Safety and efficacy of GreenLight PVP in octogenarians: evaluation of the Global GreenLight Group database.

INTRODUCTION: The present study analyzes the largest international GreenLight database, the Global GreenLight Group (GGG), to evaluate the functional and safety profile of GreenLight photoselective vaporization of the prostate (PVP) in octogenarians. METHODS: The GGG is a database comprised of patients that underwent GreenLight PVP from 2011 to 2019 performed by 8 experienced urologists at 7 international hospitals. Patients 80 years or older at the time of surgery were categorized as octogenarians. They were compared to a similar group of PVP patients below the age of 80. RESULTS: Among 3,648 patients, 586 men were above the age of 80. Compared to patients under the age of 80, octogenarians had larger prostates (76.0 vs 71.9 ml, p = 0.02) and a lower BMI (25.6 vs 26.7, p = 0.045). Operative time was not significantly longer in octogenarians. The improvement in functional outcomes between 80-year-old patients and control patients was not significantly different at one-year follow-up, with the exception of maximum urinary flow (Qmax) that favoured younger patients (10.3 vs 12.6 ml/s, p = 0.02). The odds of transfusion were greater for older patients [OR 8.2 (95% CI 3.6-18.9, p < 0.01)], but they were not at increased risk of hematuria. Octogenarians had higher readmission rates (23.0 vs 11.9%, p < 0.01). CONCLUSIONS: GreenLight PVP is a safe option in well-selected octogenarians in a cohort of patients treated by surgeons experienced with the technology. The odds of transfusion were higher in patients over 80, but the absolute risk remains low. The 30-day hospital readmission rate was higher in octogenarians.

Functional outcomes of GreenLight 180-W photoselective vaporization in patients with large (≥ 80 cc) prostates: an analysis of over 3000 men in the Global Greenlight Group (GGG) database.

INTRODUCTION: GreenLight photoselective vaporization of the prostate (PVP) has gained widespread adoption as an option to traditional transurethral resection of the prostate. Prior reports expressed concern with the use of PVP in large prostates. The aim of this study was to investigate the adjusted outcomes of GreenLight PVP in men with large (≥ 80 cc) vs. small prostates (< 80 cc). METHODS: Data were obtained from the Global Greenlight Group which pools data from 7 high volume centers. Men with established benign prostatic hyperplasia who underwent GreenLight PVP using the XPS-180 W system between 2011 and 2019 were eligible and assigned into two groups based on their prostate size (≥ 80 and < 80 cc). 11 functional and perioperative covariates were collected. Analyses were adjusted for patient age and presence of median lobe. RESULTS: 3426 men met the inclusion criteria. 34.6% (n = 1187) of patients had a large prostate size. Baseline age and prostate volume were significantly different between the groups. The magnitude of absolute improvement in unadjusted international prostate symptom score was significantly greater in the large (≥ 80 cc) prostate group at 12 months, with an absolute change of 19.17 points (95% CI 18.46-19.88; p < 0.01). There was also a significant drop in PVR at both 6- (p = 0.007) and 12 months (p = 0.005). There were no significant differences in transfusion (p = 0.42), hematuria (p = 0.80), or 30-day readmission rates (p = 0.28). CONCLUSIONS: Greenlight PVP is a safe and effective alternative for patients with prostate sizes ≥ 80 cc, with durable outcomes relatively independent from prostate size.

The impact of 5-ARI on perioperative and functional outcomes of GreenLight PVP: an analysis of the Global GreenLight Group database.

