Inflatable penile prosthesis implant length with baseline characteristic correlations: preliminary analysis of the PROPPER study.

BACKGROUND: "Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration" (PROPPER) is a large, multi-institutional, prospective clinical study to collect, analyze, and report real-world outcomes for men implanted with penile prosthetic devices. We prospectively correlated co-morbid conditions and demographic data with implanted penile prosthesis size to enable clinicians to better predict implanted penis size following penile implantation. We present many new data points for the first time in the literature and postulate that radical prostatectomy (RP) is negatively correlated with penile corporal length. METHODS: Patient demographics, medical history, baseline characteristics and surgical details were compiled prospectively. Pearson correlation coefficient was generated for the correlation between demographic, etiology of ED, duration of ED, co-morbid conditions, pre-operative penile length (flaccid and stretched) and length of implanted penile prosthesis. Multivariate analysis was performed to define predictors of implanted prosthesis length. RESULTS: From June 2011 to June 2017, 1,135 men underwent primary implantation of penile prosthesis at a total of 11 study sites. Malleable (Spectra), 2-piece Ambicor, and 3-piece AMS 700 CX/LGX were included in the analysis. The most common patient comorbidities were CV disease (26.1%), DM (11.1%), and PD (12.4%). Primary etiology of ED: RP (27.4%), DM (20.3%), CVD (18.0%), PD (10.3%), and Priapism (1.4%), others (22.6%). Mean duration of ED is 6.2¡À4.1 years. Implant length was weakly negatively correlated with White/Caucasian (r=-0.18; P<0.01), history of RP (r=-0.13; P<0.01), PD as comorbidity (r=-0.16; P<0.01), venous leak (r=-0.08; P<0.01), and presence of stress incontinence (r=-0.13; P<0.01). Analyses showed weak positive correlations with Black/AA (r=0.32; P<0.01), CV disease as primary ED etiology (r=0.08; P<0.01) and pre-operative stretched penile length (r=0.18; P<0.01). There is a moderate correlation with pre-operative flaccid penile length (r=0.30; P<0.01). CONCLUSIONS: Implanted penile prosthesis length is negatively correlated with some ethnic groups, prostatectomy, and incontinence. Positive correlates include CV disease, preoperative stretched penile length, and flaccid penile length.

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.

The Who, How and What of Real-World Penile Implantation in 2015: The PROPPER Registry Baseline Data.

PURPOSE: To date, the published data on patients treated with penile implantation generally consist of small series of single surgeon, retrospective experiences rather than prospective or large, multicenter evaluations. This study establishes a baseline of data collection from the PROPPER (Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration). The PROPPER is the first large, prospective, multicenter, multinational, monitored, and internal review board approved study of real-world outcomes for patients with penile implants. MATERIALS AND METHODS: Data from the PROPPER study were examined to determine patient baseline characteristics and primary and secondary etiologies before treatment of erectile dysfunction. Data include type and size of implant received, surgical steps/techniques used during implantation, and duration of hospital stay. RESULTS: Through April 2, 2015 a total of 1,019 patients were enrolled in the study at 11 sites, with radical prostatectomy being the predominant etiology in 285 (28%). Of those 285 patients treated with radical prostatectomy 280 (98.2%) received an AMS 700™. Of these patients 65.0% (182 of 280) had placement of the reservoir in the traditional retropubic space vs 31.8% (89 of 280) in a submuscular location. Of those patients not treated with radical prostatectomy receiving an AMS 700, fewer underwent reservoir placement in the submuscular location (17.7%, 124 of 702, vs 80.9%, 568 of 702; p <0.001). Of those patients receiving an AMS 700, those treated with radical prostatectomy and those with diabetes had more outpatient admissions (less than 24 hours, 56.8% and 52.1%, respectively) compared to those with cardiovascular disease and Peyronie's disease (42.0% and 35.6%, respectively, p <0.001). CONCLUSIONS: This first-of-its-kind, large, prospective, multicenter study reveals most penile implant cases in North America receive an inflatable penile prosthesis and that radical prostatectomy is the most common primary etiology of penile implant surgery. Moreover, patients treated with radical prostatectomy were more likely to have the reservoir placed in a submuscular location, have a longer operating room time and be admitted to the hospital overnight compared with other patient groups.

Basic Science Evidence for the Link Between Erectile Dysfunction and Cardiometabolic Dysfunction.

