Low Intensity Shock Wave Treatment for Erectile Dysfunction-How Long Does the Effect Last?

PURPOSE: We studied the long-term efficacy of penile low intensity shock wave treatment 2 years after an initially successful outcome. MATERIALS AND METHODS: Men with a successful outcome of low intensity shock wave treatment according to the minimal clinically important difference on the IIEF-EF (International Index of Erectile Function-Erectile Function) questionnaire were followed at 6, 12, 18 and 24 months. Efficacy was assessed by the IIEF-EF. Failure during followup was defined as a decrease in the IIEF-EF below the minimal clinically important difference. RESULTS: We screened a total of 156 patients who underwent the same treatment protocol but participated in different clinical studies. At 1 month treatment was successful in 99 patients (63.5%). During followup a gradual decrease in efficacy was observed. The beneficial effect was maintained after 2 years in only 53 of the 99 patients (53.5%) in whom success was initially achieved. Patients with severe erectile dysfunction were prone to earlier failure than those with nonsevere erectile dysfunction. During the 2-year followup the effect of low intensity shock wave treatment was lost in all patients with diabetes who had severe erectile dysfunction at baseline. On the other hand, patients with milder forms of erectile dysfunction without diabetes had a 76% chance that the beneficial effect of low intensity shock wave treatment would be preserved after 2 years. CONCLUSIONS: Low intensity shock wave treatment is effective in the short term but treatment efficacy was maintained after 2 years in only half of the patients. In patients with milder forms of erectile dysfunction the beneficial effect is more likely to be preserved.

Low Intensity Extracorporeal Shock Wave Therapy Improves Erectile Function in a Model of Type II Diabetes Independently of NO/cGMP Pathway.

PURPOSE: Erectile dysfunction is highly prevalent in type II diabetes mellitus. Low intensity extracorporeal shock wave therapy improves erectile function in patients with erectile dysfunction of vasculogenic origin, including diabetes. However, its mode of action remains unknown. We investigated the effects of low intensity extracorporeal shock wave therapy compared to or combined with sildenafil on erectile dysfunction in a type II diabetes mellitus model. Our purpose was to test our hypothesis of a mode of action targeting the cavernous nitric oxide/cyclic guanosine monophosphate pathway. MATERIALS AND METHODS: GK rats, a validated model of type II diabetes mellitus, and age matched Wistar rats were treated with low intensity extracorporeal shock wave therapy twice weekly for 3 weeks. Treatment was repeated after a 3-week no-treatment interval. The penis was stretched and dipped in a specifically designed water-filled cage. Shock waves were delivered by a calibrated probe yielding a controlled energy flux density (0.09 mJ/mm(2)). The probe was attached to an electrohydraulic unit with a focused shock wave source, allowing for accurate extrapolation to humans. Following a 4-week washout period erectile function was assessed as well as endothelium dependent and independent, and nitrergic relaxations of the corpus cavernosum of GK rats. RESULTS: Low intensity extracorporeal shock wave therapy significantly improved erectile function in GK rats to the same extent as sildenafil. Treatment effects were potentiated when combined with sildenafil. Shock wave effects were not associated with improved cavernous endothelium dependent or independent, or nitrergic reactivity. CONCLUSIONS: Low intensity extracorporeal shock wave therapy improved erectile function in GK rats. Unexpectedly, this was not mediated by a nitric oxide/cyclic guanosine monophosphate dependent mechanism. Sildenafil increased shock wave efficacy. This preclinical paradigm to deliver low intensity extracorporeal shock wave therapy to the rat penis should help further exploration of the mode of action of this therapy on erectile tissue.

Penile Low Intensity Shock Wave Treatment is Able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study.