INTRODUCTION: In this study, we sought to investigate the impact of 5-alpha reductase inhibitors (5-ARI) on the perioperative and functional outcomes of 180-Watt XPS GreenLight photovaporization of the prostate (PVP) using a large international database. MATERIALS AND METHODS: Data were obtained from the Global GreenLight Group (GGG) database, which includes eight high-volume, experienced surgeons from seven international centers.  All men with established benign prostatic hyperplasia (BPH) with known 5-ARI status who underwent GreenLight PVP using the XPS-180W system between 2011 and 2019 were eligible for the study.  Patients were assigned to two groups based on the preoperative use of 5-ARI.  Analyses were adjusted for patient age, prostate volume, and American Society of Anesthesia (ASA) score. RESULTS: We included 3,500 men, of which 1,246 (36%) had preoperative 5-ARI use.  Patients in both groups were similar with regards to age and prostate size.  On multivariable analysis, total operative time was slightly shorter (-3.26 min 95% CI: 1.20 - 5.32, p < 0.01) and required 35.6kJ less laser energy (95% CI: -48.0kJ - -23.3kJ, p < 0.01) for patients on 5ARI compared to those without 5-ARI.  However, no clinically significant difference was appreciated regarding postoperative transfusion rates [OR 0.048 (95% CI -0.82-0.91; p = 0.91)], hematuria rates [OR 0.96 (95% CI 0.72-1.3; p = 0.81)], 30-day readmission rates [OR 0.98 (95% CI 0.71-1.4; p = 0.90)], or overall functional outcomes. CONCLUSION: Our findings suggest that preoperative 5-ARI is not associated with any clinically significant different perioperative or functional outcomes for GreenLight PVP using the XPS-180W system.  There is no role for the initiation or discontinuation of 5-ARI prior to GreenLight PVP.

Global experience and progress in GreenLight-XPS 180-Watt photoselective vaporization of the prostate.

PURPOSE: To evaluate changes in global perioperative data of GreenLight-XPS 180-Watt photo-selective vaporization of the prostate (GL-XPS) of the Global Greenlight Group (GGG) database. METHODS: 3441 men, who underwent GL-XPS for symptomatic BPH between 2011 and 2019 at seven high volume international centers, were included. Primary outcome measurements were operative time (OT; min), effective laser time (LT; min of OT), as well as intraoperative and postoperative adverse events (AEs), all analyzed by year of surgery (2011-2019) and prostate volume (PV) group (< 80 ml vs. 80-150 ml vs. > 150 ml). RESULTS: The median age was 70 years (interquartile range 64-77), the median PV was 64 ml (IQR 47-90). The OT and LT slightly increased but stayed highly efficient all in all. Median OT was 60 min (IQR 45-83) and LT was 33 min (IQR 23-46). Median energy use was 253 kJ (IQR 170-375) with an energy density of 3.94 kJ/ml (IQR 2.94-5.02). The relative probability of perioperative AEs decreased by 17% each year (p < 0.001). The relative probability of perioperative transfusion dropped significantly from 2% in 2011 to 0% in 2019 (p = 0.007). The early postoperative complications (within 30 days after surgery) decreased significantly from 48.8% (n = 106) in 2011 to 24.7% (n = 20) in 2019 (p > 0.001). CONCLUSION: These findings from the GGG demonstrate significant improvement secondary to growing experience with GL-XPS between 2011 and 2019 in intraoperative AEs, including transfusions, and postoperative AEs. While staying highly efficient in OT and LT of GL-XPS within a 9-year period of experience.

GreenLight photovaporization of the prostate in high-medical-risk patients: an analysis of the Global GreenLight Group (GGG) database.

PURPOSE: We sought to characterize the adjusted outcomes of GreenLight photoselective vaporization of the prostate (PVP) in high-medical-risk (HMR) patients using data from the largest international database. METHODS: Data were obtained from the Global GreenLight Group (GGG) database which pools data of eight high-volume, experienced surgeons, from a total of seven international centers. Eligible study participants underwent GreenLight PVP using the XPS-180 W system between 2011 and 2019. HMR patients were defined as patients with ASA III or greater and were compared to non-HMR patients. Analyses were adjusted for patient age and prostate volume. RESULTS: In the HMR group, patients on average were older and had smaller prostates than the non-HMR control group. Compared to non-HMR patients, transfusions occurred more frequently (2.6% vs. 0.14%, p < 0.01) and the odds of readmission were elevated [OR 2.0, (95% CI 1.4-2.8, p < 0.01)] among HMR patients. Twelve months postoperatively, HMR patients experience greater improvement in QoL than the control group [+ 0.54 (95% CI 0.07-1.0, p = 0.02)]. PVR also decreased 93.1 ml more in HMR than in non-HMR patients after 12 months (95% CI 33.6-152.6, p < 0.01). CONCLUSION: We found that GreenLight PVP is safe and effective in improving functional outcomes in higher-risk patients with severe systemic disease compared to their lower-risk counterparts. Though absolute risks remain low, GreenLight PVP is associated with higher odds of transfusion and readmission in the high-risk cohort. The findings of our study reaffirm current guidelines that propose PVP as a viable treatment option for HMR patients.

