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.

Guideline-Nonconformant Investigational Treatments for Erectile Dysfunction: What are Patients Learning?

OBJECTIVE: To evaluate the validity of YouTube content on shockwave, platelet-rich plasma, and stem cell therapies for erectile dysfunction (ED). The consumerization of men's health is particularly notable among regenerative ED treatments, and the popularity of these treatments has been amplified by social media sites such as YouTube. METHODS: We searched YouTube utilizing the following terms: "shockwave therapy-," "platelet-rich plasma- and "stem cell therapy-" "-for erectile dysfunction." The first 50 resulting videos per query were screened (inclusion criteria: relevant title/content, English language, >100 views) and judged by 2 independent graders using the validated DISCERN instrument for consumer health information. Regression analysis assessed association of video characteristics with DISCERN score. RESULTS: Seventy-one unique videos met criteria. More content featured non-physicians (37%) or non-urologist physicians (35%) than urologists (28%). Mean DISCERN score was low at 42.8 of 80. DISCERN score significantly differed by video category and characteristics. Educational and urologist-featuring videos were associated with higher score. News reports were associated with lower score. Only 3 videos mentioned investigational/experimental status of the therapies. Only 2 cited society guidelines. CONCLUSION: Most YouTube videos on regenerative ED therapies are unreliable and from non-urologists. The misrepresentation of proven efficacy may be encouraging patients to seek these still investigational treatments at high fiscal costs to the patient. Videos with urologists were more likely to be higher quality and guideline based. The urological and academic communities should continue to leverage the power of social media to provide evidence-backed consumer health information in this space.

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.

Impact of the COVID-19 Pandemic on Patient Preferences and Decision Making for Symptomatic Urolithiasis.

Background: Pandemic restrictions have changed how patients approach symptomatic kidney stones. We used a mixed-methods digital ethnographic approach to evaluate social media discussions about patient concerns and preferences for urolithiasis care during the COVID-19 pandemic. Materials and Methods: We retrospectively analyzed kidney stone-related discussions on a large social media platform using qualitative analysis and natural language processing-based sentiment analysis. Posts were mined for demographic details, treatments pursued, and health care encounters. Pre-COVID-19 (January 1, 2020-February 29, 2020) and COVID-19 (March 1, 2020-June 1, 2020) posts were extracted from the popular online Reddit discussion board, "r/KidneyStones," which is dedicated to discussions related to urolithiasis. Results: We extracted n = 649 posts (250 pre-COVID-19, 399 COVID-19); 150 from each cohort underwent thematic analysis and data extraction. Quantitative sentiment analysis was performed on 418 posts (179 pre-COVID-19, 239 COVID-19) that described stone-related decision making before intervention. Notable discussion themes during COVID-19 focused on barriers to care and concerns about stone management. Discussants exhibited more negative and anxious tones during COVID-19, based on sentiment analysis (p < 0.01). Patient preferences shifted away from in-person visits and procedures (p < 0.001). Mean reported stone size among those visiting emergency room (ER) increased from 5.1 to 10.5 mm (p < 0.001). The proportion of discussants preferring conservative management with stones ≥10 mm increased (12.5% pre-COVID-19 vs 26% during COVID-19, p = 0.002). Opioid mentions increased from 9% to 27% of posts (p < 0.001) and were most associated with conservative management discussions. Conclusions: Online discussion forums provide contemporaneous insight into patients' experiences during a time when traditional patient-centered research methodologies are limited due to social distancing. During the pandemic, patients with symptomatic kidney stones expressed anxiety regarding outpatient encounters and reluctance toward procedural intervention. Patients opted instead for at-home conservative treatment beyond clinical guidelines and reserved ER visits for larger stones, potentially causing self-harm. Opioid discussions proliferated, an alarming consequence of the pandemic.

Perceived Impact of Urologic Surgery Training Program Modifications due to COVID-19 in the United States.

OBJECTIVE: To assess urology residency program modifications in the context of COVID-19, and perceptions of the impact on urology trainees. METHODS: A cross-sectional survey of program leadership and residents at accredited US urology residencies was administered between April 28, 2020 to March 11, 2020. Total cohort responses are reported, and subanalyses were preformed comparing responses between those in in high vs low COVID-19 geographic regions, and between program leaders vs residents. RESULTS: Program leaders from 43% of programs and residents from 18% of programs responded. Respondents reported decreased surgical volume (83%-100% varying by subspecialty), increased use of telehealth (99%), a transition to virtual educational platforms (95%) and decreased size of inpatient resident teams (90%). Most residents are participating in care of COVID-19 patients (83%) and 20% endorsed that urology residents have been re-deployed. Seventy nine percent of respondents perceive a negative impact of recent events on urology surgery training and anxiety regarding competency upon completion of residency training was more pronounced among respondents in high COVID-19 regions. CONCLUSION: Major modifications to urology training programs were implemented in response to COVID-19. Attention must be paid to the downstream effects of the training disruption on urology residents.

