Safety and efficacy of botulinum neurotoxin in the treatment of erectile dysfunction refractory to phosphodiesterase inhibitors: Results of a randomized controlled trial.

BACKGROUND: There has been recent interest in the use of botulinum neurotoxin (BoNT) in the field of Andrology, whereby it has been investigated in the treatment of penile retraction and premature ejaculation. OBJECTIVES: To evaluate the safety and efficacy of intracavernosal BoNT-A injection in the treatment of patients with erectile dysfunction (ED) refractory to oral phosphodiesterase inhibitors (PDE5Is). PATIENTS AND METHODS: A double-blind randomized placebo-controlled prospective comparative study conducted at one center and involved 70 patients with ED refractory to PDE5Is. At baseline, the following data were collected: erection hardness score (EHS), peak systolic velocity (PSV), end diastolic velocity (EDV), sexual health inventory for men (SHIM), and the sexual encounter profile 2&3 (SEP-2&3) questionnaires. Treatment group (n = 35) received a single ICI of 100 units of BoNT-A in 2 ml of saline and control group (n = 35) received a single ICI of 2 ml of saline. EHS, PSV, and EDV were assessed at 2 weeks post treatment. SHIM, SEP-2, SEP-3, and global assessment questionnaire (GAQ-Q1&Q2) were completed at 2-, 6-, and 12-weeks post treatment. RESULTS: Two weeks post treatment, the treatment group showed a statistically significant improvement in the mean EHS, PSV, EDV, and GAQ-Q1 positive responders (p < 0.001) compared to the control group. At 6- and 12-weeks post treatment, the treatment group showed a statistically significant improvement in the SHIM scores, SEP-2, and GAQ-Q1&Q2 positive responders compared to the control group. At 6 weeks, where there was a 5-point improvement in the mean SHIM score of the treatment group (10±5.9 from 5.4±1.7 at baseline) versus no improvement in the placebo group, 18 patients in the treatment group (53%) were able to have an erection hard enough for vaginal penetration versus only one patient in the control group. CONCLUSION: BoNT-A is safe and effective as a potential treatment for ED refractory to PDE5I therapy.

Intra-cavernous injection of BOTOX® (50 and 100 Units) for treatment of vasculogenic erectile dysfunction: Randomized controlled trial.

BACKGROUND: Erectile dysfunction (ED) is a socioeconomic problem.There are several options for its management including intra-cavernosal injection (ICI). OBJECTIVE: To compare the safety, efficacy, and durability of ICI of onabotulinum toxin-A (BTX) in different doses (50 and 100 U) against placebo (saline) in the management of vasculogenic ED non-responding to pharmacological therapy (phosphodiesterase type 5 inhibitors or/and ICI of trimix). MATERIALS AND METHODS: A prospective randomized double-blind placebo-controlled trial was conducted between July 2016 and February 2019. A total of 176 patients were randomly assigned (1:1:1) to one of the treatment sequences: Botox 100 U group (BTX-100; 62 patients), Botox 50 U group (BTX-50; 59 patients), or placebo group (55 patients). All patients were followed up for 6 months. RESULTS: Significant improvement in all parameters, that is, SHIM score & Erection Hardness Score (EHS), Sexual Encounter Profile (SEP), Global Assessment Score (GAS), and Doppler parameters (p < 0.001) was observed in patients of BTX-100 and BTX-50 groups with maximum improvement at 3rd month of treatment. Around 40% of patients were responders and were able to engage in sexual intercourse. Patients in placebo group did not experience significant improvement (p = 0.264). It was noted that at the 2nd week and 3rd months after treatment, there was no statistically significant difference in the improvement of these parameters in BTX-100 and BTX-50 groups (p > 0.05). In the 6th month, there was a statistically significant difference between the aforementioned groups in favor of BTX-100 (p < 0.01). CONCLUSIONS: Only one-time ICI of BTX (50 U and 100 U) is effective and safe for the treatment of refractory ED. This agent has a considerable long duration of action, particularly BTX-100U seems to be more durable.

