Trends, safety, and efficacy of wearable male sexual devices.

INTRODUCTION: The prevalence of male sexual dysfunction (MSD) increases with age, with >50% of men aged >40 years reporting erectile dysfunction (ED). In recent years, wearable male sex devices (WMSDs) have been increasingly utilized by patients and recommended by sexual medicine clinicians. OBJECTIVES: This study seeks to investigate the safety and efficacy of products currently marketed for the treatment of MSD. METHODS: Available products for WMSDs were reviewed by analyzing product websites, forums, advertisements, and clinical recommendations. Qualitative comparisons were based on patient reviews, cost, and specific features. Investigatory evidence and Food and Drug Administration status were also reviewed. Additionally, Google Trends was used to determine the popularity of devices over time. RESULTS: Eight WMSDs for the treatment of MSD and enhancement of sexual pleasure were reviewed. Constriction bands, such as the Maintain Ring Loop, Eddie by Giddy, and Xialla, have shown significant benefits in clinical trials and were the most popular devices among patients. Smart devices can provide real-time feedback on erectile quality and/or sexual performance. Similar to the RigiScan, the Adam sensor provides feedback on erectile quality while monitoring changes in penile tumescence during sleep with additional analysis available through a mobile application. Neuromodulation devices such as the Morari Patch and vPatch/in2 Patch use electrical stimulation to delay ejaculation and improve sexual function. The FirmTech Performance Ring uses sensors to track the vital signs of erectile fitness with clinical trials ongoing. CONCLUSIONS: Overall, this review describes the available investigatory evidence for a range of WMSDs and highlights the potential benefits and limitations of these devices in treating MSD and enhancing sexual pleasure. Further research is needed to evaluate the effectiveness of these devices and to determine which ones may be the most suitable for individual patients.

Sexual Medicine Society of North America (SMSNA)/American Urological Association (AUA) telemedicine and men's health white paper.

PURPOSE: The purpose of this white paper is to educate health care professionals about the evolution of telemedicine (TM) and to propose a hybrid model that leverages the strengths of traditional in-person medicine as well as virtual medicine while maximizing the safety and quality of men's sexual health care. LITERATURE SEARCH STRATEGY: A literature search focused on the use of TM in urology and men's health was performed through PubMed/MEDLINE, Embase, and Web of Science (January 1, 2012-April 26, 2022). Keywords included all known permutations of the terminology used to refer to virtual health, care as well as the terminology used to refer to urologic diseases, issues specific to men's health, and men's sexual health concerns. Publications that emerged after the literature search that met this criterion also were incorporated. Opinion pieces, letters to the editor, meeting abstracts, and conference proceedings were excluded. Additional resources were retrieved, such as governmental technical reports, legislative updates and reviews, and blogs. This search strategy yielded 1684 records across databases after removal of duplicates. Abstracts from the retrieved records were reviewed for relevance. Relevant publications were defined as those that reported data on any aspect of TM use specific to urology, men's health, and/or men's sexual health. If relevance was unclear from the abstract, then the full text of the article was retrieved for a more detailed review. In addition, the published evidence-based practice guidelines relevant to care for erectile dysfunction, Peyronie's disease, ejaculatory dysfunction, and hypogonadism were retrieved. The most common reasons for article exclusions were a focus on TM use in disciplines other than urology and the absence of data (ie, opinion pieces). After exclusions, a total of 91 publications remained and constituted the evidence base for this paper.

Does climate impact inflatable penile prosthesis infection (IPP) risk? Assessment of temperature and dew point on IPP infections.

BACKGROUND: Variations in climate have been associated with a greater risk of surgical site infections, urinary tract infections, and changes in the skin microbiome; however, limited data exist on the impact of climate on inflatable penile prosthesis (IPP) infections. AIM: We sought to evaluate the impact of climate on the risk of IPP infections in a large international, multicenter cohort. METHODS: We performed a multi-institutional, retrospective study of patients undergoing IPP surgery. We then evaluated whether the month or season, during which surgery was performed, affected device infections. Implant infections were defined as infections requiring device explantation. A univariate logistic regression analysis was undertaken. OUTCOMES: Our primary outcome was implant infection. RESULTS: A total of 5289 patients with a mean age of 62.2 ± 10.8 years received IPP placement. There was a fairly even distribution of implants performed in each season. A total of 103 (1.9%) infections were recorded. There were 32 (31.1%) IPP infections in patients who underwent surgery in the summer, followed by 28 (27.2%) in the winter, 26 (25.2%) in the spring, and 17 (16.5%) in the fall. No statistically significant differences were recorded in terms of season (P = .19) and month (P = .29). The mean daily temperature (P = .43), dew point (P = .43), and humidity (P = .92) at the time of IPP placement was not associated with infection. CLINICAL IMPLICATIONS: These findings provide reassurance to prosthetic urologists that infection reduction strategies do not need to be tailored to local climate. STRENGTHS AND LIMITATIONS: Climate data were not directly recorded for each hospital, but rather based on the monthly averages in the city where the surgery was performed. CONCLUSION: The climate at time of IPP placement and time of year of surgery is not associated with IPP infection risk.

