endothelial nitric oxide synthase (eNOS), neuronal NOS (nNOS) and brain derived-neurotropic factor (BDNF). Given its prolific use, a thorough understanding of the mechanism of action of this therapy at a cellular level is critical prior to recommendation of this therapy on a larger scale. Objective Objective data post LiESWT is sparse. In this study, we aimed to determine whether markers for neovascularization and nerve regeneration can be detected in the serum of penile tissue in men following LiESWT treatment. We hypothesized that LiESWT results in appreciable increases in vascular and neuronal factors post therapy. Methods Patients were prospectively enrolled in a clinical trial of LiESWT for ED. Patients received 12 bi-weekly LiESWT treatments of 0.2mJ/mm2 at 5Hz, 1500 shocks delivered per treatment, with follow up at 1-2 weeks, 4-6 weeks, 3 months and 6 months post-treatment. Cavernosal penile blood samples were obtained prior to treatment and at each visit post-treatment. The concentrations of eNOS, nNOS, VEGF, and BDNF in penile plasma samples were measured using Enzyme-Linked Immunosorbent Assay (ELISA) with specific commercial kits, following the protocols provided by the manufacturer. Results Twenty-five patients completed all five study visits. Mean patient age was 63. Mean baseline IIEF-EF score prior to treatment was 14.24 (±1.21). At the time of data analysis, plasma samples from 9 men were analyzed for BDNF, eNOS, and nNOS levels using the ELISA assay, and samples from all 25 men were analyzed for VEGF. BDNF levels demonstrated a sustained decrease after the first treatment (P = 0.0001, Figure 1A). Levels of eNOS were noted to trend upward, but no significant changes in eNOS, nNOS or VEGF levels were noted. Conclusions To our knowledge, this is the first study in human tissues to attempt to quantify objective measures of neurogenesis and neovascularization in penile tissue following LiESWT for ED. Though our N is small, our results suggest that LiESWT may decrease BDNF levels after initial LiESWT treatment while VEGF, eNOS and nNOS levels remain unchanged. The clinical significance of these findings is currently unknown, as our findings are not consistent with histological studies in animals which demonstrate upregulation of these markers in penile tissues. However, we believe this represents a promising first step in attempting to understand the effect of LiESWT at a tissue level in men undergoing LiESWT. Disclosure No.

(151) Safety and Feasibility of the COCKTAIL (Combining Shockwave Therapy and Platelet-Rich Plasma for Erectile Dysfunction) Trial: A Single Center, Randomized, Double-Blind, Sham-Controlled Study Update

Abstract Introduction Therapeutic approaches focusing on tissue neovascularization play a crucial role in the development of treatments for erectile dysfunction (ED). Autologous Platelet-Rich Plasma (PRP) and Low-Intensity Shockwave Therapy (SWT) are two restorative therapies that potentially target underlying causes of ED. Pre-clinical evidence suggests their angiogenic and regenerative properties, indicating a potential synergistic pathway to improve vasculogenic ED. Objective The primary objective aims to investigate and compare the treatment efficacy of PRP injection and SWT vs placebo injection/SHAM treatment in men with mild-moderate ED, as measured by IIEF. The secondary objective aims to study incidence of adverse events and safety of PRP injection and SWT treatment in men with mild-moderate ED, as measured by IIEF. Methods The COCKTAIL (Combining Shockwave Therapy and Platelet Rich Plasma) trial is a Phase II, single-center study assessing the safety and efficacy of PRP and SWT in combination for ED (NCT05048667). Thirty-five men with mild to moderate ED were enrolled based on International Index of Erectile Function-EF subdomain (IIEF-EF) questionnaire (12-25). Data from a cohort of men treated with PRP and SWT were analyzed, comparing it to men who received placebo saline injections and sham SWT. Patients received two PRP or placebo injections directly into the corpus cavernosum and penile SWT every week for 5 weeks. Assessment included pain scale evaluations, immediate post-procedure examination, and follow-up for complications. IIEF scores were recorded at baseline, 3-month, and 6-month follow-up visits. All statistics and analyses were conducted with IBM SPSS Statistics 27.0.1. Non-parametric tests were used for analysis. Mann-Whitney U test was used to compare independent groups (Group A vs. Group B) at different time points. Related Samples Wilcoxon -Signed Rank test was used for dependent repeated groups, the serial measurements of IIEF-EF scores at different time points for each patient within a specific group. Findings at p&amp;lt; 0.05 were considered statistically significant. Results The primary endpoint of this study was to investigate the incidence of Serious Adverse Events (SAEs). Encouragingly, no adverse events were reported, suggesting that the procedure appears to be safe for the participants. The median baseline IIEF scores for patients in Group A were 17 (±4), and at the three-month follow-up, the scores increased to 19 (±4), slightly dropping to 18 (±8) at six months. In Group B, the median baseline IIEF scores were 19.50 (±4), which improved to 20 (±7) at the three-month follow-up and further increased to 21 (±10) at six months. No statistical differences were found likely because this is an ongoing study, and we only have complete data for 12 men. We aim to accrue a total of 30 men in each arm and plan to complete the recruitment by January 2024 and complete the study by July 2024. Currently, both the investigators and the patients remain blinded. Conclusions The combination of PRP and SWT appears to be safe, as no adverse events were reported. Although preliminary data do not show differences between the treatment and sham groups currently, we intend to complete the trial to perform a comprehensive statistical calculation for efficacy. Disclosure No.