PURPOSE: We performed sham controlled evaluation of penile low intensity shock wave treatment effect in patients unable to achieve sexual intercourse using PDE5i (phosphodiesterase type 5 inhibitor). MATERIALS AND METHODS: This prospective, randomized, double-blind, sham controlled study was done in patients with vasculogenic erectile dysfunction who stopped using PDE5i due to no efficacy. All patients had an erection hardness score of 2 or less with PDE5i. A total of 58 patients were randomized, including 37 treated with low intensity shock waves (12 sessions of 1,500 pulses of 0.09 mJ/mm(2) at 120 shock waves per minute) and 18 treated with a sham probe. In the sham group 16 patients underwent low intensity shock wave treatment 1 month after sham treatment. All patients were evaluated at baseline and 1 month after the end of treatment using validated erectile dysfunction questionnaires and the flow mediated dilatation technique for penile endothelial function. Erectile function was evaluated while patients were receiving PDE5i. RESULTS: In the low intensity shock wave treatment group and the sham group 54.1% and 0% of patients, respectively, achieved erection hard enough for vaginal penetration, that is an EHS (Erection Hardness Score) of 3 (p <0.0001). According to changes in the IIEF-EF (International Index of Erectile Function-Erectile Function) score treatment was effective in 40.5% of men who received low intensity shock wave treatment but in none in the sham group (p = 0.001). Of patients treated with shock waves after sham treatment 56.3% achieved erection hard enough for penetration (p <0.005). CONCLUSIONS: Low intensity shock wave treatment is effective even in patients with severe erectile dysfunction who are PDE5i nonresponders. After treatment about half of them were able to achieve erection hard enough for penetration with PDE5i. Longer followup is needed to establish the place of low intensity shock wave treatment in these challenging cases.

Penile low-intensity shock wave therapy: a promising novel modality for erectile dysfunction.

Penile extracorporeal low-intensity shock wave therapy (LIST) to the penis has recently emerged as a novel and promising modality in the treatment of erectile dysfunction (ED). LIST has angiogenic properties and stimulates neovascularization. If applied to the corpora cavernosa, LIST can improve penile blood flow and endothelial function. In a series of clinical trials, including randomized double-blind sham-controlled studies, LIST has been shown to have a substantial effect on penile hemodynamics and erectile function in patients with vasculogenic ED. LIST is effective in patients who are responsive to phosphodiesterase 5 inhibitors (PDE5i) and can also convert PDE5i nonresponders to responders. The response to LIST wanes gradually over time, and after 2 years, about half of the patients maintain their function. Extensive research is needed to understand the effect of LIST on erectile tissue, to modify the treatment protocol to maximize its outcomes, and to identify the patients who will benefit the most from this treatment.

European Association of Urology guidelines on priapism.

CONTEXT: Priapism is defined as a penile erection that persists beyond or is unrelated to sexual interest or stimulation. It can be classified into ischaemic (low flow), arterial (high flow), or stuttering (recurrent or intermittent). OBJECTIVE: To provide guidelines on the diagnosis and treatment of priapism. EVIDENCE ACQUISITION: Systematic literature search on the epidemiology, diagnosis, and treatment of priapism. Articles with highest evidence available were selected to form the basis of these recommendations. EVIDENCE SYNTHESIS: Ischaemic priapism is usually idiopathic and the most common form. Arterial priapism usually occurs after blunt perineal trauma. History is the mainstay of diagnosis and helps determine the pathogenesis. Laboratory testing is used to support clinical findings. Ischaemic priapism is an emergency condition. Intervention should start within 4-6h, including decompression of the corpora cavernosa by aspiration and intracavernous injection of sympathomimetic drugs (e.g. phenylephrine). Surgical treatment is recommended for failed conservative management, although the best procedure is unclear. Immediate implantation of a prosthesis should be considered for long-lasting priapism. Arterial priapism is not an emergency. Selective embolization is the suggested treatment modality and has high success rates. Stuttering priapism is poorly understood and the main therapeutic goal is the prevention of future episodes. This may be achieved pharmacologically, but data on efficacy are limited. CONCLUSIONS: These guidelines summarise current information on priapism. The extended version are available on the European Association of Urology Website (www.uroweb.org/guidelines/). PATIENT SUMMARY: Priapism is a persistent, often painful, penile erection lasting more than 4h unrelated to sexual stimulation. It is more common in patients with sickle cell disease. This article represents the shortened EAU priapism guidelines, based on a systematic literature review. Cases of priapism are classified into ischaemic (low flow), arterial (high flow), or stuttering (recurrent). Treatment for ischaemic priapism must be prompt in order to avoid the risk of permanent erectile dysfunction. This is not the case for arterial priapism.

