IIEF-EF Score Research Articles

Predictors of Male Sexual Dysfunction in Urologic Chronic Pelvic Pain Syndrome (UCPPS), Other Chronic Pain Syndromes, and Healthy Controls in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network

BackgroundSexual dysfunction (SD), including erectile (ED) and ejaculatory dysfunction, is associated with diminished quality of life (QoL) in men with UCPPS (chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and/or interstitial cystitis/bladder pain syndrome (IC/BPS)). AimWe sought to compare SD among male patients with UCPPS, other chronic pain conditions (positive controls, PC), and healthy controls (HC) without chronic pain, and to evaluate the association of comorbidities, psychosocial factors, and urologic factors of SD in all 3 groups. MethodsBaseline data from male UCPPS participants, PC (irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia) and HC enrolled in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network Epidemiology and Phenotyping Study were included in the analysis. Sexual function was assessed using the International Index of Erectile Function-Erectile Function Domain (IIEFEF) and Ejaculatory Function Scale (EFS). Male ED was defined as a composite IIEF-EF score <21. Higher EFS score indicated worse sexual dysfunction; no threshold to define SD was identified for the EFS. Multivariable logistic and linear regression was used to investigate associations of comorbidities, psychosocial factors, and urologic factors with ED and ejaculatory, respectively. OutcomesComorbidities, genital pain, and psychosocial factors are associated with SD across the study population and male patients with UCPPS had a high prevalence of ED and greater ejaculatory dysfunction. ResultsThere were 191 males with UCPPS; 44 PC; and 182 HC. Males with UCPPS had worse SD compared to PC and HC including lower mean IIEF-EF scores, greater degree of ejaculatory dysfunction, and lower quality of sexual relationships. Among all 3 cohorts, depression, stress, and pain were associated with ED in univariable and multivariable analysis, as was diabetes mellitus. Pain in the genitalia, severity of urinary symptoms, depression, stress, and history of childhood sexual trauma were associated with ejaculatory dysfunction in univariable and multivariable analysis. Clinical ImplicationsA multidisciplinary approach that addresses the identified risk factors for SD may improve overall QoL in males with UCPPS. Strengths and LimitationsOur study is strengthened by its use of validated, patient-reported questionnaires and inclusion of healthy and positive controls. Our understanding of the role of IC in this study is limited because only 1 patient in the study had IC/BPS as a sole diagnosis. ConclusionsWhen compared to healthy controls and patients with other chronic pain conditions, males with UCPPS experience higher degrees of SD, including erectile and ejaculatory dysfunction.Loh-Doyle JC, Stephens-Shields AJ, Rolston R, et al. Predictors of Male Sexual Dysfunction in Urologic Chronic Pelvic Pain Syndrome (UCPPS), Other Chronic Pain Syndromes, and Healthy Controls in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. J Sex Med 2022;19:1804–1812.

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.

Effects of Low-intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-analysis.

This present systemic review and meta-analysis was conducted to assess the effectiveness of low-intensity extracorporeal shockwave therapy (Li-ESWT) on erectile dysfunction (ED) based on the relevant randomised controlled trials (RCTs). A comprehensive search of databases, including Medline and Embase databases, from 1st January 2012 to 31st July 2020, that investigated the efficacy of Li-ESWT for ED, was searched. All the trials were divided into two groups: the experimental group received a different shockwave treatment, and the control group received the same treatment as the corresponding experimental group vibration, sound, etc) but no energy transmission. The primary endpoint was the International Index of Erectile Function-Erectile Function domain (IIEF-EF) score/questionnaire or erectile hardness score (EHS). The average IIEF-EF score was increased with statistical significance in the Li-ESWT group relative to the control group (p<0.001). Besides, the Li-ESWT group had evidently elevated changes in IIEF-EF score (p<0.001). Altogether seven articles reported the remarkably elevated EHS score with different total pulses (p<0.001). The favourable outcomes in terms of the average IIEF scores were observed in the cases developing mild or moderate ED (p<0.001). Compared with placebo treatment, Li-ESWT alleviates ED symptoms in patients, particularly those who have mild or moderate ED. Taken together, these results suggest that the Li-ESWT may hold promise for patients with ED. Key Words: Erectile dysfunction, Low-intensity extracorporeal shockwave therapy, Meta-analysis, Randomised controlled trials.

Platelet-rich plasma (PRP) improves erectile function: A double-blind, randomized, placebo-controlled clinical trial

ABSTRACT Introduction Animal studies postulate that platelet-rich plasma (PRP) injections improve key elements of the pathophysiologic mechanisms leading to erectile dysfunction (ED). Objectives To conduct the first double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of PRP injections in patients with mild and moderate ED. Methods Sixty sexually active patients with mild and moderate ED were randomly assigned to two sessions, with a one-month difference, of 10 mL PRP (n=30) or placebo (n=30) intracavernosal injections. An FDA-approved separation system was used. Patients were evaluated at one, three and six months after completion of the treatment protocol. A per-protocol analysis was applied. All participants withheld any ED treatment during the trial. The primary outcome was the achievement of minimal clinically important difference (MCID) in the International Index of Erectile Function – Erectile Domain (IIEF-EF) from baseline to six months after final treatment. Erectile function at all time points, as well as safety of PRP injections, were also evaluated. Results At six months, a MCID was achieved by 20/29 (69%) patients in the PRP group compared to 7/26 (27%) in the placebo group. The risk difference between the two groups was 42% (95%CI: 18-66), p&amp;lt;0.001 and the baseline-adjusted mean between-group-difference in the IIEF-EF score was 3.9 points (95%CI: 1.8-5.9). Similarly, a statistically significant difference of both the number of participants attaining a MCID and the IIEF-EF score was also observed at the one- and three-month evaluation between the two groups. Accordingly, patients receiving PRP were more satisfied with the treatment. No adverse events were observed during the study period. Conclusions Intracavernosal PRP injection therapy used as outlined in this trial appears to be a safe and effective short-term treatment for the management of mild to moderate ED. Therefore, it may be a promising addition to the urologist's armamentarium for the management of ED. Still, further high-quality studies are warranted to corroborate our findings. Disclosure Work supported by industry: no.