(122) Preservation of Sexual Function: 12-month Outcomes from a Randomized, Double-Blind, Sham Controlled Study Evaluating the Optilume BPH System, a Novel Drug Coated Balloon

Abstract Introduction Many front-line treatments for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), such as medications and transurethral resection of the prostate, have well established negative effects on sexual function. New minimally invasive surgical therapy (MIST) for LUTS/BPH need to preserve sexual function to meet the needs of men. Data from the randomized controlled blinded study of the Optilume BPH System was analyzed to evaluate the sexual side effects of this novel treatment. Objective The PINNACLE study is a prospective, randomized, double-blind, sham controlled study evaluating the Optilume BPH System. Optilume BPH is a novel MIST that combines mechanical dilation with delivery of paclitaxel for treatment of LUTS/BPH. The mechanical dilation with Optilume BPH achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing, while preserving sexual function. Methods 148 subjects with symptomatic LUTS/BPH and a prostate size between 20-80 grams were randomized in a 2:1 fashion (Optilume to Sham) at 18 centers in the US and Canada. Follow-up is complete through 12-months. To evaluate the effect of the treatment on sexual function, the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire to assess Ejaculatory Dysfunction (MSHQ-EjD) questionnaires were used. Questionnaires were administered at baseline and 3, 6, and 12-months post procedure, regardless of sexual activity at baseline. A sub-set of 15 non-randomized subjects treated with Optilume BPH underwent further testing for semen quality and measurement of the amount of paclitaxel found in semen post-treatment. Results The average IIEF-EF score at baseline was 15-16 for both arms, mild to moderate erectile dysfunction (Figure 1). Scores across all domains improved slightly from baseline through 12 months, indicating that treatment with the Optilume BPH device had no significant impact on perceived sexual function. This finding is consistent when looking at men who were sexually active at baseline (Figure 2). Ejaculatory function also showed slight improvement from baseline to 12 months in both the overall population and the subset of men who were sexually active at baseline (Figure 1, Figure 2). There is no appreciable change in ejaculation bother from baseline to 12-months in the overall population and the sexually active subset (Figure 1, Figure 2). Overall semen quality parameters did not change post-procedure (Table 1). A slight decrease in sperm concentration was noted post-treatment, although this decrease was not significant at the 3- and 6-month timepoints. Paclitaxel was detected in semen in the majority of subjects tested at 30 days and 3 months post-procedure. The paclitaxel concentration in semen steadily decreased over time, nearing the limit of quantitation of the method by 6 months post-procedure. Conclusions Treatment with Optilume BPH preserved erectile and ejaculatory function. IIEF and MSHQ-EjD scores were not different from control at any time point. New MISTs for LUTS/BPH need to preserve sexual function to meet the needs of men and Optilume appears to meet this objective. Disclosure Yes, this is sponsored by industry/sponsor: Urotronic. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Urotronic.