Analysis of Pathogenicity and Virulence Factors of Ageratum leaf curl Sichuan virus.

Ageratum leaf curl Sichuan virus (ALCScV) is a novel monopartite begomovirus, which was identified from Ageratum conyzoides plants in Sichuan Province, China. In this study, we showed that ALCScV can induce typical dwarf and downward leaf-curling symptoms in Ageratum conyzoides, Helianthus annuus, and Nicotiana benthamiana plants and that the noncognate betasatellite can enhance disease symptoms and increase viral accumulation. Expression of the ALCScV-encoded V2, C1, and C4 proteins through a Potato virus X (PVX) vector caused severe symptoms in N. benthamiana. Further study revealed no symptoms in N. benthamiana plants inoculated with infectious ALCScV clones lacking the C4 protein and that the relative viral DNA accumulation levels significantly decreased when compared with ALCScV-inoculated plants. Thus, our mutational analyses demonstrated that C4 is a pathogenicity determinant that plays key roles in symptom formation and virus accumulation. Furthermore, we also demonstrated that the second glycine of C4 was critical for ALCScV pathogenicity.

Suppression of nbe-miR1919c-5p Expression in Nicotiana benthamiana Enhances Tobacco Curly Shoot Virus and Its Betasatellite Co-Infection.

MicroRNAs (miRNAs) are non-coding but functional RNA molecules of 21-25 nucleotides in length. MiRNAs play significant regulatory roles in diverse plant biological processes. In order to decipher the relationship between nbe-miR1919c-5p and the accumulations of tobacco curly shoot virus (TbCSV) and its betasatellite (TbCSB) DNAs, as well as viral symptom development, we investigated the function of nbe-miR1919c-5p during TbCSV and TbCSB co-infection in plants using a PVX-and a TRV-based short tandem target mimic (STTM) technology. Suppression of nbe-miR1919c-5p expression using these two technologies enhanced TbCSV and TbCSB co-infection-induced leaf curling symptoms in Nicotiana benthamiana plants. Furthermore, suppression of nbe-miR1919c-5p expression enhanced TbCSV and TbCSB DNA accumulations in the infected plants. Our results can advance our knowledge on the nbe-miR1919c-5p function during TbCSV and TbCSB co-infection.

Tobacco curly shoot virus C3 protein enhances viral replication and gene expression in Nicotiana benthamiana plants.

Geminiviruses are single-stranded DNA viruses that cause devastating diseases in many crops worldwide. The replication enhancer proteins (REn), encoded by the C3 (AC3, and AL3) ORFs of geminiviruses, have critical roles in viral DNA accumulation and symptom development in infected plants. In the current study, we have constructed an infectious clone of the Tobacco curly shoot virus (TbCSV) C3 mutant, TbCSVΔC3, that contains two start codon mutations that abrogated C3 ORF expression, but did not alter the amino acid sequence of the C2 ORF. As predicted, the absence of the C3 protein reduced TbCSV DNA accumulation, and over-expression of the C3 protein enhanced TbCSV DNA accumulation in infected leaves of Nicotiana benthamiana. The C3 mutation reduced the expression levels of both virion- and complementary-sense TbCSV genes whereas over-expression of the C3 protein increased TbCSV gene expression. Furthermore, the expression of the wild-type and site-directed mutants of C3 proteins using the potato virus X (PVX) system showed that Y93A mutation reduced the replication enhancement activity of the C3 protein in N. benthamiana. All the available evidence demonstrates that the C3 protein is tightly coupled with TbCSV DNA accumulation. However, the TbCSVΔC3 mutant was nearly as infectious in N. benthamiana as TbCSVWT and only had slightly delayed and attenuated symptom expression. Our findings demonstrate that TbCSV C3 protein enhances viral replication and gene expression, but has only moderate effects on symptom development in N. benthamiana.

