An Online Investigation Into Direct-to-Consumer Men's Health Clinics: The Who, What, and Where.

OBJECTIVE: To characterize direct-to-consumer (DTC) men's health clinics by reviewing their online content. Increasing numbers of patients are seeking treatment for erectile dysfunction (ED) and hypogonadism from DTC "men's health" clinics. Treatments are often used off-label, with lack of transparency of provider credentials and qualifications. METHODS: We identified DTC Men's Health Clinics in the United States by internet search by state using the terms, "Men's Health Clinic," and "Low T Center." All stand-alone clinics were reviewed. RESULTS: Two hundred and twenty-three clinics were reviewed, with 147 (65.9%) offered ED treatments and 196 (87.9%) offering testosterone replacement, and 120 (53.8%) offering both ED treatment and testosterone replacement. Of those clinics offering ED treatments, 93 (63.3%) advertised shockwave therapy and 84 (57.1%) PRP therapy. There were 56 (38%) who offered shockwave therapy and PRP. ICI was significantly more likely to be offered if there was a urologist on staff (p <.001). Clinic providers represented 20 different medical and alternative medicine specialties. Internal medicine was most common (17.4%), followed by family medicine (11.1%). A nonphysician (nurse practitioner or physician assistant) was listed as the primary provider in 10 clinics (4.5%) and 45 clinics (20.1%) did not list their providers. Urologists were listed as the primary provider in 10.3% of clinics. A naturopathic provider was listed as a staff member in 22 (11.6%) of clinics. CONCLUSION: There is significant heterogeneity and misinformation available to the public regarding men's health. Familiarity with and insight into practice patterns of "men's health" clinics will help provide informed patient care and counseling.

The Omission of Genitourinary Physical Exam in Telehealth Pre-Vasectomy Consults Does not Reduce Rates of Office Procedure Completion.

OBJECTIVE: To determine whether the omission of preprocedure genitourinary exam for vasectomy inherent to a virtual consultation reduces the likelihood of successfully completing in-office vasectomy. Currently, the AUA Vasectomy guidelines encourage in-person examination when possible, though COVID-19 has catalyzed the uptake of virtual consultations at many institutions. We hypothesized that rates of completed in-office vasectomy do not significantly differ between patients examined during consultation in the office and those seen virtually with no exam. METHODS: Virtual vasectomy consults from April to December 2020 were retrospectively reviewed and compared to a size-matched, randomly-selected control group who underwent in-office vasectomy consultation. The primary outcome was completion of in-office bilateral vasectomy. Baseline demographic characteristics were compared. Fisher's exact test and Student's t-test were performed on categorical and continuous variables, respectively. RESULTS: Of 211 patients who underwent virtual vasectomy consultation during the study period, 153 presented for in-office vasectomy. They were compared to 153 vasectomies from the in-person consult cohort. No demographic differences were observed between virtual and in-office consult groups. No statistical difference was observed in completion rates of in-office vasectomy, which was 97.4% (149/153) in the virtual consult cohort and 98.7% (151/153) in the in-office consultation cohort (P = .68). CONCLUSION: Rates of completed in-office vasectomy did not significantly differ based on consult platform, suggesting that a pre-vasectomy physical exam is not required to predict successful completion of the procedure. Telehealth should be utilized as an additional platform to improve access for male contraceptive procedures in a young and busy population.

Men With Chronic Orchialgia Exhibit Differential Neuroinflammatory Gene Expression Relative to Asymptomatic Controls.

OBJECTIVE: To identify differences in neuroinflammatory gene expression in individuals with chronic orchialgia (CO) compared to asymptomatic controls. METHODS: Vas deferens, spermatic cord fascia, blood, and urine were collected from 9 men with CO at time of microscopic spermatic cord denervation and 7 asymptomatic controls at time of vasectomy. RNA was isolated and analyzed with the NanoString Human Neuroinflammation panel. Data were normalized, gene expression fold changes and enriched pathways relative to asymptomatic controls were determined. Gene expression was considered significantly different if there was a >2-fold change and P-value <.05 relative to controls. RESULTS: Mean patient age was 51 years and median symptom duration 12 months. There were 26 genes with significantly differential expression in vas deferens. cFos, a marker of nociceptive pain, had the greatest difference (30.2-fold change, P <.000001). Enriched pathways in vas deferens included nerve function, matrix remodeling, and innate immune responses. In fascia, cFos also had the greatest differential expression (38-fold, P = .000002), followed by S100A12 (11-fold, inducer of innate immune response). Enriched pathways in fascia included nerve function and inflammation. In blood, there were no differentially expressed genes, and in urine there were 95 differentially expressed genes. CONCLUSION: Men with CO have a diverse set of neuroinflammatory genes with differential expression in tissue and urine relative to healthy controls. These findings confirm pathologic changes in tissue targeted by denervation surgery, and suggest molecular changes in neuropathic pain that could lead to biomarker identification and novel treatment.

