Molecular and diffusion features for identification of clinically significant prostate cancer in PI-RADS 3 lesions.

BACKGROUND: The recommendation to perform biopsy of PIRADS 3 lesions has not been adopted with strength as compared to higher scored lesions on multiparametric MRI. This represents a challenging scenario and an unmet need for clinicians to apply a risk adapted approach in these cases. In the present study, we examined clinical and radiologic characteristics in men with PI-RADS 3 index lesions that can predict csPCa on mpMRI-target biopsy. METHODS: Revision of a prospective database with patients who underwent targeted and systematic biopsies from 2015 to 2023 for PI-RADS 3 lesions identified on mpMRI. Baseline variables were collected, such as PSA density (PSAd), 4Kscore, prostate size, and the apparent diffusion coefficient (ADC) value of the lesion on mpMRI. Logistic regression, receiver operating characteristic (ROC) and decision curve analyses (DCA) assessing the association between clinic-radiologic factors and csPCa were performed. RESULTS: Overall, 230 patients were included in the study and the median age was 65 years. The median prostate size and PSA were 50 g and 6.26 ng/mL, respectively. 17.4% of patients had csPCa, while 27.5% had Gleason group 1. In univariable logistic analyses, we found that age, BMI, prostate size, PSAd, ADC, and 4Kscore were significant csPCa predictors (P < 0.05). PSAd showed the best prediction performance in terms of AUC (= 0.679). On multivariable analysis, PSAd and 4Kscore were associated with csPCa. The net benefit of PSAd combined with clinical features was superior to those of other parameters. Within patients with PSAd < 0.15, 4Kscore was a statistically significant predictor of csPCa (OR = 3.25, P = 0.032). CONCLUSION: PSAd and 4Kscore are better predictors of csPCa in patients with PIRADS 3 lesions compared to ADC. The predictive role of 4Kscore is higher in patients with low PSAd. These results can assist practitioners in the risk stratification of patients with equivocal lesions to determine the need of biopsy.

Study Protocol for a Randomized Controlled Trial of Low Intensity Shockwave Therapy for the Treatment of Post-Radical Prostatectomy Erectile Dysfunction: "SHARP-ED TRIAL".

Introduction: Erectile Dysfunction (ED) is a common challenge post Radical Prostatectomy (RALP), affecting men's sexual health after undergoing definitive cancer therapy. Despite employing nerve-sparing techniques, ED remains a prevalent issue in this population. Studies indicate that approximately 70%-85% of men experience varying degrees of ED following RALP. The existing treatment landscape for post-RALP-ED presents limitations, and a discernible knowledge gap persists. To address this, our study aims to investigate the efficacy of Shockwave Therapy (SWT) as a potential intervention for managing ED after RALP. Methods: This prospective, randomized, sham-controlled clinical trial aims to recruit 189 eligible patients post-RP and assess the effects of SWT. Comprehensive screening, including medical history, physical examinations, and biochemical evaluations, will be conducted to confirm eligibility. The intervention involves utilizing a device to administer focal shockwaves targeted at cavernosal tissue. Safety measures include continuous monitoring for adverse events and rigorous reporting protocols. The primary endpoint assesses changes in participants' ability to engage in penetrative intercourse from baseline to study completion, while secondary endpoints encompass various measures of erectile function, including questionnaire-based assessments, ultrasound parameters, and clinical outcomes. Results: Statistical analysis, encompassing ANOVA for continuous variables and Fisher's exact test for categorical ones, will evaluate demographic characteristics, baseline data, and primary as well as secondary outcomes for statistical significance. Detailed analysis of trends, subgroup comparisons, and treatment effects will provide a comprehensive understanding of the impact of SWT on post-RP ED. Conclusion: This study protocol represents a rigorous investigation into the potential therapeutic role of SWT in managing post-RP ED. The outcomes from this study aim to contribute valuable insights into the efficacy, safety, and potential improvements in erectile function following SWT, providing significant guidance for future interventions aimed at addressing this challenging condition affecting men's health and quality of life.

