International Society For Sexual Medicine Research Articles

Variation in collagenase Clostridium histolyticum practice patterns: a Survey of ISSM Members.

Collagenase clostridium histolyticum (CCH, Xiaflex, Xiapex) is the only FDA-approved medication for treatment of Peyronie's disease. It is unclear how practitioners actually use CCH in their own practices. The objectives of the study were: (1) to identify variability in practice patterns for CCH among practitioners, (2) to assess adherence to the package insert instructions, and (3) to evaluate whether provider satisfaction was associated with adherence to instructions. A 30-question online survey was distributed to 1270 members of the International Society for Sexual Medicine (ISSM) from the EU, USA, Canada and Australia. Of the 30 questions, 10 survey questions had only one response consistent with the CCH package insert recommendations. An "adherence" score was calculated for each survey participant depending on how many of these questions were answered correctly. The average adherence scores of various groups were compared using a student's t-test. A chi-squared test was used to determine association between categorical variables. Of 202 total responses, 132 practitioners reported using CCH out of 1270 ISSM members from countries where CCH is available (10.4% response rate). Practitioners from outside the USA were more likely to be satisfied with CCH (p = 0.006), and more experienced users (>20 uses) were more likely to be satisfied than less experienced users (<10 uses) (p = 0.046). Satisfied users of CCH did not have significantly different adherence scores than non-satisfied users. Even though 67% of practitioners believed they followed the package insert guidelines, only 11% adhered to all the recommendations evaluated by the survey. Treatment adherence to package insert guidelines does not appear to be associated with provider satisfaction. We believe there is utility in seeing a snapshot of these practice patterns so practitioners may feel more comfortable adapting their own practice in light of newer data supporting alternative administration methods.

Current practice in the management of ischemic priapism: an anonymous survey of ISSM members.

Penile shunting is the standard of care in management of ischemic priapism refractory (IPR) to non-surgical interventions. Due to high rates of impotence, corporal fibrosis, and loss of penile length, recent literature suggests these patients benefit from immediate penile prosthesis (PP) placement. An IRB-exempt anonymous electronic survey of the 2,168 members of the International Society for Sexual Medicine (ISSM) was conducted. The survey included demographic information, confidence and experience related management of IPR. The aim was to evaluate current practice patterns in management of IPR and to investigate the role of immediate PP implantation in the management of prolonged (>36-hours) IPR. The survey response rate was 11.6% (n=251). Most respondents were urologists (173), from the USA (49.1%), and had completed a fellowship in male sexual medicine, men’s health, reconstruction, or andrology (71.1%). The majority (91.3%) see at least one case of prolonged priapism (>36 hours) that requires surgical management yearly. When looking at volume in training and after, our respondents had a significantly higher experience with penile prostheses (over 70%, >=10) as compared to shunts (less than 40%, >=10). Overall, 70.9% of respondents felt more comfortable with a malleable PP than a shunt. However, penile shunts are still preferred as the first line of surgical management by nearly 80% of respondents as compared to 12.7% who instead prefer a PP. We also found that under 40% of respondents currently use penile MRI or corporal biopsies in their management of prolonged assessment. This is the first study to assess current clinical practices in management of IPR globally. As in any anonymous self-reported survey-based research, recall bias, sampling bias are an inherent limitation. Penile shunting for IPR continues to be the preferred treatment despite emerging data. Respondents performed PP surgery routinely and feel more confident placing PP than performing penile shunting procedures.