MP27-03 DELAYING POST-OPERATIVE RADIATION THERAPY AFTER RADICAL PROSTATECTOMY IS ASSOCIATED WITH INCREASED FUNCTIONAL OUTCOMES: RESULTS FROM A LARGE SINGLE, REFERRAL CENTER SERIES

You have accessJournal of UrologyCME1 May 2022MP27-03 DELAYING POST-OPERATIVE RADIATION THERAPY AFTER RADICAL PROSTATECTOMY IS ASSOCIATED WITH INCREASED FUNCTIONAL OUTCOMES: RESULTS FROM A LARGE SINGLE, REFERRAL CENTER SERIES Mario de Angelis, Elio Mazzone, Giorgio Gandaglia, Armando Stabile, Simone Scuderi, Francesco Barletta, Daniele Robesti, Luigi Nocera, Riccardo Leni, Vito Cucchiara, Marco Bandini, Emanuele Zaffuto, Nazareno Suardi, Andrea Necchi, Shahrokh F. Shariat, Francesco Montorsi, and Alberto Briganti Mario de AngelisMario de Angelis More articles by this author , Elio MazzoneElio Mazzone More articles by this author , Giorgio GandagliaGiorgio Gandaglia More articles by this author , Armando StabileArmando Stabile More articles by this author , Simone ScuderiSimone Scuderi More articles by this author , Francesco BarlettaFrancesco Barletta More articles by this author , Daniele RobestiDaniele Robesti More articles by this author , Luigi NoceraLuigi Nocera More articles by this author , Riccardo LeniRiccardo Leni More articles by this author , Vito CucchiaraVito Cucchiara More articles by this author , Marco BandiniMarco Bandini More articles by this author , Emanuele ZaffutoEmanuele Zaffuto More articles by this author , Nazareno SuardiNazareno Suardi More articles by this author , Andrea NecchiAndrea Necchi More articles by this author , Shahrokh F. ShariatShahrokh F. Shariat More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Alberto BrigantiAlberto Briganti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002570.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Previous studies reported a detrimental effect of postoperative radiotherapy (RT) on functional outcomes in men treated with radical prostatectomy (RP). However, it is still unclear whether an optimal timing to mitigate such detrimental effect may exist. We explored the correlation between time from RP to RT on urinary continence (UC) and erectile function (EF) recovery. METHODS: We evaluated 3,867 men treated with RP between 2000 and 2018 at a single center and stratified for RT schedule (adjuvant RT [aRT], salvage RT [sRT], no RT). We examined EF and UC recovery rates at 3-year according to RT schedule, and according to time from RP to RT. UC recovery was defined as no pad use, while IIEF-EF score ≥22 defined EF recovery. Multivariable Cox regressions tested predictors of functional outcomes. Covariates consisted of type of approach (robotic vs open), nerve-sparing status, preoperative EF and UC status and year of surgery. The correlation between time from RP to RT and UC and EF recovery rates at 3-yr was explored using the Lowess function. RESULTS: Overall, 3032 (79%) received no postoperative RT, while 456 (12%) and 336 (9%) men underwent aRT or sRT. Median time to aRT and sRT were 4 and 24 months, respectively. The 3-year EF rates were 35%, 29% and 12% in men who received no RT, sRT and aRT (p <0.001). The 3-year UC rates were 84%, 60% and 70% in patients who received no RT, aRT and sRT (p <0.001). Cox regressions confirmed the negative impact of RT type on UC (aRT OR 0.51 p<0.001; sRT OR 0.71 p=0.009) and EF (aRT OR 0.27 p<0.001; sRT OR 0.58 p<0.001) recovery. At Lowess analysis, UC recovery was lower when men received postoperative RT within 18 months after RP, thereafter a substantial plateau of 3-yr UC was recorded. Similarly, the predicted 3-yr EF recovery rate progressively increased with delayed RT from RP, with rates ranging from 8 to 33% but without reaching a plateau (Fig. 1A-B). CONCLUSIONS: Postoperative RT was strongly associated with lower rates of UC and EF recovery. A variable correlation with time to RT was observed. Particularly, when postoperative RT is planned, UC recovery could be optimized if RT is administered later than 18 months from surgery. Conversely, for EF recovery, a linear correlation with time to RT was observed. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e450 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mario de Angelis More articles by this author Elio Mazzone More articles by this author Giorgio Gandaglia More articles by this author Armando Stabile More articles by this author Simone Scuderi More articles by this author Francesco Barletta More articles by this author Daniele Robesti More articles by this author Luigi Nocera More articles by this author Riccardo Leni More articles by this author Vito Cucchiara More articles by this author Marco Bandini More articles by this author Emanuele Zaffuto More articles by this author Nazareno Suardi More articles by this author Andrea Necchi More articles by this author Shahrokh F. Shariat More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Expand All Advertisement PDF DownloadLoading ...