Comparative outcomes of partial versus total penectomy for penile carcinoma: A retrospective cohort study on demographics and postoperative complications.

When feasible from an oncologic standpoint, partial penectomy (PP) is often preferred to total penectomy (TP) for penile cancer treatment, for the preservation of functional urinary outcomes. However, to date, there has not been a direct comparison of perioperative outcomes between PP and TP. Comparing treatments for penile cancer has proven difficult due to the rarity of penile cancer in the United States. We aimed to report differences in pre-operative risk factors, intra-operative outcomes, and postoperative outcomes between TP and PP for penile cancer. Using the National Surgical Quality Improvement Program database, we conducted a retrospective cohort review of penile cancer patients enlisted in the database between the years 2006-2016 using the International Classification of Diseases clinical modification 9th revision codes. A total of 260 patients, 67 TP and 193 PP patients, were included. PP patients were less likely to be transferred patients (p = 0.002), diabetic (p = 0.026), and were more likely to have preoperative laboratory values within normal limits. PP patients also had shorter lengths of stay in the hospital (p < 0.001) and operating time (p < 0.001). Significant differences were also found for inpatient stay (p < 0.001), 30-day post-surgery complications (p < 0.001), deep incisional surgical site infection (SSI) (p = 0.017), wound disruption (p = 0.017), intraoperative or postoperative transfusion (p = 0.029), and sepsis (p < 0.005). Finally, PP patients required fewer concurrent surgical procedures (p < 0.001). Demographic differences between PP and TP patients may reflect patients presenting with more advanced oncologic disease. PP is associated with fewer postoperative complications, shorter surgeries, shorter hospital stays, fewer concurrent surgical procedures, and comorbid conditions compared to TP. A gap remains in the reported data pertaining to postoperative sexual function and erectile outcomes for PP at a national level.

A phase 2 randomized, placebo-controlled crossover trial to evaluate safety and efficacy of platelet-rich plasma injections for Peyronie's disease: clinical trial update.

Peyronie's Disease (PD) is characterized by fibrotic plaques in the penile tunica albuginea, causing curvature and painful erections. Current treatments have limited established efficacy. Platelet-Rich Plasma (PRP), known for modulating inflammation, offers a potential alternative. This randomized, placebo-controlled, crossover study at the University of Miami assesses PRP's safety and efficacy for PD. Forty-one PD patients were randomized into PRP-placebo (Group A) and placebo-PRP (Group B) sequences, receiving two injections of each treatment over three months, with a crossover to receive two injections of alternate treatment over the next three months. Assessments include pain scale, goniometry, questionnaires, and curvature evaluations. Preliminary analysis of 28 patients shows that PRP is safe. There were no adverse events, including penile complications, during follow-up. Pain scores during treatments showed no significant difference between PRP and placebo (p = 0.52). Over six months, the PRP-Placebo group's median PDQ score decreased from 1.9 (IQR: 1.7-2.9) to 1.4 (IQR: 0.7-2.1). This change was not statistically significant (p = 0.098). In contrast, the Placebo-PRP group showed a significant reduction from 1.8 (IQR: 1.4-2.6) to 1.2 (IQR: 1.0-2.0) (p = 0.020). No significant changes in IIEF scores were observed. Both groups initially had a median penile curvature of 40 degrees. At 3 months, the PRP-Placebo group's curvature decreased to 38 degrees (IQR: 35-47.5), while the Placebo-PRP group decreased to 35 degrees (IQR: 30-60). At 6 months, the PRP-Placebo group showed a significant reduction to 25 degrees (IQR: 20-40, p = 0.047), while the Placebo-PRP group's reduction to 32.5 degrees (IQR: 20-50) was not significant (p = 0.490). These early results indicate a delayed PRP effect, prompting further investigation into its long-term impacts. Although limited by sample size, this study suggests PRP injections as a safe treatment for PD, with ongoing research aiming to clarify its therapeutic value.