Impact of the presence of a median lobe on functional outcomes of greenlight photovaporization of the prostate (PVP): an analysis of the Global Greenlight Group (GGG) Database.

OBJECTIVES: Previous analyses of the impact of median lobe presence on Greenlight photoselective vaporization of the prostate (PVP) outcomes were limited by their small sample size and the ability to adjust for important confounders. As such, we sought to investigate the impact of prostate median lobe presence on the operative outcomes of 180 W XPS GreenLight PVP using a large international database. METHODS: Data were obtained from the Global GreenLight Group (GGG) database which pools data of eight high-volume, experienced surgeons, from a total of seven international centers. All men with established benign prostatic hyperplasia who underwent GreenLight PVP using the XPS-180 W system between 2011 and 2019 were eligible for the study. Patients were assigned to two groups based on presence or absence of median lobes. Analyses were adjusted for patient age, prostate volume, body mass index, and American Society of Anesthesia (ASA) score. RESULTS: A total of 1650 men met the inclusion criteria. A median lobe was identified in 621 (37.6%) patients. Baseline prostate volume, patient age, and ASA score varied considerably between the two groups. In adjusted analyses, the operative and lasing time of patients with median lobes was 6.72 (95% CI 3.22-10.23; p < 0.01) minutes and 2.90 (95% CI 1.02-4.78; p < 0.01) minutes longer than the control group. Men with median lobes had similar postoperative functional outcomes to those without a median lobe except for a 1.59-point greater drop in the 12-month IPSS score compared to baseline (95% CI 0.11-3.08; p = 0.04) in the median lobe group, and a decrease in PVR after 6 months which was 46.51 ml (95% CI 4.65-88.36; p = 0.03) greater in patients with median lobes compared to men without median lobes. CONCLUSIONS: Our findings suggest that the presence of a median lobe has no clinically significant impact on procedural or postoperative outcomes for patients undergoing Greenlight PVP using the XPS-180 W system.

Global Greenlight Group: largest international Greenlight experience for benign prostatic hyperplasia to assess efficacy and safety.

INTRODUCTION: Greenlight photo-selective vaporization of the prostate (GL-PVP) has gained international acceptance as a safe and effective alternative procedure for the treatment of benign prostatic hyperplasia (BPH), especially in anticoagulated men. This descriptive analysis aims to characterize the current state of GL-PVP, pooling data from international centers. METHODS: Data from 3627 patients who underwent GL-PVP with the XPS-180 W system in seven international centers performed by eight expert surgeons between 2011 and 2019 were retrospectively analyzed. Demographic, perioperative, and postoperative data were collected, including IPSS, QoL, Qmax, PVR, and PSA, and complications. RESULTS: At baseline, median age, prostate volume, PSA, and IPSS were 70 years (interquartile range 64-77), 64 (47-90), 3.1 ng/mL (1.8-6), and 22 (19-27), respectively. Median lasing and operative time were 34 (23-48) and 62 min (46-85), respectively. Median energy use was 250.0 kJ (168.4-367.9), with 92.6% of procedures being completed with one laser fiber. In 60.1% of cases, catheter was removed on postoperative day 1 with median length of 2 days. All-cause mortality within 30 days was 0.3%. Median PSA reduction at 3 months and 60 months compared to baseline was 43.9 and 46.4%, respectively (p < 0.001). All functional outcomes (IPSS, QoL, Qmax, and PVR) were significantly improved across study period when compared to baseline (p < 0.001). For those men with longer follow-up available, the observed surgical BPH retreatment rate was 1.5% CONCLUSION: Using the largest multi-user, international database of GL-PVP, Greenlight XPS laser treatment in experienced hands is a safe, effective, and durable BPH treatment option.

Multicenter Investigation of the Micro-Organisms Involved in Penile Prosthesis Infection: An Analysis of the Efficacy of the AUA and EAU Guidelines for Penile Prosthesis Prophylaxis.