Female Sexual Dysfunction: A Systematic Review of Outcomes Across Various Treatment Modalities.

BACKGROUND: Female sexual dysfunction (FSD) is a highly prevalent condition. Nevertheless, the scientific literature has only recently begun to accumulate evidence for treatment modalities that address the underlying etiologies of FSD. AIM: The purpose of this systematic review is to elucidate what treatments are effective across the various symptom complexes of FSD. METHODS: Utilizing Meta-analysis of Observational Studies in Epidemiology guidelines, we conducted a systematic review of PubMed, EMBASE, clinicaltrials.gov, and the Cochrane Review databases. Eleven search strings, encompassing the terms "female sexual dysfunction" and "treatment," in combination with "vulvovaginal atrophy," "vaginismus," "vaginal atrophy," "vulvodynia," "vestibulitis," "hypoactive sexual desire," "arousal disorder," "sexual pain disorder," "genitourinary syndrome of menopause," and "orgasmic disorder" were utilized. 605 Relevant articles were retrieved. A total of 103 original studies met inclusion criteria. OUTCOMES: We assess peer-reviewed literature. RESULTS: 42 Treatment modalities were utilized, including 26 different classes of medications. Although outcome measures varied, the most substantial improvement across multiple studies was noted with various hormonal regimens. The most common treatments included hormonal therapy (25 studies), phosphodiesterase type-5 inhibitors (9 studies), botulinum toxin A (5 studies), and flibanserin (5 studies). The psychotherapeutic approach was detailed in 36 articles while 3 studies utilized homeopathic treatments. Numerous treatments showed efficacy in a single case series, including the promising results associated with the micro-ablative carbon-dioxide laser. Despite the marked improvement in specific FSD domains, neither pharmacologic treatments nor psychotherapeutic interventions demonstrate consistent disease resolution. CONCLUSIONS: Treatment of FSD is multi-factorial; medications alone do not resolve FSD. The wide variability of treatment and outcome measures across the literature attests to the complexity of FSD and the need for a treatment algorithm that addresses all 4 domains of FSD. Weinberger JM, Houman J, Caron AT, et al. Female Sexual Dysfunction: A Systematic Review of Outcomes Across Various Treatment Modalities. Sex Med Rev 2019;7:223-250.

Female Sexual Dysfunction and the Placebo Effect: A Meta-analysis.

OBJECTIVE: To quantify the placebo effect of various pharmacologic modalities including neuromodulators, hormonal agents, and onabotulinum toxin A for female sexual dysfunction. DATA SOURCES: Using Meta-analyses Of Observational Studies in Epidemiology guidelines, we conducted a systematic review of PubMed, EMBASE, ClinicalTrials.gov, and the Cochrane Review databases. METHODS OF STUDY SELECTION: Eleven search terms, "female sexual dysfunction" "treatment" in combination with "hypoactive sexual desire," "arousal disorder," "sexual pain disorder," "genitourinary syndrome of menopause," "orgasmic disorder," "vulvovaginal atrophy," "vaginismus," "vaginal atrophy," "vulvodynia," and "vestibulitis," were used. Studies were included if their design was randomized, included a placebo arm, and used the Female Sexual Function Index as an outcome measure. TABULATION, INTEGRATION, AND RESULTS: The placebo effect on the Female Sexual Function Index was compared with each respective study's treatment effect using inverse-variance weighting in a random-effects analysis model. Six hundred five relevant articles were retrieved. Twenty-four randomized controlled trials included a placebo arm. Of these, eight studies used the Female Sexual Function Index. Across these studies, 1,723 women with clinical pretreatment female sexual dysfunction received placebo. Two thousand two hundred thirty-six women were in the treatment arm of the respective studies and received various pharmacologic interventions including flibanserin, bupropion, onabotulinum toxin A, intravaginal prasterone, intranasal oxytocin, ospemifene, and bremelanotide. Women receiving placebo improved 3.62 (95% CI 3.29-3.94) on the Female Sexual Function Index. The treatment arm had a corresponding increase of 5.35 (95% CI 4.13-6.57). CONCLUSION: This meta-analysis of Level I evidence demonstrates that 67.7% of the treatment effect for female sexual dysfunction is accounted for by placebo. Our findings suggest that the current treatments for female sexual dysfunction are, overall, minimally superior to placebo, which emphasizes the ongoing need for more efficacious treatment for female sexual dysfunction.