Follicle-stimulating hormone modestly predicts improvement in semen parameters in men with infertility treated with clomiphene citrate.

Clomiphene citrate is a commonly prescribed empiric medical therapy for male infertility, but outcomes data and response rates remain incompletely understood. We retrospectively reviewed our single-institutional experience of infertile men prescribed clomiphene. Clomiphene treatment in the final cohort of 140 men was associated with a modest increase in median sperm concentration from 2.2 to 2.5 million/ml (p < 0.001). A total of 46/140 (33%) of men upgraded according to World Health Organization concentration categories. Clomiphene treatment in 26/113 (23%) of previously ineligible men became eligible for intrauterine insemination. Using both univariate and multivariable regression, pre-treatment follicle-stimulating hormone was inversely associated with change in semen concentration with clomiphene treatment. On binary logistic regression, follicle-stimulating hormone level was inversely related to World Health Organization concentration category upgrade (p = 0.01). Unfortunately, 17/140 (12%) of men paradoxically worsened on clomiphene, but no predictors for this could be identified. In summary, clomiphene citrate confers a clinically relevant but modest benefit in a subset (1/3rd ) of infertile men, particularly those with lower pre-treatment follicle-stimulating hormone levels. Men with elevated follicle-stimulating hormone over 15 IU/ml are less likely to benefit from treatment and should be counselled on other relevant treatment alternatives.

Socioeconomic Disparities and Risk Factors in Patients Presenting With Ischemic Priapism: A Multi-Institutional Study.

OBJECTIVES: To evaluate contemporary clinical presentations of priapism, their association with socioeconomic characteristics, and the role of prescribing providers in priapism episodes in a large cohort of patients managed at 3 major academic health systems. METHODS: We identified all consecutive patients presenting with ischemic priapism to the emergency departments of three major academic health systems (2014 -2019). Demographic characteristics, priapism etiologies, and clinical management were evaluated. Univariable and multivariable analyses were used to assess the contribution of socioeconomic characteristics and the role of prescribing providers in priapism episodes. RESULTS: We identified 102 individuals with a total of 181 priapism encounters. Hispanic race, lower income quartile, sickle-cell disease, and illicit drug use were associated with increased risk of recurrent episodes. Of ICI users, 57% received their prescriptions from non-urological medical professionals (NUMPs); the proportion with recurrent episodes was higher for NUMPs compared to urologists (24% vs 0%, P = 0.06) with no demographic differences identified between patients treated by either group. CONCLUSION: Socioeconomic disparities exist among patients presenting with recurrent episodes of priapism, potentially highlighting systemic issues with access to care and patient education. With most patients who developed ischemic priapism from ICI being prescribed these medications by NUMPs, further investigation is required to elucidate the prescribing and counseling patterns of these providers. Increased awareness of disparities and complications may improve patient safety.

The prognostic value of digital rectal exam for the existence of advanced pathologic features after prostatectomy.

BACKGROUND: Accurate staging at the time of prostate cancer diagnosis is fundamental to risk stratification and management counseling. Digital rectal exam (DRE) is foundational in clinical staging of prostate cancer, even with a known limited interexaminer agreement and poor sensitivity for detecting extraprostatic disease. We sought to evaluate the prognostic value of DRE for the presence of advanced pathologic features (APFs) following radical prostatectomy (RP). METHODS: All patients undergoing RP as primary treatment for clinically localized prostate cancer in the National Cancer Database between 2008 and 2014 were identified. Patients with additional malignancies, prior treatment with radiation or systemic therapy, incongruent clinical staging and DRE findings or without fully evaluable clinical staging were excluded. The primary outcome was the presence of postsurgical APFs, defined as positive surgical margins, nodal disease, or pathologic stage T3 or greater. Multivariable logistic regression analysis was performed to account for prostate-specific antigen (PSA), biopsy grade group, percent of positive biopsy cores, and clinical stage. RESULTS: In total, 91,525 patients consisting of 69,182 cT1, 20,641 cT2, and 1702 cT3-T4 were included. The average age was 61.1 ± 7.0 years, and the average PSA was 8.6 ± 10.3 ng/ml. On multivariable analysis, cT3 and T4 were associated with the presence of APFs (odds ratio [OR] 11.12, p < .01 and 5.28, p = .04), however, cT2 was only slightly associated with the presence of APFs when compared with cT1 (OR 1.15, p < .01). Furthermore, cT2 was associated with more node-positive disease (OR 1.63, p < .01), positive margins (OR 1.06, p < .01), and more than or equal to pT3 disease (OR 1.22, p < .01). CONCLUSIONS: Overall, advanced clinical stage as assessed by DRE was independently associated with an increasing risk of APFs. For individual APFs, the greatest effect is noticed between clinical stage and nodal positivity and less so between clinical stage and positive margins. DRE continues to hold value, particularly for patients with locally advanced disease and potential lymph node disease.

