Erectile Function-Erectile Function Domain Score Research Articles

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.

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

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

Safety and Effectiveness of Repeated Botulinum Toxin A Intracavernosal Injections in Men with Erectile Dysfunction Unresponsive to Approved Pharmacological Treatments: Real-World Observational Data.

Intracavernosal injections of botulinum toxin A (BTX/A ic) may be effective for difficult-to-treat erectile dysfunction (ED). This is a retrospective case series study of the effectiveness of repeated off-label BTX/A ic (onabotulinumtoxinA 100U, incobotulinumtoxinA 100U or abobotulinumtoxinA 500U) in men with ED and insufficient response to phosphodiesterase type 5 inhibitors (PDE5-Is) or prostaglandinE1 intracavernosal injections (PGE1 ICIs), defined as an International Index of Erectile Function-Erectile Function domain score (IIEF-EF) < 26 on treatment. Further injections were performed on patients' requests, and the files of men who underwent at least two injections were reviewed. The response to BTX/A ic was defined as the achievement of the minimally clinically important difference in IIEF-EF adjusted to the severity of ED on treatment at baseline. Out of 216 men treated with BTX/A ic and PDE5-Is or PGE1-ICIs, 92 (42.6%) requested at least a second injection. The median time since the preceding injection was 8.7 months. In total, 85, 44 and 23 men received, respectively, two, three and four BTX/A ic. The overall response rate was 77.5%: 85.7% in men with mild ED, 79% for moderate ED and 64.3% for severe ED on treatment. The response increased with repeated injections: 67.5%, 87.5% and 94.7%, respectively, after the second, third and fourth injections. Post-injection changes in IIEF-EF were similar across injections. The time from injection to request for a further injection varied little. Four men reported penile pain at the time of injection (1.5% of all injections), and one experienced a burn at the penile crus. Repeated BTX/A injections combined with PDE5-Is or PGE1-ICIs produced an effective and durable response, with acceptable safety.

The use of low-intensity extracorporeal shockwave therapy in management of erectile dysfunction following prostate cancer treatment: a review of the current literature.

Erectile dysfunction (ED) is a prevalent and impactful complication post definitive management of prostate cancer. The mechanism of ED is thought to be secondary to vascular and neural injury as well as corporal smooth muscle damage with resultant fibrosis. The use of penile rehabilitation in ED following treatment for prostate cancer has been studied. Low-intensity extracorporeal shockwave therapy (Li-ESWT) is a novel treatment for ED thought to stimulate neovascularization and nerve regeneration, and as such, has gained interest in treatment of ED related to radical prostatectomy or radiation therapy. Herein, we performed a narrative review on the use of Li-ESWT in management of ED following treatment for prostate cancer. A literature review was performed using PubMed and Google Scholar. Studies evaluating Li-ESWT following prostate cancer treatment were included. We identified three randomized controlled trials and two observational studies that assessed use of Li-ESWT for ED after prostate surgery. Use of Li-ESWT across most studies showed improvements in the International Index of Erectile Function-erectile function (IIEF-EF) domain scores, but this improvement was not statistically significant. Additionally, use of Li-ESWT in an early versus delayed fashion does not appear to affect changes in long-term sexual function scores. No data on use of Li-ESWT after radiotherapy were identified. There is a paucity of data regarding use of Li-ESWT for penile rehabilitation in treatment of ED post-prostate cancer therapy. Current protocols for Li-ESWT are not standardized and have a limited number of participants with short duration of follow-up. Additional evaluation is needed to determine optimal Li-ESWT protocols. Ideally, studies should have longer follow-up to truly evaluate the clinical significance of Li-ESWT in the treatment of post-prostatectomy ED. Furthermore, the role of Li-ESWT after radiotherapy remains elusive.

Is there a relationship between mean platelet volume and response to treatment with daily tadalafil in patients with erectile dysfunction?

