Peyronie's Disease Intervention Studies: An Exploration of Modern-Era Challenges in Study Design and Evaluating Treatment Outcomes.

INTRODUCTION: Peyronie's disease (PD) is characterized by pain, deformity, sexual dysfunction, and psychological bother. Several treatments are available with varying levels of efficacy, and significant limitations exist with the currently available literature. AIM: To explore modern-era methodological challenges inherent to PD research as they pertain to intervention studies. METHODS: We performed a critical review of the PD intervention literature to identify common methodological challenges with emphasis on aspects of patient assessment and treatment outcomes, study design, and statistical analysis. The key objective was to provide an impetus on which to build future research protocols, rather than focus on weaknesses with any individual studies. MAIN OUTCOME MEASURE: Expert opinion was used to summarize limitations with commonly reported objective outcomes such as penile curvature, girth, and length along with imaging modalities and objective questionnaires. Appropriate study design and statistical analysis were also reviewed to discuss common pitfalls in the PD literature. RESULTS: There are multiple shortcomings inherent to studying objective PD outcomes such as penile curvature, girth, and length. These include lack of standardized protocols for preintervention and postintervention assessment, interobserver and intraobserver variability, and lack of consistent definitions for what defines an objective outcome as clinically "meaningful" for patients. Similarly, imaging studies including penile ultrasound are subject to marked variation, thereby limiting their utility to measure predefined primary or secondary study outcomes including cavernosal artery hemodynamics and penile plaque size. Objective and validated questionnaires such as the Peyronie's Disease Questionnaire and International Index of Erectile Function require that patients have recently engaged in sexual activity, which is challenging for many patients as a result of penile deformity with PD. Finally, careful study design and statistical analysis (including appropriate study power) are imperative to ensure reliable results. Current shortcomings in the majority of studies contribute to the low level of evidence available for most PD interventions. CLINICAL IMPLICATIONS: Future PD intervention studies should focus on optimizing study design and statistical analysis. Furthermore, authors must incorporate standardized protocols for assessing preintervention and postintervention outcomes. STRENGTH & LIMITATIONS: The current analysis and recommendations for future study are based on the expertise and opinion of the manuscript authors. CONCLUSION: Multiple areas of weakness in study design, statistical analysis, and patient outcomes assessment limit the reliability of data derived from PD intervention studies in the modern era. The global themes identified herein should serve as a basis upon which to build future research protocols. Ziegelmann MJ, Trost LW, Russo GI, et al. Peyronie's Disease Intervention Studies: An Exploration of Modern-Era Challenges in Study Design and Evaluating Treatment Outcomes. J Sex Med 2020;17:364-377.

Prevalence and Predictors of Climacturia and Associated Patient/Partner Bother in Patients With History of Definitive Therapy for Prostate Cancer.

BACKGROUND: Climacturia is an under-reported complication of definitive therapy for prostate cancer (PCa) - that is, radical prostatectomy (RP) and/or radiation therapy (RT). AIM: We sought to identify the prevalence and predictors of climacturia and associated patient/partner bother in patients with and without prior PCa treatment. METHODS: We analyzed a database of patients who presented to our Men's Health clinic and filled out a questionnaire related to sexual function and pertinent medical histories. The prevalence of climacturia and associated patient/partner bother in patients with/without prior RP/RT was calculated. Univariable and multivariable logistic regressions were performed to identify predictors associated with climacturia and patient/partner bother. OUTCOMES: The primary outcomes were the prevalence and predictors of climacturia and associated patient/partner bother in patients with/without history of definitive PCa treatment. RESULTS: Among 1,117 patients able to achieve orgasm, 192 patients (17%) had prior history of definitive therapy for PCa (RP alone = 139 [72%]; RT alone = 22 [11%]; RP + RT = 31 [16%]). Climacturia was reported by 39%, 14%, 52%, and 2.4% of patients with history of RP alone, RT alone, RP + RT, and neither RP nor RT, respectively (P < .05 between all groups). 33 to 45 percent of patients with climacturia noted significant patient/partner bother. Factors significantly associated with climacturia were prior RP, prior RT, history of other prostate surgery, and erectile dysfunction, although erectile dysfunction was not significant on multivariable analysis. Significant reduction in climacturia prevalence was noted for patients who were ≥1 year out from RP, compared with patients who were <1 year out. Among patients with prior RP/RT, stress urinary incontinence was associated with increased risk of climacturia, whereas diabetes was associated with decreased risk. No factors were associated with patient/partner bother. Among patients with prior RP, nerve-sparing technique did not predict presence of climacturia but was associated with reduced patient/partner bother. CLINICAL TRANSLATION: Given significant prevalence of climacturia and associated patient/partner bother, patients should be counseled on the risk of climacturia before undergoing RP/RT. STRENGTHS AND LIMITATIONS: Strengths include the large study population and the focus on both RP and RT. Limitations include the facts that this is a single-institution study that primarily relies on patients' subjective reporting and that the study population may not represent the general population. CONCLUSIONS: Climacturia affects a significant proportion of patients with history of RP/RT for PCa, and many patients and their partners find this bothersome. Jimbo M, Alom M, Pfeifer ZD, et al. Prevalence and Predictors of Climacturia and Associated Patient/Partner Bother in Patients With History of Definitive Therapy for Prostate Cancer. J Sex Med 2020;17:1126-1132.