Botulinum Neurotoxin and Its Potential Role in the Treatment of Erectile Dysfunction.

INTRODUCTION: Botulinum toxin type A (BoNT-A) has been used to treat several striated and smooth muscle disorders. During the past year, human and animal studies conducted in Egypt and Canada by two different groups of investigators have suggested a possible role for the intracavernosal injection of BoNT-A in the treatment of erectile dysfunction (ED). AIM: To discuss BoNT-A and its current medical uses, the rationale for its new potential use in the treatment of ED, and the available evidence and concerns. METHODS: A literature search was conducted. This review was based on the available studies presented at the European Society for Sexual Medicine, Sexual Medicine Society of North America, and International Society for Sexual Medicine meetings in 2016 by the two groups. MAIN OUTCOME MEASURES: Sinusoidal diameter; penile color Doppler study; Erection Hardness Score; Sexual Health Inventory for Men questionnaire; and Sexual Encounter Profile questions 2 and 3. RESULTS: Two human studies conducted by the authors and two animal studies (one from the authors' group and one from Canada) were reviewed. These seemed to suggest generally favorable outcomes with the use of BoNT-A in the treatment of ED. CONCLUSION: BoNT-A could be a potential therapy for ED. In addition to the findings of the three pilot studies, larger multicenter trials need to be conducted to further explore the true therapeutic efficacy and clinical safety of BoNT-A in the treatment of ED. Ghanem H, Raheem AA, AbdelRahman IFS, et al. Botulinum Neurotoxin and Its Potential Role in the Treatment of Erectile Dysfunction. Sex Med Rev 2018;6:135-142.

Infrapubic Liposuction for Penile Length Augmentation in Patients with Infrapubic Adiposities.

INTRODUCTION: Hidden penis, inconspicuous and concealed penis are synonyms for the same entity "buried penis" where the penile shaft is hidden below the surface of the prepubic fat to an extent that gives an impression of a short penis, despite corporeal length being normal. AIM: The aim of our work is the reduction in the amount of the suprapubic fat by liposuction to reveal the buried penis and assess the results, patient satisfaction and possible complications. METHODS: The procedure of suprapubic liposuction was carried out on ten men who were attending the outpatient clinic of Andrology complaining of small-sized penis. MAIN OUTCOME MEASURES: Pre-, immediate (on table) postoperative and 3 months postoperative skin to tip flaccid and stretched penile lengths were measured. Patient satisfaction was assessed using the five-point Likert scale. RESULTS: There was a statistically significant increase between the pre- and postoperative flaccid and stretched penile lengths in our patients with a p value <0.001 in both. CONCLUSION: An acquired adult buried penis is a correctable problem. Simple buried penis due to excess fat at the mons pubis should be differentiated from other complex cases that may require combined techniques to achieve good results with minor complications. Suprapubic liposuction is a very safe and successful procedure with minor or no complications if performed meticulously. It could improve self-esteem along with the associated physical and esthetic concerns. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

SOP conservative (medical and mechanical) treatment of erectile dysfunction.