Low-Intensity Extracorporeal Shock Wave Therapy in Vascular Disease and Erectile Dysfunction: Theory and Outcomes.

INTRODUCTION: Low-intensity extracorporeal shock wave therapy (LI-ESWT) to the penis has recently emerged as a new and promising modality in the treatment of erectile dysfunction (ED). AIM: To review the published literature on the mechanism of action of LI-ESWT; and to report our clinical data on its efficacy in men with vasculogenic ED. METHODS: A Medline search using the relevant keywords on this topic has been done. RESULTS: From the results of numerous preclinical and animal studies that have been done to date, sufficient evidence shows that the underlying mechanism of action of LI-ESWT is probably neovascularization. Therefore, local application of LI-ESWT to the corpora cavernosa may potentially act in the same mechanism and increase corporal blood flow. We found that the application of LI-ESWT to patients who responded to oral therapy (PDE5i) eliminated their dependence on PDE5i and they were able to successfully achieve erections and vaginal penetration (60-75%). Furthermore, PDE5i non-responders became responders and capable of vaginal penetration (72%). Additionally, LI-ESWT resulted in long-term improvement of the erectile mechanism. CONCLUSIONS: LI-ESWT has the potential to improve and permanently restore erectile function by reinstating the penile blood flow. Although these results on LI-ESWT are promising, further multi- centered studies with longer follow-up are needed to confirm these findings. Gruenwald I, Kitrey ND, Appel B, and Vardi Y. Stem low-intensity extracorporeal shock wave therapy in vascular disease and erectile dysfunction: Theory and outcomes. Sex Med Rev 2013;1:83-90.

Shockwave treatment of erectile dysfunction.

Low-intensity extracorporeal shock wave therapy (LI-ESWT) is a novel modality that has recently been developed for treating erectile dysfunction (ED). Unlike other current treatment options for ED, all of which are palliative in nature, LI-ESWT is unique in that it aims to restore the erectile mechanism in order to enable natural or spontaneous erections. Results from basic science experiments have provided evidence that LI-ESWT induces cellular microtrauma, which in turn stimulates the release of angiogenic factors and the subsequent neovascularization of the treated tissue. Extracorporeal shock wave therapy (ESWT) has been clinically investigated and applied in several medical fields with various degrees of success. High-intensity shock wave therapy is used for lithotripsy because of its focused mechanical destructive nature, and medium-intensity shock waves have been shown to have anti-inflammatory properties and are used for treating a wide array of orthopedic conditions, such as non-union fractures, tendonitis, and bursitis. In contrast, LI-ESWT has angiogenetic properties and is therefore used in the management of chronic wounds, peripheral neuropathy, and in cardiac neovascularization. As a result of these characteristics we initiated a series of experiments evaluating the effect of LI-ESWT on the cavernosal tissue of patients with vasculogenic ED. The results of our studies, which also included a double-blind randomized control trial, confirm that LI-ESWT generates a significant clinical improvement of erectile function and a significant improvement in penile hemodynamics without any adverse effects. Although further extensive research is needed, LI-ESWT may create a new standard of care for men with vasculogenic ED.

EAU guidelines on penile curvature.