Evaluation and Management of Testosterone Deficiency: AUA Guideline.

PURPOSE: There has been a marked increase in testosterone prescriptions in the past decade resulting in a growing need to give practicing clinicians proper guidance on the evaluation and management of the testosterone deficient patient. MATERIALS AND METHODS: A systematic review utilized research from the Mayo Clinic Evidence Based Practice Center and additional supplementation by the authors. Evidence-based statements were based on body of evidence strength Grade A, B, or C and were designated as Strong, Moderate, and Conditional Recommendations with additional statements presented in the form of Clinical Principles or Expert Opinions (table 1 in supplementary unabridged guideline, http://jurology.com/). RESULTS: This guideline was developed by a multi-disciplinary panel to inform clinicians on the proper assessment of patients with testosterone deficiency and the safe and effective management of men on testosterone therapy. Additional statements were developed to guide the clinician on the appropriate care of patients who are at risk for or have cardiovascular disease or prostate cancer as well as patients who are interested in preserving fertility. CONCLUSIONS: The care of testosterone deficient patients should focus on accurate assessment of total testosterone levels, symptoms, and signs as well as proper on-treatment monitoring to ensure therapeutic testosterone levels are reached and symptoms are ameliorated. Future longitudinal observational studies and clinical trials of significant duration in this space will improve diagnostic techniques and treatment of men with testosterone deficiency as well as provide more data on the adverse events that may be associated with testosterone therapy.

Restoration of Penile Function and Patient Satisfaction with Intralesional Collagenase Clostridium Histolyticum Injection for Peyronie's Disease.

PURPOSE: Collagenase clostridium histolyticum is approved for the treatment of Peyronie's disease. To date, no post-release study to our knowledge has evaluated patient perceived outcomes and satisfaction. Therefore, we evaluated patient perceived experience with collagenase clostridium histolyticum injection for Peyronie's disease in a clinical practice. MATERIALS AND METHODS: From March 2014 to July 2015, 69 patients underwent 1 to 4 series of collagenase clostridium histolyticum injections for Peyronie's disease at our institution. Objective changes in penile curvature as well as patient reported functional outcomes and patient perceived curvature improvements were evaluated. RESULTS: By the time of analysis 31 patients (45%) had completed 4 trials, 47 (68%) completed 3 trials and 59 (86%) completed 2 trials. Patient reported improvements (percentage) in curvature increased with each series (trial 1-14%, trial 2-28%, trial 3-30% and trial 4-37%, p <0.05). Among those completing therapy 57% reported that collagenase clostridium histolyticum injections negated a need for surgery and 52% reported restoration of penetration. Overall 81% of men perceived collagenase clostridium histolyticum treatment as meaningful and 88% reported subjective improvements after 4 series of injections. Objective measures demonstrated a mean 23-degree curvature improvement (38%, p <0.0001). Seven patients (10%) experienced penile hematomas and no patients experienced tunical rupture. CONCLUSIONS: Collagenase clostridium histolyticum reduced the need for surgery and restored penetration in the majority of patients completing 4 series of injections. It also significantly reduced the degree of objectively measured penile curvature. Subjective improvements in curvature increased with each series of collagenase clostridium histolyticum injections as well and the majority of patients considered the therapy worthwhile.