Mean platelet volume (MPV) has been related to erectile dysfunction (ED). However, its value in predicting therapeutic response to phosphodiesterase-5 inhibitors is not evaluated. This study aimed to investigate the value of MPV as a marker for the prediction of the response of the tadalafil treatment of ED. A retrospective analysis of patients who were admitted to the andrology outpatient clinic between 2020-2022 were performed. The inclusion criteria were, ≥40 years old male, International Index of Erectile Function-Erectile Function domain score < 26, not received any ED treatment before, have a stable heterosexual relationship, and prescribed 5mg daily tadalafil for primary treatment of ED. A total of 116 patients were included in the study. The mean age of the patients was 53.7 ± 8.7 years. The response rate to 5mg tadalafil treatment was 52.6% (Group-1; N=61). An MPV value 3 10.05 fL was associated with 66% sensitivity and 75,4% specificity for no response to 5mg daily tadalafil treatment (Area under curve=76.9% [95% CI 68.2%-85.6%; p < 0.001]). Initial IIEF-EF score, fasting blood glucose, and MPV level was independently associated with the response to the tadalafil treatment. This is the only study to evaluate the value of MPV level on the therapeutic response of ED to tadalafil. Strict inclusion criteria were applied to the cohort. However, the diagnose of vascular ED has been made by clinical evaluation and retrospective design of the study were the limitations of the study. The results of our study suggest that MPV might be used to predict the result of 5mg daily tadalafil treatment in selected ED patients as a fast and cost-effective test.

Impact of neoadjuvant androgen deprivation therapy (NADT) on erectile function recovery (EFR) after radical prostatectomy (RP)

ABSTRACT Introduction NADT has gained increasing recognition in the management of men with high risk disease prior to RP No large study to date has examined EFR in such patients Objective we aimed to define such outcomes with this analysis. Methods Men who underwent NADT pre-RP with ≥2-year follow-up post-RP constituted the study population. Patients who received ADT post-RP and radiation therapy pre and post-RP were excluded. Demographics, comorbidity, hormone and pathological parameters were recorded. EFR was assessed using the International Index Erectile Function-Erectile Function Domain (EFD) score. Predictors of EFR were analyzed using logistic regression models. Results 260 men were analyzed. Mean age of 63.6 ± 7.1 years. 11.2% had diabetes, 55% hypertension, 54.2% dyslipidemia, and 16.9% and 5.8% history of sleep apnea and coronary artery disease respectively. Regarding smoking history, 6.9% was current smoker, and 33.1% former smoker. Baseline testosterone was 352.1 ± 225.9 ng/dL, PSA 9.6 ± 8.4 ng/mL, and median EFD score 24 (IQR = 14-30). Median Gleason sum was 7 (IQR = 7-9). 43.4% patients had bilateral nerve sparing status (NSS), and 34% unilateral. 13.1% received NADT. Median duration of NADT was 1 (IQR = 1-3) months. At 2 years post-RP, median EFD was 7 (IQR = 3-22) for men without NADT and 4 (IQR = 2-13) for men with NADT; 8.8% and 21.2% had an EFD score ≥ 24 in men with and without NADT. 73.5% and 55.3% had an EFD score ≤ 10 in men with and without NADT. Conclusions Men with NADT had lower EFR at 2 years post-RP, however NADT did not predict EFR in our cohort. Disclosure Work supported by industry: no.

Effectiveness and Safety of Intracavernosal IncobotulinumtoxinA (Xeomin®) 100 U as an Add-on Therapy to Standard Pharmacological Treatment for Difficult-to-Treat Erectile Dysfunction: A Case Series.

Registered pharmacological treatments are insufficiently effective for erectile dysfunction (ED) in around 30% of affected men. Intracavernosal injection (ICI) of ona- and abobotulinumtoxinA can reduce ED in insufficient responders. We aimed to assess the safety and effectiveness of incobotulinumtoxinA ICI as an add-on therapy to phosphodiesterase-type 5 inhibitors (PDE5-Is) or prostaglandinE1 ICIs (PGE1 ICIs) to treat ED that did not respond sufficiently to this treatment alone. We retrospectively analyzed data from 66 men with difficult to treat ED treated with single or repeated incobotulinumtoxinA 100U ICI as an add-on therapy. Response rate (increase in International Index of Erectile Function-Erectile Function domain score ≥ the minimum clinically important difference) was 52% (median (1st–3rd quartile) 43.5 (34–71) days post-incobotulinumtoxinA ICI). ED etiology (except spinal cord injury) and severity did not influence effectiveness. Only a clinically significant response to the 1st injection predicted a request for a 2nd injection (OR = 5.6, 95%, CI 1.6–19.4). Three men reported mild penile pain during the injection. These results provide preliminary evidence for the effectiveness and safety of incobotulinumtoxinA ICI as an add-on therapy to treat ED that is insufficiently responsive to standard care and provides support for the multicenter randomized clinical trial NCT05196308.