CONTEXT: Penile curvature can be congenital or acquired. Acquired curvature is secondary due to La Peyronie (Peyronie's) disease. OBJECTIVE: To provide clinical guidelines on the diagnosis and treatment of penile curvature. EVIDENCE ACQUISITION: A systematic literature search on the epidemiology, diagnosis, and treatment of penile curvature was performed. Articles with the highest evidence available were selected and formed the basis for assigning levels of evidence and grades of recommendations. EVIDENCE SYNTHESIS: The pathogenesis of congenital penile curvature is unknown. Peyronie's disease is a poorly understood connective tissue disorder most commonly attributed to repetitive microvascular injury or trauma during intercourse. Diagnosis is based on medical and sexual histories, which are sufficient to establish the diagnosis. Physical examination includes assessment of palpable nodules and penile length. Curvature is best documented by a self-photograph or pharmacologically induced erection. The only treatment option for congenital penile curvature is surgery based on plication techniques. Conservative treatment for Peyronie's disease is associated with poor outcomes. Pharmacotherapy includes oral potassium para-aminobenzoate, intralesional treatment with verapamil, clostridial collagenase or interferon, topical verapamil gel, and iontophoresis with verapamil and dexamethasone. They can be efficacious in some patients, but none of these options carry a grade A recommendation. Steroids, vitamin E, and tamoxifen cannot be recommended. Extracorporeal shock wave treatment and penile traction devices may only be used to treat penile pain and reduce penile deformity, respectively. Surgery is indicated when Peyronie's disease is stable for at least 3 mo. Tunical shortening procedures, especially plication techniques, are the first treatment options. Tunical lengthening procedures are preferred in more severe curvatures or in complex deformities. Penile prosthesis implantation is recommended in patients with erectile dysfunction not responding to pharmacotherapy. CONCLUSIONS: These European Association of Urology (EAU) guidelines summarise the present information on penile curvature. The extended version of the guidelines is available on the EAU Web site (www.uroweb.org/guidelines/).

Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study.

PURPOSE: We investigated the clinical and physiological effect of low intensity extracorporeal shock wave therapy on men with organic erectile dysfunction who are phosphodiesterase type 5 inhibitor responders. MATERIALS AND METHODS: After a 1-month phosphodiesterase type 5 inhibitor washout period, 67 men were randomized in a 2:1 ratio to receive 12 sessions of low intensity extracorporeal shock wave therapy or sham therapy. Erectile function and penile hemodynamics were assessed before the first treatment (visit 1) and 1 month after the final treatment (followup 1) using validated sexual function questionnaires and venoocclusive strain gauge plethysmography. RESULTS: Clinically we found a significantly greater increase in the International Index of Erectile Function-Erectile Function domain score from visit 1 to followup 1 in the treated group than in the sham treated group (mean ± SEM 6.7 ± 0.9 vs 3.0 ± 1.4, p = 0.0322). There were 19 men in the treated group who were initially unable to achieve erections hard enough for penetration (Erection Hardness Score 2 or less) who were able to achieve erections sufficiently firm for penetration (Erection Hardness Score 3 or greater) after low intensity extracorporeal shock wave therapy, compared to none in the sham group. Physiologically penile hemodynamics significantly improved in the treated group but not in the sham group (maximal post-ischemic penile blood flow 8.2 vs 0.1 ml per minute per dl, p <0.0001). None of the men experienced discomfort or reported any adverse effects from the treatment. CONCLUSIONS: This is the first randomized, double-blind, sham controlled study to our knowledge that shows that low intensity extracorporeal shock wave therapy has a positive short-term clinical and physiological effect on the erectile function of men who respond to oral phosphodiesterase type 5 inhibitor therapy. The feasibility and tolerability of this treatment, coupled with its potential rehabilitative characteristics, make it an attractive new therapeutic option for men with erectile dysfunction.

Is the female G-spot truly a distinct anatomic entity?

INTRODUCTION: The existence of an anatomically distinct female G-spot is controversial. Reports in the public media would lead one to believe the G-spot is a well-characterized entity capable of providing extreme sexual stimulation, yet this is far from the truth. AIM: The aim of this article was to provide an overview of the evidence both supporting and refuting the existence of an anatomically distinct female G-spot. METHODS: PubMed search for articles published between 1950 and 2011 using key words "G-spot," "Grafenberg spot," "vaginal innervation," "female orgasm," "female erogenous zone," and "female ejaculation." Clinical trials, meeting abstracts, case reports, and review articles that were written in English and published in a peer-reviewed journal were selected for analysis. MAIN OUTCOME MEASURE: The main outcome measure of this article was to assess any valid objective data in the literature that scientifically evaluates the existence of an anatomically distinct G-spot. RESULTS: The literature cites dozens of trials that have attempted to confirm the existence of a G-spot using surveys, pathologic specimens, various imaging modalities, and biochemical markers. The surveys found that a majority of women believe a G-spot actually exists, although not all of the women who believed in it were able to locate it. Attempts to characterize vaginal innervation have shown some differences in nerve distribution across the vagina, although the findings have not proven to be universally reproducible. Furthermore, radiographic studies have been unable to demonstrate a unique entity, other than the clitoris, whose direct stimulation leads to vaginal orgasm. CONCLUSIONS: Objective measures have failed to provide strong and consistent evidence for the existence of an anatomical site that could be related to the famed G-spot. However, reliable reports and anecdotal testimonials of the existence of a highly sensitive area in the distal anterior vaginal wall raise the question of whether enough investigative modalities have been implemented in the search of the G-spot.