Is Opioid-free Post-Vasectomy Analgesia a Pain? A Single Surgeon Experience.

OBJECTIVE: To determine the impact of transitioning from opioid to non-opioid analgesia post-vasectomy on unplanned opioid prescriptions and health encounters. METHODS: A retrospective review for patients who underwent vasectomy from October 2018 through December 2019 was performed. Beginning February 1st, 2019, patients were counseled to take scheduled acetaminophen and ibuprofen in lieu of acetaminophen with codeine, with an opioid prescription only provided upon request. Analysis was performed comparing 200 consecutive patients before and after this transition. Baseline patient characteristics, unplanned postoperative encounters for pain within 30 days of vasectomy, and associated narcotic prescriptions were compared between groups. RESULTS: 400 patients were included, consisting of 200 patients pre and 200 patients postintervention. There were no differences in socioeconomic characteristics between groups. No differences between the pre- and postintervention groups were observed in terms of generating telephone calls to clinic (9% vs 11%, P = .5), clinic visits (2.5% vs 2.5%, P = 1), or ED visits (0% vs 1%), P = .5) for the pre and postintervention cohorts, respectively. CONCLUSIONS: Patients that are not prescribed opioids after vasectomy do not generate additional phone calls, clinic, or ED visits compared to those that were routinely prescribed prior to our institutional change. We have permanently discontinued the routine use of opioids for post-vasectomy analgesia. Other physicians performing vasectomy should consider making this change as well.

Assessing online price transparency of sperm cryopreservation across the United States.

Although the lack of information on the costs and pricing of healthcare services prevails throughout the medical industry, empiric observations have demonstrated that pricing information is even more obscured in the sperm cryopreservation market. Thus, the objectives of our study are to assess and compare online price transparency and the price of sperm cryopreservation across various healthcare settings in the United States. This study examined online pricing published by facilities that have an active registration to store spermatozoa with the Food and Drug Administration. Less than one-fifth of registered facilities display any pricing information online. Price transparency also varies among census regions and facility types. Nationally, the median initial bank fee and annual price of storage are $350 and $385 respectively. Although there were no differences in the initial fee by facility type and census region, the annual price of storing spermatozoa is highest in the Northeast, which could be attributed to laboratory techniques, demographic patterns or insurance coverage. Guidelines from professional societies or different legislation and regulatory requirements across different US states can increase price transparency, which can promote consumer decision-making and decrease the barrier for men seeking fertility preservation.

Pain management following robotic-assisted radical prostatectomy: transitioning to an opioid free regimen.

Few studies demonstrate the safety and efficacy of postoperative pain regimens that exclude opioids altogether in patients undergoing robot-assisted radical prostatectomy (RARP). To reduce opioid use, we sought to develop an opioid-free regimen for RARP and determine perioperative outcomes before and after implementation. A retrospective, pre-post-interventional study was performed at a single institution between 8/2018 and 10/2019. An opioid-free pain regimen was developed and instituted on 3/7/2019, and all patients received preoperative counseling regarding pain expectations and management. Postoperative pain score was the primary outcome. Secondary outcomes included postoperative opioid use, length of stay, adverse events and unplanned health encounters within 30 days of discharge. Pearson's chi-squared and Student's t-tests were performed on categorical and continuous variables, respectively. Multivariable analysis was performed to determine risk factors for postoperative opioid use in the opioid-free cohort. A total of 89 patients were included for analysis; consisting of 47 (53%) pre-intervention and 42 (47%) post-intervention patients. Baseline characteristics were similar between groups. A significantly lower proportion of patients in the post-intervention group were administered opioids postoperatively (5% vs 53%, p < 0.01), despite having similar postoperative pain scores (2.69 vs 3.11, p = 0.19) and length of stay (1.0 days vs 1.2 days, p = 0.07). The post-intervention group had a significantly lower rate of opioid discharge prescriptions (14% vs 96%, p < 0.01). The rate of ED visits (12% vs 15%, p = 0.68), pain-related phone calls (17% vs 19%, p = 0.76) or adverse events (19% vs 13%, p = 0.42) were similar between groups. Among the opioid-free group, older patients were less likely to be administered postoperative opioids (OR 0.84, p = 0.046). A structured opioid-free pain regimen following RARP is non-inferior compared to traditional opioid-based standard of care. Adoption of similar regimens can help address the ongoing opioid epidemic in the United States and future work is needed to apply these principles broadly.