MP21-12 STILL ONE OUT OF FIVE MEN PRESENTING FOR ERECTILE DYSFUNCTION ARE YOUNG THAN 40 YEARS OF AGE: FINDINGS OF A REAL-LIFE CROSS-SECTIONAL STUDY OVER LAST DECADE

You have accessJournal of UrologyCME1 May 2022MP21-12 STILL ONE OUT OF FIVE MEN PRESENTING FOR ERECTILE DYSFUNCTION ARE YOUNG THAN 40 YEARS OF AGE: FINDINGS OF A REAL-LIFE CROSS-SECTIONAL STUDY OVER LAST DECADE Edoardo Pozzi, Paolo Capogrosso, Giuseppe Fallara, Luca Boeri, Christian Corsini, Daniele Cignoli, Massimiliano Raffo, Luigi Candela, Nicolò Schifano, Alessia d'Arma, Rayan Matloob, Federico Dehò, Vincenzo Mirone, Francesco Montorsi, and Andrea Salonia Edoardo PozziEdoardo Pozzi More articles by this author , Paolo CapogrossoPaolo Capogrosso More articles by this author , Giuseppe FallaraGiuseppe Fallara More articles by this author , Luca BoeriLuca Boeri More articles by this author , Christian CorsiniChristian Corsini More articles by this author , Daniele CignoliDaniele Cignoli More articles by this author , Massimiliano RaffoMassimiliano Raffo More articles by this author , Luigi CandelaLuigi Candela More articles by this author , Nicolò SchifanoNicolò Schifano More articles by this author , Alessia d'Arma Alessia d'Arma More articles by this author , Rayan MatloobRayan Matloob More articles by this author , Federico DehòFederico Dehò More articles by this author , Vincenzo MironeVincenzo Mirone More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Andrea SaloniaAndrea Salonia More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002554.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Erectile dysfunction (ED) has been demonstrated to be reasonably prevalent among young men (≤40 yr). We aimed to i) assess changes in patterns of reported ED in men ≤40 yr, and ii) compare the sociodemographic and clinical characteristics of ED men ≤40 yr vs. >40 yr of age over a 8-yr period at a single academic centre. METHODS: Data of 1179 patients seeking first medical help for ED and assessed by a single Sexual Medicine expert between 2013 and 2021 were analysed. All patients completed the IIEF at baseline. Descriptive statistics tested the sociodemographic and clinical characteristics of ED men ≤ 40 yr vs. > 40 yr of age. Within the two groups, multivariable linear regression models tested the association between advancing age and IIEF scores. Local polynomial regression models were applied to explore and graphically display ≤ 40 yr patients’ likelihood to report ED over the analysed time frame and to display changes of the IIEF-EF scores over increasing age between the two groups. RESULTS: Overall, median (IQR) age was 52 (41-62) yr. Median (IQR) IIEF-EF was 18 (15-22) at baseline. Of all, 268 (22.7%) were ≤40 yr whereas 911 (77.3%) were >40 yr at baseline. Rates of severe ED according to IIEF-EF did not differ between men ≤40 yr and >40yr (60 (22.4%) vs. 155 (17%)). No significant differences were found for the IIEF domains (-IS, -OS, -SD) but IIEF-OF domains, which scored higher in younger men (9 () vs. 8 (), p=0.002). At baseline, younger patients reported less comorbidities, less active smoking, lower BMI, higher total testosterone (tT) levels than older patients (all p<0.005). At linear regression models, within the ≤ 40 yr group, increasing age was not associated with changes across all IIEF domains. In contrast, in men > 40 yr, increasing age was linearly correlated with decreasing IIE-EF (all p<0.001), after adjusting for tT, BMI, CCI, smoking and arterial hypertension. Figure 1 graphically displays a stable 8-yr temporal trend of ≤40 yr ED patients. CONCLUSIONS: One out of five men seeking first medical help for ED at a single academic centre were younger than 40 yr. This trend has remained stable over the last 8-years. Increasing age among younger patients is not associated with worse erectile function as oppositely occurs among patients > 40 yr. Source of Funding: N/A © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e331 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Edoardo Pozzi More articles by this author Paolo Capogrosso More articles by this author Giuseppe Fallara More articles by this author Luca Boeri More articles by this author Christian Corsini More articles by this author Daniele Cignoli More articles by this author Massimiliano Raffo More articles by this author Luigi Candela More articles by this author Nicolò Schifano More articles by this author Alessia d'Arma More articles by this author Rayan Matloob More articles by this author Federico Dehò More articles by this author Vincenzo Mirone More articles by this author Francesco Montorsi More articles by this author Andrea Salonia More articles by this author Expand All Advertisement PDF DownloadLoading ...

