Development of a North American coordinated registry network for surgical treatment of benign prostatic hyperplasia.

PURPOSE: To create a prospective, multicenter coordinated registry network (CRN) of robust "real world" data for benign prostatic hyperplasia (BPH) that links surgical practices to objective and subjective outcomes of patients who undergo surgery for the improvement in lower urinary tract symptoms (LUTS) secondary to BPH. METHODS: We gathered a group of BPH experts from various institutions to identify the minimum core data elements needed to assess BPH procedures. To achieve consensus on the data elements, we used a Delphi method adaptation, in which a series of surveys were answered by the expert panel individually and anonymously. Survey results were collected and analyzed. Questions for the following round were based on response analysis from the prior survey. This process was repeated until consensus was achieved. RESULTS: Participation rates in the first and second rounds were 100% and 90%, respectively. The expert panel reached consensus on 148 data elements out of the 182 proposed, capturing patient medical and surgical history, procedure, discharge, short- and long-term follow-up, device factors, surgery, and surgeon factors. CONCLUSION: We have successfully developed a set of core data elements to support the study of BPH surgical therapies by gathering an expert panel on BPH and using the Delphi method. These data elements influence provider decisions about treatment and include important outcomes related to efficacy and safety.

Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART II-Surgical Evaluation and Treatment.

PURPOSE: Surgical therapies for symptomatic bladder outlet obstruction (BOO) due to benign prostatic hyperplasia (BPH) are many, and vary from minimally invasive office based to high-cost operative approaches. This Guideline presents effective evidence-based surgical management of male lower urinary tract symptoms secondary/attributed to BPH (LUTS/BPH). See accompanying algorithm for a detailed summary of procedures (figure[Figure: see text]). MATERIALS/METHODS: The Minnesota Evidence Review Team searched Ovid MEDLINE, Embase, Cochrane Library, and AHRQ databases to identify eligible studies published between January 2007 and September 2020, which includes the initial publication (2018) and amendments (2019, 2020). The Team also reviewed articles identified by Guideline Panel Members. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, information is provided as Clinical Principles and Expert Opinions (table[Table: see text]). RESULTS: Twenty-four guideline statements pertinent to pre-operative and surgical management were developed. Appropriate levels of evidence and supporting text were created to direct urologic providers towards suitable and safe operative interventions for individual patient characteristics. A re-treatment section was created to direct attention to longevity and outcomes with individual approaches to help guide patient counselling and therapeutic decisions. CONCLUSION: Pre-operative and surgical management of BPH requires attention to individual patient characteristics and procedural risk. Clinicians should adhere to recommendations and familiarize themselves with criteria that yields the highest likelihood of surgical success when choosing a particular approach for a particular patient.

Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I-Initial Work-up and Medical Management.

PURPOSE: Benign prostatic hyperplasia (BPH) is a histologic diagnosis describing proliferation of smooth muscle and epithelial cells within the prostatic transition zone. The prevalence and severity of lower urinary tract symptoms (LUTS) in aging men are progressive and impact the health and welfare of society. This revised Guideline provides a useful reference on effective evidence-based management of male LUTS/BPH. See the accompanying algorithm for a summary of the procedures detailed in the Guideline (figures 1 and 2[Figure: see text][Figure: see text]). MATERIALS AND METHODS: The Minnesota Evidence Review Team searched Ovid MEDLINE, Embase, Cochrane Library, and AHRQ databases to identify eligible English language studies published between January 2008 and April 2019, then updated through December 2020. Search terms included Medical Subject Headings (MeSH) and keywords for pharmacological therapies, drug classes, and terms related to LUTS or BPH. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, information is provided as Clinical Principles and Expert Opinions (table 1[Table: see text]). RESULTS: Nineteen guideline statements pertinent to evaluation, work-up, and medical management were developed. Appropriate levels of evidence and supporting text were created to direct both primary care and urologic providers towards streamlined and suitable practices. CONCLUSIONS: The work up and medical management of BPH requires attention to individual patient characteristics, while also respecting common principles. Clinicians should adhere to recommendations and familiarize themselves with standards of BPH management.

Trends in Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia, 2004 to 2013: the Urologic Diseases in America Project.