INTRODUCTION: Erectile dysfunction (ED) is the most frequently treated male sexual dysfunction worldwide. ED is a chronic condition that exerts a negative impact on male self-esteem and nearly all life domains including interpersonal, family, and business relationships. AIM: The aim of this study is to provide an updated overview on currently used and available conservative treatment options for ED with a special focus on their efficacy, tolerability, safety, merits, and limitations including the role of combination therapies for monotherapy failures. METHODS: The methods used were PubMed and MEDLINE searches using the following keywords: ED, phosphodiesterase type 5 (PDE5) inhibitors, oral drug therapy, intracavernosal injection therapy, transurethral therapy, topical therapy, and vacuum-erection therapy/constriction devices. Additionally, expert opinions by the authors of this article are included. RESULTS: Level 1 evidence exists that changes in sedentary lifestyle with weight loss and optimal treatment of concomitant diseases/risk factors (e.g., diabetes, hypertension, and dyslipidemia) can either improve ED or add to the efficacy of ED-specific therapies, e.g., PDE5 inhibitors. Level 1 evidence also exists that treatment of hypogonadism with total testosterone < 300 ng/dL (10.4 nmol/L) can either improve ED or add to the efficacy of PDE5 inhibitors. There is level 1 evidence regarding the efficacy and safety of the following monotherapies in a spectrum-wide range of ED populations: PDE5 inhibitors, intracavernosal injection therapy with prostaglandin E1 (PGE1, synonymous alprostadil) or vasoactive intestinal peptide (VIP)/phentolamine, and transurethral PGE1 therapy. There is level 2 evidence regarding the efficacy and safety of the following ED treatments: vacuum-erection therapy in a wide range of ED populations, oral L-arginine (3-5 g), topical PGE1 in special ED populations, intracavernosal injection therapy with papaverine/phentolamine (bimix), or papaverine/phentolamine/PGE1 (trimix) combination mixtures. There is level 3 evidence regarding the efficacy and safety of oral yohimbine in nonorganic ED. There is level 3 evidence that combination therapies of PDE5 inhibitors + either transurethral or intracavernosal injection therapy generate better efficacy rates than either monotherapy alone. There is level 4 evidence showing enhanced efficacy with the combination of vacuum-erection therapy + either PDE5 inhibitor or transurethral PGE1 or intracavernosal injection therapy. There is level 5 evidence (expert opinion) that combination therapy of PDE5 inhibitors + L-arginine or daily dosing of tadalafil + short-acting PDE5 inhibitors pro re nata may rescue PDE5 inhibitor monotherapy failures. There is level 5 evidence (expert opinion) that adding either PDE5 inhibitors or transurethral PGE1 may improve outcome of penile prosthetic surgery regarding soft (cold) glans syndrome. There is level 5 evidence (expert opinion) that the combination of PDE5 inhibitors and dapoxetine is effective and safe in patients suffering from both ED and premature ejaculation.

Erectile dysfunction.

Erectile dysfunction is a common clinical entity that affects mainly men older than 40 years. In addition to the classical causes of erectile dysfunction, such as diabetes mellitus and hypertension, several common lifestyle factors, such as obesity, limited or an absence of physical exercise, and lower urinary tract symptoms, have been linked to the development of erectile dysfunction. Substantial steps have been taken in the study of the association between erectile dysfunction and cardiovascular disease. Erectile dysfunction is a strong predictor for coronary artery disease, and cardiovascular assessment of a non-cardiac patient presenting with erectile dysfunction is now recommended. Substantial advances have occurred in the understanding of the pathophysiology of erectile dysfunction that ultimately led to the development of successful oral therapies, namely the phosphodiesterase type 5 inhibitors. However, oral phosphodiesterase type 5 inhibitors have limitations, and present research is thus investigating cutting-edge therapeutic strategies including gene and cell-based technologies with the aim of discovering a cure for erectile dysfunction.

SOP: physical examination and laboratory testing for men with erectile dysfunction.

INTRODUCTION: Physical examination and laboratory evaluation of men with erectile dysfunction (ED) are opportunities to identify potentially life-threatening etiologies and comorbid conditions. AIM: To review genital anatomy, identify any physical abnormalities, assess for comorbid conditions, and reveal significant risk factors for ED. METHODS: Expert opinion was based on evidence-based medical literature and consensus discussions between members of this International Society for Sexual Medicine (ISSM) standards committee. RESULTS: For men with ED, a general examination including blood pressure and pulse measurements and a focused genital exam are advised. Fasting blood sugar, serum total testosterone, prolactin levels, and a lipid profile may reveal significant comorbid conditions. CONCLUSIONS: Though physical examination and laboratory evaluation of most men with ED may not reveal the exact diagnosis, these opportunities to identify critical comorbid conditions should not be missed.