INTRODUCTION: Penile prosthesis infections remain challenging despite advancements in surgical technique, device improvements, and adoption of antibiotic prophylaxis guidelines. AIM: To investigate penile prosthesis infection microbiology to consider which changes in practice could decrease infection rates, to evaluate current antibiotic prophylaxis guidelines, and to develop a proposed algorithm for penile prosthesis infections. METHODS: This retrospective institutional review board-exempt multi-institutional study from 25 centers reviewed intraoperative cultures obtained at explantation or Mulcahy salvage of infected three-piece inflatable penile prostheses (IPPs). Antibiotic usage was recorded at implantation, admission for infection, and explantation or salvage surgery. Cultures were obtained from purulent material in the implant space and from the biofilm on the device. MAIN OUTCOME MEASURES: Intraoperative culture data from infected IPPs. RESULTS: Two hundred twenty-seven intraoperative cultures (2002-2016) were obtained at salvage or explantation. No culture growth occurred in 33% of cases and gram-positive and gram-negative organisms were found in 73% and 39% of positive cultures, respectively. Candida species (11.1%), anaerobes (10.5%) and methicillin-resistant Staphylococcus aureus (9.2%) constituted nearly one third of 153 positive cultures. Multi-organism infections occurred in 25% of positive cultures. Antibiotic regimens at initial implantation were generally consistent with American Urological Association (AUA) and European Association of Urology (EAU) guidelines. However, the micro-organisms identified in this study were covered by these guidelines in only 62% to 86% of cases. Antibiotic selection at admissions for infection and salvage or explantation varied widely compared with those at IPP implantation. CONCLUSION: This study documents a high incidence of anaerobic, Candida, and methicillin-resistant S aureus infections. In addition, approximately one third of infected penile prosthesis cases had negative cultures. Micro-organisms identified in this study were not covered by the AUA and EAU antibiotic guidelines in at least 14% to 38% of cases. These findings suggest broadening antibiotic prophylaxis guidelines and creating a management algorithm for IPP infections might lower infection rates and improve salvage success. Gross MS, Phillips EA, Carrasquillo RJ, et al. Multicenter Investigation of the Micro-Organisms Involved in Penile Prosthesis Infection: An Analysis of the Efficacy of the AUA and EAU Guidelines for Penile Prosthesis Prophylaxis. J Sex Med 2017;14:455-463.

Penile Prosthesis Surgery: Current Recommendations From the International Consultation on Sexual Medicine.

INTRODUCTION: Penile prosthesis implantation has emerged as a definitive treatment to restore sexual function to the motivated man with erectile dysfunction. Substantial improvements in the design of inflatable devices have been made since they first became available more than four decades ago. AIM: To review the history of the penile prosthesis, the indications, preoperative evaluation, and patient and partner satisfaction. The current approaches to addressing intra- and postoperative complications, provide an understanding of prosthesis infection, and placement of these devices will be reviewed. METHODS: A committee of worldwide experts in this field was assembled during the 2015 International Consultation on Sexual Medicine (ICSM) and performed a systematic review of the peer-reviewed published medical literature pertaining to penile prosthesis. Particular attention was given to higher level trials when available. Recommendations are based upon the Oxford Criteria. MAIN OUTCOME MEASURES: Unfortunately there is limited level 1 and 2 evidence, and where expert opinion was utilized, the decision was unanimous within the committee with a goal of presenting a clinically relevant guideline pertaining to penile prostheses. RESULTS: Penile prosthesis has undergone an evolution over the past 40 years resulting in a more effective and reliable treatment for advanced erectile dysfunction not responding to less invasive methods including oral treatment with PDE5 inhibitors, vacuum erection device, and intracorporal injection therapy. It should be considered an appropriate treatment option for the man who wishes to restore erectile function and who understands the potential risk of mechanical failure and infection, both of which are less common now as a result of improvements made in device design as well as surgical protocols adhered to in the operating room. Patients must be clearly informed of the risks associated with penile prosthesis including mechanical failure, infection, shortening of the penis, change in sensation and configuration of the penis, as well as injury to local structures. Intraoperative complications are unusual but do occur and can usually be addressed intraoperatively to allow placement of the device at the time of initial surgery. Postoperative complications may also be addressed when they occur but may require more advanced reconstructive surgical techniques. Men with Peyronie's disease, corporal fibrosis due to infection, trauma, prior prosthesis explantation, priapism, and men who have undergone construction of a neophallus may require additional advanced maneuvers to obtain optimum results with a penile prosthesis. CONCLUSION: Penile prosthesis remains as an important, viable, and effective treatment for male erectile dysfunction that does not respond to other less invasive approaches or when these approaches are contraindicated or not acceptable to the patient. These devices provide the patient with the ability to engage in penetrative sexual activity without interfering with urination, ejaculation, sensation, or orgasm. Although mechanical failure can occur, the current devices are more reliable as a result of design modifications. Infection remains the most dreaded complication but since the introduction of antibiotic and hydrophilic coatings, infection is less common. Overall, patient and partner satisfaction appear to be reasonably high when a penile prosthesis is used to restore erectile function.