PURPOSE: Our current understanding of recent trends in the management of lower urinary tract symptoms associated with benign prostatic hyperplasia is incomplete, particularly in younger men. The 2018 Urologic Diseases in America Project attempted to fill this gap by analyzing multiple large administrative claims databases which include men of all ages and permit longitudinal followup. To our knowledge we report these findings for the first time in the scientific literature. MATERIALS AND METHODS: The 2 data sources used in this study included the de-identified Optum® Clinformatics® Data Mart database for men 40 to 64 years old and the Medicare 5% Sample for men 65 years old or older. To assess trends in lower urinary tract symptoms/benign prostatic hyperplasia related medication prescriptions and surgical procedures from 2004 to 2013 we created annual cross-sectional cohorts and a longitudinal cohort of patients with incident lower urinary tract symptoms/benign prostatic hyperplasia and 5 years of followup. RESULTS: The use of medications related to lower urinary tract symptoms/benign prostatic hyperplasia increased with age, particularly among men 40 to 60 years old. While medication use increased with time, surgical procedures decreased. Increasing age correlated with a higher rate of surgical procedures in the longitudinal cohort. Younger men were more likely to elect treatments of lower urinary tract symptoms/benign prostatic hyperplasia which reportedly optimize sexual function. CONCLUSIONS: Medication use increased and surgery decreased during the study period. Treatment approaches to lower urinary tract symptoms/benign prostatic hyperplasia varied greatly by patient age. While the minority of men in the fifth and sixth decades of life required treatment, a sharp increase in treatment use was seen between these decades. Younger men were more likely to elect less invasive surgical options. Future studies of lower urinary tract symptoms/benign prostatic hyperplasia should focus on age specific treatment selection.

A Thematic Analysis of the Online Discussion Board, FrankTalk, Regarding Penile Implant.

INTRODUCTION: Medical websites and discussion boards are commonly used by patients to obtain information. The online forum FrankTalk.org provides a venue specifically for men to discuss sexual dysfunction and particularly inflatable penile prosthesis (IPP). By querying and better understanding the content of this forum related to implants, we can better understand patient concerns before and after IPP. AIM: The aim of this study is to understand the main topics being discussed about IPPs online and to use these topics to understand patient concerns and patient needs and to improve care. METHODS: Messages posted in a 6-month window from January 2018 to June 2018 under the topic "Implant" were identified on FrankTalk.org. Posts were broken down into preoperative and postoperative and then organized using a 3-stage analysis to determine central themes of each post: open coding, axial coding, and selective coding. MAIN OUTCOME MEASURE: The primary outcome measure is the prevalence of each selective code. RESULTS: Of all 587 posts, 304 were written preoperatively with the most common theme being "Size" (23.0%), followed by "seeking support" (18.4%). 283 posts were considered postoperative, of which the most common theme was "Concern about healing" (22.6 %) which questioned if they needed to see a physician, followed by size concerns (20.1%).When analyzed with the 3-stage coding system, there were a total of 41 axial codes which were organized into 6 selective codes: "Social Support" (27.8% of all posts), "Pre-Operative Worries" (23.58%),"Technical Issues" (11.1%), "Prosthesis Logistics" (14.37%), "Post-Operative Worries" (20.22%), "Forum and Misc" (2.93%) for topics outside the scope of penile prosthesis. CLINICAL IMPLICATIONS: The percentage of men seeking medical opinion is concerning, and providers should consider using resources to better educate patients on normal postoperative findings. Implanters should continue to preoperatively counsel patients on size-related changes with surgery. STRENGTH & LIMITATIONS: Strengths include the use of a common online website for men to discuss IPPs and a systematic coding system. Limitations include the applicability of these results to nonheterosexual men as these are likely oversampled in this population. The inherent bias of those willing to post on an online forum may have influenced results along with no oversight for factual accuracy. CONCLUSION: Patients use online discussion boards like FrankTalk.org for social support, medical advice, and validation of their concerns. Providers should be aware of these online topic focuses to help open a discussion with patients about concerns they may feel are difficult to approach with providers. Lu JY, Miller EJ, Welliver C. A Thematic Analysis of the Online Discussion Board, FrankTalk, Regarding Penile Implant. J Sex Med 2020;17:325-330.

Analyzing and Characterizing Why Men Seek Care for Lower Urinary Tract Symptoms.