SOP: corpus cavernosum assessment (cavernosography/cavernosometry).

INTRODUCTION: There is no universal gold standard diagnostic test to differentiate psychogenic from organic erectile dysfunction (ED). Cavernosography/cavernosometry has been used to evaluate veno-occlusive dysfunction (VOD) in men with a proposed organic ED. AIM: To develop evidence-based guidelines for the performance and interpretation of cavernosography/cavernosometry. METHODS: Review the methodology behind cavernosography/cavernosometry and evaluate the evidence that supports its use and interpretation of results. MAIN OUTCOME MEASURE: Expert opinion based on review of the literature, extensive internal committee discussion, public presentation, and debate. RESULTS: The detailed technique of cavernosography/cavernosometry is described. An evidence-based perspective to the use and interpretation of cavernosometry is presented. CONCLUSION: The positive predictive value of cavernosometry still needs further assessment. It is unknown how many potent men would test positive for VOD (false positive).

Position paper: Management of men complaining of a small penis despite an actually normal size.

INTRODUCTION: With the worldwide increase in penile augmentation procedures and claims of devices designed to elongate the penis, it becomes crucial to study the scientific basis of such procedures or devices, as well as the management of a complaint of a small penis in men with a normal penile size. AIM: The aim of this work is to study the scientific basis of opting to penile augmentation procedures and to develop guidelines based on the best available evidence for the management of men complaining of a small penis despite an actually normal size. METHODS: We reviewed the literature and evaluated the evidence about what the normal penile size is, what patients complaining of a small penis usually suffer from, benefits vs. complications of surgery, penile stretching or traction devices, and outcome with patient education and counseling. Repeated presentation and detailed discussions within the Standard Committee of the International Society for Sexual Medicine were performed. MAIN OUTCOME MEASURE: Recommendations are based on the evaluation of evidence-based medical literature, widespread standards committee discussion, public presentation, and debate. RESULTS: We propose a practical approach for evaluating and counseling patients complaining of a small-sized penis. CONCLUSIONS: Based on the current status of science, penile lengthening procedure surgery is still considered experimental and should only be limited to special circumstances within research or university institutions with supervising ethics committees.

Priapism: pathogenesis, epidemiology, and management.

INTRODUCTION: Priapism describes a persistent erection arising from dysfunction of mechanisms regulating penile tumescence, rigidity, and flaccidity. A correct diagnosis of priapism is a matter of urgency requiring identification of underlying hemodynamics. AIMS: To define the types of priapism, address its pathogenesis and epidemiology, and develop an evidence-based guideline for effective management. METHODS: Six experts from four countries developed a consensus document on priapism; this document was presented for peer review and debate in a public forum and revisions were made based on recommendations of chairpersons to the International Consultation on Sexual Medicine. This report focuses on guidelines written over the past decade and reviews the priapism literature from 2003 to 2009. Although the literature is predominantly case series, recent reports have more detailed methodology including duration of priapism, etiology of priapism, and erectile function outcomes. MAIN OUTCOME MEASURES: Consensus recommendations were based on evidence-based literature, best medical practices, and bench research. RESULTS: Basic science supporting current concepts in the pathophysiology of priapism, and clinical research supporting the most effective treatment strategies are summarized in this review. CONCLUSIONS: Prompt diagnosis and appropriate management of priapism are necessary to spare patients ineffective interventions and maximize erectile function outcomes. Future research is needed to understand corporal smooth muscle pathology associated with genetic and acquired conditions resulting in ischemic priapism. Better understanding of molecular mechanisms involved in the pathogenesis of stuttering ischemic priapism will offer new avenues for medical intervention. Documenting erectile function outcomes based on duration of ischemic priapism, time to interventions, and types of interventions is needed to establish evidence-based guidance. In contrast, pathogenesis of nonischemic priapism is understood, and largely attributable to trauma. Better documentation of onset of high-flow priapism in relation to time of injury, and response to conservative management vs. angiogroaphic or surgical interventions is needed to establish evidence-based guidance.