Challenges in Testosterone Measurement, Data Interpretation, and Methodological Appraisal of Interventional Trials.

INTRODUCTION: Male hypogonadism is a common condition, with an increasing body of literature on diagnosis, implications, and management. Given the significant variability in testosterone (T) from a physiologic and assay perspective, a thorough understanding of factors affecting T values and study methodology is essential to interpret reported study outcomes appropriately. However, despite the large number of publications on T, there are no reference materials consolidating all relevant and potentially confounding factors necessary to interpret T studies appropriately. AIMS: To create a resource document that reviews sources of T variability, free vs total T, assay techniques and questionnaires, and study methodology relevant to interpreting outcomes. METHODS: A PubMed search was performed of all the T literature published on T variability, assay techniques, and T-specific questionnaires. Results were summarized in the context of their impact on interpreting T literature outcomes and methodology. MAIN OUTCOME MEASURES: Effect of various factors on T variability and their relevance to study methodology and outcomes. RESULTS: Several factors affect measured T levels, including aging, circadian rhythms, geography, genetics, lifestyle choices, comorbid conditions, and intraindividual daily variability. The utility of free T over total T is debatable and must be compared using appropriate threshold levels. Among various assay techniques, mass spectrometry and equilibrium dialysis are gold standards. Calculated empirical estimates of free T also are commonly used and accepted. Hypogonadism-specific questionnaires have limited utility in screening for hypogonadism, and their role as objective end points for quantifying symptoms remains unclear. Numerous aspects of study methodology can directly or indirectly affect reported outcomes, including design (randomized, prospective, retrospective), duration, populations studied (age, comorbid conditions), low T threshold, therapeutic agent used, objective measurements and end points selected, and statistical interpretation. CONCLUSION: Critical appraisal of the T literature requires an understanding of numerous factors resulting in T variability, study design and methodology, and limitations of assay techniques and objective measurement scales.

External Mechanical Devices and Vascular Surgery for Erectile Dysfunction.

INTRODUCTION: The field of sexual medicine is continuously advancing, with novel outcomes reported on a regular basis. Given the rapid evolution, updated guidelines are essential to inform practicing clinicians on best practices. AIM: To summarize the current literature and provide clinical guidelines on penile traction therapy, vacuum erection devices, and penile revascularization. METHODS: A consensus panel was held with leading sexual medicine experts during the 2015 International Consultation on Sexual Medicine (ICSM). Relevant literature was reviewed and graded based on Oxford criteria to develop evidence-based guideline and consensus statements. MAIN OUTCOME MEASURES: The development of clinically relevant guidelines. RESULTS: Penile traction therapy is a viable therapy to modestly improve penile length as a primary therapy, before penile prosthesis placement in men with decreased penile length or after surgery for Peyronie's disease. It also might have a role in the acute phase of Peyronie's disease but has inconsistent outcomes in the long-term phase. Vacuum erection devices are effective in creating an erection satisfactory for intercourse, even in difficult-to-treat populations. They also might be used in the post-prostatectomy setting to maintain penile length but have insufficient evidence as a penile rehabilitation therapy. For vasculogenic erectile dysfunction, men with suspected arterial insufficiency can be evaluated with penile Duplex Doppler ultrasonography and confirmatory angiography. Penile revascularization procedures have consistently demonstrated benefits in very select patient populations; however, inadequate data exists to suggest the superiority of one technique. Men with vascular risk factors are likely poor candidates for penile revascularization, although veno-occlusive dysfunction and age are less significant. Therapies for treating primary veno-occlusive dysfunction are not recommended and should be reserved for clinical trials. CONCLUSIONS: Since the prior ICSM meeting, multiple developments have occurred in external mechanical devices and penile revascularization for the treatment of erectile and sexual dysfunction. Sexual medicine clinicians are encouraged to review and incorporate recommendations as applicable to their scope of practice.

Ectopic Penile Prosthesis Reservoir Placement: An Anatomic Cadaver Model of the High Submuscular Technique.