Native Tissue Repairs for Pelvic Organ Prolapse.

Pelvic organ prolapse (POP) is a generalized term that refers to prolapse of any of the three vaginal compartments: anterior (cystocele), posterior (rectocele), and apical (uterine and vault prolapse). POP may affect up to 50% of parous women, and as a result, one in nine women will undergo at least one surgery for POP in her lifetime. Native tissue repair is the cornerstone of prolapse surgery, especially in light of the scrutiny placed on the use of mesh for prolapse. Refinements in the procedures over time have been based on both basic anatomy and fundamentals of surgery, as well as the ongoing acquisition of new knowledge through clinical studies.

Influence of graft source and configuration on revision rate and patient-reported outcomes after MPFL reconstruction: a systematic review and meta-analysis.

PURPOSE: The purpose of this systematic review and meta-analysis was to determine the influence of graft source (allograft vs. autograft) and configuration (single-limbed vs. double-limbed) on failure rate and disease-specific patient-reported outcome (Kujala score) after medial patellofemoral ligament (MPFL) reconstruction for patellar instability. METHODS: A systematic review of PubMed, Scopus, and the Cochrane Library was performed. A total of 31 studies met inclusion/exclusion criteria and were used to extract cohorts of patients who underwent ligament reconstruction with various allograft, autograft, single-limbed, and double-limbed constructs. Failure rates and postoperative improvements in Kujala scores were compared between cohorts using inverse-variance weighting in a random-effects analysis model and appropriate comparative statistical analyses (Chi-squared and independent samples t tests). RESULTS: A total of 1065 MPFL reconstructions were identified in 31 studies. Autograft reconstructions were associated with greater postoperative improvements in Kujala scores when compared to allograft (32.2 vs. 22.5, p < 0.001), but there was no difference in recurrent instability (5.7 vs. 6.7 %, p = 0.74). Double-limbed reconstructions were associated with both improved postoperative Kujala scores (37.8 vs. 31.6, p < 0.001) and lower failure rate (10.6 vs. 5.5 %, p = 0.030). CONCLUSION: MPFL reconstructions should be performed using double-limbed graft configurations. While autograft tendon may be associated with higher patient-reported outcomes in the absence of associated connective tissue disorders or ligamentous laxity, patient factors and allograft processing techniques should be carefully considered when selecting an MPFL graft source, as revision rates were no different between graft sources. LEVEL OF EVIDENCE: IV.

Validation of the lower urinary tract symptom score.

INTRODUCTION: To develop and validate a lower urinary tract symptom score (LUTSS) as a measure of lower urinary tract symptom (LUTS) severity and a treatment outcome tool in adults. MATERIALS AND METHODS: An expert panel was convened to develop the LUTSS questionnaire. Content validity was achieved by obtaining subject and expert feedback from two prospective drafts. Subjects were divided into three groups: normal, LUTS and overactive bladder (OAB). Questionnaire was administered on two separate occasions within 1-2 weeks. Test-retest reliability, internal consistency, discriminant validity, criterion validity and responsiveness to change were also assessed. RESULTS: The questionnaire contains 14 questions with answers scored on a 5-point Likert scale (0-4). It includes 9 storage, 4 voiding and 1 bother question. One hundred ninety-one patients completed it; 80 males and 111 females, mean age 65 years (range 22-91). Seventy-two had OAB, 91 LUTS without OAB and 28 were normal. Test-retest intraclass correlation was 0.96 and Cronbach's-□ was 0.77, indicating strong test-retest reliability and internal consistency, respectively. ANOVA and post-hoc bootstrap-generated adjustments showed significant differences between the three groups (p < 0.001), demonstrating discriminant validity. Responsiveness to change was exhibited by the significant decrease between preop and postop scores and a concurrent patient global impression of improvement (PGI-I) score indicative of symptomatic improvement. CONCLUSION: The 14-question LUTSS is a validated questionnaire that assesses a full range of LUTS in men and women. The ordinal nature of the data with its highly specific description of symptoms makes it ideally suited as a nuanced and comprehensive symptom score and patient reported outcome (PRO) tool.

Outcomes of reduction cystoplasty in men with impaired detrusor contractility.