Impact of Neoadjuvant Androgen Deprivation Therapy (NADT) on Erectile Function Recovery (EFR) after Radical Prostatectomy (RP)

ABSTRACT Introduction NADT has gained increasing recognition in the management of men with high risk disease prior to RP No large study to date has examined EFR in such patients Objective We aimed to define such outcomes with this analysis. Methods Men who underwent NADT pre-RP with ≥2-year follow-up post-RP constituted the study population. Patients who received ADT post-RP and radiation therapy pre and post-RP were excluded. Demographics, comorbidity, hormone and pathological parameters were recorded. EFR was assessed using the International Index Erectile Function-Erectile Function Domain (EFD) score. Predictors of EFR were analyzed using logistic regression models. Results 260 men were analyzed. Mean age of 63.6 ± 7.1 years. 11.2% had diabetes, 55% hypertension, 54.2% dyslipidemia, and 16.9% and 5.8% history of sleep apnea and coronary artery disease respectively. Regarding smoking history, 6.9% was current smoker, and 33.1% former smoker. Baseline testosterone was 352.1 ± 225.9 ng/dL, PSA 9.6 ± 8.4 ng/mL, and median EFD score 24 (IQR = 14-30). Median Gleason sum was 7 (IQR = 7-9). 43.4% patients had bilateral nerve sparing status (NSS), and 34% unilateral. 13.1% received NADT. Median duration of NADT was 1 (IQR = 1-3) months. At 2 years post-RP, median EFD was 7 (IQR = 3-22) for men without NADT and 4 (IQR = 2-13) for men with NADT; 8.8% and 21.2% had an EFD score ≥ 24 in men with and without NADT. 73.5% and 55.3% had an EFD score ≤ 10 in men with and without NADT. Conclusions Men with NADT had lower EFR at 2 years post-RP, however NADT did not predict EFR in our cohort. Disclosure No

Efficacy of phosphodiesterase type 5 inhibitors in patients with erectile dysfunction after nerve-sparing radical prostatectomy: a systematic review and meta-analysis.

BackgroundNerve-sparing radical prostatectomy (NSRP) had to be performed because approximately 94% of patients are diagnosed with localized prostate cancer (PCa). Although NSRP is generally done to improve functional outcomes, erectile dysfunction (ED) is one of the most prevailing complications after radical prostatectomy (RP). Phosphodiesterase type 5 inhibitors (PDE5-Is) are the most well-known treatment agent for postoperative ED. This study aimed to assess the efficacy of PDE5-Is in patients with ED after NSRP.MethodsIn this systematic literature review, randomized controlled trials on the efficacy and safety of PDE5-Is in patients who underwent NSRP were searched in MEDLINE, EMBASE, and the Cochrane Controlled Trials Register using the OVID platform. This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Cochrane Review Methods. The quality of the evidence of the outcome data was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.ResultsA total of 14 trials involving 2,822 patients were included. Significant improvements in the International Index of Erectile Function—Erectile Function (IIEF) domain score [mean difference (MD) =4.93; 95% confidence interval (CI): 4.14–5.71; P<0.00001] and erectile function recovery events [odds ratio (OR) =2.06; 95% CI: 1.45–2.94; P<0.0001] were observed after PDE5-I treatment. A higher positive response to Sexual Encounter Profile (SEP) question 2 (OR =2.27; 95% CI: 1.80–2.86; P<0.00001) and question 3 (OR =2.78; 95% CI: 1.97–3.91; P<0.00001) was also found after PDE5-I treatment. However, the incidence of treatment-emergent adverse events (TEAEs) was higher after PDE5-I treatment than after placebo treatment (OR =2.91; 95% CI: 1.84–4.61). Furthermore, the incidence of headache (OR =3.38; 95% CI: 2.40–4.75) and flushing (OR =9.44; 95% CI: 4.30–20.70) was also significantly higher after PDE5-I treatment (P<0.00001). In terms of the quality of the evidence of the outcome data, inconsistency problems were detected in all outcomes and imprecision problems in most outcomes.DiscussionPDE5-I treatment was more effective to placebo treatment in patients with ED after NSRP. No clinically serious complications were found in spite of the incidence of TEAEs being higher after PDE5-I treatment.