INTRODUCTION: High submuscular ectopic placement of inflatable penile prosthesis (IPP) reservoirs via the inguinal canal has been popularized as an alternative to the retropubic (orthotopic) location, particularly among men with prior pelvic surgery. Published results suggest minimal complications and high patient satisfaction. However, in our practice, we identified several patients presenting for IPP revision after high submuscular placement who were found to have reservoirs within the peritoneal cavity. AIM: Given the potential for complications, we performed a cadaveric study to define the anatomic location of reservoirs placed using this technique. METHODS: We utilized 10 fresh male cadavers without embalming. Bilateral ectopic reservoir placement (10 AMS Conceal [Boston Scientific, Marlborough, MA] and 10 Coloplast Cloverleaf [Coloplast Corp, Humlebaek, Denmark]) was performed using the high submuscular technique via a penoscrotal incision. Strict adherence to published reports detailing the technique was emphasized to assure reliability of findings. MAIN OUTCOME MEASURES: Anatomic dissection was performed to identify reservoir location within the abdominal wall layers. RESULTS: Twenty IPP reservoirs were placed without difficulty or concern for inadvertent malpositioning. Sixteen reservoirs (80%) were found anterior to the transversalis fascia, including 7 (35%) deep to the rectus muscle and 9 (45%) deep to the external oblique fascia and lateral to the rectus muscle belly. Two reservoirs (10%) were identified in the retroperitoneal space, while 1 (5%) was preperitoneal (deep to transversalis fascia) and 1 (5%) was intraperitoneal. CONCLUSION: Placement of IPP reservoirs using the high submuscular technique results in variable anatomic locations, including within or immediately superficial to the peritoneal cavity. Given the lack of immediate recognition and risk of delayed complications with suboptimal reservoir placement, further studies are mandated to assess the long-term safety of the technique.

The Effect of Duration of Penile Traction Therapy in Patients Undergoing Intralesional Injection Therapy for Peyronie's Disease.

PURPOSE: The concomitant use of penile traction therapy with interferon α-2b has been previously described. We present an update on our clinical experience to assess the benefit and duration of daily traction. MATERIALS AND METHODS: A retrospective review of patients who underwent interferon α-2b therapy between 2001 and 2012 was performed. Charts were reviewed and data collected regarding various patient demographics, vascular parameters, objective length and curvature measurements, and use of penile traction therapy. Penile traction therapy was further stratified according to duration of daily use. RESULTS: A total of 112 patients underwent a median of 12 interferon α-2b injections (range 6 to 24). Daily use of penile traction therapy was reported by 31% of patients. There were no differences in patient demographics, initial vascular status, pretreatment stretched penile length, erect circumference and curvature between patients who followed a penile traction therapy regimen and those who did not. Overall, the use of penile traction therapy did not effect change in penile circumference (with therapy +3.2 mm [SD 6.5] vs no therapy +2.1 mm [SD 7.4], p=0.45), change in curvature (with therapy -8.1 degrees [SD 16.0] vs no therapy -9.9 degrees [SD 11.8], p=0.49) or change in stretched penile length (with therapy +2.4 mm [SD 0.9] vs no therapy +1.3 mm [SD 0.8], p=0.56). Men who used penile traction therapy 3 or more hours per day gained significantly greater stretched penile length compared to those who did not use penile traction therapy (4.4 mm [SD 0.5] vs 1.3 mm [SD 0.8], p=0.04). CONCLUSIONS: Routine penile traction therapy during intralesional injection with interferon α-2b for Peyronie's disease may result in a small but subjectively meaningful improvement in stretched penile length, without affecting curvature, if used for at least 3 hours a day.

Comparative Analysis of Tunical Plication vs. Intralesional Injection Therapy for Ventral Peyronie's Disease.

INTRODUCTION: Approximately 10% of Peyronie's disease (PD) patients present with ventral curvatures and, as such, there is a paucity of data describing the optimal approach for treatment. AIM: This study aims to compare the outcomes of surgery (tunical plication [TP]) and intralesional injection (ILI) therapy (interferon-α2b) in men with ventral PD. MATERIALS AND METHODS: Retrospective data were collected from two centers: Tulane University (ILI) and Technical University of Munich (TP). Collected variables included patient demographics, pre- and post-treatment sexual function, rigorous penile measurements (curvature, length, and penile vascular findings), and post-treatment outcomes. RESULTS: A total of 35 patients with ventral PD (21 ILI and 14 TP) were included in the study. There were no significant differences between the two groups prior to the interventions. There was a significantly better improvement in mean curvature with TP (46.4 degrees) as compared with ILI (9.3), P < 0.0001. TP was also associated with a significantly higher rate of ≥20% improvement in curvature as compared with ILI (100% vs. 67%, P = 0.027). Although there was no significant difference in post-treatment change in Sexual Health Inventory for Men (SHIM) scores between the groups, 36% of the ILI patients noted an improved SHIM score as compared with none in the TP group. Erect penile length was preserved or improved in 67% of the ILI group vs. 14% of the TP group, P = 0.005. CONCLUSIONS: TP confers a better overall improvement in penile curvature as compared with ILI in patients with ventral PD. Preserved or improved erect penile length and SHIM scores may be observed in patients undergoing ILI. 12:2492-2498.