Medical Management of Premature Ejaculation

Premature ejaculation (PE) is the most common form of male sexual dysfunction across all age groups. PE is associated with negative psychological consequences including frustration, distress, and low self-confidence, which can create an obstacle while forming new partner relationships. Given the subjective and highly variable nature of sexual dysfunction, there are multiple and often inconsistent definitions PE. The International Society for Sexual Medicine provides the most comprehensive definition of PE: both acquired and lifelong PE are characterized by ejaculation that always or nearly always occurs approximately within 1 min of vaginal penetration or when the patient has a clinically bothersome reduction in intravaginal ejaculatory latency time or due to an inability to delay ejaculation in all or nearly all vaginal penetrations–all of which lead to the accumulation of negative psychosocial burden. The etiology of PE may stem from genetic predisposition or psychologic components; however, the precise mechanism has not been elucidated and likely differs from individual to individual. There is a well-established link between PE and neurotransmitter signaling through which SSRIs (selective serotonin reuptake inhibitor) have a tangible therapeutic effect. There have been significant advances in management of PE with the use of psychosexual therapy and pharmacotherapy, mainly local anesthetics and SSRIs. This review contains 3 figures, 2 tables, and 36 references. Key Words: classification, epidemiology, male sexual dysfunction, medical management, premature ejaculation

Differences between ICD-11 MMS and DSM-5 definition of premature ejaculation: a continuation of historical inadequacies and a source of serious misinterpretation by some European Regulatory Agencies (PART 2).

Recently, the ICD-11 for Mortality and Morbidity Statistics (ICD-11-MMS, 2018 Version) has been published with a new definition of premature ejaculation (PE), including a third PE subtype. This definition differs from Diagnostic and Statistical Manual of Mental Disorders (DSM-5) definition of PE. We hereby address the similarities and differences between ICD-11-MMS and DSM-5 definition of PE and call attention to the illogical policy of some European (EU) National Regulatory Agencies to remain with a 1-min cut-off point of ejaculation time for Lifelong, Acquired and Subjective PE. The advantage of ICD-11-MMS is the inclusion of a third PE subtype, which is congruent with Subjective PE. A serious disadvantage of DSM-5 is that a 1-min criterion is used for both Lifelong and Acquired PE, and that a third PE subtype is not mentioned. Despite the incomplete DSM-5 definition of PE, some EU regulatory agencies adhere to a definition of PE which relies only on the 1-min ejaculation time cut-off point of DSM-5, and do not recognize the more recent PE definitions of ICD-11-MMS and International Society for Sexual Medicine. There is no scientific evidence for this illogical position. The continued use of a 1-min cut-off point for all subgroups of PE ignores the existence of Acquired PE (Intravaginal Ejaculation Latency Time (IELT) <3 min) and Subjective PE (IELT <approx. 6 min), both of which have been shown to be clinically and psychologically important. In conclusion, some EU regulatory agencies are not recognizing ongoing developments in the definition of three different subgroups of PE. We propose combining the DSM-5 and ICD-11 MMS definitions to optimize the whole PE spectrum for future registered drug treatment studies, so that it properly reflects patient needs.

Variability in penile duplex ultrasound international practice patterns, technique, and interpretation: an anonymous survey of ISSM members

Penile duplex ultrasound (PDU), combined with pharmacologic stimulation of erection, is the gold standard for evaluation of multiple penile conditions. A 30-question electronic survey was distributed to members of the International Society for Sexual Medicine (ISSM). The survey assessed variability in current PDU practice patterns, technique and interpretation. Chi-square test was used to determine association between categorical variables. Approximately 9.5% of all 1,996 current ISSM members completed the survey. Almost 80% of members surveyed reported using PDU, with more North American practitioners utilizing PDU than their European counterparts (94% vs. 69%, p < 0.01). Approximately 62% of PDU studies were performed by a urologist and more than 76% were interpreted by a urologist. Although almost 90% of practitioners reported using their own protocol, extreme variation in technique existed among respondents. Over 10 different pharmacologic mixtures were used to generate erections, and 17% of respondents did not repeat dosing for insufficient erection. Urologists personally performing PDU were more likely to assess cavernosal artery flow using recommended techniques with the probe at the proximal penile shaft (73% vs 40%) and at a 60-degree angle or less (68% vs 36%) compared to non-urologists (p < 0.01). Large differences in PDU diagnostic thresholds were apparent. Only 38% of respondents defined arterial insufficiency with a peak systolic velocity < 25 cm/sec, while 53% of respondents defined venous occlusive disease with an end diastolic velocity > 5 cm/sec. This is the first study to assess variability in PDU protocol and practice patterns and to pinpoint areas of improvement. As in other surveys, recall bias, generalizability, and response rate (9.5%) are inherent limitations to this study. Although most respondents report utilizing a standardized PDU protocol, widespread variation exists among practitioners in terms of both technique and interpretation, limiting accurate diagnosis and appropriate treatment of penile conditions.