Efficacy and Safety of Udenafil Once Daily in Patients with Erectile Dysfunction after Bilateral Nerve-Sparing Robot-Assisted Laparoscopic Radical Prostatectomy: A Randomized, Double-Blind, Placebo-Controlled Study.

To evaluate the efficacy and safety of udenafil 75 mg once daily in patients with erectile dysfunction following bilateral nerve-sparing robot-assisted laparoscopic radical prostatectomy (BNS-RALP). A multi-center, prospective, randomized, controlled, double-blind study was conducted. Among patients with localized prostate cancer with international index of erectile function-erectile function domain (IIEF-EF) score of 18 or higher before BNS-RALP, those who developed postoperative erectile dysfunction (IIEF-EF score 14 or less at 4 weeks after BNS-RALP) were enrolled. Enrolled patients were randomly assigned to the udenafil 75 mg daily group or the placebo group in a 2:1 ratio. Each subject was followed up at 8 weeks (V2), 20 weeks (V3), and 32 weeks (V4) to evaluate the efficacy and safety of udenafil. In all, 101 patients were screened, of whom 99 were enrolled. Of the 99 patients, 67 were assigned to the experimental group and 32 to the control group. Ten (14.93%) patients in the experimental group and 10 (31.25%) in the control group dropped out of the study. After 32 weeks of treatment, IIEF-EF score of 22 or higher was seen in 36.51% (23/63) of patients in the experimental group and 13.04% (3/23) patients in the control group (p=0.021). The proportion of patients with IIEF-EF improvement of 25% or more compared to the baseline was 82.54% (52/63) in the experimental group and 62.96% (17/27) in the control group (p=0.058). Udenafil 75 mg once daily after BNS-RALP improved the erectile function without any severe adverse effects.

Long Term Effectiveness and Safety of Intracavernosal Botulinum Toxin A as an Add-on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 Injections for Erectile Dysfunction

Some evidence suggests that intracavernosal botulinum toxin A (BTX-A IC) injections administered in addition to phosphodiesterase type 5 inhibitors (PDE5-Is) or prostaglandin E1 intracavernosal injections (PGE1 ICI) could effectively treat erectile dysfunction (ED) in non-responders, or insufficient responders to these pharmacologic treatments. To determine the long-term effectiveness and safety of combined treatment involving a single injection of BTX-A IC as an add on therapy to PDE5-Is or PGE1-ICI for the treatment of ED of different etiologies. A retrospective, uncontrolled, single center study was conducted. Data from 123 consecutive patients with ED who were insufficient responders to PDE5-Is or PGE1-ICI and who received onabotulinumtoxinA 100 U, abobotulinumtoxinA 250 U or 500 U IC as an add on to their current pharmacologic treatment were analyzed. All analyses were exploratory. Qualitative data were compared using the Fisher's exact test. Univariate and multivariate analysis were performed using logistic regression with Odds Ratios (OR). Only variables with P < .05 in the univariate analysis were selected for multivariate analysis. The minimally clinically important difference (relative to baseline severity of ED) in the International Index of Erectile Function-Erectile function domain (IIEF-EF) score was achieved in 50% of patients at 34 (27-42) days and in 41% at 5.9 (3.9 - 8.1) months following BTX-A IC in combination with PDE5-Is or PGE1 ICI. The severity of ED influenced response to BTX-A IC according to the multivariate analysis (OR = 0.3, IC(95%]) = (0.16 - 0.56). Neither being post prostatectomy nor the type of BTX-A affected the response. Effectiveness tended to decrease more over time with abobotulinumtoxinA 250 U than 500 U.The only side-effects were mild penile pain on injection (n = 1) and mild penile pain for 3 days following injection (n = 1); no systemic effects were reported. BTX-A IC (all types) administered as an add on to registered pharmacologic treatments improved erectile function for at least 6 months in 41% of patients with ED of varying etiologies, and was safe. A relatively large cohort of patients with ED was included, with a long follow-up period, however the study was retrospective, and uncontrolled. This study provides preliminary evidence that BTX-A IC administered as an add-on therapy for ED that is insufficiently responsive to standard therapy is effective for at least 6 months, and is safe. Randomized clinical trials are now needed to fully confirm these results.