Low-intensity extracorporeal shock wave therapy--a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy.

INTRODUCTION: Low-intensity shock wave therapy (LI-ESWT) has been reported as an effective treatment in men with mild and moderate erectile dysfunction (ED). AIM: The aim of this study is to determine the efficacy of LI-ESWT in severe ED patients who were poor responders to phosphodiesterase type 5 inhibitor (PDE5i) therapy. METHODS: This was an open-label single-arm prospective study on ED patients with an erection hardness score (EHS) ≤ 2 at baseline. The protocol comprised two treatment sessions per week for 3 weeks, which were repeated after a 3-week no-treatment interval. Patients were followed at 1 month (FU1), and only then an active PDE5i medication was provided for an additional month until final follow-up visit (FU2). At each treatment session, LI-ESWT was applied on the penile shaft and crus at five different anatomical sites (300 shocks, 0.09 mJ/mm(2) intensity at 120 shocks/min). Each subject underwent a full baseline assessment of erectile function using validated questionnaires and objective penile hemodynamic testing before and after LI-ESWT. MAIN OUTCOME MEASURES: Outcome measures used are changes in the International Index of Erectile Function-erectile function domain (IIEF-ED) scores, the EHS measurement, and the three parameters of penile hemodynamics and endothelial function. RESULTS: Twenty-nine men (mean age of 61.3) completed the study. Their mean IIEF-ED scores increased from 8.8 ± 1 (baseline) to 12.3 ± 1 at FU1 (P = 0.035). At FU2 (on active PDE5i treatment), their IIEF-ED further increased to 18.8 ± 1 (P < 0.0001), and 72.4% (P < 0.0001) reached an EHS of ≥ 3 (allowing full sexual intercourse). A significant improvement (P = 0.0001) in penile hemodynamics was detected after treatment and this improvement significantly correlated with increases in the IIEF-ED (P < 0.05). No noteworthy adverse events were reported. CONCLUSIONS: Penile LI-ESWT is a new modality that has the potential to treat a subgroup of severe ED patients. These preliminary data need to be reconfirmed by multicenter sham control studies in a larger group of ED patients.

Is there an association between female urinary incontinence and decreased genital sensation?

AIM: To explore the relationship between urinary incontinence and genital sensory functioning in females with sexual dysfunction disorders. METHODS: A retrospective consecutive chart review was conducted for all women who were referred to our tertiary female urology clinic with a primary complaint of sexual dysfunction between October 1999 and January 2009. Our study sample included 177 women, all of whom underwent a thorough clinical evaluation. Urinary incontinence was diagnosed based on clinical history and physical examination by a urogynecologist. The Genital Thermal and Vibratory Sensory Analyzer (GSA) was used for sensory testing in the genital area. Independent t-test and multivariate linear regression were used for statistical analysis. RESULTS: Of the 177 study patients (median age 34, range 18-68), 63 (36%) had urinary incontinence. Women with urinary incontinence were found to be less sensitive to warm, cold, and vibratory thresholds at both the anterior and the posterior vaginal wall and the clitoral area (P < 0.05). CONCLUSIONS: Women with urinary incontinence and sexual dysfunction are less sensitive to all sensory testing in the genital region than women with sexual dysfunction alone. This relationship may be attributable to afferent nerve damage and the critical role it may play in the etiology of urinary incontinence.

Summary of the recommendations on sexual dysfunctions in men.