WORLD MEETING ON SEXUAL MEDICINE 2018 (21ST WORLD MEETING OF THE INTERNATIONAL SOCIETY FOR SEXUAL MEDICINE AND 20TH CONGRESS OF THE EUROPEAN SOCIETY FOR SEXUAL MEDICINE): VIEW FROM THE POSITION UROLOGIST AND ANDROLOGIST

In this article presented the report about the world meeting on sexual medicine, joint congress 21st World Meeting of the International Society for Sexual Medicine (ISSM) and 20th congress of the European Society for Sexual Medicine (ESSM), held in Lisbon from 28 February to 3 March 2018.Disclosure: The study did not have sponsorship. The authors have declared no conflicts of interest.

Acquired premature ejaculation in Parkinson's disease and possible mechanisms.

Premature ejaculation (PE) has been reported in 40.6-51.5% of men affected by Parkinson's disease (PD), however, this non-motor sexual complaint has not been studied in detail. We describe eight PD patients who asked for a sexological consultation between 2008 and 2014 because of a new-onset of PE. They were diagnosed with acquired PE (APE) according to the DSM-V criteria and the International Society for Sexual Medicine (ISSM) committee. Patients' demographic, medical and sexual related data were retrieved and studied. The average age of onset of PD was 53.3 ± 12.7 years (range 38-77 years) and the sexual problem appeared 4.0 ± 3.1 years later. The mean intravaginal ejaculation latency (IELT) before APE onset was 7.3 (range 2-20) min. Interestingly, the ejaculatory disorder appeared abruptly, characterized by a dramatically shortened IELT in all patients, while in three of the cases ejaculation occurred before vaginal penetration, hampering sexual intercourse. Some patients had 2 additional sexual problems, (four with erectile dysfunctions, five with libido changes: increased desire in four and reduced in one). In this case series of PD patients with APE, the ejaculatory dysfunction developed when patients were on antiparkinsonian medications, suggesting a possible medication effect.

Premature ejaculation: a modern view at the problem

Data are submitted on the frequency of premature ejaculation and its definitions in the International Classification of Diseases of the 10th Revision, the Diagnostic and Statistical Manual of Mental Disorders of the 4th and 5th Revisions (USA), and in the recommendations of the special committee of the International Society for Sexual Medicine. The biological and the biopsychosocial approach to assessing the duration of sexual intercourse are presented and characterized. It is concluded that the biological approach to its evaluation which is fully applicable to animals is insufficient for humans, since it does not take into account the extremely important recreational aspect of intimate intimacy in people. Psychogenic and biogenic factors involved in the formation of premature ejaculation are presented. It is concluded that attempts to completely eliminate or significantly downplay the role of biogenic factors in the genesis of this dysfunction should be considered untenable.

The relationship between female sexual function index domains and premature ejaculation.

The aim of this prospective, observational study was to investigate the relationship between premature ejaculation (PE) and female sexual response cycle, using the female sexual function index (FSFI). The FSFI evaluates female sexual function in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. All men were considered to have PE if they fulfilled the criteria of the second Ad Hoc International Society for Sexual Medicine (ISSM) Committee. All men were also assessed by the Premature Ejaculation Diagnostic Tool (PEDT) and intravaginal ejaculatory latency time (IELT) using stopwatch which was held by the partner. All women completed the FSFI. A total of 181 couples who had regular sexual intercourse with one partner for the past 6months were enrolled the study. By the definition of ISSM Committee, there were 117 men with PE and 64 men without PE. Partners of men with PE had significantly lower total FSFI scores than did partners of men without PE (21.8 ± 3.5 for PE and 26.4 ± 3.1 for non-PE, p < 0.001). Moreover, all the domains of the FSFI scoring system were separately associated with PE. According to the mean FSFI scores, the 48.43% of women had sexual dysfunction in the non-PE group, and all women had sexual dysfunction in PE group. PE is associated with female sexual dysfunction and all of the female sexual dysfunction domains, as determined by FSFI scores.