Detection of a tadalafil analogue as an adulterant in a dietary supplement for erectile dysfunction.

INTRODUCTION: Several cases of adulteration of dietary supplements with tadalafil, sildenafil, and vardenafil, or their unapproved analogues have been reported worldwide. Mainly, the presence of the latter represents a serious health risk to consumers as their efficacy and toxic effects have not been assessed and may result in unpredictable adverse effects. AIM: To investigate the suspected adulteration with synthetic phosphodiesterase type 5 (PDE-5) inhibitors in a dietary supplement marketed in Argentina for the treatment of erectile dysfunction (ED). METHODS: The content of the capsules of the dietary supplement (sample A) was analyzed by thin layer chromatography (TLC) and high-performance liquid chromatography (HPLC) diode-array detection. From the organic extract of sample A, a major compound was purified by column chromatography (CC). The isolated compound was identified by proton nuclear magnetic resonance (1H NMR) and carbon NMR (13C NMR), heteronuclear single quantum coherence, distortionless enhancement by polarization transfer (DEPT 135), electrospray ionization mass spectrometry, and ultraviolet, and infrared (Fourier transform infrared spectroscopy) spectroscopy. MAIN OUTCOME MEASURE: Proof of adulteration of herbal products with synthetic PDE-5 inhibitors. RESULTS: By TLC and HPLC analysis, a major compound was detected in sample A organic extract. The purification of this extract by CC led to the isolation of a pure compound which was identified according to its spectral data as (6R,12aR)-2-amino-6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydropyrazino [1',2':1,6] pyrido [3,4-b] indole-1,4-dione or aminotadalafil. CONCLUSIONS: An unapproved PDE-5 inhibitor analogue, which was identified as aminotadalafil, has been detected in a dietary supplement. This study represents the first report in Latin America and one of the few independent studies of an adulteration with an unapproved PDE-5 inhibitor of an herbal product for ED treatment.

The International Society for Sexual Medicine's Process of Care for the Assessment and Management of Testosterone Deficiency in Adult Men.

INTRODUCTION: In 2014, the International Society for Sexual Medicine (ISSM) convened a panel of experts to develop an evidence-based process of care for the diagnosis and management of testosterone deficiency (TD) in adult men. The panel considered the definition, epidemiology, etiology, physiologic effects, diagnosis, assessment and treatment of TD. It also considered the treatment of TD in special populations and commented on contemporary controversies about testosterone replacement therapy, cardiovascular risk and prostate cancer. AIM: The aim was to develop clearly worded, practical, evidenced-based recommendations for the diagnosis and treatment of diagnosis and management of TD for clinicians without expertise in endocrinology, such as physicians in family medicine and general urology practice. METHOD: A comprehensive literature review was performed, followed by a structured, 3-day panel meeting and 6-month panel consultation process using electronic communication. The final guideline was compiled from reports by individual panel members on areas reflecting their special expertise, and then agreed by all through an iterative process. RESULTS: This article contains the report of the ISSM TD Process of Care Committee. It offers a definition of TD and recommendations for assessment and treatment in different populations. Finally, best practice treatment recommendations are presented to guide clinicians, both familiar and unfamiliar with TD. CONCLUSION: Development of a process of care is an evolutionary process that continually reviews data and incorporates the best new research. We expect that ongoing research will lead to new insights into the pathophysiology of TD, as well as new, efficacious and safe treatments. We recommend that this process of care be reevaluated and updated by the ISSM in 4 years.