Low-dose prednisone is an effective rescue for deteriorating semen parameters following vasovasostomy.

OBJECTIVE: This retrospective study aimed to evaluate the effectiveness of low-dose prednisone as a rescue therapy for patients with deteriorating semen parameters following vasovasostomy. MATERIALS AND METHODS: Electronic medical records were queried at the University of Miami with documented CPT code 55400 (Bilateral Vasovasostomy) between January 2016 and April 2023. Records were then reviewed to identify patients who demonstrated ≥50% decrease in semen parameters, specifically sperm concentration, motility and total motile sperm count. Patients who were treated with 6 weeks of low-dose prednisone were identified, and baseline semen parameters and subsequent changes after prednisone therapy were assessed. A Mann-Whitney U Test was used to compare semen parameter changes before and after prednisone. Adverse effects associated with prednisone were monitored. RESULTS: A total of 8 patients were identified with deteriorating semen parameters who were treated with 6 weeks of low-dose prednisone. Following prednisone therapy, all patients demonstrated improvements in total motile sperm count (TMSC), with a median improvement of 6 million. The median relative improvement in TMSC was 433%. Sperm concentration and motility also improved compared to post-operative baseline. No adverse effects were reported during the treatment period. CONCLUSIONS: Low-dose prednisone therapy appears to be a safe and effective intervention for managing deteriorating semen parameters following VV. The observed improvements in TMSC suggest the potential of prednisone to rescue patients with delayed failure after VV. Further research with larger sample sizes is warranted to confirm the safety and efficacy of low-dose prednisone as a rescue therapy in this specific patient population. Optimizing VV outcomes is crucial in male infertility, and further exploration of steroid therapy and innovative biotechnologies is warranted.

Low-dose prednisone is an effective rescue for deteriorating semen parameters following vasovasostomy

ABSTRACT Objective: This retrospective study aimed to evaluate the effectiveness of low-dose prednisone as a rescue therapy for patients with deteriorating semen parameters following vasovasostomy. Materials and Methods: Electronic medical records were queried at the University of Miami with documented CPT code 55400 (Bilateral Vasovasostomy) between January 2016 and April 2023. Records were then reviewed to identify patients who demonstrated ≥50% decrease in semen parameters, specifically sperm concentration, motility and total motile sperm count. Patients who were treated with 6 weeks of low-dose prednisone were identified, and baseline semen parameters and subsequent changes after prednisone therapy were assessed. A Mann-Whitney U Test was used to compare semen parameter changes before and after prednisone. Adverse effects associated with prednisone were monitored. Results: A total of 8 patients were identified with deteriorating semen parameters who were treated with 6 weeks of low-dose prednisone. Following prednisone therapy, all patients demonstrated improvements in total motile sperm count (TMSC), with a median improvement of 6 million. The median relative improvement in TMSC was 433%. Sperm concentration and motility also improved compared to post-operative baseline. No adverse effects were reported during the treatment period. Conclusions: Low-dose prednisone therapy appears to be a safe and effective intervention for managing deteriorating semen parameters following VV. The observed improvements in TMSC suggest the potential of prednisone to rescue patients with delayed failure after VV. Further research with larger sample sizes is warranted to confirm the safety and efficacy of low-dose prednisone as a rescue therapy in this specific patient population. Optimizing VV outcomes is crucial in male infertility, and further exploration of steroid therapy and innovative biotechnologies is warranted.

COVID-19 Vaccination and Reproductive Health: a Comprehensive Review for Healthcare Providers.