Efficacy and safety of low-intensity pulsed ultrasound at different intervals by mechanical force in treating erectile dysfunction: a preliminary study

Objective: To study the efficacy and safety of low-intensity pulsed ultrasound (LIPUS) at different intervals by mechanical force in treating erectile dysfunction (ED). Method: Forty patients with mild to moderate ED were randomized in a 1∶1 ratio to receive 16-treatment sessions of LIPUS in group A and group B, applied 3 times per week and 2 times per week, respectively. End-point assessments were made at 8th week after treatment. Efficacy were evaluated using International Index of Erectile Function-Erectile Function domain score (IIEF-EF), Erectile Hardness Score (EHS), Self-Esteem and Relationship Questionnaire (SEAR), Sexual Encounter Profile (SEP), Global Assessment Question (GAQ), and pain were assessed by Visual Analogue Score (VAS).Treatment response was confirmed by a minimal clinically importance difference (MCID) at 8th week. Results: Compared with baseline, IIEF-EF score [(17.1±5.48 vs 23.4±3.75, P<0.05) and (18.9±4.34 vs 24.1±4.32, P<0.05)], proportion of EHS 4 [(0 vs 40%, P<0.05) and (16.7% vs 55.6%, P<0.05)], and Overall Relationship score [(50.6 vs 67.5, P<0.05) and (44.4 vs 70.1, P<0.05)] were significantly improved at 8th week in two groups, respectively. Compared with baseline, the positive responses to SEP-3 increased significantly at 8th week in two groups (50.0% vs 80.0%,P<0.05) and (44.4% vs 88.9%, P<0.05), respectively. The positive responses to GAQ-2 were 90.0% and 88.9% at 8th week in two groups, respectively. There were no significant differences in IIEF-EF, EHS, SEAR, SEP and GAQ at 8th week between two groups. There was no significant difference in treatment response using MCID between two groups at end-point (80.5% vs 77.5%). The treatment duration for full sessions were 2.5 weeks less in group A than group B. No adverse effects were reported in all cases. Conclusion: LIPUS at two different intervals is effective and safe for mild to moderate ED, and the regimen at 3 times per week can achieve quite good effect in relatively short duration,while the long-term effects is still be clarified in further study.

MP45-11 EFFECT OF ERYTHROPOIETIN ON ERECTILE FUNCTION AFTER RADICAL PROSTATECTOMY: THE ERECT RANDOMIZED CLINICAL TRIAL

Erectile dysfunction significantly impacts quality of life for men undergoing radical prostatectomy for prostate cancer. Erythropoietin is a promising neurotrophic factor for neurogenic erectile dysfunction based on preclinical and retrospective data. ERECT (NCT00737893) is a phase 2, double-blinded, randomized, placebo-controlled trial (July 2017-December 2019) evaluating the impact of perioperative erythropoietin on recovery of erectile function and other patient-reported, health-related quality of life outcomes after bilateral nerve-sparing radical prostatectomy (3, 6, 9, and 12 months). Erythropoietin (20,000 units) or saline placebo was injected subcutaneously the day before, day of, and day after surgery for 3 total doses. Of 63 patients assessed for eligibility, 56 patients were randomized. Arms (29 erythropoietin, 27 placebo) were well balanced (89.3% robotic, median age 55.5 years). International Index of Erectile Function-Erectile Function Domain (IIEF-EF) scores increased from median 12.5 at 3 months to 24.5 at 12 months. Median 2-week serum hemoglobin was higher for the erythropoietin arm compared to placebo (14.7 vs 13.6, p=0.02). There was no statistically significant difference in IIEF-EF scores at 6 months comparing erythropoietin to placebo (p=0.50) or at other time points (mixed model regression coefficient: -1.7, 95% CI -6.1-2.7, p=0.45). Excellent nerve-sparing rating (10/10) was associated with improved IIEF-EF recovery (+5.2, p=0.022). Other patient-reported, health-related quality of life domains as well as oncologic outcome and complications were similar between arms during followup. In the context of brief perioperative dosing, erythropoietin did not improve recovery of erectile function for men undergoing radical prostatectomy for prostate cancer compared to placebo. Further research to identify effective adjuncts to improve health-related quality of life for these men is needed.