PD23-12 A DETAILED CHARACTERIZATION OF MEN WITH PEYRONIE’S DISEASE AND NO ASSOCIATED RISK FACTORS

You have accessJournal of UrologyCME1 May 2022PD23-12 A DETAILED CHARACTERIZATION OF MEN WITH PEYRONIE’S DISEASE AND NO ASSOCIATED RISK FACTORS Christian Corsini, Paolo Capogrosso, Edoardo Pozzi, Federico Belladelli, Giuseppe Fallara, Massimiliano Raffo, Daniele Cignoli, Luigi Candela, Nicolò Schifano, Alessia d'Arma, Luca Boeri, Eugenio Ventimiglia, Rayan Matloob, Federico Dehò, Francesco Montorsi, and Andrea Salonia Christian CorsiniChristian Corsini More articles by this author , Paolo CapogrossoPaolo Capogrosso More articles by this author , Edoardo PozziEdoardo Pozzi More articles by this author , Federico BelladelliFederico Belladelli More articles by this author , Giuseppe FallaraGiuseppe Fallara More articles by this author , Massimiliano RaffoMassimiliano Raffo More articles by this author , Daniele CignoliDaniele Cignoli More articles by this author , Luigi CandelaLuigi Candela More articles by this author , Nicolò SchifanoNicolò Schifano More articles by this author , Alessia d'ArmaAlessia d'Arma More articles by this author , Luca BoeriLuca Boeri More articles by this author , Eugenio VentimigliaEugenio Ventimiglia More articles by this author , Rayan MatloobRayan Matloob More articles by this author , Federico DehòFederico Dehò More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Andrea SaloniaAndrea Salonia More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002565.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The actual aetiology of Peyronie’s Disease (PD) is still unknown. Although several associated risk factors have been identified (e.g., penile trauma, hypertension, diabetes mellitus, smoking, etc.) some patients develop PDdespite the absence of commonly recognised risk factors. We aimed to investigate the rate of and the clinical characteristics of men with PD and no risk factors versus patients with PD and at least 1 risk factor. METHODS: Complete demographic, clinical and laboratory data from 566 patients seeking first medical help for PDbetween 2015-2021 at a single tertiary-referral center were analysed. Every patient completed the IIEF-15 and PDQ questionnaires. Descriptive statistics was used to compare categorical and continuous variables, between the entire cohort segregated according to the presence of known risk factors, such as: diabetes, dyslipidemias, hypertension, ischemic cardiopathy, autoimmune diseases (e.g., Dupuytren’s disease or other connective tissue diseases), previous pelvic surgery (e.g., radical prostatectomy), smoking, alcohol consumption (>1L/week), erectile disfunction (ED), and low testosterone levels (< 3 ng/mL). Health-significant comorbidities were scored with the Charlson Comorbidity Index (CCI). In order to better measure the degree of curvature after intra cavernous injection (ICI) and evaluate the penile haemodynamic (peak systolic velocity (PSV) < 35 cm/s and/or resistance index (RI) ≤ 0.80 at 20 minutes after ICI), dynamic penile color doppler duplex ultrasound (CDDU) was suggested to all patients. RESULTS: Of 566, 96 (17%) patients did not report any associated comorbidity or risk factor, and none had a positive clinical history for penile trauma. No differences were found between groups in terms of PDQ scores in each PDQ subscale (i.e., Pain, Bother and Symptoms) and serum hormones. Patients with no risk factors had lower age (median (IQR) 48 (34, 56) vs. 58 (48, 64) yrs; p<0.001), BMI (23.7 (22.0, 26,2) vs. 25.4 (23.7, 27.8) kg/m^2; p<0.001) and CCI (CCI≥1 in 3 (3%) vs. 47 (10%) patients; p=0.04). IIEF-EF was lower in patients with known risk factors (median (IQR) IIEF-EF score 20 (9, 27) vs. 26 (16.50, 28.50); p=0,03). At CDDU, patients with no risk factors for PD had worse degree of curvature (70 (52.5, 90.0) vs. 50 (30, 80) degrees; p=0.02), better PSV values (44.6 (41.7, 53.2) vs. 37.9 (30.9, 42.1) cm/s; p=0,01) and comparable RI values. CONCLUSIONS: Approximately one out of five men presenting for PD had no risk factors or known associated comorbidity. To our knowledge, this is the first study highlighting the clinical characteristics of this subgroup of patients. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e414 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Christian Corsini More articles by this author Paolo Capogrosso More articles by this author Edoardo Pozzi More articles by this author Federico Belladelli More articles by this author Giuseppe Fallara More articles by this author Massimiliano Raffo More articles by this author Daniele Cignoli More articles by this author Luigi Candela More articles by this author Nicolò Schifano More articles by this author Alessia d'Arma More articles by this author Luca Boeri More articles by this author Eugenio Ventimiglia More articles by this author Rayan Matloob More articles by this author Federico Dehò More articles by this author Francesco Montorsi More articles by this author Andrea Salonia More articles by this author Expand All Advertisement PDF DownloadLoading ...

Peyronie's Disease Does Not Significantly Impact Patient-Reported Outcomes After Penile Prosthesis Implantation