With all the current misinformation on social media platforms about the COVID-19 vaccine and its potential effects on fertility, it is essential for healthcare providers to have evidenced-based research to educate their patients, especially those who are trying to conceive, of the risks to mothers and fetuses of being unvaccinated. It is well known that COVID-19 infection puts pregnant women at higher risk of complications, including ICU admission, placentitis, stillbirth, and death. In February of 2021, the American College of Obstetricians and Gynecologists (ACOG), the American Society for Reproductive Medicine (ASRM), and the Society for Maternal-Fetal Medicine (SMFM) released a statement denying any link between COVID vaccination and infertility. ASRM later confirmed and stated that "everyone, including pregnant women and those seeking to become pregnant, should get a COVID-19 vaccine". In this review, we aim to provide a compilation of data that denies any link between vaccination and infertility for healthcare providers to be able to educate their patients based on evidence-based medicine. We also reviewed the effect of COVID-19 virus and vaccination on various parameters and processes that are essential to obtaining a successful pregnancy.

Primer on Female Infertility for the Reproductive Urologist.

This review is intended to serve as an aid in decision-making and patient counseling for the reproductive urologist when female factor infertility is found concurrently with male factor infertility. This review pairs the pathophysiology of female infertility with its implications for the treatment of male infertility, which most commonly includes ovulatory disorders, tubal abnormalities, and uterine abnormalities. By gaining a deeper understanding of these factors, reproductive urologists can employ a tailored approach to managing male factor infertility, taking into account the female partner's specific medical history.

Platelet-rich plasma for erectile dysfunction: a review of the current research landscape.

INTRODUCTION: Erectile dysfunction (ED) is the inability to achieve or maintain erection for satisfactory sexual performance. ED drastically reduces the quality of life for men and their partners and is commonly linked to comorbid conditions such as diabetes and cardiovascular disease. As a result, clinicians and researchers are working to improve treatments for ED. Current guideline-approved ED treatments include oral phosphodiesterase type 5 inhibitors, intraurethral alprostadil, penile intracavernosal injections, and penile prosthesis surgery. Today, there is increasing interest in restorative therapies such as intracavernosal platelet-rich plasma (PRP) for the management of ED. OBJECTIVES: This narrative review describes the current trials investigating intracavernosal PRP for ED and proposes future directions to increase the strength of evidence to support use of PRP in this population. METHODS: A comprehensive literature search of PubMed, Science Direct, and Scopus was performed to identify all randomized clinical trials using PRP for the treatment of ED. RESULTS: We identified 4 randomized clinical trials investigating the safety and efficacy of PRP for ED. We found significant heterogeneity among study protocols, including collection of PRP, dosing of PRP, and follow-up. CONCLUSION: While intracavernosal PRP is considered safe, its efficacy for the management of ED remains unknown due to variability among clinical trials.

Biopsychosocial approach to male chronic pelvic pain syndrome: recent treatments and trials.

INTRODUCTION: Chronic pelvic pain syndrome (CPPS) is a common urologic condition that can cause significant disability in affected individuals. Physiologic explanations of chronic pain are often incomplete; appropriate management of CPPS includes recognition of biological, psychological, and social elements, known as the biopsychosocial model. OBJECTIVE: The aim of this narrative review is to investigate treatments for men with CPPS, with a special focus on those utilizing the biopsychosocial model of care. METHODS: A comprehensive literature search was conducted on the electronic databases PubMed, Embase, and Cochrane Library, using relevant Medical Subject Heading terms and keywords related to CPPS treatments. The search was limited to studies published in English from inception to January 2023. Additionally, reference lists of selected studies were manually reviewed to find studies not identified by the initial search. Studies were included if they investigated pharmacologic or nonpharmacologic treatments for men with CPPS. RESULTS: A total of 30 studies met the inclusion criteria. Antibiotics, α-blockers, nonsteroidal anti-inflammatory drugs, gabapentinoids, antidepressants, and phosphodiesterase type 5 inhibitors were among the pharmacologic agents included in trials attempting to reduce symptoms of male CPPS. Studies that focused on treating CPPS without medication included interventions such as shockwave therapy, acupuncture, physical therapy, botulinum toxin, cryotherapy, electrotherapy, exercise, and cognitive behavioral therapy. CONCLUSION: α-Blockers and nonsteroidal anti-inflammatory drugs have shown promising results in treating CPPS in men, while the effectiveness of antibiotics remains controversial. Antidepressants and phosphodiesterase type 5 inhibitors may also be useful in decreasing symptoms in patients with CPPS. Treatments such as pelvic floor muscle therapy, acupuncture, shockwave therapy, and cognitive behavioral therapy must be considered effective complements to medical management in men with CPPS. While these interventions demonstrate benefits as monotherapies, the individualization and combination of treatment modalities are likely to result in reduced pain and improved quality of life.