The relationship between hematologic malignancies on male hypogonadism: a scoping review.

INTRODUCTION: The associated symptoms of hypogonadism have been reported in patients with various types of cancer. However, the prevalence and significance of hypogonadism among certain hematologic malignancies have not been completely summarized in recent literature. OBJECTIVE: In this review we aimed to examine the current literature on hypogonadism in patients with hematologic malignancies, with emphasis on leukemias, lymphomas, and multiple myeloma (MM). METHODS: This review included relevant studies published before July 2023 that were retrieved through a search of PubMed using the keywords "hematologic cancer," "hematologic malignancy," blood cancer," "leukemia," "lymphoma," "hypogonadism," "multiple myeloma," and "testosterone." RESULTS: The search yielded 214 studies, of which 21 met the inclusion criteria. Commonly reported findings were that patients who had received hematopoietic stem cell therapy for acute lymphoblastic leukemia and acute myelogenous leukemia as children had laboratory-confirmed hypogonadism as adults. However, the impact of these diseases on hypogonadal symptoms was variable in these studies.Studies reporting on lymphoma and hypogonadism had mixed results, with some studies finding that the degree of cytotoxic chemotherapy was associated with hypogonadism, while others showed no correlation. Regardless, multiple studies found that hypogonadism secondary to lymphoma treatment and symptoms of hypogonadism had no apparent association.The most comprehensive assessment of the frequency of hypogonadism in an MM cohort found that 74% of 561 MM patients were classified as hypogonadal compared to 33% of patients in a control population. Testosterone supplementation was found to lower interleukin-6 levels, which could potentially help manage some of the adverse effects of MM, including decreased bone mineral density. CONCLUSION: There is a relationship between hematologic malignancies and hypogonadism, which is likely multifactorial. In this review we established that the most plausible factors are related to the secondary effects of gonadotoxic treatments and/or systemic inflammatory responses to the diseases.

Multiple sclerosis and hypogonadism: is there a relationship?

INTRODUCTION: Multiple sclerosis (MS) is a chronic autoimmune disease that affects the central nervous system and is widely recognized as a disease primarily affecting women. The relationship between MS and hypogonadism is complex and not fully understood, with recent evidence showing that hypogonadism may have a significant impact on the quality of life and disease progression of patients with MS. OBJECTIVES: This review aims to provide an overview of the current knowledge regarding the relationship between MS and hypogonadism, including the mechanisms underlying this relationship; the effects of hypogonadism on patients with MS; and the potential benefits and drawbacks of testosterone replacement therapy for patients with MS and hypogonadism. METHODS: This scientific review analyzed 19 articles that investigated the potential relationship among MS, testosterone levels, and hypogonadism. The articles were published between November 2008 and March 2022 and were identified through a comprehensive search of the PubMed database. The search terms used included "multiple sclerosis," "testosterone," "hypogonadism," and "MS and testosterone levels." RESULTS: Of the 19 articles reviewed, 11 described a positive correlation between low testosterone levels and dysfunction within the hypothalamic-pituitary-gonadal axis in individuals with MS. These findings suggest that low testosterone levels may contribute to dysfunction within the hypothalamus-pituitary-gonadal axis, which plays a crucial role in regulating testosterone production. The results also showed a relationship between sexual dysfunction and low testosterone levels, as well as a positive correlative relationship between these factors. CONCLUSION: The reviewed articles indicate a complex relationship among MS, testosterone levels, and the hypothalamic-pituitary-gonadal axis, with low testosterone levels potentially contributing to dysfunction in this axis and to sexual dysfunction. Further research is needed to better understand the effects of testosterone therapy on MS and sexual dysfunction in patients with MS.

Do Phosphodiesterase Type 5 Inhibitors Increase the Risk of Biochemical Recurrence After Radical Prostatectomy?