ABSTRACT Introduction Penile prosthesis (PP) implantation with concurrent straightening maneuvers is the gold standard surgical therapy for men with Peyronie's Disease (PD) and concurrent medication-refractory ED. Satisfaction rates exceed 80-90% in modern series. PD is characterized by other bothersome effects on penile morphology (i.e. penile shortening) that also negatively impact patient satisfaction with PP. We hypothesized that men with both PD+ED would report lower overall satisfaction with PP implantation compared to those with ED alone. Objective To compare patient outcomes in a cohort of patients undergoing PP implantation for ED with and without concurrent PD. Methods We identified all patients who underwent PP implantation by a single surgeon between May 2012 and August 2019 (n=354). A retrospective chart review was performed to evaluate pertinent clinical demographics and surgical outcomes. A survey was mailed to all patients in July 2019. This included validated ED questionnaires (IIEF, EDITS, and QOLSP) and clinician-derived questions to evaluate subjective outcomes. Survey results were compared between those patients with and without a history of PD, using two-sample student t- and chi-squared tests (p-value &amp;lt; 0.05 considered significant). Results 79 patients completed the survey (response rate 22%), including 38 (48%) with PD+ED. Mean survey follow-up duration was 45.5 (SD 19.5) months. There was no significant difference in patient demographics amongst those patients who did and did not respond to the survey. Amongst survey respondents, the mean preoperative IIEF-EF score was significantly higher for patients with PD+ED (10.2; SD 9.1) compared to those with ED alone (3.9; SD 5.0, p=0.003). Respondents with a history of both PD+ED were also less likely to have previously used oral therapy and intracavernosal injection to treat ED prior to PP implantation (p&amp;lt;0.009). For those respondents with PD+ED, mean preoperative curvature was 59O (SD 43). Adjunctive straightening maneuvers at the time of PP implantation included manual modeling (87%), plication (5%), and incision/grafting (50%). Overall, device infection occurred in 4/79 patients (5%), and mechanical malfunction occurred in 3/79 (4%). 87% of all survey respondents felt their ED was “very much” or “much” improved. 80% stated they would recommend PP to a friend. 60% reported postoperative penile length loss, but only 35% were “dissatisfied” with current length and only 20% were dissatisfied with penile girth. In those with PD+ED, 91% were satisfied with the degree of penile straightening. There was no significant difference in patient-reported outcomes pertaining to length, girth, and overall satisfaction between those with and without PD. The mean follow-up IIEF-EF was 27.4 (SD 5.7), mean EDITS was 18 (SD 8), and mean QOLSP was 55 (SD 15). Once again, there was no significant difference in these outcomes based on the presence of PD. Conclusions PP results in high rates of patient satisfaction. The presence of concurrent PD, even amongst those requiring adjunctive maneuvers, does not appear to significantly impact patient outcomes. While there are inherent limitations to a survey-based study including reporter bias, these results support the use of PP and concurrent straightening as an excellent treatment option for men with PD and ED. Disclosure Yes, this is sponsored by industry/sponsor: This project was funded by an investigator-initiated grant from Coloplast Corporation. Clarification: Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast Corporation (Dr. Laurence Levine - consultant); Boston Scientific (Dr. Laurence Levine - Consultant)

Effect of Stem Cell Infusion Therapy on Sexual Function in Men and Women with Type 2 Diabetes and Metabolic Syndrome: Results from the ACESO & CERES Clinical Trials

ABSTRACT Introduction Despite growing interest in restorative therapies for sexual function, there exists a paucity of human research into potential therapeutic applications of stem cell therapy (SCT). Mesenchymal Stem Cells (MSCs) and its effects on sexual function have not yet been explored in patients with Type 2 Diabetes Mellitus (DM) and Metabolic Syndrome (MetS) Objective To determine the effect of stem cell infusion therapy on sexual function in men and women with DM or MetS. Methods We used International Index of Erectile Function (IIEF-15) collected from men and Sexual Quality of Life Questionnaire-Female (SQOL-F) collected from women enrolled in the ACESO (NCT02886884) and CERES (NCT03059355) pilot/phase I clinical trials. Participants were enrolled in the trials based on diagnosis of DM or MetS, respectively, and endothelial dysfunction - defined as Brachial Artery Flow Mediated Vasodilation (FMD) &amp;lt;7%. Intervention in both trials was peripheral intravenous infusion of allogeneic MSCs. Follow-up was for 1 year. Questionnaires were collected at baseline and at 1-, 3-, 6-, and 12-months post-infusion. Participants received 20 or 100 million MSCs from either bone marrow (n=21) or umbilical cord (n=6). We performed subgroup analyses evaluating dose, source, and study diseases. Descriptive and analytic statistics were used to analyze the data. Results Data was pooled from 20 men and 7 women from the two trials. Overall, 14 received 100 million MSCs and 13 received 20 million MSCs. Median age was 61 [IQR=55-73] years. Incidence of hypertension, coronary artery disease, smoking and alcohol use were similar among each trial. Erectile dysfunction (ED) was defined by an IIEF-Erectile Function (IIEF-EF) sub-domain score ≤24 at baseline (n=16). Among men with ED, median IIEF-EF score at baseline was 5 [IQR=2-17], 6 [IQR=3-17] at 1 month, 3 [IQR=2-8] at 3 months, 4 [IQR=3-13] at 6 months, and 5.5 [IQR=2-16] at the end of 12 months (p=0.8127). Subgroup analyses revealed no changes in erectile function in either treatment dose. Similar patterns were found in other IIEF sub-domains, except median sexual desire score which increased among all men from 1-3 months post-infusion, then subsided from 6-12 months (p=0.4723). SQOL-f is a validated self-assessment questionnaire rated on a six-point scale in which higher scores reflect better female sexual quality of life. Median SQOL score among all women at baseline was 30 [IQR=19-50], 25 [IQR=23-36] at 1 month, 34 [IQR=19-46] at 3 months, 29 [IQR=21-32] at 6 months, and 34 [IQR=26-49] at the end of 12 months (p=0.8866). Main limitations of this study include the small sample size, sexual function was not a primary endpoint, and the absence of a placebo comparison arm. Conclusions Neither ED or SQOL appears to have improved following peripheral infusion of MSCs in patients with DM and MetS, but nevertheless appears to be safe with no decline in sexual function over 1 year. The optimal route, source, and dose of SCT to enact a meaningful change in sexual function in different patient populations has yet to be determined and deserves further research in future larger randomized clinical trials. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Longeveron LLC

Could COVID-19 Induced Endothelial Dysfunction Explain New Onset Peyronie's Disease?