Evaluation of Efficacy and Safety of Dapoxetine in Premature Ejaculation: A Placebo Controlled Study

Premature Ejaculation (PE) is a common male sex problem and incidence wise it is much commoner than erectile dysfunction with incidence in some studies being greater than 30% [1, 2]. In spite of this it does not attain enough attention of research workers. Ejaculation time (ET) may vary, but patient usually seeks medical help when it consistently becomes short at every coitus and causes distress to the couple. American Urological Association (AUA) defines PE when it “occurs sooner than desire” and causes “distress to one or both partners” [3]. For clinical assessment quantification is essential and in this case is possible by measuring Intravaginal Ejaculation Latency Time (IELT).this calculated by time period between vaginal penetration of phallus and intravaginal ejaculation. A more categorical and working definition comes from the International Society for Sexual Medicine (ISSM) which states that PE is “ejaculation that occurs prior to or within 1 minute of vaginal penetration” [4]. In our study we have taken IELT of less than 1 minute as PE. Serotonin has been found to have an inhibitory action on seminal emission/ejaculation via action on brain, brainstem, raphe nuclei and reticular formation. These observation leads to several studies which show that selective serotonin reuptake inhibitor (SSRI) achieve significant increase in IELT [5].

AB041. Perioperative nursing care of penile pacemaker implantation

The International Society for Sexual Medicine (ISSM) defines erectile dysfunction (ED) as the persistent failure to achieve or maintain adequate erection of the penis in order to achieve a satisfactory sexual life. ED seriously affects quality of life and family harmony. More and more ED patients are choosing inflatable penile implants to improve their quality of life. The purpose of this report is to introduce the key points and experiences of perioperative care of three sets of inflatable penile implants.

AB017. Challenges in the diagnosis and treatment of testosterone deficiency in men

Testosterone deficiency (TD) profoundly affects men’s quality of life. Men receiving testosterone therapy often experience resolution or improvement in their sexual symptoms and non-sexual health benefits. Although testosterone has been available since 1930s, the diagnosis and management of TD can be challenging and many controversies still exist. Clinical assessment based on symptoms and signs with a confirmatory testosterone level below normal range are required for diagnosis of TD. Screening for TD in the general population is not recommended. Screening for TD should be taken in men who report symptoms or signs associated with TD, particularly sexual dysfunctions as well as in men with obesity, type 2 diabetes, and metabolic syndrome. The International Society for Sexual Medicine recommended that symptomatic men with total T <350 ng/dL (12 nmol/L) should be treated with T therapy and a trial of T therapy in symptomatic men with total T levels >350 ng/dL can be considered based on clinical presentation. Patients who report no symptomatic improvement after at least 3 to 6 months of testosterone therapy despite adequate serum T levels should discontinue treatment.

The Graham Jackson Memorial Lecture ISSM 2016-"The Man Who Knew Too Much": Time to Recognize Erectile Dysfunction and Low Testosterone as Independent Risk Factors for Cardiovascular Disease.