PURPOSE: There have been conflicting studies on the association between phosphodiesterase type 5 inhibitor (PDE5i) use and biochemical recurrence (BCR) following radical prostatectomy (RP). Our aim was to determine whether PDE5i drug exposure after RP increases the risk of BCR in patients undergoing RP. MATERIALS AND METHODS: An institutional database of prostate cancer patients treated between January 2009 and December 2020 was reviewed. BCR was defined as 2 PSA measurements greater than 0.1 ng/mL. PDE5i exposure was defined using a 0 to 3 scale, with 0 representing never use, 1 sometimes use, 2 regularly use, and 3 routinely use. The risk of BCR with any PDE5i exposure, the quantity of exposure, and the duration of PDE5i exposure were assessed by multivariable Cox proportional hazards models. RESULTS: The sample size included 4630 patients to be analyzed, with 776 patients having BCR. The median follow-up for patients without BCR was 27 (IQR 12, 49) months. Eighty-nine percent reported taking a PDE5i at any time during the first 12 months after RP, and 60% reported doing so for 6 or more months during the year after RP. There was no evidence of an increase in the risk of BCR associated with any PDE5i use (HR 1.05, 95% CI 0.84, 1.31, P = .7) or duration of PDE5i use in the first year (HR 0.98 per 1 month duration, 95% CI 0.96, 1.00, P = .055). Baseline oncologic risk was lower in patients using PDE5i, but differences between groups were small, suggesting that residual confounding is unlikely to obscure any causal association with BCR. CONCLUSIONS: Prescription of PDE5i to men after RP can be based exclusively on quality of life considerations. Patients receiving PDE5is can be reassured that their use does not increase the risk of BCR.

Erectile response profiles of men using PDE5 inhibitors combined with intracavernosal injections as part of a penile rehabilitation program after radical prostatectomy.

BACKGROUND: Phosphodiesterase type 5 (PDE5) inhibitor labeling states that these agents should not be used in conjunction with other erectogenic medications for fear of priapism occurring. AIM: We explored the risk of priapism and prolonged erections in men in our post-radical prostatectomy (RP) penile injection program who were using regular PDE5 inhibitor and intracavernosal injections (ICIs) as part of their rehabilitation program. METHODS: The study cohort included men on penile injection therapy who (1) were taking tadalafil 5 mg daily or taking sildenafil 25 mg on noninjection days, (2) had an RP, (3) were using their respective PDE5 inhibitor regularly at the time of penile injection training, and (4) complied with the program instructions regarding penile injection use. Demographics, comorbidity details, PDE5 inhibitor dose and utilization, and injection dose and utilization data were collected. All patients underwent in-office injection training and used trimix (papaverine/phentolamine/prostaglandin E1) as the intracavernosal medication. OUTCOMES: Priapism was defined as a patient self-reported penetration hardness erection ≥4 hours in duration, while prolonged erection was defined as a penetration hardness erection lasting ≥2 hours. RESULTS: A total of 112 tadalafil users and 364 sildenafil users were compared. Mean age and duration post-RP were 62 ± 14 years and 5.2 ± 12 months, respectively, and there was no difference between tadalafil and sildenafil groups. The mean trimix dose was tadalafil 24 ± 24 units and sildenafil 31 ± 37 units (P < .05). Priapism occurred in 2 (1.7%) of 112 tadalafil users and 5 (1.4%) of 364 sildenafil users (P = .47). Excluding those men experiencing priapism on any occasion, those with any reported penetration hardness erection lasting ≥2 hours were 7 (6.3%) of 112 tadalafil users and 12 (3.3%) of 364 sildenafil users (P < .01). A total of 53% of these prolonged erections occurred within the first 6 injections at home (no difference between tadalafil and sildenafil groups). CLINICAL IMPLICATIONS: We emphasize the need for continued monitoring and education on proper injection techniques to minimize the risk of adverse events in ICI and PDE5 inhibitor combination therapy. STRENGTHS & LIMITATIONS: This study has a relatively large patient population with a considerable follow-up time. Additionally, the rigorous training, education, and monitoring of the participants, as well as the use of formal definitions for priapism and prolonged erections, enhances the accuracy and reliability of the results. However, there are some limitations, such as social desirability, confounding factors, and recall bias. CONCLUSION: There is no significant difference in the incidence of priapism in an ICI program in which men combine ICI with tadalafil or sildenafil. However, tadalafil patients had a higher rate of prolonged erections, which was found to occur mostly early during the titration phase.

Maximizing outcomes in penile prosthetic surgery: exploring strategies to prevent and manage infectious and non-infectious complications.