Antioxidant Supplementation for Erectile Dysfunction: Systematic Review and Meta-Analysis of Double-Blind, Randomized, Placebo-Controlled Trials.

This meta-analysis aimed to determine the efficacy and safety of antioxidant supplementation for treating erectile dysfunction (ED). We systematically searched MEDLINE, Embase, and the Cochrane Library for double-blind, randomized, placebo-controlled trials of oral antioxidant supplementation in men with ED. Erectile function was assessed by the International Index of Erectile Function-Erectile Function domain (IIEF-EF) score. Using random-effects meta-analysis models, antioxidant and placebo groups were compared for erectile function using the mean difference in IIEF-EF score adjusted to a 6-30 scale and for side effects using the log risk ratio. The review included 23 trials of 1,583 men (median age 51 years) treated with antioxidant supplementation or placebo for a median of 12 weeks (range, 4 weeks to 6 months). Antioxidant supplementation significantly improved erectile function compared to placebo, with a mean difference of 5.5 points (95% confidence interval [CI]: 3.7 to 7.3; p<0.001) on the IIEF-EF. In meta-regression, the treatment benefit was greater in men with more severe ED (p<0.001). Side effects were uncommon, none were serious, and the frequency was comparable between antioxidant (3.8%) and placebo (2.1%) groups (log risk ratio=0.36; 95% CI: -0.24 to 0.97; p=0.24). Antioxidant supplementation appears safe and significantly improves erectile function in men with ED, particularly those with more severe symptoms. Limitations of this review included unknown long-term efficacy and safety and the inability to make specific product and dosing recommendations due to the variety of antioxidants and regimens studied.

Do Antiplatelet Drugs Use Contribute to Clinical Outcomes in Patients Receiving Penile Low- Intensity Shock Wave Therapy (Li-SWT) for Erectile Dysfunction?

Aim: Low-intensity extracorporeal shock wave therapy (Li-SWT) is one of the recommended treatment options in patients with erectile dysfunction (ED). Li-SWT is safe in patients using antiplatelet drugs (APs), however, there are no specific studies on the contribution of APs use to clinical improvement in erectile function. We aimed to evaluate the early clinical results of Li-SWT administration and whether the use of APs had an additional positive contribution to clinical improvement and safe in ED patients.&#x0D; Methods: Patients with ED for more than 6 months despite using (5 mg/day) PDE5i were included in our study. Patients treated with Li-SWT and using PDE5i were classified as Group 1, patients treated with Li-SWT and using APs and using PDE5i were considered Group 2. The evaluation results of the International Index of Erectile Function-Erectile Function Area(IIEF-EF) in all patients baseline and after treatment were examined.&#x0D; Results: There are 25 patients in each group. Analysis of IIEF-EF scores showed significant increases in both groups after treatment [group 1 (p=0.001); group 2 (p=0.001)]. When the IIEF-EF scores of the groups before and after the treatment were compared with each other; it was shown that baseline scores were similar(p=0.746) and that APs use had no statistically significant effect on post-treatment scores (p=0.613) No side effects were seen in APs.&#x0D; Conclusions: This study showed that penile Li-SWT significantly increases the IIEF-EF scores and response of (5 mg/day) PDE5i in ED patients and safe, also in AP users. However, Using AP in Li- SWT does not contribute positively to clinical results.

Therapeutic outcomes and analysis of Doppler findings in 25 patients with non-ischemic priapism