INTRODUCTION: Although clinical evidence supports an association between cardiovascular/metabolic diseases (CVMD) and erectile dysfunction (ED), scientific evidence for this link is incompletely elucidated. AIM: This study aims to provide scientific evidence for the link between CVMD and ED. METHODS: In this White Paper, the Basic Science Committee of the Sexual Medicine Society of North America assessed the current literature on basic scientific support for a mechanistic link between ED and CVMD, and deficiencies in this regard with a critical assessment of current preclinical models of disease. RESULTS: A link exists between ED and CVMD on several grounds: the endothelium (endothelium-derived nitric oxide and oxidative stress imbalance); smooth muscle (SM) (SM abundance and altered molecular regulation of SM contractility); autonomic innervation (autonomic neuropathy and decreased neuronal-derived nitric oxide); hormones (impaired testosterone release and actions); and metabolics (hyperlipidemia, advanced glycation end product formation). CONCLUSION: Basic science evidence supports the link between ED and CVMD. The Committee also highlighted gaps in knowledge and provided recommendations for guiding further scientific study defining this risk relationship. This endeavor serves to develop novel strategic directions for therapeutic interventions.

Technological Improvements in Three-Piece Inflatable Penile Prosthesis Design over the Past 40 Years.

INTRODUCTION: The advent of the penile prosthesis revolutionized the treatment of erectile dysfunction (ED), resulting in near-complete treatment efficacy and high patient satisfaction rates. While several types of penile prosthesis are available, the inflatable penile prosthesis (IPP) is the most commonly used device in the United States. AIMS: To describe the key modifications to IPPs from the two major manufacturers-American Medical Systems (AMS) and Coloplast-since the invention of the IPP, and to relate these changes to improvements in prosthesis function and patient outcomes based on available literature. METHODS: Review and evaluation of the literature between 1973 and present describing modifications in IPP design and the influence of these modifications on IPP durability and patient-related factors. MAIN OUTCOME MEASURES: Data describing the impact of iterative improvements in three-piece IPP design on device function, durability, and patient outcomes. RESULTS: There were progressive improvements in IPP technology from both major manufacturers not only on the durability of the prosthesis but also on patient outcomes, with fewer device failures and lower infection rates. Notable improvements include incorporation of kink-resistant tubing, changes in the weave or addition of shear- and infection-resistant coatings to cylinder layers, pump and tubing connection modifications, the addition of rear tip extenders, and the incorporation of lockout valves to prevent autoinflation. CONCLUSIONS: Numerous incremental modifications to the IPP from both major manufacturers since its invention have increased its durability and improved patient outcomes.

GGF2 is neuroprotective in a rat model of cavernous nerve injury-induced erectile dysfunction.

INTRODUCTION: Erectile dysfunction is a major complication of radical prostatectomy, commonly associated with penile neuropathy. In animal models of peripheral nerve injury, glial growth factor-2 (GGF2), a member of the neuregulin family of growth factors, has neuroprotective and neurorestorative properties, but this potential has not been established after cavernous nerve (CN) injury. AIMS: The effectiveness of GGF2 in preserving axonal integrity and recovering erectile function in a rat model of radical prostatectomy-associated CN injury. METHODS: Adult male Sprague-Dawley rats underwent bilateral CN crush injury (BCNI) or sham surgery. Rats were administered GGF2 (0.5, 5, or 15 mg/kg) or vehicle subcutaneously 24 hour pre and 24-hour post-BCNI, and once weekly for 5 weeks. Erectile function was assessed in response to electrical stimulation of the CN. CN survival was assessed by fluorogold retrograde axonal tracing in major pelvic ganglia (MPG). Unmyelinated axons in the CNs were quantitated by electron microscopy. MAIN OUTCOME MEASURES: Erectile function recovery, CN survival, and unmyelinated CN axon preservation in response to GGF2 treatment following BCNI. RESULTS: Erectile function was decreased (P < 0.05) after BCNI, and it was improved (P < 0.05) by all doses of GGF2. The number of fluorogold-labeled cells in the MPG was reduced (P < 0.05) by BCNI and was increased (P < 0.05) by GGF2 (0.5 and 5 mg/kg). The percentage of denervated Schwann cells in the BCNI group was higher (P < 0.05) than that in the sham-treated group and was decreased (P < 0.05) in the GGF2-treated (5 mg/kg) BCNI group. In the BCNI + GGF2 (5 mg/kg) group, the unmyelinated fiber histogram demonstrated a rightward shift, indicating an increased number of unmyelinated axons per Schwann cell compared with the BCNI group. CONCLUSIONS: GGF2 promotes erectile function recovery following CN injury in conjunction with preserving unmyelinated CN fibers. Our findings suggest the clinical opportunity to develop GGF2 as a neuroprotective therapy for radical prostatectomy.