PURPOSE OF REVIEW: The goal of this paper is to summarize existing literature on prevalence of lower urinary tract symptoms (LUTS) that may be attributed to benign prostatic hyperplasia (BPH, LUTS/BPH), factors associated with seeking treatment and treatment success, and subjective and objective methods of evaluating LUTS. RECENT FINDINGS: Men primarily seek treatment for LUTS/BPH because bother overcomes barriers to treatment. Factors such as severity, bother, or persistence of symptoms primarily motivate individuals to seek treatment, while low-symptom severity mainly leads individuals to not seek treatment. Among men that seek treatment, nocturia and storage symptoms predominate. LUTS are assessed with self-report questionnaires; subjective evaluations translate moderately well to objective measurements of LUTS severity. Current symptom classifications and patient groupings may be overly simplified and not evidence-based. Further studies evaluating novel symptom clusters and patient-centered BPH treatment approaches can guide future treatment.

National Trends in the Management of Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.

PURPOSE OF REVIEW: To gain an understanding of current practices in the management of lower urinary tract symptoms (LUTSs) in the setting of benign prostatic hyperplasia (BPH). Including both medication therapy and emerging minimally invasive options including peri-procedure considerations, expected outcomes, and value-based considerations. RECENT FINDINGS: Medical therapy, primarily alpha blockers (ABs), and 5 alpha reductase inhibitors (5-ARI) remain the most commonly utilized intervention for LUTS associated with BPH. Several minimally invasive surgical treatments (MISTs) have emerged to provide efficacious and durable results, while largely sparing men from the sexual adverse effects of more invasive surgical options. The introduction of value-based health care has led to more cost-conscious medical care and is poised to influence the landscape of LUTS associated with BPH treatment. As the population-based and societal needs continue to influence medical care for men with LUTS associated with BPH, a paradigm shift in management is expected.

Scrotoplasty at Time of Penile Implant is at High Risk for Dehiscence in Diabetics.

INTRODUCTION: Scrotoplasty has become a common practice during insertion of penile prosthesis, improving patient perception of penile length. Previous reports on scrotoplasty outcomes have only focused on the perceived benefits. The risk of wound complications after scrotoplasty is unknown. AIM: Identify wound complications and associated risk factors of scrotoplasty with insertion of penile prosthesis. METHODS: A retrospective review of a single-surgeon series (T.S.K.) of patients who underwent scrotoplasty with initial insertion of inflatable penile prosthesis (IPP) was performed from 2009-2014. Surgical outcomes and wound complications after scrotoplasty were examined, along with patient information, including basic demographics, medical comorbidities, and perioperative data. MAIN OUTCOME MEASURES: Studied outcomes included rate of wound complications after scrotoplasty and IPP insertion and identification of risk factors for wound dehiscence. RESULTS: Of the 103 scrotoplasties performed during the study period, a total of 15 had mild, moderate, or major wound dehiscence. Of these 15 cases, 9 had mild dehiscence and 5 cases had moderate dehiscence and required stitches to be placed in clinic to reinforce the closure. 1 patient had a major dehiscence requiring a return to the operating room for a washout, with exchange of IPP to malleable prosthesis. Multiple risk factors for wound dehiscence were found, including diabetes (odds ratio 6.1, CI 1.5, 25.0, P = .0129) and scrotoplasty technique (odds ratio 4.9, CI 1.2, 8.6, P = .003). Other examined variables, including patient age, Peyronie's disease, hypertension, intraoperative penile modeling, smoking, and device manufacturer, were not associated with wound dehiscence. CLINICAL IMPLICATIONS: Patients with diabetes and scrotoplasties performed via V-Y plasty are more likely to experience wound dehiscence. STRENGTHS & LIMITATIONS: Strengths include a single surgeon, thus lending continuity of skill and technique, a consecutive series, and 100% short-term follow-up. Limitations include retrospective design, single institution series, and lack of long-term follow-up. CONCLUSION: Although scrotoplasty can improve patient satisfaction with IPP, scrotoplasty can lead to increased patient morbidity. Diabetic patients are at increased risk for wound complication after scrotoplasty. Gupta NK, Sulaver R, Welliver C, et al. Scrotoplasty at Time of Penile Implant is at High Risk for Dehiscence in Diabetics. J Sex Med 2019;16:602-608.

Optimizing Outcomes in the Virgin Penile Implant Patient.