Graham Jackson introduced the concept that erectile dysfunction (ED) is a marker for undiagnosed cardiovascular (CV) disease and future events. In the Princeton 3 guidelines, he recognized the important impact of testosterone deficiency (TD) on all-cause and CV mortality. Recent evidence suggests that testosterone therapy to target levels and for sufficient duration decreases CV events. Unfortunately, this had a modest impact on CV disease management because ED is not incorporated into current risk calculators. This report is based on the Graham Jackson Memorial Lecture presented at the International Society for Sexual Medicine (ISSM) in Beijing in2016. To examine recent evidence as to whether ED should be upgraded to a risk factor, especially with the high predictive value in younger men, and to develop a case for TD to be considered an independent risk factor based on a large number of long-term studies during the past 5 years. A Medline search was undertaken to include articles on ED and TD and related terms from 1998 to 2016 during the preparation of ISSM guidelines on ED and TD. A rational justification for ED and low testosterone to be considered risk factors for CV disease and be included in risk calculators. The evidence for inclusion of ED and TD might be stronger than for accepted risk factors and have the advantages of being easily assessed, quantitative, symptomatic, and clinically relevant, especially in younger men. Because important studies are often published in endocrine, sexual medicine, urology, and cardiology journals, a multidisciplinary approach is needed. There is strong evidence that ED and low testosterone might be of more practical relevance to programs that decrease CV risk than some current recognized risk factors. Hackett G. The Graham Jackson Memorial Lecture ISSM 2016-"The Man Who Knew Too Much": Time to Recognize Erectile Dysfunction and Low Testosterone as Independent Risk Factors for Cardiovascular Disease. Sex Med Rev 2017;5:256-265.

Prevalence and Associated Factors of Premature Ejaculation in the Anhui Male Population in China: Evidence-Based Unified Definition of Lifelong and Acquired Premature Ejaculation

IntroductionIn 2014, new evidence-based definitions of lifelong premature ejaculation (LPE) and acquired premature ejaculation (APE) were proposed by the International Society for Sexual Medicine. Based on the new PE definitions, the prevalence of and factors associated with LPE and APE have not been investigated in China.AimTo evaluate the prevalence of and factors associated with LPE and APE in men with the complaint of PE in China.MethodsFrom December 2011 to December 2015, a cross-sectional field survey was conducted in five cities in the Anhui province of China. Questionnaire data of 3,579 men were collected in our database. The questionnaire included subjects' demographic information and medical and sexual histories. Men who were not satisfied with their time to ejaculate were accepted as having the complaint of PE. Men with the complaint of PE who met the new definition of PE were diagnosed as having LPE or APE.Main Outcome MeasuresNew definition of LPE and APE.ResultsOf 3,579 men who completed the questionnaire, 34.62% complained of PE. Mean age, body mass index, and self-estimated intravaginal ejaculatory latency time for all subjects were 34.97 ± 9.02 years, 23.33 ± 3.56 kg/m2, and 3.09 ± 1.36 minutes, respectively. The prevalences of LPE and APE in men with the complaint of PE were 10.98% and 21.39%, respectively. LPE and APE were associated with age, body mass index, and smoking and exercise rates (P < .001 for all comparisons). Men with APE reported more comorbidities than men with LPE, especially in the presence of hypertension, diabetes mellitus, and heart disease (P < .001 for all comparisons).ConclusionIn this study, the prevalences of LPE and APE in men with the complaint of PE were 10.98% and 21.39%, respectively. Patients with APE were older and more likely to smoke, had more comorbidities, and had a higher body mass index than patients with LPE.

036 Comparison of Paroxetine and Dapoxetine Regarding Intra Vaginal Ejaculatory Latency Time and Frequency of Sexual Intercourse in the Management of Lifelong Premature Ejaculation

To compare the efficacy of on demand use of Paroxetine or dapoxetine in the management of lifelong premature ejaculation. 64 patients with lifelong premature ejaculation according to the International Society of Sexual Medicine (ISSM) 2008 criteria have been included in the study. History taking, general and systemic examination have been done for all patients. Paroxetine 20 mg was given four hours before intercourse for 3 months, for at least 36 successive intercourses, followed by administration of dapoxetine 30mg one hour before intercourse for the same period, followed by administration of dapoxetine 60mg one hour before intercourse for the same period. A wash out period of two weeks with no medication was given before each treatment to avoid the cumulative effect of the drugs. Intra Vaginal ejaculatory Latency ejaculatory time (IELT) was assessed by the patients at home with a stopwatch. The mean IELT significantly increased from (0.7 ± 0.3) min at the base line to (1.8 ± 0.8) min (1.6 folds), (2.4 ± 1.1) min(2.4 folds)and (3.6 ± 1.8) min (3.8 folds) for Paroxetine 20 mg, dapoxetine 30 mg and dapoxetine 60 mg respectively P<0.001. The mean number of intercourse also has been significantly increased from 2.6 ± 1.5 times / week at the basal line to 3.9 ± 1.3 times per week , 3.7 ± 1.1 times per week and 3.8 ± 1.2 times / week for Paroxetine 20 mg, dapoxetine 30 mg and dapoxetine 60 mg respectively P<0.001.