IntroductionCoronavirus Disease 2019 (COVID-19) is an emerging infectious disease caused by a novel coronavirus (SARS-CoV-2) which has been found to cause systemic inflammation in some patients. Many possible long-term sequelae of COVID-19 have yet to be identified. Since endothelial cells have both angiotensin-converting enzyme 2 (ACE2) and transmembrane protease, serine 2 (TMPRSS2) receptors, and SARS-CoV-2 requires both receptors for cell entry, we hypothesized that widespread endothelial damage caused by COVID-19 infection leads to Peyronie's disease (PD).ObjectiveNew-onset PD after resolved COVID-19 infection was evaluated.MethodsThis study was performed after Institutional Review Board approval. After comprehensive history and physical exam, penile duplex was used to evaluate blood flow and characterize any plaques. International Index of Erectile Function (IIEF) was used to evaluate erectile function. Brachial artery flow-mediated dilation (FMD) and endothelial progenitor cell – colony forming units (EPC-CFU) assays were utilized as measures of endothelial function. Available data from two separate control groups were used for comparisons: “No PD” contains subjects with a history of cardiovascular disease and normal erectile function according to IIEF-EF score (n=27). This group was selected to serve as a negative control with endothelial dysfunction. A second control group “Healthy Controls” was selected as a positive control containing male participants who were free from any significant cardiovascular medical history (n=9).ResultsNew-onset PD after resolution of COVID-19 infection was identified in one patient. The penile duplex with erectogenic agents demonstrated normal vascular flow with presence of calcified plaques. The PD group median EPC-CFU levels were 0 as compared to 1.60 in the no PD (negative control) group and 20.00 in healthy (positive) controls. Similarly, median FMD% was impaired in the PD group (2.35%) and no PD group (3.88%) as compared to healthy controls (7.75%).ConclusionsThese findings reveal a novel mechanism for PD after resolution of COVID-19 infection. These findings have significant clinical and biological implications for males with PD and should be considered as a possible sequela of COVID-19 infection.DisclosureAny of the authors act as a consultant, employee or shareholder of an industry for: Acerus Pharmaceuticals, Boston Scientific, Coloplast, Endo Pharmaceuticals, Empower Pharmacy, Nestle Health, Olympus

Sexual dysfunction in patients with late complications of hypospadias surgery.

Most hypospadias cases are successfully treated in childhood. Still, patients with sequelae of failed hypospadias repair and sexual dysfunction may be encountered. We evaluated 112 patients with a history of failed hypospadias repair, defined as the presence of voiding symptoms or cosmetic problems remaining despite previous surgery or caused by it. Patients' median age was 29.5years (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. About 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.

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.

Adjuvant daily therapy with L-arginine 2,500 mg and tadalafil 5 mg increases efficacy and duration of benefits of low-intensity extracorporeal shock wave therapy for erectile dysfunction: A prospective, randomized, single-blinded study with 1-year follow-up.

PurposeTo investigate a therapeutic protocol for erectile dysfunction (ED) based on the combination of low-intensity extracorporeal shock wave therapy (Li-ESWT), tadalafil, and L-arginine.Materials and MethodsRecruited patients completed the International Index of Erectile Function erectile function domain (IIEF-EF) and the Erection Hardness Score (EHS) questionnaires at baseline and were randomly assigned in two groups: A (treatment group) and B (control group). Men in both groups received six weekly applications of Li-ESWT. Group A was prescribed adjuvant oral therapy with tadalafil 5 mg and L-arginine 2,500 mg. Follow-up visits were scheduled 1, 6, and 12 months after the last Li-ESWT application. At each follow-up visit, the IIEF-EF and EHS questionnaires were administered again. The main outcome measures were the changes from baseline to every follow-up visit in IIEF-EF and EHS scores.ResultsThe mean IIEF-EF score in group A was 16.0±4.0, 24.8±3.4, 23.3±4.6, and 21.6±5.5 at baseline, 1, 6, and 12 months of follow-up, respectively, whereas in group B the mean IIEF-EF score was 16.5±4.1, 22.7±4.2, 21.5±4.5, and 19.5±4.9, respectively. We reported an increase in the mean EHS score in group A from 2.07±0.72 at baseline to 3.39±0.59, 3.17±0.67, and 2.98±0.72 at 1, 6, and 12 months, respectively, and in group B from 2.12±0.80 at baseline to 3.07±0.78 and 2.95±0.76 at 1 and 6 months, respectively.ConclusionsAdjuvant daily therapy with L-arginine 2,500 mg and tadalafil 5 mg was safe and effective in increasing the efficacy and the duration of benefits of Li-ESWT.

A single-centre result of two courses of low-intensity shockwave therapy (Li-SWT) in erectile dysfunction.

The purpose of this study is to evaluate the results of two courses of low-intensity shock wave therapy (Li-SWT) in the treatment of patients with erectile dysfunction (ED). Between June 2015 and December 2020, diabetic and non-diabetic patients with ED treated with two Li-SWT courses were evaluated retrospectively among the data of 317 patients. The outcomes were evaluated using the International Index of Erectile Function-Erectile Function Domain (IIEF-EF) questionnaire values at baseline and 6months post-treatment for each Li-SWT course with (0.09mJ/mm²) 18000 shock waves. Successful treatment criteria for patients who also underwent physical examination and anamnesis before and after each course were IIEF-EF scores≥26 during the 6months follow-up. Forty-one patients with a mean age of 51.61±11.80years were included in the study. The mean IIEF-EF scores were 15.17±3.75 at baseline, 21.61±3.60 after the first course [mean difference(MD): -6.439; 95%, confidence interval(CI), -7.138: -5.740; t=-18.621; p<0.001], and 25.27±4.05 after the second course(MD: -3.658; 95% CI, -4,067: -3.249; t=-18,071; p<0.001). Evaluation of score increases in diabetic patients was also statistically significant for each course (p<0.001). Our study shows that two courses of Li-SWT treatments are safe for both diabetic and non-diabetic patients with ED and effective for each course.