INTRODUCTION: Sexual health is an integral part of overall health. Sexual dysfunction can have a major impact on quality of life and psychosocial and emotional well-being. AIM: To provide evidence-based, expert-opinion consensus guidelines for clinical management of sexual dysfunction in men. METHODS: An international consultation collaborating with major urologic and sexual medicine societies convened in Paris, July 2009. More than 190 multidisciplinary experts from 33 countries were assembled into 25 consultation committees. Committee members established scope and objectives for each chapter. Following an exhaustive review of available data and publications, committees developed evidence-based guidelines in each area. Main Outcome Measures. New algorithms and guidelines for assessment and treatment of sexual dysfunctions were developed based on work of previous consultations and evidence from scientific literature published from 2003 to 2009. The Oxford system of evidence-based review was systematically applied. Expert opinion was based on systematic grading of medical literature, and cultural and ethical considerations. RESULTS: Algorithms, recommendations, and guidelines for sexual dysfunction in men are presented. These guidelines were developed in an evidence-based, patient-centered, multidisciplinary manner. It was felt that all sexual dysfunctions should be evaluated and managed following a uniform strategy, thus the International Consultation of Sexual Medicine (ICSM-5) developed a stepwise diagnostic and treatment algorithm for sexual dysfunction. The main goal of ICSM-5 is to unmask the underlying etiology and/or indicate appropriate treatment options according to men's and women's individual needs (patient-centered medicine) using the best available data from population-based research (evidence-based medicine). Specific evaluation, treatment guidelines, and algorithms were developed for every sexual dysfunction in men, including erectile dysfunction; disorders of libido, orgasm, and ejaculation; Peyronie's disease; and priapism. CONCLUSIONS: Sexual dysfunction in men represents a group of common medical conditions that need to be managed from a multidisciplinary perspective.

Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction.

BACKGROUND: Low-intensity extracorporeal shockwave therapy (LI-ESWT) is currently under investigation regarding its ability to promote neovascularization in different organs. OBJECTIVE: To evaluate the effect of LI-ESWT on men with erectile dysfunction (ED) who have previously responded to oral phosphodiesterase type 5 inhibitors (PDE5-I). DESIGN, SETTING, AND PARTICIPANTS: We screened 20 men with vasculogenic ED who had International Index of Erectile Function ED (IIEF-ED) domain scores between 5-19 (average: 13.5) and abnormal nocturnal penile tumescence (NPT) parameters. Shockwave therapy comprised two treatment sessions per week for 3 wk, which were repeated after a 3-wk no-treatment interval. INTERVENTION: LI-ESWT was applied to the penile shaft and crura at five different sites. MEASUREMENTS: Assessment of erectile function was performed at screening and at 1 mo after the end of the two treatment sessions using validated sexual function questionnaires, NPT parameters, and penile and systemic endothelial function testing. The IIEF-ED questionnaire was answered at the 3- and 6-mo follow-up examinations. RESULTS AND LIMITATIONS: We treated 20 middle-aged men (average age: 56.1 yr) with vasculogenic ED (mean duration: 34.7 mo). Eighteen had cardiovascular risk factors. At 1 mo follow-up, significant increases in IIEF-ED domain scores were recorded in all men (20.9 +/- 5.8 vs 13.5+/- 4.1, p<0.001); these remained unchanged at 6 mo. Moreover, significant increases in the duration of erection and penile rigidity, and significant improvement in penile endothelial function were demonstrated. Ten men did not require any PDE5-I therapy after 6-mo follow-up. No pain was reported from the treatment and no adverse events were noted during follow-up. CONCLUSIONS: This is the first study that assessed the efficacy of LI-ESWT for ED. This approach was tolerable and effective, suggesting a physiologic impact on cavernosal hemodynamics. Its main advantages are the potential to improve erectile function and to contribute to penile rehabilitation without pharmacotherapy. The short-term results are promising, yet demand further evaluation with larger sham-control cohorts and longer follow-up.

Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation.