359 Global Guidelines for Sexual Dysfunction in Men With Type2 Diabetes Mellitus

Sexual dysfunction (SD) is common in type 2 diabetic men, but few subjects are diagnosed and treated. The prevalence of diabetes mellitus is increasing worldwide. It is expected that the number of subjects suffering from SD will increase in the near future. Sexual dysfunction is an under appreciated, under-recognized, under-discussed, and commonly untreated complication of diabetes. Sexual dysfunction has a major impact on quality of life (QoL) as well as psychosocial and emotional well-being of persons. The purpose of this review is to highlight the paucity of international guidelines in sexual dysfunction in men with type 2 diabetes mellitus (T2DM). A literature search was performed to identify and evaluate the existing data on guidelines for sexual dysfunction management in men with T2DM. SD in T2DM would be better appreciated and managed if guidelines were set by international bodies like the International Society for Sexual Medicine. (ISSM)

Penile vascular diagnostic categorization using penile duplex Doppler ultrasound: Differences in vascular hemodynamics parameters by differences in anatomic sampling location.

In 2013 the International Society for Sexual Medicine(ISSM) published the guidelines regarding the standard operating procedure (SOP) for penile duplex Doppler ultrasound (PDDU). Although ISSM-SOP have given important strides in reducing interobserver variability in PDDU by procedural protocol and parameters these guidelines do not address the anatomic location along the penis at which hemodynamic measurements have to be done. In our opinion a "double sampling" may be interesting to detect the arteriogenic or venogenic nature of the erectile dysfunction (ED). In particular sampling measurements at the "crus" (at the level of the peno-scrotal junction) may be significative for detection of veno-occlusive dysfunction (VOD),whereas an evaluation at "mid penis" (1/2 distance between peno-scrotal junction and coronal sulcus), may be useful to diagnose an arterial insufficiency (AI). We evalued 90 men, mean age 56.3, affected with ED of medium degree, responder to PDE5-I that urdergone to PDDU and also responder after pharmacologic intracavernosal injection (PII)of prostaglandin E1 20 mcg, with rigid erection and normal maintenance. We moreover evalued 90 men in youthful age (mean 35.2), in absence of vascular risk factors, no responder to PDE5-I that undergone to PDDU by PII at high dosage (bimix: prostaglandin E1 20 mcg, papaverine 20 mg). In the first pool the sampling at "mid penis" resulted significative for arterial insuffciency (AI) in 81% (73), in presence of normal or borderline end diastolic velocity (EDV). Sampling at the "crus" resulted negative for VOD in 90% (81). In the second pool, 66.6% (60) resulted responder with rigid erection and normal maintenance in presence of normal hemodynamic parameters: peak systolic velocity (PSV) and end diastolic velocity (EDV) both at the "crus" and at "mid penis" sampling. 33.4% (30) responded with a semirigid erection and manifested a constant deficit of maintenance; at the "crus"and at "mid penis" the hemodynamic arterial parameters resulted normal. At the "crus" the EDV resulted significantly augmented (VOD index) in 96.6% (29); at "mid penis" augmented EDV was founded in 50% (15). These observational data would be able to confirm the utility of a routinary "double sampling" procedure, at the "crus" and at "md penis", during PDDU in order to better distinguish between VOD or AI or in any case to be useful to stimulate a future more precise standardization in execution of PDDU examination.