The Impact of Ovulation Calculators on the Stress Levels of Fertility-Seeking Couples: An Evaluation Study.

Introduction Infertility affects a significant portion of couples seeking pregnancy, leading to stress and emotional strain. Ovulation calculators, widely used as a tool to predict fertile days, may play a role in the stress experienced by couples undergoing fertility treatments. The aim of this study was to evaluate the impact of ovulation calculators on the stress levels of couples seeking fertility. Methods Participants were recruited from the University of Miami Health System Clinics. Fifty couples consulting for infertility were asked to participate in the study and complete anonymous self-reported surveys. The surveys consisted of validated questions related to stress levels and the use of ovulation calculators. The completed surveys were collected and analyzed using descriptive statistics. The data collected included age, number of years trying to conceive, and answers to questions related to stress levels and the use of ovulation calculators. Responses from 50 couples who met the inclusion criteria were included in the final analysis. Results A total of 50 couples who were attempting conception and who completed all the questionnaires were included in the study. Whether or not they were using ovulation calculators, females scored similarly in the four variables of the Female Sexual Function Index (FSFI), including arousal, orgasm, satisfaction, and lubrication. When evaluating International Index of Erectile Function (IIEF) scores for male erectile function, the average score of males tracking ovulation was 12.0 ± 4.8, compared to 11.5 ± 5.4 in male patients who were not (P = 0.81). The results showed no statistically significant difference in stress levels between couples who used ovulation calculators and those who did not. However, in couples experiencing higher stress levels due to infertility, both male and female participants reported higher levels of sexual dysfunction. Fertility-related stress was also found to be significantly associated with mental health implications, with increased anxiety and depression reported by couples undergoing fertility treatments. Conclusion The findings suggest that the use of ovulation calculators did not significantly influence the stress experienced by couples seeking fertility treatment. However, the study highlights the significant impact of infertility-related stress on sexual function and mental health in both male and female partners. These results emphasize the importance of addressing the psychological aspects of infertility and providing comprehensive support to couples undergoing fertility treatments. Further research is warranted to explore the complex interplay between ovulation calculator usage, infertility-related stress, sexual dysfunction, and mental health implications in couples seeking to conceive. Healthcare providers should consider incorporating mental health support into fertility treatment programs to optimize patient outcomes and overall well-being.

Fertility outcomes in men with prior history of anabolic steroid use.