An update of the International Society of Sexual Medicine's guidelines for the diagnosis and treatment of premature ejaculation (PE).

INTRODUCTION: In 2009, the International Society for Sexual Medicine (ISSM) convened a select panel of experts to develop an evidence-based set of guidelines for patients suffering from lifelong premature ejaculation (PE). That document reviewed definitions, etiology, impact on the patient and partner, assessment, and pharmacological, psychological, and combined treatments. It concluded by recognizing the continually evolving nature of clinical research and recommended a subsequent guideline review and revision every fourth year. Consistent with that recommendation, the ISSM organized a second multidisciplinary panel of experts in April 2013, which met for 2 days in Bangalore, India. This manuscript updates the previous guidelines and reports on the recommendations of the panel of experts. AIM: The aim of this study was to develop clearly worded, practical, evidenced-based recommendations for the diagnosis and treatment of PE for family practice clinicians as well as sexual medicine experts. METHOD: A comprehensive literature review was performed. RESULTS: This article contains the report of the second ISSM PE Guidelines Committee. It offers a new unified definition of PE and updates the previous treatment recommendations. Brief assessment procedures are delineated, and validated diagnostic and treatment questionnaires are reviewed. Finally, the best practices treatment recommendations are presented to guide clinicians, both familiar and unfamiliar with PE, in facilitating treatment of their patients. CONCLUSION: Development of guidelines is an evolutionary process that continually reviews data and incorporates the best new research. We expect that ongoing research will lead to a more complete understanding of the pathophysiology as well as new efficacious and safe treatments for this sexual dysfunction. We again recommend that these guidelines be reevaluated and updated by the ISSM in 4 years.

An evidence-based unified definition of lifelong and acquired premature ejaculation: report of the second International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation.

INTRODUCTION: The International Society for Sexual Medicine (ISSM) Ad Hoc Committee for the Definition of Premature Ejaculation developed the first evidence-based definition for lifelong premature ejaculation (PE) in 2007 and concluded that there were insufficient published objective data at that time to develop a definition for acquired PE. AIM: The aim of this article is to review and critique the current literature and develop a contemporary, evidence-based definition for acquired PE and/or a unified definition for both lifelong and acquired PE. METHODS: In April 2013, the ISSM convened a second Ad Hoc Committee for the Definition of Premature Ejaculation in Bangalore, India. The same evidence-based systematic approach to literature search, retrieval, and evaluation used by the original committee was adopted. RESULTS: The committee unanimously agreed that men with lifelong and acquired PE appear to share the dimensions of short ejaculatory latency, reduced or absent perceived ejaculatory control, and the presence of negative personal consequences. Men with acquired PE are older, have higher incidences of erectile dysfunction, comorbid disease, and cardiovascular risk factors, and have a longer intravaginal ejaculation latency time (IELT) as compared with men with lifelong PE. A self-estimated or stopwatch IELT of 3 minutes was identified as a valid IELT cut-off for diagnosing acquired PE. On this basis, the committee agreed on a unified definition of both acquired and lifelong PE as a male sexual dysfunction characterized by (i) ejaculation that always or nearly always occurs prior to or within about 1 minute of vaginal penetration from the first sexual experience (lifelong PE) or a clinically significant and bothersome reduction in latency time, often to about 3 minutes or less (acquired PE); (ii) the inability to delay ejaculation on all or nearly all vaginal penetrations; and (iii) negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy. CONCLUSION: The ISSM unified definition of lifelong and acquired PE represents the first evidence-based definition for these conditions. This definition will enable researchers to design methodologically rigorous studies to improve our understanding of acquired PE.

Standard operating procedure for the preservation of erectile function outcomes after radical prostatectomy.