PURPOSE OF REVIEW: Patient satisfaction with inflatable penile prosthesis (IPP) is an elective procedure that restores erectile function. RECENT FINDINGS: While the return of usable erections is almost always achieved with IPP, patients may still be unhappy with the procedure if the outcome has not met their expectations. Optimizing patient satisfaction and outcomes should incorporate considerations for pre-, intra-, and postoperative factors. Length optimization regimens and improved pain control options have dominated the recent literature.

Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline.

PURPOSE: Male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is common in men and can have negative effects on quality of life (QoL). It is the hope that this Guideline becomes a reference on the effective evidence-based surgical management of LUTS/BPH. MATERIALS AND METHODS: The evidence team searched Ovid MEDLINE, the Cochrane Library, and the Agency for Healthcare Research and Quality (AHRQ) database to identify studies indexed between January 2007 and September 2017. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions (table 1 in supplementary unabridged guideline, http://jurology.com/). RESULTS: This Guideline provides updated, evidence-based recommendations regarding management of LUTS/BPH utilizing surgery and minimally invasive surgical therapies; additional statements are made regarding diagnostic and pre-operative tests. Clinical statements are made in comparison to what is generally accepted as the gold standard (i.e. transurethral resection of the prostate [TURP]-monopolar and/or bipolar). This guideline is designed to be used in conjunction with the associated treatment algorithm. CONCLUSIONS: The prevalence and the severity of LUTS increases as men age and is an important diagnosis in the healthcare of patients and the welfare of society. This document will undergo additional literature reviews and updating as the knowledge regarding current treatments and future surgical options continues to expand.

The Utility of Sex Hormone-Binding Globulin in Hypogonadism and Infertile Males.

PURPOSE: We sought to determine the role of sex hormone-binding globulin in patients with male infertility. MATERIALS AND METHODS: We retrospectively reviewed the records of 168 males seen at a fertility clinic from 2012 to 2014 to investigate the accuracy of total testosterone in the biochemical diagnosis of hypogonadism using calculated bioavailable testosterone as the reference value. We used multivariable analysis to assess sex hormone-binding globulin as an independent predictor of infertility. RESULTS: Computations using calculated bioavailable testosterone as a standard in the measurement of definitive biochemical hypogonadism (less than 156 ng/dl) revealed 81% sensitivity, 83% specificity, 81% positive predictive value and 82% negative predictive value for diagnosing hypogonadism with total testosterone alone. Of the 90 men with total testosterone greater than 300 ng/dl, 20% had low bioavailable testosterone less than 156 ng/dl, 52% had borderline low bioavailable testosterone less than 210 ng/dl and only 48% could be considered biochemically eugonadal according to calculated bioavailable testosterone. Of the 80 patients with total testosterone less than 300 ng/dl, 19% had free testosterone levels greater than 6.5 ng/dl and, thus, could be considered to be eugonadal. By a magnitude similar to that of follicle-stimulating hormone, sex hormone-binding globulin independently predicted decreased sperm concentration (p = 0.0027) and motility (p = 0.0447). After excluding men with azoospermia, only sex hormone-binding globulin levels differed significantly in classically hypogonadal men (group 1-total testosterone less than 300 ng/dl) and those missed but hypogonadal (group 2-calculated bioavailable testosterone less than 210 ng/dl) (p = 0.0001). At a more stringent cutoff of calculated bioavailable testosterone less than 156 ng/dl, sperm motility was significantly different for groups 1 and 2 (p = 0.014). CONCLUSIONS: Adding sex hormone-binding globulin to total testosterone serum testing facilitates more accurate diagnosis with free testosterone and calculated bioavailable testosterone, and clinical implications of decreased semen parameters to a magnitude similar to that of follicle-stimulating hormone. This warrants further study of the role of sex hormone-binding globulin in male infertility.

Serum levels of enclomiphene and zuclomiphene in men with hypogonadism on long-term clomiphene citrate treatment.