Change in Frequency and Predictors of Erectile Dysfunction With Changes in the International Index of Erectile Function-Erectile Function Domain Score in Patients With ST-Elevation Myocardial Infarction: A Prospective, Longitudinal Study

BackgroundErectile dysfunction (ED) has been proposed as an early indicator for future coronary and peripheral vascular disease. AimWe aimed to investigate the longitudinal change in proportion and predictors for ED with changes in erectile function domain (EFD) of the International Index of Erectile Function-15 (IIEF-15) in patients with ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PPCI). MethodsBetween December 2018 and June 2019, 286 male patients aged between 40 and 70 years who were treated with PPCI for STEMI were included. The patients were asked to complete the IIEF-EFD form 3 days after the procedure for the evaluation of baseline erectile functions. During follow-up 3 months after the index procedure, the patients were asked to refill the IIEF-EFD form. Both baseline and third-month IIEF-EFD scores were calculated, and the patients were classified into ED severity groups as per the IIEF-EFD scores. A linear mixed model was used to identify predictors of ED at 3 months. OutcomesThis study identifies the prevalence and predictors of ED with STEMI who underwent PPCI. ResultsThe median age was 54 (range 48–61) years. The median IIEF-EFD scores at 3 days and 3 months were 25.5 (range 20.0–27.0) and 22.00 (range 18.25–25.00), respectively. Half of the patients were found to have ED with varying severity as per baseline IIEF-EFD scores. This rate increased to 79% at the 3-month follow-up visit. The IIEF-EFD scores of the patients decreased over time (P < .001). Advanced age (β = −0.603, se = 0.192, P = .002), presence of three-vessel coronary artery disease (β = −3.828, se = 0.783, P < .001), and diabetes (β = −2.934, se = 0.685, P < .001) were found to be inversely associated with the IIEF-EFD scores. Clinical ImplicationsAdvanced age, presence of three-vessel disease, and diabetes mellitus are the indicators of sexual rehabilitation needs in patients after STEMI. Strengths & LimitationsThis is the first study investigating the predictor variables for the development of ED after coronary artery disease treatment. The limitations include the lack of evaluation of anxiety and depression and the measurements of testosterone levels. ConclusionThe prevalence of ED was high among patients with coronary artery disease, and the frequency of ED increased during 3-month follow-up. Advanced age, three-vessel disease, and diabetes were significant predictors of ED with changes in IIEF-EFD score in patients with STEMI who underwent PPCI.Karabay E, Karsiyakali N, Cinier G, et al. Change in Frequency and Predictors of Erectile Dysfunction With Changes in the International Index of Erectile Function-Erectile Function Domain Score in Patients With ST-Elevation Myocardial Infarction: A Prospective, Longitudinal Study. J Sex Med 2020;17:1101–1108.

Long-term effectiveness and predictors of success of low-intensity shockwave therapy in phosphodiesterase type 5 inhibitors non-responders

ABSTRACTObjective: To evaluate the long-term (18 months) effectiveness, safety, and factors that may predict the success of low-intensity shockwave lithotripsy (Li-SWT) in patients with erectile dysfunction (ED) who fail to respond to oral phosphodiesterase type 5 inhibitors (PDE5i).Patients and Methods: This prospective study included 52 patients with ED of vascular origin who failed to respond to oral PDE5i. The International Index of Erectile Function-Erectile Function domain (IIEF-EF) and Erection Hardness Score (EHS) questionnaires were used to evaluate EF. Patients under went two Li-SWT treatment sessions per week for 3 weeks, followed by a 3-week treatment-free period, and the cycle was repeated until each patient received 12 treatment sessions. Patients were followed-up after Li-SWT at 3, 6, 12, and 18 months.Results: At the 18-month follow-up, 33 patients (63.5%) were able to achieve an erection sufficient for penetration with or without PDE5i (22 were maintained on oral PDE5i). The remaining 19 patients (36.5%) had a poor response to Li-SWT and oral PDE5i. The initial response showed some decline in 50% of the initial responders. Younger men (aged <45 years), short ED duration (<2 years), and moderate ED severity responded better to Li-SWT. There were no adverse side-effects.Conclusion: In the present study, Li-SWT was a safe and effective treatment in 63.5% of men with ED who failed to respond to oral PDE5i. Factors such as age (<45 years), ED duration (<2 years), and ED severity can predict treatment outcome in such patients.Abbreviations: CDU: colour Doppler ultrasonography; ED: erectile dysfunction; EDV: end-diastolic velocity; EF: erectile function; EHS: Erection Hardness Score; FU: follow-up; IIEF-EF: International Index of Erectile Function-EF domain; Li-SWT: low-intensity shockwave lithotripsy; PDE5i: phosphodiesterase type 5 inhibitors; PGE1: prostaglandin E1; PSV: peak systolic velocity; RI: resistive index; VOD: veno-occlusive dysfunction