Reservoir alternate surgical implantation technique: preliminary outcomes of initial PROPPER study of low profile or spherical reservoir implantation in submuscular location or traditional prevesical space.

PURPOSE: Alternative reservoir site placement has become an accepted technique for patients who require an inflatable penile prosthesis. To our knowledge there has been no prospective evaluation of this technique, which is currently off label. We performed a prospective, multicenter, multinational, internal review board approved study to evaluate the effectiveness and safety of alternative reservoir site placement. MATERIALS AND METHODS: PROPPER initiated in June 2011, is a database containing patient outcomes of inflatable penile prosthesis implantation. Patients with AMS® penile prostheses continue to be enrolled at 13 North American sites. We examined PROPPER study data to determine surgical implantation use patterns for the AMS 700™ series. We evaluated reservoir implantation site and complications by implantation site. RESULTS: A total of 759 patients had been implanted with an AMS 700 series implant by the time of evaluation. Mean patient followup was 17.8 months (range 0 to 36). There was no reported case of revision surgery for a palpable reservoir and no report of vascular or hollow viscous injury associated with alternative reservoir site placement. Two cases of reservoir herniation in the alternative reservoir site placement group and 2 in the space of Retzius group were treated with reservoir reimplantation. Patients with 1-year assessment available were satisfied or very satisfied with the device and reported a frequency of use of more than once per month. CONCLUSIONS: Alternative reservoir placement in the submuscular location is an option in patients who undergo inflatable penile prosthesis surgery. Implant surgeons should consider alternative reservoir site placement a safe, effective alternative to reservoir placement in the space of Retzius.

Traditional plant aphrodisiacs and male sexual dysfunction.

INTRODUCTION: There has been a long history of man's fascination with better and stronger sex drive and performance across different cultures. Several literature texts from the Hindu, Egyptian, Chinese and Roman civilizations document the human endless search for substances that can enhance sexual experiences and/or treat erectile dysfunction. AIM: This review will discuss the current research done on the most popular plant aphrodisiacs and provide evidence to support or discourage the use of any of them to enhance sexual desire and/or function in men. METHODS: We review the current evidence on the use of natural substances as aphrodisiacs. RESULTS: We found very little evidence to support the use of plant aphrodisiacs in the treatment of male sexual dysfunction. The vast majority of studies were conducted on animals with very few clinical studies. Available data suggest a beneficial effect of ginseng as a pro-sexual supplement and not an independent treatment for male sexual dysfunction. CONCLUSIONS: Trans-culturally, many herbal therapies show some potential benefits in improving men's sexual function; however, adequate studies on the specific benefits and health risks associated with their use are needed. We strongly recommend the design and execution of well-controlled clinical studies to determine the efficacy and safety of plant aphrodisiacs.

The effect of vasectomy on the sexual life of couples.

INTRODUCTION: There are several contraceptive methods to prevent pregnancy, reversible as well as nonreversible ones. The sexual satisfaction of couples is affected by many types of contraceptives used. AIM: The aim of this study was to evaluate prospectively the effect of vasectomy on the sexual life and satisfaction of couples. METHODS: Seventy-six couples took part in this evaluation and filled out respective questionnaires before and after vasectomy. All the questionnaires were evaluated statistically for differences in the respective sexual domain scores. MAIN OUTCOME MEASURES: Standardized questionnaires were used. The International Index of Erectile Function (IIEF) as well as postoperative pain score were completed by men. Female Sexual Function Index (FSFI) was completed by the female partner. For statistical analysis, the T-Square Test was used. RESULTS: The average age of couples, who chose the vasectomy procedure, was 37 years for women and 39 years for men. The contraception method most frequently used prior to the vasectomy was the birth control pill. For the male partner, the IIEF showed no significant change in the respective domains. Out of the 76 couples, 93% of the males and 96% of their female partners would recommend and do vasectomy again. The postoperative pain score was 3.5 on 0-10 scale, and there were no postoperative complications reported. The best improvement of the sexual function was noticed for the female partners. The FSFI showed a significant improvement in the domains desire (P < 0.05), arousal (P < 0.05), orgasm (P < 0.05), lubrication (P < 0.05), and satisfaction (P < 0.05). CONCLUSION: This is the first report to our very best knowledge that showed the positive impact of vasectomy on sexual satisfaction of couples. Vasectomy is a safe operation with minimal complication rates.

Psychotropics and sexual dysfunction.