Sexual Function in Men Living With a Fontan Circulation.

Introduction: It is unknown if the Fontan circulation has an impact on sexual health in men. This study assessed self-reported sexual health and fertility in men with a Fontan circulation.Aims: In this prospective, cross-sectional study, Australian men ≥18 years enrolled in the Fontan Registry of Australia and New Zealand were invited to complete the International Index of Erectile Function (IIEF), alongside questions assessing fertility. These data were compared to historical, age-matched controls.Results: Of 227 eligible men, 54 completed the survey; of those 37 were sexually active and included in the final analysis. Mean age was 28 ± 3 years, age at Fontan was 5 ± 3 years. Fontan type was extra-cardiac conduit in 15 (41%), lateral tunnel in 12 (32%), and atriopulmonary connection (APC) in 10 (27%). Ventricular function was normal in 24 (83%), and all were New York Heart Association Class I (23 patients, 79%) and II (six patients, 21%). Nine participants (24%) had erectile dysfunction (IIEF-EF score ≤25). The severity was mild (IIEF 22–24) in six (16%), mild–moderate (IIEF 17–21) in two (5%), and moderate (IIEF 11–16) in one (3%). Baseline characteristics and current medication usage were similar in those with and without erectile dysfunction. Compared with historical control values, erectile function was not significantly impaired in the Fontan population (p =0.76). Men with a Fontan circulation had decreased levels of sexual desire and overall satisfaction (p < 0.001). There was no correlation between the presence of erectile dysfunction and any assessed parameter. Eleven (30%) of the cohort reported a pregnancy with a prior partner.Conclusion: In our cohort, overall erectile function was comparable between men with a Fontan circulation and historical controls, however sexual desire and overall satisfaction were reduced. There was no correlation between study parameters and the presence of erectile dysfunction. The proportion of the cohort who had a prior pregnancy was congruent with population data.

Low-intensity extracorporeal shockwave therapy for erectile dysfunction: an overview of systematic reviews.

BackgroundLow-intensity extracorporeal shockwave therapy (LI-ESWT) may be a successful complementary treatment approach for erectile dysfunction (ED). In this study, we aimed to review and summarize the research evidence from systematic reviews (SRs)/meta-analyses (MAs) regarding the clinical effectiveness of LI-ESWT for ED.MethodsStudies on LI-ESWT for ED were searched using eight electronic databases from establishment of each database to 31 June 2021 with the language restrictions of Chinese and English. All articles were screened, and qualifying data were recorded based on the inclusion criteria. Methods including: the Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2); the Risk of Bias in Systematic Reviews (ROBIS); the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA); and Grading of Recommendations, Assessment Development, and the Evaluation (GRADE) were used by two independent raters to assess methodological quality, risk of bias, reporting quality, and SR evidence of quality, respectively.ResultsEight SRs/MAs met all inclusion criteria. Seven reviews were rated as critically low on overall confidence and one review was low on confidence based on the AMSTAR-2 appraisal tool. While most PRISMA criteria were met, the major reporting flaws were in relation the financial statements not being included, along with no protocol registrations. Three SRs/MAs were classed as low risk regarding bias as measured by the ROBIS tool. Based on the GRADE method, only one SRs/MAs of high-quality evidence and seven SRs/MAs of moderate-quality evidence were found. The present research results supported LI-ESWT as a complementary therapy for ED patients, but the evidence should be considered carefully due to the methodological flaws identified.DiscussionOur results showed that LI-ESWT as an adjunctive therapy has benefits for ED patients. There were no obvious side effects, and the number of shockwave treatments and energy flux density (EFD) would affect the IIEF-EF, EHS and PSV scores. However, due to the limited sample size and the quality of reporting evidence, our conclusions may not be fully representative.

Comparison of the efficacy of low-intensity shock wave therapy and its combination with platelet-rich plasma in patients with erectile dysfunction.

We aimed to compare the efficacy of low-intensity shock wave therapy (Li-SWT) alone and its combination with platelet-rich plasma (PRP) in the treatment of patients with erectile dysfunction (ED). Between January 2015 and October 2020, patients who did not benefit from the use of phosphodiesterase type 5 inhibitors (PDE5i; 5mg/day) for at least 3months and underwent Li-SWT or Li-SWT with PRP were evaluated retrospectively. There were 93 patients who were subjected to Li-SWT only (Group 1) and 91 patients subjected to Li-SWT with PRP (Group 2). Analysis of the International Index of Erectile Function-Erectile Function Area (IIEF-EF) scores showed a significant increase in both the groups post-treatment (Group 1: from 14.33±4.39 to 23.8±4.37, p=.001; Group 2: from 17.82±3.44 to 26.3±2.55, p=.001). When the increase in the IIEF-EF scores was compared pre- and post-treatment between the groups with respect to the ED grades, there was no statistically significant difference between them. Furthermore, while the intravaginal ejaculatory latency time (IELT) in successfully treated patients of Group 1 remained the same, Group 2 presented 1.5-3.5 times (mean, 2.4) prolongation. Their mean IELT score showed an increase from 2.2 (0.8-3.5)min to 5.3 (2.8-10.5)min. Our study shows that combination treatment of Li-SWT with PRP injections is not only safe for patients with ED, but also effective and safe in prolonging the IELT.

The impact of extracorporeal shock wave therapy for the treatment of young patients with vasculogenic mild erectile dysfunction: A prospective randomized single-blind, sham controlled study.