OBJECTIVES: To determine the relative concentrations of enclomiphene (ENC) and zuclomiphene (ZUC) isomers in men with hypogonadism on long-term clomiphene citrate (CC) therapy, and to determine whether patient age, body mass index (BMI) or duration of therapy were predictive of relative concentrations of ENC and ZUC. PATIENTS AND METHODS: Men already receiving CC 25 mg daily therapy for secondary hypogonadism for a minimum of 6 weeks were recruited to have their ENC and ZUC levels assessed. Total testosterone, free testosterone, oestradiol, follicle stimulating hormone (FSH), and luteinizing hormone (LH) before initiation of and while on CC therapy were recorded for all patients. Patient demographics including age, BMI and medical comorbidites were recorded. Serum samples were obtained at the time of enrolment to determine ENC and ZUC concentrations. RESULTS: A total of 15 men were enrolled in the period from June 2015 to August 2015. The median (range) patient age was 36 (22-70) years, BMI 32.0 (21.1-40.3) kg/m2 and duration of treatment 25.9 (1.7-86.6) months. Baseline median total testosterone, oestradiol and LH levels were 205.0 ng/dL, 17.0 pg/mL and 4.0 mlU/mL, respectively. The post-treatment median total testosterone, oestradiol and LH level increased to 488.0 ng/dL, 34.0 pg/mL and 6.1 mIU/mL, respectively (all P<0.001). The median ENC and ZUC concentrations were 2.2 and 44.0 ng/mL, respectively. After at least 6 weeks of CC therapy, the median ZUC: ENC serum concentration ratio was 20:1. On linear regression analysis. patient age, BMI, duration of treatment and serum testosterone levels were not predictive of ENC or ZUC concentrations. CONCLUSIONS: Long-term CC therapy resulted in a significant alteration of ENC and ZUC concentrations, with ZUC as the predominant isomer. Given the vastly different biochemical and toxicological properties of ENC and ZUC, this study supports the need for the development of a pure selective oestrogen receptor antagonist for the treatment of men with hypogonadism.

Is There a Role for Preoperative 5 Alpha Reductase Inhibitors in Reducing Prostate Vascularity and Blood Loss?

Benign prostatic hyperplasia (BPH) and the related medical problems are a major burden as health care costs and as a cause of patient morbidity. The introduction of medical therapy largely offered an alternative to surgical therapy, and these medications have been linked with multiple positive BPH-related outcomes. With ubiquitous use, however, a variety of adverse side effects and unsupported claims to these medications have been reported both in scientific literature and popular press. The use of 5 alpha reductase inhibitors (5ARIs) to reduce recurrent bleeding due to BPH is a reasonable option for men with recurrent trips to the physician or hospital. After a largely anecdotal report of their use in the preoperative period to reduce bleeding during BPH surgery, there was interest in the use of 5ARIs for this indication considering the effusive bleeding that can occur during BPH-related surgery, a dreaded and not uncommon complication. While the pathophysiology for the use of 5ARI to reduce BPH-related bleeding is sound, the actual clinical outcomes still require scrutiny to determine if the efficacy is both scientifically valid and clinically significant. This report will review the current literature on this topic and make attempts to determine if the use of a 5ARI before BPH-related surgery should be encouraged.

Manufacturers' data show increasing implanted cylinder sizes and measured corporal lengths in inflatable penile implants.

INTRODUCTION: We sought to determine whether measured corporal length (MCL) or implanted device size (IDS) has changed. METHODS: Data were obtained from the two major penile implant companies from the years of 2005-2010 and analyzed. While we requested similar data, companies supplied information at their discretion with MCL provided by American Medical Systems and IDS provided by Coloplast. Intra-patient corporal discrepancies, disease state effects, rear tip extenders (RTEs) use and place of implantation were also provided in some part by companies. RESULTS: MCL and IDS increased during the study period. Despite the general trend of MCL/IDS, clinically significant (0.5 cm or greater) decreases in MCLs were noted in patients with Peyronie's disease (PD) or a history of radical pelvic surgery (excludes prostatectomy). In only 2.7 % of cases was there an intra-patient discrepancy in cylinder size (>1 cm). IDS was longer in the USA (US, 19.4 cm) compared to outside the US (OUS, 17.7 cm, p < 0.0001). Cylinders were implanted without RTEs in 48.3 % of US cases and 73.7 % of OUS cases (p < 0.0001). In Coloplast devices there was an overall statistically significant change in the use of 16 cm (less utilized) and 20 and 22 cm (more utilized) cylinder lengths during the study period in US implants. CONCLUSION: MCL and IDS increased during the study period. Men with a history of PD or radical pelvic surgery are at highest risk to have shorter MCL and to possibly receive shorter implants. Intra-patient IDS inconsistency is rare and should prompt investigation.