OBJECTIVE: To study sperm parameters recovery and fertility outcomes in men with azoospermia or severe oligospermia caused by anabolic steroid use who underwent a standardized treatment regimen for spermatogenesis recovery. DESIGN AND SUBJECTS: A retrospective analysis of a cohort of men with a prior history of anabolic steroid use and infertility complaints (between 2018 and 2022) was conducted. EXPOSURE: The standardized treatment approach involved discontinuing testosterone replacement therapy and administering a combination regimen of clomiphene citrate and human chorionic gonadotropin for a minimum of 3 to 6 months. MAIN OUTCOME MEASURES: The main outcome measures included changes in sperm parameters, predominantly sperm concentration, and subsequent pregnancy outcomes. RESULTS: A total of 45 men (median age 37 years, IQR 32-45) met the inclusion criteria for this analysis. Median duration of prior T use was 4 years (IQR 1.3-10), with the 2 most common modalities consisting of injection therapy (43.5%) and oral therapy (34.8%). The median initial sperm concentration was 0 million/cc (IQR 0-1.15), and 23 (51.1%) men initially presented with azoospermia. The median duration of combination human chorionic gonadotropin/clomid therapy was 5 months (IQR 3-12). In initially azoospermic men (N: 23), 5 were lost to follow-up, 6 (33.3%) progressed to severe oligospermia (<5 million/cc), 6 (33.3%) to oligospermia (<15 million/cc), 1 (5.6%) to normozoospermia (>15 million/cc), and 5 (27.8%) remained azoospermic after medical treatment for 6 months. Among the 24 couples who responded to the follow-up call, a total of 9 (37.5%) achieved a successful subsequent pregnancy. Of these, 33.3% (3 couples) used assisted reproductive technology, whereas 66.7% (6 couples) conceived naturally. On logistic regression analysis, no significant predictors for improved sperm parameters or successful pregnancy were identified. CONCLUSION: Despite appropriate treatment regimens, a significant proportion of men with a prior history of anabolic steroid use continue to exhibit severe oligospermia, with more than half showing limited improvement in semen parameters after 6 months of treatment. Only a fraction of men achieves normozoospermia after treatment. Further research is needed to explore predictors for improved sperm parameters and successful pregnancy outcomes in men with a history of anabolic steroid use.

Efficacy of Clomiphene Citrate Versus Enclomiphene Citrate for Male Infertility Treatment: A Retrospective Study.

Introduction Infertility and hypogonadism in males can greatly affect their reproductive health and overall well-being. Since exogenous testosterone administration for hypogonadism management may disrupt the normal hormonal cascade necessary for spermatogenesis, clomiphene citrate (CC) and enclomiphene citrate (EC) are medications often used to manage hypogonadism and male infertility. This study aims to directly compare the effects of CC and EC on serum testosterone levels and semen parameters in men to determine which medication may have an advantage in managing these conditions. Materials and methods We retrospectively analyzed ≥18-year-old men presenting with primary infertility, abnormal semen parameters, or hypogonadism who received CC or EC monotherapy for at least three months between January 2021 and December 2022. We compared baseline and follow-up hormone levels, semen parameters, and demographics. Variables were compared using paired and unpaired t-tests. Significance was assessed at p<0.05. Results A total of 46 men received EC and 32 men received CC. The median age was 42 (IQR: 34-47.75) years in men who received EC and 41 (IQR: 36-44) years in men who received CC (p=0.450). The two treatment groups exhibited a significant increase in serum total testosterone, while only EC had a statistically significant increase in FSH and LH. Semen volume and concentration did not significantly change with either treatment. Sperm motility increased in both groups, but total motile sperm count (TMSC) only significantly increased in men who received EC.  Conclusions Our study found that EC and CC are effective treatments in increasing total testosterone without negatively affecting spermatogenesis. EC demonstrated to be more effective in raising gonadotropin levels and TMSC.

A case report on the prolonged viability of postmortem human testicular sperm.

Objective: To report a case of postmortem sperm retrieval with prolonged viability and motility. Design: Case report. Setting: Hospital and Medical Examiner Department. Patients: A 44-year-old African American male patient with a history of recreational marijuana use and occasional alcohol consumption who died from a cardiac arrest because of drug overdose. Interventions: Multiple testicular biopsies and sperm analyses. Main Outcome Measures: Sperm viability and motility of testicular biopsies at serial time intervals. Results: Sperm obtained from the testis in the morgue remained viable and motile even at 106 hours (>4 days) postmortem. Conclusions: Our study found that sperm obtained from the testis remained viable and motile even after being thawed after cryopreservation, even when obtained up to 100 hours postmortem. This may have implications on the timeframe that postmortem sperm retrieval can be performed successfully several days after death.

Exploring representation of underrepresented minority men in a restorative therapy clinical trial for erectile dysfunction: addressing barriers and promoting inclusion.