CONTEXT: Erectile dysfunction (ED) and premature ejaculation (PE) are the two most prevalent male sexual dysfunctions. OBJECTIVE: To present the updated version of 2009 European Association of Urology (EAU) guidelines on ED and PE. EVIDENCE ACQUISITION: A systematic review of the recent literature on the epidemiology, diagnosis, and treatment of ED and PE was performed. Levels of evidence and grades of recommendation were assigned. EVIDENCE SYNTHESIS: ED is highly prevalent, and 5-20% of men have moderate to severe ED. ED shares common risk factors with cardiovascular disease. Diagnosis is based on medical and sexual history, including validated questionnaires. Physical examination and laboratory testing must be tailored to the patient's complaints and risk factors. Treatment is based on phosphodiesterase type 5 inhibitors (PDE5-Is), including sildenafil, tadalafil, and vardenafil. PDE5-Is have high efficacy and safety rates, even in difficult-to-treat populations such as patients with diabetes mellitus. Treatment options for patients who do not respond to PDE5-Is or for whom PDE5-Is are contraindicated include intracavernous injections, intraurethral alprostadil, vacuum constriction devices, or implantation of a penile prosthesis. PE has prevalence rates of 20-30%. PE may be classified as lifelong (primary) or acquired (secondary). Diagnosis is based on medical and sexual history assessing intravaginal ejaculatory latency time, perceived control, distress, and interpersonal difficulty related to the ejaculatory dysfunction. Physical examination and laboratory testing may be needed in selected patients only. Pharmacotherapy is the basis of treatment in lifelong PE, including daily dosing of selective serotonin reuptake inhibitors and topical anaesthetics. Dapoxetine is the only drug approved for the on-demand treatment of PE in Europe. Behavioural techniques may be efficacious as a monotherapy or in combination with pharmacotherapy. Recurrence is likely to occur after treatment withdrawal. CONCLUSIONS: These EAU guidelines summarise the present information on ED and PE. The extended version of the guidelines is available at the EAU Web site (http://www.uroweb.org/nc/professional-resources/guidelines/online/).

Standards for clinical trials in male sexual dysfunctions.

INTRODUCTION: Clinical trials in male sexual dysfunction (MSD) are expanding. Consequently, there is a need for consensus standards in this area. AIM: To develop an evidence-based, state-of-the-art consensus report on standards for clinical trials in MSD. METHODS: A literature review was performed examining clinical trials in erectile dysfunction (ED), premature ejaculation (PE), delayed/absent ejaculation, libido disorders/loss of desire, hypogonadism, and Peyronie's disease, focusing on publications published in the last 20 years. This manuscript represents the opinions of eight experts from seven countries developed in a consensus process. 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. MAIN OUTCOME MEASURE: Expert opinion was based on the grading of evidence-based medical literature, widespread internal committee discussion, public presentation, and debate. RESULTS: According to experience and recent publications in dealing with clinical trials in sexual dysfunction, recommendations have been made for conducting trials in patients with ED, PE, delayed ejaculation, libido disorders, hypogonadism, and Peyronie's disease. CONCLUSIONS: It is important that future clinical trials are conducted using standards upon which investigators can rely when reading manuscripts or conducting new trials in this field.

Who's afraid of the G-spot?

INTRODUCTION: No controversy can be more controversial than that regarding the existence of the G-spot, an anatomical and physiological entity for women and many scientists, yet a gynecological UFO for others. METHODS: The pros and cons data have been carefully reviewed by six scientists with different opinions on the G-spot. This controversy roughly follows the Journal of Sexual Medicine Debate held during the International Society for the Study of Women's Sexual Health Congress in Florence in the February of 2009. MAIN OUTCOME MEASURE: To give to The Journal of Sexual Medicine's reader enough data to form her/his own opinion on an important topic of female sexuality. RESULTS: Expert #1, who is JSM's Controversy section editor, reviewed histological data from the literature demonstrating the existence of discrete anatomical structures within the vaginal wall composing the G-spot. He also found that this region is not a constant, but can be highly variable from woman to woman. These data are supported by the findings discussed by Expert #2, dealing with the history of the G-spot and by the fascinating experimental evidences presented by Experts #4 and #5, showing the dynamic changes in the G-spot during digital and penile stimulation. Experts #3 and #6 argue critically against the G-spot discussing the contrasting findings so far produced on the topic. CONCLUSION: Although a huge amount of data (not always of good quality) have been accumulated in the last 60 years, we still need more research on one of the most challenging aspects of female sexuality.