Avanafil for the Treatment of men With Erectile Dysfunction: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Previous studies have reported the clinical efficacy of avanafil for erectile dysfunction (ED), but these findings are controversial. This study aims to investigate the safety and efficacy of avanafil for ED. EMBASE, PubMed, and Cochrane Library were searched extensively to obtain eligible studies. Clinical outcomes including successful vaginal penetration (SVP), successful intercourse (SI), International Index of Erectile Function-Erectile Function domain (IIEF-EF) score and treatment adverse events (TAEs) were compared using RevMan v.5.3. Eight RCTs involving 3,709 patients were included. The analysis demonstrated that compared with placebo, the SVP (RR = 3.20, 95% CI [2.60, 3.95], p < .001), SI (RR = 2.53, 95% CI [2.19, 2.92], p < .001), change in IIEF-EF score (MD = 4.57, 95% CI [3.68, 5.46], p < .001) and TAEs (RR = 1.78, 95% CI [1.38, 2.31], p < .0001) were significantly higher in the avanafil. In addition, avanafil 200 mg were higher than avanafil 100 mg in SI (RR = 0.86, 95% CI [0.75, 0.99], p = .03) and change in IIEF-EF score (MD = −1.34, 95% CI [−1.67, −1.01], p < .001), but there were no obvious differences in SVP (RR = 0.89; 95% CI [0.74, 1.08], p = .23) and TAEs (RR = 0.97, 95% CI [0.83, 1.14], p = .74) between the two doses. The present evidence suggests that avanafil (especially 200 mg) has the potential to be the drug of choice for ED, but more strict and larger sample size RCTs are need to validate the findings.

Safety and Efficacy of Intracavernosal Injections of AbobotulinumtoxinA (Dysport®) as Add on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 for Erectile Dysfunction-Case Studies.

Erectile dysfunction (ED) is a highly prevalent condition with a variety of possible risk factors and/or etiologies. Despite significant advances regarding ED pharmacological management, there are still insufficient responders to existing pharmacological treatments e.g., approximately 30% of patients are insufficient responders to phosphodiesterase type 5 inhibitors (PDE5-Is). It has been recently proposed that botulinum toxin A intracavernosally (IC) delivered could be effective in these patients. Data from a retrospective uncontrolled single center study of 47 ED patients, consecutively recruited, insufficient responders to existing pharmacological treatments e.g., PDE5-Is or IC PGE1 injections treated with IC abobotulinumtoxinA 250 or 500 U as free combination with their existing treatment have been analyzed. Response rate, according to the International Index of Erectile Function-Erectile Function domain score, 6 weeks following IC abobotulinumtoxinA in combination with prior pharmacological treatment, was 54%. Two patients have reported mild penile pain on injection or during the 3 days following injection. Therapeutic efficacy did not seem to be influenced by the etiologies and/or risk factors for ED. Conversely, the less severe ED, the higher the response rate. Preliminary evidence for the therapeutical potential with acceptable safety of IC abobotulinumtoxinA as add-on therapy for ED not sufficiently responsive to standard therapy should be confirmed in randomized clinical trials.

Meta-analysis of randomized controlled trials that assess the efficacy of low-intensity shockwave therapy for the treatment of erectile dysfunction.