Alternative treatment modalities for the hypogonadal patient.

Testosterone (T) deficiency syndrome (TDS) is a prevalent condition, commonly managed with exogenous T. Despite an abundance of T formulations, alternative treatments are often sought for various reasons. To evaluate outcomes of alternative therapies, a PubMed search was performed of all publications that included men with TDS from 1990 through October 2013, with results summarized. Proposed mechanisms of action were also reviewed to provide a pathophysiologic basis for reported outcomes. Nonpharmacologic therapies that increase endogenous T are weight loss, exercise, and varicocelectomy, while medications used off-label include aromatase inhibitors, human chorionic gonadotropin, and selective estrogen receptor modulators. All reported therapies increase T, while changes in estradiol and adverse events vary by therapeutic class. Although limited data preclude direct comparisons between therapies, exercise and weight loss alone or in combination with medications may be considered first line. The role for surgical therapy in TDS remains undefined and requires further study.

Outcomes of intralesional interferon-α2B for the treatment of Peyronie disease.

PURPOSE: We evaluated the efficacy of intralesional interferon-α2b for Peyronie disease, reviewed the impact of the timing of therapy from disease onset and identified variables predictive of a response. MATERIALS AND METHODS: We retrospectively reviewed the charts of patients treated with intralesional interferon-α2b from 2001 to 2012. Demographic information, disease characteristics, pretreatment and posttreatment penile duplex ultrasound findings, and objective measures were analyzed. Response was defined as a 20% or greater improvement in curvature. Statistical analysis was done to identify significant changes in variables and identify predictive factors. RESULTS: A total of 127 patients with a mean age of 55 years (range 25 to 76) and a mean±SD pretreatment curvature of 42.4±18.6 degrees underwent a median of 12 biweekly interferon-α2b injections (range 6 to 24). The median history of Peyronie disease was 2.0 years (range 0.5 to 23). Of the patients 54% responded to therapy with an overall mean improvement of 9.0 degrees (p<0.001). Patients with less than 30-degree curvature were most likely to experience a 20% or greater improvement with interferon-α2b (86% response, p<0.001). However, similar overall improvement in pretreatment curvature was noted in all cases. No statistically significant improvement was observed in penile vascular status or ultrasound parameters. The duration of Peyronie disease did not impact the change in curvature. Age, pretreatment curvature, vascular status, penile ultrasound findings, curvature site and International Index of Erectile Function (IIEF) score did not predict the response to therapy. CONCLUSIONS: Intralesional therapy with interferon-α2b resulted in significantly improved curvature without impacting penile vascular parameters. The absolute improvement in curvature was independent of pretreatment curvature or Peyronie disease duration.

Managing the difficult penile prosthesis patient.