Low-intensity extracorporeal shock wave therapy (ESWT) for the treatment of vasculogenic erectile dysfunction (ED) has emerged as a promising method directly targeting the underlying pathophysiology of the disease. To compare outcomes in ED patients after ESWT and placebo treatment. Prospective randomized placebo-controlled single-blinded trial on 66 patients with mild ED. The study comprised a 4-week washout phase, a 4-week treatment phase, and a 48-week follow-up. Inclusion criteria included age between 18 and 75years and diagnosis of mild ED (IIEF-EF score=17-25) being made at least six months prior to study inclusion and being confirmed by Penile Doppler ultrasonography (US) at baseline examination. Efficacy endpoints were changes from baseline in patient-reported outcomes of erectile function (International Index of Erectile Function domain scores [IIEF-EF]), as well as erection hardness and duration (Sexual Encounter Profile diary [SEP] and Global Assessment Questions [GAQ]). Safety was assessed throughout the study. A total of 66 enrolled patients were allocated to ESWT (n=44) or placebo (n=22). Mean age of ESWT and placebo group was 42.32±9.88 and 39.86±11.64 (p=0.374), respectively. Mean baseline IIEF-EF scores of ESWT group and placebo were 20.32±2.32 and 19.68±1.55 respectively (p=0.34). At 3-months follow-up, mean IIEF-EF scores were significantly higher in ESWT patients than in placebo patients (23.10±2.82 vs. 20.95±2.19, p=0.003), and IIEF-EF scores of ESWT patients remained high during the 6months (22.67±3.35 vs. 19.82±1.56) follow-up. The percentage of patients reporting both successful penetration (SEP2) and intercourse (SEP3) in more than 50% of attempts was significantly higher in ESWT-treated patients than in placebo patients (p=0.001). A minimal clinically important difference between the IIEF=EF baseline and 3-months follow-up was found in 74% of ESWT and 36% of placebo. No serious adverse events were reported. ESWT significantly improved the erectile function of relatively young patients with vasculogenic mild ED when compared to placebo and the beneficial effect of this treatment up to 6months. These findings suggest that ESWT could be a useful treatment option in vasculogenic ED.

Estradiol-Testosterone Imbalance Is Associated with Erectile Dysfunction in Patients with Klinefelter Syndrome.

Erectile dysfunction (ED) is a frequent sexual disorder in adult men. Klinefelter syndrome (KS) is the most common sex chromosomal disorder and a frequent cause of male hypogonadism. Psychological and cognitive aspects are quite typical in KS and have been linked to ED, while the role of testosterone (T) levels in sexual function of KS subjects has not been fully elucidated. The purpose of the present study is to investigate the role of hormonal disturbances in erectile function of subjects with KS. We conducted a retrospective study involving 52 Klinefelter patients newly diagnosed who never received androgen replacing therapy. All the subjects underwent medical history, accurate physical examination, and blood tests. The International Index of Erectile Function questionnaire (IIEF-EF) score correlated negatively with estradiol/testosterone ratio (E2/T); this correlation remained statistically significant after correction for age (ρ −0.320 p = 0.018). A multiple linear regression analysis identified age and E2/T as the main predictors of IIEF-EF score (R2 0.169 F = 3.848 p = 0.008). Our findings corroborate previous KS data obtained in the general population showing an association between higher E2/T ratio and impaired erectile function. Larger studies are required to better elucidate the pathophysiology of ED in patients with KS.

Platelet-Rich Plasma (PRP) Improves Erectile Function: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Animal studies postulate that platelet-rich plasma (PRP) injections improve key elements of the pathophysiologic mechanisms leading to erectile dysfunction (ED). To conduct the first double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of PRP injections in patients with mild and moderate ED. Sixty sexually active patients with mild and moderate ED were randomly assigned to two sessions, with a one-month difference, of 10 mL PRP (n=30) or placebo (n=30) intracavernosal injections. An FDA-approved separation system was used. Patients were evaluated at 1, 3 and 6 months after completion of the treatment protocol. A per-protocol analysis was applied. All participants withheld any ED treatment during the trial. The achievement of minimal clinically important difference (MCID) in the International Index of Erectile Function - Erectile Domain (IIEF-EF) from baseline to 6 months after final treatment. Erectile function at all time points, as well as safety of PRP injections, were also evaluated. At 6 months, a MCID was achieved by 20/29 (69%) patients in the PRP group compared to 7/26 (27%) in the placebo group. The risk difference between the two groups was 42% (95%CI: 18-66), P < 0.001 and the baseline-adjusted mean between-group-difference in the IIEF-EF score was 3.9 points (95%CI: 1.8-5.9). Similarly, a statistically significant difference of both the number of participants attaining a MCID and the IIEF-EF score was also observed at the 1- and 3-month evaluation between the two groups. Accordingly, patients receiving PRP were more satisfied with the treatment. No adverse events were observed during the study period. Intracavernosal PRP injection therapy used as outlined in this trial appears to be a safe and effective short-term treatment for the management of mild to moderate ED. We conducted the first clinical trial exploring the role of PRP in the management of ED. Conversely, our findings lack external validity due to single-center design. Furthermore, our results cannot be extrapolated to other PRP separation systems. PRP intracavernosal injections may be a promising addition to the urologist's armamentarium for the management of ED. Still, further high-quality studies are warranted to corroborate our findings. Evangelos P, Mykoniatis I, Pyrgidis N, etal. Platelet-Rich Plasma (PRP) Improves Erectile Function: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial. J Sex Med 2021;18:926-935.