Background:The aim of this study was to perform a meta-analysis of randomized controlled trials (RCTs) that evaluate the efficacy of low-intensity extracorporeal shock wave therapy (LiESWT) for the treatment of erectile dysfunction (ED).Materials and methods:A comprehensive search of PubMed, Medline, and Cochrane databases was performed from November 2005 to July 2018. RCTs evaluating efficacy of LiESWT in the treatment of ED were selected. The primary outcomes were the mean difference between treatment and sham patients in the International Index of Erectile Function-Erectile Function (IIEF-EF) domain score 1 month after treatment, and the mean change in IIEF-EF from baseline to 1 month post-treatment. The secondary analysis considered the percentage of men whose erectile hardness score (EHS) changed from <2 at baseline to >3 after treatment. All analyses used a random effects method to pool study-specific results.Results:A total of seven RCTs provided data for 607 patients. The mean IIEF-EF 1 month post-treatment ranged from 12.8 to 22.0 in the treatment group versus 8.17–16.43 in the sham group. The mean difference between the treatment and sham groups at the 1 month follow up was a statistically significant increase in IIEF-EF of 4.23 (p = 0.012). Overall, five of the seven trials provided data on the proportion of patients with baseline EHS <2 who improved to EHS >3 at 1 month post-treatment. The proportions ranged from 3.5 to 90% in the treatment group versus 0–9% in the sham group and the pooled relative risk of EHS improvement for the treated versus sham group was 6.63 (p = 0.0095). No significant adverse events were reported.Conclusions:This is the first meta-analysis that evaluates RCTs exploring LiESWT as a treatment modality strictly for ED. This therapeutic strategy appears to be well tolerated with short-term benefits. However further studies exploring specific treatment regimens and long-term outcomes are needed.

Low-Intensity Shockwave Therapy for Erectile Dysfunction.

Vasculogenic erectile dysfunction (ED) is one of the leading causes of male sexual dysfunction. In the past decade, multiple studies have examined the use of low-intensity extracorporeal shockwave therapy (Li-ESWT) for the treatment of ED. Investigate the efficacy of Li-ESWT for the treatment of ED. We reviewed the published literature, including randomized controlled trials (RCTs), meta-analyses, and select single-arm studies on the use of Li-ESWT for the treatment of ED. Changes in International Index of Erectile Function scores were evaluated in patients undergoing Li-ESWT. There is no consensus from RCTs on the efficacy of Li-ESWT for the treatment of ED. Published meta-analyses have shown significant improvement in International Index of Erectile Function-erectile function domain scores in men undergoing Li-ESWT, especially when compared to men receiving sham treatment. However, differences in treatment protocols limit the generalizability of these findings. Li-ESWT may be more beneficial in cases of mild ED or when combined with phosphodiesterase type 5 inhibitors in men with moderate to severe ED. The role of Li-ESWT in the treatment of non-vasculogenic ED remains poorly defined. Li-ESWT could be beneficial in specific sub-sets of men with vasculogenic ED. However, future RCTs should attempt to optimize treatment protocols and have more stringent inclusion criteria to confirm these findings. Rizk PJ, Krieger JR, Kohn TP, etal. Low-Intensity Shockwave Therapy for Erectile Dysfunction. Sex Med Rev 2018;6:624-630.

High prevalence of hypogonadism determined by serum free testosterone level in Japanese testicular cancer survivors.

Hypogonadism is a major complication in testicular cancer survivors, but its prevalence varies among studies. In Japan, free testosterone has been used for diagnosis of late-onset hypogonadism syndrome. In the present study, we evaluated the hormone level of testicular cancer survivors and its impact on their quality of life. Overall, 50 testicular cancer survivors treated from 1990 to 2013 were enrolled. The median age was 44 years. The serum levels of free testosterone, total testosterone and luteinizing hormone were measured. All patients completed the Aging Males' Symptom scale and International Index of Erectile Function-15. The hormone levels of 337 healthy volunteers were used as the control. A total of 32 (64%) patients showed free testosterone levels <8.5 pg/mL. In contrast, just 26% of 50 patients showed total testosterone levels <3.5 ng/mL. Testicular cancer survivors had significantly lower free testosterone and higher luteinizing hormone compared with healthy controls. In contrast, there was no difference in total testosterone between patients and controls. The prevalence of late-onset hypogonadism symptoms of any grade (Aging Males' Symptom total score ≥27) was 60%. Overall, 64% were defined as having moderate erectile dysfunction (International Index of Erectile Function-Erectile Function domain score <17). However, Aging Males' Symptom, International Index of Erectile Function-15 and Erectile Function domain scores did not differ by free testosterone or total testosterone level. This is the first report on the prevalence of hypogonadism determined by free testosterone level in Japanese testicular cancer survivors. Because Aging Males' Symptom and International Index of Erectile Function-15 scores do not necessarily reflect the hormone level, measuring free testosterone is also important in the follow up of these patients.