Regenerative therapies for erectile dysfunction: the influence of direct-to-consumer marketing on patient interest.

Background: Despite a lack of evidence, a number of "regenerative" therapies have become popularized treatments for erectile dysfunction (ED). Platelet-rich plasma (PRP) injections and shockwave therapy have received significant attention through direct-to-consumer marketing and are advertised as viable alternatives to guideline-backed therapies. Additionally, focused low-intensity shock wave therapy (LiSWT) has become conflated with acoustic or radial wave therapy (rWT), although their mechanism of wave generation and tissue penetration is distinct. GAINSWave, a marketing platform for acoustic wave therapy, has also pervaded the marketplace. We aim to evaluate the relative impact of direct-to-consumer marketing of shockwave therapy and PRP by analyzing the quantity of Google internet search queries for selected regenerative and guideline-backed non-regenerative therapies for ED. Methods: National Google Search trends in the United States (www.google.com/trends) were analyzed to characterize interest in different forms of therapy for ED. Search trends for PRP, LiSWT (and various iterations), intracavernosal injections (ICI), intraurethral injections (IU), vacuum erectile device (VED), and GAINSWave were analyzed. Monthly search data were compiled over multiple years, ending at 2/28/2020, just before the COVID-19 pandemic and state of emergency in the United States. Macro-level changes in public interest were quantified using yearly averages. Results: Patterns in Google Search interest in PRP and LiSWT increased respectively by 3-fold and 275-fold over the decade, representing a larger share of Google Searches by 2020. Trends in Google Search interest in selected types of shockwave therapy for ED also show that queries for GAINSWave commanded public interest, increasing by 219-fold from 2016 to 2020. Conclusions: Regenerative therapies for ED have produced interest surpassing other adjunct guideline-backed therapies, despite receiving the designation of "experimental" or "investigational" therapies. The establishment of GAINSWave also constitutes an inflection point for the whole shockwave market: searches for shockwave therapy increased by 782% between 2016 and 2020. Direct-to-consumer marketing of PRP and shockwave therapy has upturned the customary role of physicians in counseling patients about evidence-based therapies for ED. This increase in public interest in GAINSWave emphasizes its success as a marketing platform. The urological community should consider strategies to address misinformation, such as search-engine optimization, social media, and educational outreach.

Analysis of Medical Malpractice Outcomes for Sports Orthopedic Procedures.

Orthopedic sports medicine surgeons are especially vulnerable to litigation, largely because of high patient expectations in the setting of complex surgeries. Understanding the factors associated with litigation may reduce physician risk as well as optimize patient satisfaction and outcomes. We used a national medicolegal database to search for medical malpractice verdicts and out-of-court settlements involving common sports injuries and their surgical management between January 1, 2000, and January 1, 2018. Univariate analysis was performed to identify predictors of case outcome and monetary awards. We identified 777 cases, but only 328 met the inclusion criteria. Of the 328 cases included in our study, 231 (70.4%) resulted in a defendant verdict, 75 (22.9%) resulted in a plaintiff verdict, and 22 (6.7%) resulted in a settlement. The most common reason for litigation was intraoperative error (183 cases, 55.8%). No statistically significant difference was found between monetary awards for plaintiff verdicts vs settlements (mean award of $1.29 million and $0.72 million, respectively, P=.07). Cases in which the plaintiff claimed neurovascular injury were significantly more likely to result in a higher monetary award (mean award of $2.37 million, P=.02). Cases involving an incorrect surgical site were significantly less likely to result in a defendant outcome, with 7 of 12 cases (58.3%) leading to a plaintiff outcome (P=.047). With more than two-thirds of cases resulting in a defendant verdict, many suits result in a favorable outcome for practitioners. Intraoperative error is the most common reason for litigation, and neurovascular injury resulted in the highest monetary payouts. Vigilance to avoid these events may improve patient outcomes and decrease liability to practitioners. [Orthopedics. 2022;45(1):e47-e52.].

Shock Wave Therapy for Erectile Dysfunction: Marketing and Practice Trends in Major Metropolitan Areas in the United States.