INTRODUCTION: Prostate cancer is common, and, thus, more men are being treated surgically. Long-term functional outcomes are of significant importance to the patient and their partners. Erectile function (EF) preservation (rehabilitation) has gained significant traction worldwide, despite the absence of definitive evidence supporting its use. AIM: To review the effectiveness of specific pharmacological therapies and other erectogenic aids in the treatment of post-radical prostatectomy (RP) erectile dysfunction. METHODS: A systematic literature review of original peer-reviewed manuscripts and clinical trials reported in Medline. MAIN OUTCOME MEASURE: This review focused on the evaluation of interventions that aimed to improve EF recovery following RP. RESULTS: Although well documented in animal models, studies supporting the rehabilitation with phosphodiesterase type 5 inhibitors in humans are scarce. Daily sildenafil has been used in trials (only one randomized placebo-controlled trial) with a significant improvement in erection recovery when compared to placebo or no rehabilitation but with a low return to baseline rates (27% vs. 4% placebo). Nightly vardenafil vs. on demand vs. placebo has been studied in the Recovery of Erections: INtervention with Vardenafil Early Nightly Therapy trial with no difference in erection recovery following RP. Intracavernosal injections, although widely used and attractive from a rehabilitation standpoint, does not yet have definitive supporting its role in rehabilitation. Vacuum erection devices use following RP has been reported, but there are no data to support its role as monotherapy. Intraurethral alprostadil was also studied vs. sildenafil in a multicenter, randomized, open-label trial, and no superiority was found. CONCLUSIONS: At this time, we are unable to define what represents the optimal rehabilitation program in regard to strategies utilized, timing of intervention, or duration of treatment.

International Society for Sexual Medicine's guidelines for the diagnosis and treatment of premature ejaculation.

INTRODUCTION: Over the past 20 years our knowledge of premature ejaculation (PE) has significantly advanced. Specifically, we have witnessed substantial progress in understanding the physiology of ejaculation, clarifying the real prevalence of PE in population-based studies, reconceptualizing the definition and diagnostic criterion of the disorder, assessing the psychosocial impact on patients and partners, designing validated diagnostic and outcome measures, proposing new pharmacologic strategies and examining the efficacy, safety and satisfaction of these new and established therapies. Given the abundance of high level research it seemed like an opportune time for the International Society for Sexual Medicine (ISSM) to promulgate an evidenced-based, comprehensive and practical set of clinical guidelines for the diagnosis and treatment of PE. AIM: Develop clearly worded, practical, evidenced-based recommendations for the diagnosis and treatment of PE for family practice clinicians as well as sexual medicine experts. Method. Review of the literature. RESULTS: This article contains the report of the ISSM PE Guidelines Committee. It affirms the ISSM definition of PE and suggests that the prevalence is considerably lower than previously thought. Evidence-based data regarding biological and psychological etiology of PE are presented, as is population-based statistics on normal ejaculatory latency. Brief assessment procedures are delineated and validated diagnostic and treatment questionnaires are reviewed. Finally, the best practices treatment recommendations are presented to guide clinicians, both familiar and unfamiliar with PE, in facilitating treatment of their patients. CONCLUSION: Development of guidelines is an evolutionary process that continually reviews data and incorporates the best new research. We expect that ongoing research will lead to a more complete understanding of the pathophysiology as well as new efficacious and safe treatments for this sexual dysfunction. Therefore, it is strongly recommended that these guidelines be re-evaluated and updated by the ISSM every 4 years.

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.

Expression of caveolin-1 in penile cavernosal tissue in a denervated animal model after treatment with sildenafil citrate.