Non-ischemic priapism (NiP) is painless partial tumescence caused by genital trauma and the formation of intracorporal arterio-venous fistula. This is a retrospective study of 25 men with NiP and reports the long-term erectile function and colour doppler ultrasound (CDUS) findings after treatment for NiP. Unstimulated CDUS was performed at diagnosis, 1 week and at last follow-up after treatment. CDUS traces were analysed: peak systolic velocity (PSV), end diastolic velocity (EDV), resistive index (RI) and mean velocity (MV) were calculated. Erectile function was assessed using the IIEF-EF questionnaire. At the last follow-up (median 24 months), 16 men had normal erectile function (64%): median IIEF-EF score 29 (IQR 28.5–30; σ2 2.78) and nine had erectile dysfunction (36%): median IIEF-EF score 17 (IQR 14–22; σ2 33.6). MV and EDV were statistically higher in those patients with erectile dysfunction at last follow-up compared to patients with normal erectile function: median MV 5.3 cm/s (IQR 2.4–10.5 cm/s; σ2 34) vs 2.95 cm/s (IQR 1.03-3.95; σ2 3.4) p < 0.002 and median EDV 4.0 cm/s (IQR 1.5–8.0; σ2 14.7) vs 0 cm/s (IQR 0–1.75; σ2 2.21) p < 0.004. Erectile dysfunction was observed in 36% of men treated for NiP and was associated with abnormal low resistance resting CDUS waveforms. Further investigation for persistent arteriovenous fistulation should be considered in these patients.

(119) The Effect of Tadalafil and Dutasteride Combination on Lower Urinary System Symptoms and Erectile Functions in Patients with and without Prostate Median Lobe

Abstract Introduction Alpha blockers, 5 alpha reductase inhibitors, anticholinergics and tadalafil are used in the treatment of LUTS due to BPH. Objective The aim of this study was to evaluate the effect of daily tadalafil+dutasteride treatment on lower urinary tract symptoms (LUTS) and erectile functions in male patients with and without a median prostate lobe. Methods Male patients over the age of 40 who applied to the Urology Outpatient Clinic due to LUTS/ED between January 2018 and December 2022 were included in the study. Ethics committee approval was obtained for the study. Detailed medical and sexual histories of the patients were taken. The International Prostate Symptom Index was used for the LUTS, and the International Erectile Function Index-Erectile Function section was used for the erectile function. PSA and total testosterone levels of the patients were recorded. Maximum urine flow rate (Qmax) was measured by uroflowmetry. Prostate volume, presence of median lobe, median lobe volume and post-void residual urine volume (PMR) were measured by transabdominal ultrasound. Then, patients with moderate and severe LUTS and prostate volume over 40 cc were divided into 2 groups as those with and without middle lobe. The patients were started on tadalafil 5mg and dutasteride 0.5mg daily. IPSS, IIEF-EF, Qmax, PV and PMR changes of the patients were compared after 24 weeks of treatment. Results A total of 96 patients were included in the study (42 with a median lobe (group-1), 54 without a median lobe (group-2). The mean age of the patients was 56.25±13.47, and the mean BMI was 29.12±7.76. The mean IPSS value of the patients was 14.25±6.69, and the IIEF-EF value was 12.11±9.93. Mean PSA value 2.25±1.36 ng/ml, total testosterone value 345.67±123.21 ng/ml, mean PV 46.71±23.22 ml, Qmax value 8.24±3.36 m/s, PVR 54.32±25.52 was ml. There was no significant difference between the baseline IPSS, IIEF-EF, PSA and Qmax values between the two groups (p&amp;gt;0.05). After daily tadalafil+dutasteride treatment, mean IPSS value of the patients at the 24th week controls was 5.42±4.09 (p&amp;lt;0.001), IIEF-EF score was 20.97±3.67p&amp;lt;0.001), PV was 38.20±10.68 ml (p= 0.021), the Qmax value was found to be 12.45±7.68 m/s (p&amp;lt;0.001). Significant improvements were observed in IPSS, IIEF-EF and Qmax values in both groups compared to the beginning of treatment when the parameters of the groups were changed at the beginning and at the 24th week. When the 24th week data of the two groups were compared, it was found that the IPSS decrease in group-2 was higher than in group-1 (p=0.012). IIEF-EF scores (p=0.034) and Qmax (p=0.001) values were found to be higher than group-1. Conclusions Daily tadalafil+dutasteride treatment is an effective and safe treatment combination in male patients with LUTS/ED. In the presence of the median lobe, the response from tadalafil+dutasteride treatment decreases. The 24-week preliminary results of the study allowed us to have an idea of the long-term results. Further studies are needed to evaluate the effect of tadalafil+dutasteride combination in the treatment of LUTS/ED. Disclosure No