INTRODUCTION: Due to the increasing prevalence of erectile dysfunction (ED) and pronounced distress for patients, a direct-to-consumer market for shock wave therapy (SWT) has emerged. We sought to evaluate trends in marketing and implementation of SWT as a restorative treatment for ED in large metropolitan areas by investigating cost to patients, provider credentials and treatment protocols. METHODS: SWT providers in 8 of the most populous metropolitan areas were identified using Google search. Search queries included: "Shockwave therapy for erectile dysfunction in [city];" "Shockwave therapy for ED in [city];" and "GAINSWave in [city]." All clinics advertising SWT for ED within the boundaries of the selected metropolitan area were included. Using a "secret shopper" methodology, clinics were contacted by telephone with the goal of identifying the pricing, duration and provider administering the treatment. RESULTS: Across 8 of the most populous cities in the U.S., 152 clinics offered SWT as a treatment for ED. Comprehensive information was available for 65% of the clinics; 25% of providers offering SWT were urologists while 13% were not physicians. The average price per treatment course was $3,338.28. Treatment duration was highly variable and ranged from 1 to indefinite courses based on individual patient circumstance. CONCLUSIONS: SWT, as a restorative therapy for ED, is performed primarily by nonurologists and is not standardized. Direct-to-consumer marketing is used to target distressed men. This study highlights concerning trends in major metropolitan markets, given the substantial financial impact for patients and inconsistent credentials among providers. Further, these findings suggest that patients are frequently seeking care for ED from nonurologists.

Direct-To-Consumer Internet Prescription Platforms Overlook Crucial Pathology Found During Traditional Office Evaluation of Young Men With Erectile Dysfunction.

OBJECTIVE: To determine comorbidities in young men with erectile dysfunction (ED) who are increasingly targeted by direct-to-consumer (DTC) internet platforms that sell phosphodiesterase-5 (PDE-5) inhibitors without comprehensive clinical evaluation; and, further, to characterize the portrayal of DTC platforms by popular news media. METHODS: We retrospectively reviewed all men age ≤40 evaluated for ED at an andrology clinic during January 2016-March 2019 to obtain demographics, exam and lab findings, and treatments. Five news sources were analyzed during the study period to characterize whether articles about DTC platforms were positive, critical, or balanced/neutral. RESULTS: We identified 388 patients, with age 29.5 ± 5.0 years, 15% rate of obesity, 20% prediabetes or diabetes, 54% dyslipidemia, and 20% hypogonadism. Serum lab findings associated with subfertility were found in 11%. Semen analysis was conducted in 64 men, of whom 40% were abnormal. Varicoceles were found in 35%. PDE-5 inhibitor was prescribed to 328 men (88%). Off-label empiric therapies included clomiphene (32.9%) or aromatase inhibitor (12.1%). Testosterone replacement was initiated in 9.7%. Analysis of news coverage revealed 18 articles, of which 61% portrayed DTC platforms exclusively in a positive light. CONCLUSION: Office consultation identified young men with significant comorbidities that would be missed by DTC platforms, which employ only questionnaires for health screening. DTC platforms present themselves as medical authorities without following AUA Guidelines, yet garner mostly positive press coverage. Patients engaging these platforms may falsely believe they are receiving adequate medical assessment. Urologists may do well to incorporate telemedicine to enfranchise young men with evidence-based evaluation.

Social Media Sensationalism in the Male Infertility Space: A Mixed Methodology Analysis.

PURPOSE: Infertile couples increasingly turn to the internet for medical guidance. The aims of this study were: (1) to identify popular male infertility content on social media, and (2) to assess the accuracy and quality of this content. We hypothesized that inaccurate/misleading information proliferates online. MATERIALS AND METHODS: We used the analytics module BuzzSumo to identify article links that were most shared on Facebook, Pinterest, Reddit, and Twitter related to male infertility during September 2018 to August 2019. We excluded articles with <100 engagements, defined as "likes," "comments," and "shares." Two researchers graded content as accurate, misleading, or inaccurate by comparing content to references cited and contemporary research. Inter-rater reliability was determined with Cohen's κ. Binary logistic regression was performed to compare user engagement with accurate versus inaccurate/misleading articles. RESULTS: Fifty-two unique article links were identified, with 421,004 total engagements. Thirty-four articles referenced 15 scientific studies; no reference was available for 18 links. Fifty-six percent of articles were accurate and 44% misleading/inaccurate (κ=0.743). No significant difference was found in total engagement between accurate vs. misleading/inaccurate links (p=0.805). Twenty-four percent of engagements referenced studies using non-human models, and 26% of studies had sample sizes <100. CONCLUSIONS: Social media platforms foster engagement with male infertility information. However, sensationalism predominates, as patients are highly likely to encounter misleading/inaccurate information, articles that overstate implications of animal research, and conclusions made based on limited sample sizes. Urologists should consider adding social media to their armamentarium to stave off misinformation and engage proactively with patients.