Reexamining the Definitions of PE and DE

Evidence-based definitions improve clinical practice and research. Nonetheless, the International Society of Sexual Medicine (ISSM) and the American Psychiatric Association's (DSM-5) definitions regarding lifelong and acquired premature ejaculation (PE) and delayed ejaculation (DE) require reexamination. Existing Intravaginal Ejaculation Latency Time (IELT) evidence, the ISSM position papers, and articles both supporting and critiquing the ISSM's definitions were reviewed. Disproportionately, the findings from those studies document that the majority of men's IELT range is approximately 4 to 10 minutes. Such robust quantitative evidence should become the basis for determining the temporal criterion when defining both PE and DE. Any bilateral deviation from that majority's ∼4- to 10-minute IELT range should meet the qualification for the temporal diagnostic criterion. However, for a man to be diagnosed with a disorder, a licensed health-care clinician (HCC) must also determine that the man suffers from “lack of control” and “distress.” Diagnosis would include subtyping Lifelong or Acquired, Global or Situational, similar to the ISSM guidelines and specifying mild, moderate, or severe—similar to DSM-5 requirements. “Control” and “distress” should trump latency and convey greater weight in the diagnostic process. Loosened latency criteria could result in false positive diagnoses; however, requiring a licensed HCC to evaluate control and distress reduces that risk.

Is there a place for surgical treatment of premature ejaculation?

Management of premature ejaculation (PE) has evolved tremandoulsy over the last 20 years. Selective serotonin reuptake inhibitor (SSRI) antidepressants and local anesthetics are the most and best studied treatments. This evidence has led to the establishment of an evidence-based definition of PE and the International Society for Sexual Medicine (ISSM) guidelines for the diagnosis and treatment of PE. The current treatment of choice for PE according to the ISSM guidelines is a centrally acting SSRI or peripherally acting topical anesthetics. Despite the progress in threating PE, the drawbacks of these medical treatments are controversial. Before the ISSM guidelines were established, selective dorsal neurectomy (SDN) and glans penis augmentation (GPA) using a hyaluronic acid (HA) gel were developed to decrease sensitivity of the glans penis but later ISSM guidelines do not recommend surgical treatment because of possible permanent loss of sexual function and insufficient reliable data. Despite the drawbacks of medical treatments and debates about the ISSM guideline, surgical treatment for PE has increased continuously in Asian countries for non-responders to medical treatment. In contrast to the concerns outlined in the ISSM guidelines, SDN has been reported as effective and safe with rare sensory loss. Percutaneous computed tomography-guided cryoablation of the dorsal penile nerve and neuromodulation of the dorsal penile nerve by pulsed radiofrequency are reported as effective and safe for PE. It is time to re-evaluate rather than ignore surgical treatments for PE because doctors and patients need surgical alternatives for patients with PE who are not satisfied with medical treatment. SDN has a definite role in the efficacy but needs more safety data to be used as standard surgical treatment for PE. SDN must be performed carefully and more well-designed studies are needed. GPA with a HA gel does not induce serious sensory loss in patients with ED erectile dysfunction and the recommendation should be re-evaluated by the ISSM after additional reliable studies are performed.

The design and methodology of premature ejaculation interventional studies.

Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and efficacy outcomes measures which comprise ideal premature ejaculation (PE) interventional trial methodology. Data on clinical trial design, epidemiology, definitions, dimensions and psychological impact of PE was reviewed, critiqued and incorporated into a series of recommendations for standardisation of PE clinical trial design, outcome measures and reporting using the principles of evidence based medicine. Data from PE interventional studies are only reliable, interpretable and capable of being generalised to patients with PE, when study populations are defined by the International Society for Sexual Medicine (ISSM) multivariate definition of PE. PE intervention trials should employ a double-blind RCT methodology and include placebo control, active standard drug control, and/or dose comparison trials. Ejaculatory latency time (ELT) and subject/partner outcome measures of control, personal/partner/relationship distress and other study-specific outcome measures should be used as outcome measures. There is currently no published literature which identifies a clinically significant threshold response to intervention. The ISSM definition of PE reflects the contemporary understanding of PE and represents the state-of-the-art multi-dimensional definition of PE and is recommended as the basis of diagnosis of PE for all PE clinical trials.