Neuroinflammatory gene expression analysis reveals potential novel mediators and treatment targets in interstitial cystitis with Hunner lesions.

BACKGROUND: We sought to study differential neuroinflammatory gene expression in men with interstitial cystitis (IC) with Hunner lesions compared with asymptomatic controls using NanoString, which uses barcoded probes to measure hundreds of genes. IC is a heterogenous condition lacking reliable biomarkers, and a subset of patients exhibits Hunner lesions, implicating the bladder as an inflammatory pain generator. METHODS: Blood, urine, and bladder biopsies were collected from 6 men with IC and Hunner lesions. 7 asymptomatic controls had blood and urine collected and 2 benign bladder biopsies were obtained from our tissue bank. RNA was isolated and analyzed with NanoString Human Neuroinflammation panel. Gene expression was considered significant if there was a >1.5-fold change and adjusted P value <0.05 compared with controls. RESULTS: Mean patient age was 61.5 years with 8 years median symptom duration. In bladder tissue, while many cytokine and chemokine genes had higher expression as expected (e.g., TNF, CXCL10), other significant genes included TRPA1 (1098-fold increased, expressed in pain sensing neurons) and TNFRSF17 (735-fold, B-cell related). In urine, there was 114-fold increase in S1PR4, which mediates pain via TRP-dependent pathways. A patient on cyclosporine had lower inflammatory gene expression levels relative to other IC patients, but no difference in TRPA1. CONCLUSIONS: Men with IC and Hunner lesions have a diverse set of neuroinflammatory genes with differential expression compared to controls. We identified genes linked to neuropathic pain through the TRP pathway and this expression was not reduced by cyclosporine. These findings open a new direction for biomarker and therapeutic discovery.

Prednisone after vasectomy reversal may improve semen parameters: one institution's experience.

INTRODUCTION: Patients with suboptimal semen parameters following vasectomy reversal represent a diagnostic and therapeutic challenge. This may be caused by either partial or complete anastomotic obstruction. Despite the relatively common clinical use of corticosteroids in this patient population, data remain sparse. Thus, we set out to evaluate the safety and efficacy of prednisone after vasectomy reversal. MATERIALS AND METHODS: A chart review was performed from January 1, 2008 to September 30, 2018 to identify men in which prednisone was used for suspected anastomotic obstruction after vasectomy reversal. Obstruction was based on sub-optimal or decreasing semen parameters and physical exam findings. A course consisted of 2 weeks of 20 mg PO daily followed by 2 weeks of 10 mg PO daily. RESULTS: A total of 89 patients were identified in which prednisone was used postoperatively. Total motile sperm counts were found to increase in the overall cohort by 10.5 million (p < 0.0002) after a course of prednisone. On sub-group analysis, men who had a bilateral vasovasostomy (VV) or VV/vasoepididymostomy experienced an increase in total motile sperm counts by 13.4 million (p < 0.0012) and 6.2 million (p < 0.014), respectively. Patients who were patent at the time of prednisone treatment were more likely to see an improvement in total motile sperm counts (76.9% versus 33.3%, p < 0.003). CONCLUSIONS: Prednisone seems to be safe and potentially efficacious in men with suspected anastomotic obstruction following vasectomy reversals. Further studies are needed to more conclusively determine the treatment's effectiveness in this patient cohort.

Resolution of Abdominal Pain After Coil Embolization of Varicocele with Robotic Resection of Gonadal Vein.