INTRODUCTION: Inflatable penile prostheses (IPPs) are associated with excellent long-term outcomes and patient/partner satisfaction. A small percentage of patients remain dissatisfied, despite acceptable surgical results. AIMS: This study aims to evaluate factors associated with patient satisfaction and dissatisfaction, define patient characteristics, which may identify elevated risk of postoperative dissatisfaction, and describe management strategies to optimize functional and psychological patient outcomes. METHODS: A review of urologic and non-urologic cosmetic surgery literature was performed to identify factors associated with patient satisfaction/dissatisfaction. Emphasis was placed on articles defining "high risk" or psychologically challenging patients. MAIN OUTCOME MEASURES: Preoperative factors associated with patient satisfaction/dissatisfaction and character traits, which may identify elevated risk of postoperative dissatisfaction or otherwise indicate a psychologically challenging patient. RESULTS: Contemporary patient and partner satisfaction rates following IPP are 92-100% and 91-95%, respectively. Factors associated with satisfaction include decreased preoperative expectations, favorable female partner sexual function, body mass index ≤30, and absence of Peyronie's disease or prior prostatectomy. Determinants of dissatisfaction include perceived/actual loss of penile length, decreased glanular engorgement, altered erectile/ejaculatory sensation, pain, diminished cosmetic outcome, difficulty with device function, partner dissatisfaction and perception of unnatural sensation, complications, and extent of alternative treatments offered. Personality characteristics which may indicate psychologically challenging IPP patients include obsessive/compulsive tendencies, unrealistic expectations, patients undergoing revision surgery, those seeking multiple surgical opinions, feeling of entitlement, patients in denial of their prior erectile/sexual function and current disease status, or those with other psychiatric disorders. The mnemonic CURSED Patient is presented: "Compulsive/obsessive, Unrealistic, Revision, Surgeon Shopping, Entitled, Denial, and Psychiatric." CONCLUSIONS: Although the majority of IPP patients experience excellent, durable satisfaction and outcomes, a challenging subset of patients may be at increased risk of postoperative dissatisfaction. Appropriate recognition/prevention and management of this cohort may help to establish and strengthen relationships, reduce physical, emotional, and legal risk, and ultimately enhance patient satisfaction.

Androgen deprivation therapy impact on quality of life and cardiovascular health, monitoring therapeutic replacement.

INTRODUCTION: Androgen deprivation therapy (ADT) is commonly utilized in the management of both localized and advanced adenocarcinoma of the prostate. The use of ADT is associated with several adverse events, physical changes, and development of medical comorbidities/mortality. AIM: The current article reviews known adverse events associated with ADT as well as treatment options, where available. Current recommendations and guidelines are cited for ongoing monitoring of patients receiving ADT. METHODS: A PubMed search of topics relating to ADT and adverse outcomes was performed, with select articles highlighted and reviewed based on level of evidence and overall contribution. MAIN OUTCOME MEASURES: Reported outcomes of studies detailing adverse effects of ADT were reviewed and discussed. Where available, randomized trials and meta-analyses were reported. RESULTS: ADT may result in several adverse events including decreased libido, erectile dysfunction, vasomotor symptoms, cognitive, psychological and quality of life impairments, weight gain, sarcopenia, increased adiposity, gynecomastia, reduced penile/testicular size, hair changes, periodontal disease, osteoporosis, increased fracture risk, diabetes and insulin resistance, hyperlipidemia, and anemia. The definitive impact of ADT on lipid profiles, cardiovascular morbidity/mortality, and all-cause mortality is currently unknown with available data. Treatment options to reduce ADT-related adverse events include changing to an intermittent treatment schedule, biophysical therapy, counseling, and pharmacotherapy. CONCLUSIONS: Patients treated with ADT are at increased risk of several adverse events and should be routinely monitored for the development of potentially significant morbidity/mortality. Where appropriate, physicians should reduce known risk factors and counsel patients as to known risks and benefits of therapy.

Oncofertility and the male cancer patient.

OPINION STATEMENT: Oncofertility as a discipline plays an important, adjunctive role in the treatment of male patients with cancer. Despite recommendations by the American Society of Clinical Oncology, many clinicians managing malignancies in males fail to consistently incorporate fertility preservation as a routine aspect of health care. Providers involved in the treatment of oncologic patients should have an awareness of the impact of their prescribed treatments on reproductive potential, just as they would be knowledgeable of the potential deleterious effects of cancer therapies on vital organs such as the kidneys, lungs, and liver. Providers should then have a discussion with their patients regarding these potential adverse therapeutic effects or consult a fertility preservation specialist to discuss these matters and fertility preservation options with the patient. Cryopreservation of sperm remains an excellent option for male fertility preservation as it is readily available and results in storage of viable gametes for future use in the event of post treatment infertility. With the use of assisted reproductive techniques (ART), cryopreserved sperm may ultimately result in successful paternity, even in the setting of very low numbers of stored sperm. While sperm cryopreservation is usually an option for adolescent and adult males, fertility preservation in pre-pubertal males presents a more challenging problem. To date, no clinically proven methods are available to preserve fertility in these males. However, some centers do offer experimental protocols under the oversight of an IRB, such as testicular tissue cryopreservation in these males. The hope is that one day science will provide a mechanism for immature germ cells from the testicular tissue of these patients to be used in vivo or in vitro to facilitate reproduction. In closing, studies have shown that the patient's regard for his provider is enhanced when the issue fertility preservation is raised. While oncologic care is often fraught with time constraints and acute medical concerns, fertility preservation care in the male can typically be administered quickly and without disruption of the overall plan of care.