INTRODUCTION: Radical pelvic surgery is a major cause of erectile dysfunction due to iatrogenic cavernous nerve damage. Endothelial nitric oxide synthase, which generates nitric oxide (NO) in the cavernosal tissues, localizes to specialized plasma membrane invaginations known as caveolae. Growing evidence suggests that caveolae are major components of signal trafficking and that stimuli that affect the concentration of the main structural protein of caveolae, caveolin-1 influence NO signaling. AIM: To evaluate caveolin-1 expression as a marker of cavernous tissue damage and determine the impact of early sildenafil administration on caveolin-1 expression in animal models of partial and total surgical penile denervation. METHODS: Thirty-six rats were divided into six groups (N = 6 per group) that received bilateral or unilateral penile denervation or sham surgery, with and without sildenafil 10 mg daily for 7 weeks. MAIN OUTCOME MEASURES: Sections were taken from the proximal middle portion of the penis of all animals. Cavernous tissue was delineated by the tunica albuginea, then the extent of immunostaining for the following parameters was quantitated to determine (i) cavernous smooth muscle layer in the cavernous space expressed as the percentage of alpha-smooth muscle actin (alpha-SMA) positive immunostaining per area and (ii) caveolin-1 expressed as a percentage of area. RESULTS: A marked decrease in both caveolin-1 and alpha-SMA expression in cavernous smooth muscle tissue and in the endothelium of rats was noted after a bilateral and unilateral neurotomy. Specimens from animals receiving sildenafil exhibited higher mean immunostaining values for both proteins in cavernous tissue. The differences were statistically significant compared with groups receiving the same surgical treatment without sildenafil. CONCLUSION: Caveolin-1 and alpha-SMA expression in cavernous tissue is significantly reduced by pelvic nerve injury, and the loss is related to the extent of the neural damage. Early administration of sildenafil elicits caveolin-1 expression, which appears to preserve cavernous tissue.

Autologous fat as a rectal-prostate spacer for prostate brachytherapy: Results at 6 months.

PURPOSE: Implanted rectal spacers (IRS) have been developed to increase the distance between the prostate and the rectum, thus optimizing dose escalation. Cost is a disadvantage and there are still uncertainties as to their durability. We have developed an autologous fat transfer (AFT) technique to use as an IRS. We aim to present the feasibility and durability at 6 months of AFT placed immediately after the implant of the seeds in low-dose-rate brachytherapy (BT). METHODS AND MATERIALS: Thirty-five patients underwent AFT (12 were treated with primary BT, 7 with a combined primary treatment of external beam radiotherapy + BT, 16 with salvage BT). The isodose used for primary BT was 14400 cGy, 11,000 cGy after 4600 cGy of external beam radiotherapy in the combined group, and 14400 cGy for the salvage group. Patients underwent a CT scan at 1, 3, and 6 months to measure the distance between the rectum and the prostate. RESULTS: An average of 32.7 cc (20-40) of fat was transferred successfully in 100% of cases. The mean distance to the rectum at the level of the base, middle, and apex at 1 and 6 months were 11.2, 9.7, and 7.6 mm; 8.3, 8.1, and 5.9 mm, respectively. No rectal toxicity or major complications were reported. CONCLUSIONS: The use of fat as an IRS seems to be a valid alternative to reduce rectal toxicity after BT, achieving equivalent distances to synthetic IRS. It is feasible, safe, and the loss of distance at 6 months is small. Cost is lower than other alternatives.

An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation.

OBJECTIVE: To develop a contemporary, evidence-based definition of premature ejaculation (PE). METHODS: There are several definitions of PE; the most commonly quoted, the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders - 4th Edition - Text Revision, and other definitions of PE, are all authority-based rather than evidence-based, and have no support from controlled clinical and/or epidemiological studies. Thus in August 2007, the International Society for Sexual Medicine (ISSM) appointed several international experts in PE to an Ad Hoc Committee for the Definition of PE. The committee met in Amsterdam in October 2007 to evaluate the strengths and weaknesses of current definitions of PE, to critically assess the evidence in support of the constructs of ejaculatory latency, ejaculatory control, sexual satisfaction and personal/interpersonal distress, and to propose a new evidence-based definition of PE. RESULTS: The Committee unanimously agreed that the constructs which are necessary to define PE are rapidity of ejaculation, perceived self-efficacy, and control and negative personal consequences from PE. The Committee proposed that lifelong PE be defined as a male sexual dysfunction characterized by ejaculation which always or nearly always occurs before or within about one minute of vaginal penetration, and the inability to delay ejaculation on all or nearly all vaginal penetrations, and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy. This definition is limited to men with lifelong PE who engage in vaginal intercourse. The panel concluded that there are insufficient published objective data to propose an evidence-based definition of acquired PE. CONCLUSION: The ISSM definition of lifelong PE represents the first evidence-based definition of PE. This definition will hopefully lead to the development of new tools and patient-reported outcome measures for diagnosing and assessing the efficacy of treatment interventions, and encourage ongoing research into the true prevalence of this disorder, and the efficacy of new pharmacological and psychological treatments.