Combination clomiphene citrate and antioxidant therapy for idiopathic male infertility: a randomized controlled trial.

OBJECTIVE: To assess the effect of treatment with a combination of clomiphene citrate as an antiestrogen and vitamin E as an antioxidant on the incidence of pregnancy and sperm variables in men with idiopathic oligozoospermia and infertility. DESIGN: Prospective, randomized, placebo-controlled trial. SETTING: The outpatient andrology clinic at a university hospital. PATIENT(S): Sixty infertile men with idiopathic oligoasthenozoospermia. INTERVENTION(S): Patients were randomly assigned to two treatment groups: a group receiving the combination of clomiphene citrate (25 mg/day) and vitamin E (400 mg/day; n = 30) against a placebo group (n = 30). Treatment was maintained for 6 months. MAIN OUTCOME MEASURE(S): Pregnancy incidence and variations in semen parameters. RESULT(S): A significantly higher pregnancy rate was found among the combination treatment group in comparison to the control group. The odds ratio was 3.76 and the 95% confidence interval was 1.03-13.64, with a 36.7% pregnancy rate (11/30) in the combination treatment group compared with 13.3% pregnancy rate (4/30) in the control group. The trial showed a significantly higher increase in sperm count and progressive sperm motility with nonsignificant changes in total sperm motility, percentage of abnormal forms and semen volume in the combination treatment group as compared to the control group. CONCLUSION(S): The combination of clomiphene citrate as an antiestrogen and vitamin E as an antioxidant can significantly increase the pregnancy rate and improve sperm count and progressive sperm motility in cases of idiopathic oligoasthenozoospermia.

Comparing penile measurements in normal and erectile dysfunction subjects.

INTRODUCTION: With the increase in penile augmentation procedures it becomes important to assess what is the normal erect penile size in both potent men and men with erectile dysfunction (ED). AIM: The aim of this work is to define the average stretched penile size in normal men and ED patients. MAIN OUTCOME MEASURES: Penile length and girth. METHODS: This study included 1,027 adult men presenting to a university hospital outpatient clinic. Two groups of patients were included in this research work. Group I comprises normal adult men (949) and Group II, ED patients (78). There were no differences of race, age, height, and weight. Penile length and girth were measured using a tape measure and rigid ruler in the fully stretched states in both groups. All penile measurements were performed by the same physician. RESULTS: In normal men (Group I) the mean of the fully stretched length was 12.9 +/- 1.9 cm and the mean of the fully stretched girth was 8.9 +/- 0.9 cm. In ED patients (Group II), the mean of the fully stretched length was 11.2 +/- 1.5 cm and the mean of fully stretched girth was 8.8 +/- 0.8 cm. Comparing the mean of fully stretched penile lengths in both groups revealed statistical significant difference (P < 0.001) between them, whereas comparing the mean of fully stretched penile girths in both groups revealed statistical nonsignificant difference (P = 0.474) between them. There were significant positive correlations between fully stretched penile lengths and fully stretched penile girths in both groups. CONCLUSION: The average of fully stretched penile length in normal potent men is 12.9 cm, whereas the patients with ED tend to have significantly shorter penises (11.2 +/- 1.5 cm).

An evidence-based perspective to the medical treatment of male infertility: a short review.