INTRODUCTION: Sexual dysfunction (SD) is common in patients taking antipsychotics, and is the most bothersome symptom and adverse drug effect compromising treatment compliance. Mechanisms involved in psychotropics-induced SD are either largely unknown or poorly understood. The aim of this review is to present an updated analysis of SD associated with the use of psychotropic drugs in psychiatric patients. RESULTS: Contemporary evidence from available studies demonstrates that SD rates are drug-related rather than drug-class specific, and that these rates vary widely. Mechanisms involved in psychotropics-induced SD are either largely unknown or poorly understood. Our understanding of psychotropics-induced SD is limited by the inability to differentiate whether these effects are really drug-induced or due to different inclusion criteria. CONCLUSIONS: Rigorous research, basic and clinical, is needed to understand the exact incidence, severity and mechanisms involved in the development of SD induced by various psychotropic treatment regimens.

A guide for inflatable penile prosthesis reservoir placement: pertinent anatomical measurements of the retropubic space.

INTRODUCTION: The primary concern for many prosthetic urologic surgeons in placing the three-piece inflatable penile prosthesis (IPP) is the concept of "blind reservoir placement." Extensive reports permeate the literature regarding bladder, bowel, vascular, and various hernial complications occurring while attempting to place the reservoir into the retropubic space. However, despite these widely documented complications, there is a paucity of published literature on surgically pertinent anatomical measurements of the retropubic space relating to reservoir placement. The focus of this project was to evaluate the special relationships and anatomical measurements of the retropubic space to better aid the surgeon in the safe placement of the reservoir. AIM: Analyses of the spatial measurements of reservoir placement into the retropubic space with a focus on utilizing a penoscrotal approach were conducted. In addition, we reviewed and evaluated the published literature for important contributions surrounding the various surgical techniques during placement of a penile prosthesis reservoir. METHODS: Cadaveric pelvic specimens were dissected to determine the distance and angulation (in degrees) from the inguinal ring to several critical anatomic structures in the pelvis. This format was utilized to simulate the basic features of reservoir placement into the classic retropubic space. We also reviewed and evaluated the published literature for important contributions describing the various surgical techniques in the placement of penile prosthesis reservoirs into the retropubic space. MAIN OUTCOME MEASURES: Anatomic measurements were obtained from the inguinal ring to the bladder, external iliac vein, and superior origin of the dorsal suspensory ligament at the anterior apex of the pendulous penis. The angle was measured from the inguinal ring to these structures and recorded. We also reviewed the published literature for various penoscrotal IPP surgical techniques involving placement of the reservoir into the retropubic space to further supplement the pertinent spatial relationships data acquired in this study. RESULTS: Of the 28 cadavers, 3 were excluded because of signs of major pelvic surgery, and an additional 6 sides were excluded because of unilateral fibrosis/surgery or difficulty in exposure. Distance to the decompressed bladder was 5-8 cm (average 6.45 cm) at a 15-30 (22.8) degrees medial measurement from the inguinal ring. The filled bladder was 2-4 cm (average 2.61 cm) from the inguinal ring. The external iliac vein distance from the inguinal ring was 2.5-4 cm (average 3.23 cm) at a 20-60 (36.4) degrees lateral measurement from the inguinal ring. Heretofore, the published literature does not appear to have detailed measurements that are provided in this study. CONCLUSIONS: These anatomical measurements of the retropubic space demonstrate the importance of decompressing the bladder and avoiding deep dissection lateral to the inguinal ring, as the external iliac vein is much closer than currently espoused. We feel that these data are significant to the surgeon proceeding with reservoir placement during IPP surgery.

Drug addiction and sexual dysfunction.

This article attempts to review the most current and the well-established facts concerning drug addiction and sexual dysfunction. Surprisingly, even though alcohol is prevalent in many societies with many myths surrounding its sexual-enhancing effects, current scientific research cannot provide a solid conclusion on its effect on sexual function. Unfortunately, the same concept applies to tobacco smoking; however, most of the current knowledge tends to support the notion that it, indeed, can negatively affect sexual function. Similar ambiguities also prevail with substances of abuse.

North American consensus document on infection of penile prostheses.

OBJECTIVE: To issue a consensus document on the prevention, management, and research of infection associated with penile prostheses, as neither professional associations nor governmental entities have issued guidelines that are specific to this infection. METHODS: Sixteen North American experts on infection of penile prostheses were identified and assembled to select and discuss certain issues related to infection of penile prostheses. After performing an extensive search of clinically important issues in published reports, the 16 experts met twice in person to finalize the selection, discuss the issues that were deemed most important, and issue pertinent recommendations. RESULTS: Although many subjects relevant to infection of penile prostheses were initially identified, the experts selected 10 issues as currently being the most important issues and for which there exists some support in the published data. The examined issues involved prevention, management, or research of infections associated with penile prostheses. CONCLUSION: In the absence of pertinent guidelines, the consensus document issued by experts in the field of prosthetic urology is anticipated to improve the quality of patient care, streamline the prevention and management of infected penile prostheses, and stimulate collaborative research. Although this consensus document could serve as best practice recommendations, the lack of adherence to these recommendations would not indicate improper care.