Two dimensional penile ultrasound vibro-elastography for measuring penile tissue viscoelasticity: A pilot patient study and its correlation with penile ultrasonography.

The purpose of this research is to demonstrate the feasibility of a 2 dimensional (2D) penile ultrasound vibro-elastography (PUVE) technique for measuring the shear wave speed map over an area of regional of interest (ROI) in the penis. In PUVE, a 0.1 s harmonic vibration at a low frequency is generated on the surface of the penis using a handheld vibrator. An ultrasound probe is used to measure the resulting shear wave propagation in the penis. The shear wave speed is analyzed in the ROI of corpus cavernosum from both sides of penis using a 2D wave speed analysis technique. The shear wave speed of the penis is measured at three excitation frequencies of 100 Hz, 150 Hz, and 200 Hz. The viscoelasticity of penis is analyzed based on the wave speed dispersion with frequency. A pilot study was performed in men with ED and/or PD. It is found that both elasticity and viscosity of corpus cavernosa positively correlate with the peak systolic velocity (PSV) from penile ultrasonography. Both elasticity and viscosity of corpus cavernosa negatively correlate with the cardiovascular (CV) risk for patients with ED and/or PD. These results suggest that PUVE may provide a noninvasive and painless technique for assessing patients with ED/PD and their future CV risk. We will further evaluate PUVE in a large cohort of patients with ED/PD.

A Novel Noninvasive Ultrasound Vibro-elastography Technique for Assessing Patients With Erectile Dysfunction and Peyronie Disease.

OBJECTIVE: To translate a novel ultrasound vibro-elastography (UVE) technique for noninvasively measuring viscoelasticity of the penis. METHODS: A pilot study of UVE was performed in men with erectile dysfunction or Peyronie disease. Assessments were performed in triplicate on the lateral aspect of the penis (bilaterally) at 100, 150, and 200 Hz before and after erectogenic injection administration. Viscoelasticity of the corpora was also calculated and compared before and after injection and against measures of erectile function, including the International Index of Erectile Function-Erectile Function Domain, and the total erectogenic medication volume required for achieving a firm erection. RESULTS: Significant increases in viscoelasticity were found after erectogenic injection, validating the ability of UVE to measure dynamic changes with erections. Baseline measures also significantly correlated with the volume of erectogenic medication required to achieve an erection (100 Hz, parameter estimate [PE] 2.21, P <.001; 150 Hz, PE 0.53, P = .03; 200 Hz, PE 0.34, P = .07) but not with age and International Index of Erectile Function-Erectile Function Domain. As erectogenic medications likely represent the most accurate measure of erectile function, these findings suggest a potential role for UVE as a viable diagnostic modality for erectile dysfunction. CONCLUSION: This first report of the use of elastography with erectile function in humans demonstrates significant associations with responsiveness to erectogenic injection medications. These data have significant potential implications for broader clinical practice and merit further study and validation.

Infection risk of undergoing multiple penile prostheses: an analysis of referred patient surgical histories.

Inflatable penile prosthesis (IPP) is the gold standard for medically refractory erectile dysfunction. Infectious complications remain a significant concern in IPP revision surgery. We sought to evaluate the impact of number of IPP surgeries on subsequent infection rates. A retrospective analysis was performed on all new patients (self or outside provider referred) presenting for consideration of IPP revision or salvage surgery between 2013 and 2015. Histories were reviewed including number of prior IPPs, reason for evaluation, and rate, number, and timing of prior IPP infections. No patients were operated on by the primary investigator prior to data acquisition. We identified 44 patients with at least one prior IPP presenting for consultation regarding IPP revision/salvage. There were 88 IPPs placed by 28 different surgeons. In patients with two or more devices, 55% had at least two different surgeons. The most common reason for presentation was malfunction (52%). The risk of specific device infection was strongly correlated and increased based on number of prior IPPs: 1st (6.8%; 3/44), 2nd (18.2%; 4/22), 3rd (33.3%; 4/12), 4th (50%; 4/8), and 5th (100%; 2/2) (R2 = 0.90, p = 0.01). Similarly, overall rates of infection positively correlated with number of prior IPP-related surgeries performed (R2 = 0.97, p < 0.01). The median time to development of infection after most recent IPP surgery was 2 months (IQR 1-3.3 months). Infection rates of revision/salvage IPP surgery increase with each subsequent IPP placement or following IPP-related surgeries. The majority of patients referred for penile implant surgery can expect to have experienced at least one infection by their 4th device. These data represent a change in paradigm on revision prosthetic surgery.