Background: Chronic pain in the region of varicocele embolization is not well described and can be a challenging symptom to manage, with limited options for treatment after failing conservative measures. It is important to counsel patients of this potential complication when determining the best option for varicocele repair. To our knowledge, there are no reported cases of gonadal vein excision for chronic abdominal pain after coil embolization. Case Presentation: A 63-year-old Caucasian male presented to our urology clinic after coil embolization. His testicular pain resolved but he reported new left-sided abdominal pain after coil embolization for a large left varicocele. After failing conservative measures including nonsteroidal anti-inflammatory drugs, antibiotics, and prednisone, he was referred for further work-up and to discuss treatment options. On presentation, the patient reported pain on the left side of his abdomen consistent with the location of gonadal vein. After extensive counseling that surgical removal may not alleviate his pain, robotic gonadal vein excision was offered, and the patient elected to proceed. Intraoperatively, the coils were easily seen through the wall of the vessel. This segment of the gonadal vein containing the coil was excised in its entirety. The patient was discharged on postoperative day 1 with only nonsteroidal pain medications. Six weeks postoperatively, the patient reported no complications, and almost complete resolution of his preoperative pain. Conclusions: To our knowledge, this is the first case report demonstrating the surgical removal of the gonadal vein for treatment of chronic abdominal pain after varicocele embolization. After failing conservative measures, this may present another viable treatment option to address this difficult complication in a select group of patients.

Evolving Trends for Selected Treatments of T1a Renal Cell Carcinoma.

OBJECTIVE: To evaluate contemporary trends in the management of small renal masses and how patient age has impacted practice patterns. METHODS: Using the NCDB Participant User File (PUF) from 2002 to 2015, we identified patients with T1a renal masses. The initial treatment was categorized as radical nephrectomy (RN), partial nephrectomy (PN), ablation, or active surveillance (AS). A multinominal logistic regression model was used to identify significant factors impacting treatment. RESULTS: We identified 75,691 patients for analysis. RN, PN, and ablation accounted for 28%, 52%, and 12%, respectively, while 8% were managed with AS. In the past decade the likelihood of undergoing PN, ablation, or surveillance compared to RN has consistently increased, independent of age, sex, race, comorbidity, tumor size, or institution. As age increased, patients were independently less likely to undergo PN and more likely to be managed with ablation or AS. Compared to patients under 40 years of age, patients between 70 and 79 were far less likely to undergo PN (RR 0.58, P< .01), and far more likely to undergo either ablation (RR 5.53, P< .01) or AS (RR 3.7, P< .01). CONCLUSION: Trends in small renal mass management continue to evolve, with PN supplanting RN over the past decade as the predominant surgical treatment. Age significantly impacts treatment selection, particularly in older cohorts whom are much more likely to undergo ablation or AS. While the use of minimally invasive therapies has increased over the past decade, AS lags behind despite quality data supporting its use. When controlling for multiple clinical factors, PN, ablation and surveillance have consistently increased in utilization compared to RN.

Characterizing Pelvic Organ Prolapse in Adult Spina Bifida Patients.

OBJECTIVE: To report the distribution of pelvic organ prolapse (POP) stages in adult spina bifida (SB) patients. The severity of POP in the SB population has not been previously reported. MATERIALS AND METHODS: Retrospective review of SB patients ≥18 years with a documented POP quantification examination between 2006 and 2014 were included. Patient demographics, gestation, parity, POP quantification examinations and prolapse symptoms were obtained. RESULTS: Thirty-three SB patients were identified with a mean age of 33.2 years. Five patients (15.2%) had stage 0 prolapse, 12 (36.4%) had stage 1, 12 (36.4%) had stage 2, 3 (9.1%) had stage 3, and 1 (3.0%) had stage 4. Of the 16 patients with advanced POP (stage 2 prolapse or greater), only 6 patients (37.5%) reported symptoms related to POP. All 6 symptomatic patients endorsed sensation of a vaginal bulge. Two of the 6 patients also reported dyspareunia. Additionally, 1 patient with advanced POP presented with vaginal bulge, noted by a caregiver, and cervical bleeding, but was otherwise asymptomatic. Twenty-four patients (72.7%) were nulliparous, and 12 of the 24 nulliparous patients (50%) demonstrated prolapse. CONCLUSION: Despite young age and frequent nulliparity, patients with SB are more likely to have POP than the general population. Additionally, the majority of SB patients with prolapse are asymptomatic. Assessment of pelvic organ prolapse should be included in the evaluation of adult SB females due to the low rate of symptoms even in the setting of advanced stage prolapse and potential impact on both urinary and bowel function.