INTRODUCTION: Evidence-based medicine (EBM) is the integration of best research evidence with clinical expertise and patient preferences and values. AIM: This narrative review aims to assist the physicians to make informed decisions based on the best available evidence in the area of male infertility and the patients' own preferences and values. METHODS: In this review we present the current state of knowledge and uncertainties about the medical management of male infertility. We describe the best available evidence from systematic reviews, randomized controlled studies and observational studies where appropriate. RESULTS: Data from the literature suggest that gonadotropin treatment of male infertility can lead to a significant increase in pregnancy rates, however larger studies are needed to confirm such findings. Studies including combinations of antiestrogens, antioxidants and androgens are promising but need confirmation with further research. CONCLUSIONS: Most current combination therapies consist of orphan medications without industry support. Andrology research centers and other dedicated departments and units need to conduct randomized controlled trials of sufficient duration, sample number and robust design for groups most likely to benefit from antiestrogens, L-carnitine, antioxidants, and combination therapy. The ease of administration, low cost and mild side effects of antiestrogens justify their utility despite insufficient evidence of effect as monotherapies. Randomized controlled trials assessing other forms of medical therapy and combination therapy are available but are still in the preliminary stages.

Alternate-day tadalafil in the management of honeymoon impotence.

INTRODUCTION: Sildenafil has been used successfully in the treatment of honeymoon impotence. However, no study investigated the potential effect of tadalafil in the treatment of honeymoon impotence. AIM: The aim of this study is to evaluate the effectiveness of alternate-day tadalafil therapy in the management of unconsummated marriages. METHODS: This is a descriptive study comprised of a series of 45 patients. The time frame for the study was 2 years. Forty-five consecutive patients underwent a complete medical and sexual history as well as a focused physical examination. Education about the male and female genital anatomy and the sexual response cycle was carried out. Alternate-day tadalafil 10-mg therapy was administered for 2 weeks with the duration extended as needed. MAIN OUTCOME MEASURES: Primary efficacy endpoints were successful vaginal intromission and change in the abridged version of the International Index of Erectile Function (IIEF-5). RESULTS: Of 45 patients included in our study, 41 (91%) were able to achieve vaginal intromission and perform sexually. Thirty-four patients (76%) needed tadalafil for less than 1 month, five (11%) for up to 3 months, and two (4%) for more than 3 months. Four patients (9%) were unsuccessful. IIEF-5 improved significantly with alternate-day tadalafil treatment in this subgroup of patients (P < 0.001). Treatment failures were managed by intracavernous injection therapy, combined with psychosexual therapy, depending on the cause. CONCLUSIONS: Tadalafil therapy was safe and effective in the short-term management of this selected group of honeymoon impotence patients. Controlled studies are needed to further confirm these findings.

An evidence-based perspective to commonly performed erectile dysfunction investigations.

INTRODUCTION: Currently there is no universally accepted gold standard diagnostic test to differentiate psychogenic from physical erectile dysfunction (ED). Instead, sexual health specialists rely on a detailed history, a focused physical examination, and specialized diagnostic tests, to decide if the etiology of the ED is mainly psychogenic or organically caused. Aim. In this review we point out the status of evidence-based principles in the area of diagnosis in Sexual Medicine. METHODS: We review the concepts of evidence-based medicine (EBM) in the area of medical diagnostic tests. We highlight four of the well-known diagnostic tests (penile duplex, pharmacoarteriography, pharmacocavernosometry/cavernosography [PHCAS/PHCAG], and nocturnal penile tumescence [NPT monitoring]) for ED evaluation within an evidence-based perspective. MAIN OUTCOME MEASURES: Assessment of diagnostic tests for ED using principles of EBM. RESULTS: Several good diagnostic tests are useful in the evaluation of men with ED. However, modern evidence-based concepts-mainly the likelihood ratio-have not yet been applied to these tests to obtain their maximum clinical benefits. CONCLUSIONS: While penile duplex/color Doppler has good evidence of supporting its use in the diagnosis of arteriogenic ED, data supporting its diagnosis of a physical disorder associated with cavernous venous occlusion dysfunction are lacking. PHCAS/PHCAG's main drawback is an unknown positive predictive value and a possibility of frequent false-positive results. NPT has many advantages when differentiating psychogenic from organic ED, however, several questions related to its physiological mechanisms do exist. Ghanem H, and Shamloul R. An evidence-based perspective to commonly performed erectile dysfunction investigations.