OBJECTIVE: To report surgical outcomes in patients with impaired detrusor contractility (IDC) treated with reduction cystoplasty (RC). METHODS: This was a retrospective study of consecutive patients with IDC who underwent RC. IDC was defined as a bladder contractility index of <100 and/or a detrusor contraction of insufficient duration resulting in a postvoid residual volume (PVR) >600 mL. Bladder outlet obstruction was defined by a bladder outlet obstruction index (BOOI) >40. All patients had preoperative International Prostate Symptom Score, maximum uroflow (Qmax), PVR, bladder diary, videourodynamics, and cystoscopy. Patients with prostatic obstruction underwent synchronous open prostatectomy. Postoperative Qmax, PVR, need for clean intermittent catheterization (CIC), and Patient Global Impression of Improvement (PGII) score were obtained. Follow-up was at 3 months, 1 year, and yearly thereafter. RESULTS: Eight men met inclusion criteria (mean age, 60; range, 43-75 years). Preoperatively, 3 of 8 patients (37.5%) had moderate-sized bladder diverticula, 4 of 8 (50%) had a bladder contractility index <100, and 6 of 8 (75%) had a BOOI <40. Two patients (25%) fulfilled criteria for bladder outlet obstruction (BOOI, 67 and 72). Three (37.5%) underwent synchronous bladder diverticulectomy, and 3 (37.5%) underwent suprapubic prostatectomy. All patients were available for follow-up at 1 year. Seven of 8 (88%) had a successful outcome (PGII ≤2). One patient was unchanged (PGII, 4) and still needed CIC. CONCLUSION: All but 1 patient who met specific criteria for RC had excellent outcomes after surgery based on the PGII, PVR, Qmax, and need for CIC. RC is a viable option for properly selected patients with IDC.

A New Staging System for Anterior Urethral Strictures.

INTRODUCTION: Currently there is no widely accepted staging system for anterior urethral strictures. We developed and evaluated the reliability of an easy to use classification system for anterior urethral strictures in men. METHODS: We devised a staging system based on cystoscopic findings of no stricture (stage 0), wide caliber stricture (stage 1), stricture requires gentle dilation with a 16Fr flexible cystoscope (stage 2), stricture cannot be dilated (stage 3) and no visible lumen (stage 4). Content validity was established by a panel of 5 urologists. On 2 separate occasions 3 urologists independently viewed videos obtained during cystoscopy and staged the tightest visible stricture. If multiple strictures were present, the stricture with the smallest visible lumen was used for the purpose of this study. All men who had undergone cystoscopy at our institution between 2011 and 2012 were included in the study. Exclusion criteria were poor video quality and not visualizing the entire urethra during cystoscopy. RESULTS: A total of 101 videos of consecutive cystoscopies were reviewed. Intra-observer agreement was 76% to 94% (Cohen κ 0.65-0.90) and interobserver agreement was 73% to 82% (Cohen κ 0.51-1.00, 0.69 overall, p <0.001). The intra-observer and interobserver agreement increased for each stage, with 3 and 4 almost unanimously identified by all 3 observers (Cohen κ 0.93 and 1.00, p <0.001). CONCLUSIONS: This new staging system is simple and easy to use, and has excellent intra-observer and good interobserver reliability. The staging system provides a simple lexicon for describing the appearance of anterior urethral strictures.

Pad count is a poor measure of the severity of urinary incontinence.

PURPOSE: We analyzed the correlation between pad use, as determined by objective pad count, and the severity of urinary incontinence, as measured by pad weight. MATERIALS AND METHODS: We performed a retrospective study of consecutive incontinent patients who wore pads on a daily basis and were instructed to complete a 24-hour pad test. They were told to use the usual pads, change them as usual and place each in a separate plastic bag the day before the scheduled appointment. All pads were weighed and total urine loss was calculated by subtracting dry pad weight from wet pad weight, assuming that a 1 gm weight increase was equivalent to 1 ml of urine loss. The number of pads was correlated to pad weight using the Spearman rank correlation coefficient due to the nonparametric nature of the data. RESULTS: The 116 patients included 51 men 39 to 89 years old (mean age 66) and 65 women 27 to 95 years old (mean age 72). When comparing the number of pads used to the gm of urine lost, the Spearman ρ was 0.26 (p=0.005) in the total cohort, and 0.40 and 0.26 (each p<0.05) in males and females, respectively. CONCLUSIONS: There was little correlation between the number of pads used and the severity of urinary incontinence (r=0.26). These data suggest that pad count should not be used as an objective measure of incontinence severity. Instead, pad weight on a 24-hour pad test should be used.