Impact of anabolic androgenic steroids on sexual function.

BACKGROUND: To describe the impact of supra-physiologic anabolic-androgenic steroid (AAS) use, including agent, dosage, and duration of therapy, on sexual function. METHODS: We reviewed data from an online survey of AAS users to evaluate their sexual function on and off AAS. The online survey consisted of questions addressing demographics, anabolic steroid use and patterns, ancillary medications, testosterone (T)-related symptoms while on and off of therapy, as well as sexual function which was assessed using the 5-item, International Index of Erectile Function (IIEF-5). RESULTS: A total of 321 men responded to the survey, of which 90 failed to meet inclusion criteria, for a final cohort of 231 AAS users. The majority of men were Caucasian (85%), employed (62%), and younger than 35 years (58%), while an equal mix were single (47%) or married (46%). The mean IIEF-5 was 22.5, with higher scores associated with increased T dosages (>600 mg/week), use of 17-alpha alkylated hormones and anti-estrogens, and absence of concurrent medical conditions. Lower mean IIEF scores were associated with current and pre-AAS low T symptoms, self-reported angry or violent tendencies, self-reported erectile dysfunction (ED), decreased libido, decreased energy, and depression. After controlling for age, low T symptoms and decreased energy remained significantly associated with lower IIEF scores. Among 127 men reporting de novo decreased libido when not taking AAS, several factors were significantly associated including frequency and duration of T and use of adjunctive therapies, while post-cycle therapies were protective. Men who reported any other de novo symptom (decreased energy, libido, muscle mass or depression) after discontinuing T were also more likely to report de novo ED, as well as those using >10 years or for >40 weeks per year. CONCLUSIONS: The long-term impact of high dose AAS use on sexual function remains poorly defined. Although high T dosages appeared to be protective of erectile function during use, de novo symptoms such as decreased libido and ED occurred more frequently after discontinuing T, particularly among those using more frequently and for longer durations. Given the importance of these findings, long-term studies evaluating the impacts of discontinuing T on sexual dysfunction are indicated.

Pharmacological Management of Peyronie's Disease.

Peyronie's disease is a localised, fibrosing condition of the penis that occurs in up to 9% of men. Although its aetiology has not been elucidated, Peyronie's disease probably results from the presence of a predisposing genetic susceptibility combined with an inciting event, most probably trauma. Following appropriate clinical evaluation, initial treatment consists of a trial of oral and/or intralesional pharmacotherapy. Oral therapies most commonly employed include para-aminobenzoate (Potaba) and tocopherol (vitamin E), with colchicine, tamoxifen, propoleum and acetyl-L-carnitine being used less frequently. Placebo-controlled studies examining these agents have failed to show a consistent beneficial effect on Peyronie's disease, with the exception of para-aminobenzoate, which may decrease plaque size and curvature, and acetyl-L-carnitine, which may reduce erectile pain and inhibit disease progression. Intralesional injection therapy for Peyronie's disease is commonly used as a first-line therapy along with oral medications. The current standard of care involves injection with interferon-alpha-2a or -2b, verapamil or collagenase over 2-week intervals for a period of 5-6 months. Interferon-alpha-2b, in particular, has been documented in a large, multicentre, placebo-controlled study to be significantly more effective than placebo in decreasing penile curvature, plaque size, penile pain and plaque density. However, interferon treatment is also associated with significant adverse effects, including fever and other flu-like symptoms. Other available therapies that have not consistently shown efficacy in placebo-controlled studies include corticosteroids and orgotein. Surgery is considered in patients with Peyronie's disease who have not responded to a trial of conservative medical therapy for 1 year and who are precluded from sexual intercourse. Procedures commonly performed include the Nesbit procedure (or variations of the Nesbit), penile plaque incision/excision with or without grafting, and implantation of a penile prosthesis. Further basic scientific research in Peyronie's disease is likely to identify additional targets for future pharmacotherapy.