This retrospective descriptive analysis explores underrepresented minority men in our clinical trial for restorative therapy for erectile dysfunction and to identify strategies to promote diversity and inclusion in the study population. Demographic data were collected from all participants and the prevalence in our population was compared to the source population. The proportion of individuals taking part in our clinical trial was compared to the overall disease population using the participation to prevalence ratio. Among the 61 participants enrolled in the Platelet-Rich Plasma for Erectile Dysfunction trial, 72.1% were Hispanic compared to 39.9% in the national source population. There were 27.9% non-Hispanic participants, and 41.2% non-Hispanic men in the local South Florida population. The racial composition of our study shows 80.3% of PRP participants identify as White, 16.4% as Black, and 3.4% as Asian. In the national source population, 61.8% of patients were White, 27.5% are black, and 1.5% are Asian. Through the implementation of strategies such as having Hispanic team members on the clinical trial staff and providing education and outreach materials both in Spanish and English, we were able to overcome barriers to participation in Hispanic men and potentially improve health outcomes for underrepresented minority men with erectile dysfunction.

A fragility index analysis of clinical trials evaluating low-intensity extracorporeal shockwave therapy for erectile dysfunction.

Erectile dysfunction is a common sexual dysfunction that affects a significant proportion of men. Low-intensity extracorporeal shockwave therapy has been evaluated in multiple clinical trials as a therapeutic option for men with erectile dysfunction. The robustness of these clinical trials is not well defined, as the trials are hindered by inconsistent treatment protocols, small study arm size and short follow-up intervals. The fragility index is a statistical analysis which is used to evaluate the robustness of clinical trials. It is calculated by evaluating the minimum number of patients in a given trial arm that would be required to have an alternative outcome to alter the statistical significance of the results. The lowest fragility index in statistically significant trials is 1, meaning that if just one participant experienced an alternate outcome, the results would no longer achieve statistical significance. The upper limit is determined by the number of participants in a given arm of the trial. Herein, a scoping review of clinical trials evaluating the efficacy of low-intensity extracorporeal shockwave therapy in erectile dysfunction to determine the fragility index of trials with clinically significant results. We hypothesized that the fragility index would be low, indicating the results are less robust and generalizable.

Platelet-rich Plasma for the Treatment of Erectile Dysfunction: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial.

PURPOSE: We assessed the safety and efficacy of 2 injections of platelet-rich plasma for treating mild to moderate erectile dysfunction by conducting a prospective, randomized, double-blind, placebo-controlled clinical trial. MATERIALS AND METHODS: Men with mild to moderate erectile dysfunction (International Index of Erectile Function scores 11-25) were randomized to receive either 2 injections of platelet-rich plasma or placebo separated by 1 month. Primary outcome was percentage of men meeting minimum clinically important difference at 1 month after the second injection. Secondary outcomes were change in International Index of Erectile Function at 1, 3, and 6 months, and changes in penile vascular parameters and adverse events at 6 months. RESULTS: We randomized 61 men: 28 into platelet-rich plasma and 33 into placebo. There was no difference between groups in percentage of men meeting minimum clinically important difference at 1 month: 14 (58.3%) in platelet-rich plasma vs 15 (53.6%) in placebo (P = .730). Mean International Index of Erectile Function-Erectile Function domain changed from 17.4 (95% CI 15.8-19.0) to 21 (17.9-24.0) at 1 month in men receiving platelet-rich plasma, vs 18.6 (17.3-19.8) to 21.6 (19.1-24.1) in the placebo group; however, there was no significant difference between groups (P = .756). There were no major adverse events and only 1 minor adverse event in each group. There were no changes in penile Doppler parameters from baseline to 6 months. CONCLUSIONS: The results of our prospective, double-blind, randomized, placebo-controlled clinical trial suggest that 2 injections of intracavernosal platelet-rich plasma separated by 1 month in men with mild to moderate erectile dysfunction is safe, but we found no difference in efficacy between platelet-rich plasma and placebo.