Impact of cannabis use on male sexual health.

INTRODUCTION: Cannabis (marijuana) is the most widely used illicit drug globally. Given the prevalence of nonprescription illicit drug abuse, there is a growing interest in the study of its potential effects on male sexual health. In this review, we discuss the effects of cannabis on male sexual health. OBJECTIVE: In this review, we discuss the effects of cannabis on male sexual health. METHODS AND MAIN OUTCOME MEASURE: Critical review of scientific literature examining the impact of cannabis use on male sexual health. RESULTS: Studies examining the effects of cannabis use on male sexual function have been limited in both quality and quantity. Most results of these studies are conflicting and contradictory. While some did outline the beneficial effects of cannabis in enhancing erectile function, others did not. However, recent animal and in vitro studies have identified potential links between cannabis and sexual health. It appears that cannabis may actually have peripheral antagonizing effects on erectile function by stimulating specific receptors in the cavernous tissue. CONCLUSIONS: Given the prevalence of cannabis use, and the potential relationships between use and the development of potentially hazardous effects on male sexual function, we encourage renewed use of research resources to determine in-depth mechanistic knowledge, and new clinically oriented studies examining the effect of cannabis on male sexual function.

The prognostic significance of capsular incision into tumor during radical prostatectomy.

BACKGROUND: The prognostic significance of capsular incision (CapI) into tumor during radical prostatectomy (RP) with otherwise organ-confined disease remains uncertain. OBJECTIVE: To evaluate the impact of CapI into tumor on oncologic outcome. DESIGN, SETTING, AND PARTICIPANTS: A retrospective review of 8110 consecutive patients with prostate cancer treated at Ottawa Hospital and at Memorial Sloan-Kettering Cancer Center, both tertiary academic centers, between 1985 and 2008. INTERVENTION: All patients underwent an open, laparoscopic or robotic RP. MEASUREMENTS: Patients were divided into four pathologic categories: group 1 (CapI group), positive surgical margins (PSMs) without extraprostatic extension (EPE); group 2, negative surgical margins (NSMs) without EPE; group 3, NSM with EPE; group 4, PSMs with EPE. Estimates of recurrence-free survival were generated with the Kaplan-Meier method. Recurrence was defined as a prostate-specific antigen (PSA) >0.2 ng/ml and rising. Cox proportional hazards regression was used to estimate the hazard ratio (HR) for recurrence controlling for pretreatment PSA, RP date, RP Gleason sum, seminal vesicle invasion, and lymph node involvement. Pathologic categories were defined in the model by including the variables EPE and surgical margins (SMs) as well as their interaction. RESULTS AND LIMITATIONS: Median follow-up was 37.3 mo. The 5-yr recurrence-free probability after RP for the CapI group was 77% (95% confidence interval [CI], 72-83). This was not only inferior to patients with NSMs and no EPE (log rank p<0.0001) but also to those with NSMs and EPE (log rank p=0.0002). In multivariate analysis the interaction between EPE and SM was not significant (p=0.26). In the adjusted model excluding the interaction term, patients with EPE had an increased risk for recurrence (HR: 1.80; 95% CI, 1.49-2.17; p<0.0001) as did those with positive margins (HR: 1.81; 95% CI, 1.51-2.15; p<0.0001). This was a retrospective study. CONCLUSIONS: CapI into tumor has a significant impact on patient outcome following RP. Patients, who otherwise would have organ-confined disease, will now have a higher probability of recurrence than those with completely resected extraprostatic disease.

A practical guide to diagnosis, management and treatment of testosterone deficiency for Canadian physicians.

The percentage of men receiving appropriate management for testosterone deficiency syndrome (TDS) is small in comparison to prevalence estimates. This is despite linkages to cardiovascular disease, osteoporosis, diabetes, sexual function, sarcopenia, emotional well-being and the metabolic syndrome. Furthermore, the availability of guidelines has not significantly enhanced the care of TDS patients. A multidisciplinary group of medical experts sought to improve the management of testosterone-deficient patients by Canadian physicians. This report describes their conclusions and defines an algorithm for appropriate TDS management.