Inflatable Penile Prostheses (IPP) implantation is a surgical treatment for patients desiring definitive treatment for erectile dysfunction. While this procedure has proven to be effective, it also carries its own set of unique risks that need to be carefully considered. The article reviews the current understanding of complications associated with penile prosthetic surgery and provides strategies to mitigate these adverse events. This article covers various aspects of IPP implantation, including the risks of infection, bleeding, injury to nearby structures, glans ischemia, and device malfunction. It also discusses the importance of careful preoperative screening to identify risk factors and the implementation of infection reduction strategies such as antimicrobial prophylaxis, skin prep, and operative techniques. In addition, it emphasizes the need for postoperative vigilance and prompt management of any complications that may arise. Overall, the article provides a comprehensive overview of the risks and strategies for mitigating complications associated with IPP implantation. Our recommendations are given based on the current consensus in the field and highlight the importance of careful planning, attention to detail, and effective communication between healthcare providers and patients. Despite the potential risks, this review underscores the fact that complications following penile prosthesis implantation are relatively rare.

A narrative review on malleable and inflatable penile implants: choosing the right implant for the right patient.

A penile prosthesis/implant is an excellent option for men with erectile dysfunction refractory to medical treatment or with contraindications to medical management. In this narrative review, we discuss the different types of penile prostheses and the considerations for patient and device selection to maximize satisfaction. There are three main prosthesis types to choose from: three-piece inflatable devices, two-piece inflatable devices, and malleable/semirigid devices. The three-piece devices are the gold standard in advanced economy countries but require reservoir placement and manual dexterity, which can be limiting to some patients. The two-piece inflatable devices are a good option for patients who have standard-sized penises, lack significant penile pathology, have limited dexterity issues, or should avoid reservoir placement due to potential complications. The malleable devices are popular in countries where insurance coverage is limited but are increasingly used in advanced economy countries for length conservation in specific patient populations. Finally, not every patient needs an implant, and assessing partner sexual function is an important consideration for patient-partner satisfaction. Surgeons need to be familiar with the strengths and limitations of each device and the patient characteristics that will yield the best outcome from penile prosthesis surgery.

Delayed placement of an inflatable penile prosthesis is associated with a high complication rate in men with a history of ischemic priapism.

BACKGROUND: Corporal fibrosis is known to result from prolonged priapism; however, the impact of the timing of penile prosthesis placement after priapism on complication rates is poorly understood. AIM: We sought to evaluate the impact of timing of inflatable penile prosthesis (IPP) placement on complications in men with a history of ischemic priapism. METHODS: We performed a multicenter, retrospective cohort study of patients with a history of priapism undergoing IPP placement by 10 experienced implantation surgeons. We defined early placement as ≤6 months from priapism to IPP. We identified a 1:1 propensity-matched group of men without a history of priapism and compared complication rates between men who had early placement, late placement, and no history of priapism. OUTCOMES: Our primary outcome was postoperative noninfectious complications, and secondary outcomes included intraoperative complications and postoperative infection. RESULTS: A total of 124 men were included in the study with a mean age of 50.3 ± 12.7 years. A total of 62 had a history of priapism and 62 were matched control subjects. The median duration of priapism was 37 (range, 3-168) hours and the median time from ischemic priapism to IPP placement was 15 months (range, 3 days to 23 years). Fifteen (24%) men underwent early (≤6 months) IPP placement at a median time of 2 months (range, 3 days to 6 months) following the ischemic priapism event. The remaining 47 (76%) underwent placement >6 months following priapism at a median time of 31.5 months (range, 7 months to 23 years). The complication rate in the delayed placement group was 40.5% compared with 0% in the early placement group and control group. Cylinder-related complications such as migration or leak accounted for 8 (57%) of 14 of the postoperative noninfectious complications. Full-sized cylinders were used in all patients who had a cylinder related complication. CLINICAL IMPLICATIONS: Priapism patients should be referred to prosthetic experts early to decrease complication rates in those needing an IPP. STRENGTHS AND LIMITATIONS: This is a multicenter study from experienced prosthetic urologists but is limited by the retrospective nature and small number of patients in the early placement group. CONCLUSION: IPP complication rates are high in men with a history of ischemic priapism, especially when implantation is delayed beyond 6 months.

Long-term assessment of the safety and effectivity of the mini-jupette sling: 5-year follow-up of the original series.

Background: In 2017, a prospective multicenter, multinational, investigational pilot study was conducted examining outcomes using a novel surgical technique, the Mini-Jupette sling, for the management of erectile dysfunction (ED) patients with climacturia and/or minimal stress urinary incontinence (SUI) after prostate procedures. Climacturia has been reported in up to 64% of patients following radical prostatectomy (RP). We sought to report the 5-year outcomes from this original cohort to assess long-term safety and effectivity of the mini-jupette sling in the treatment of ED and concomitant mild SUI and/or climacturia. Methods: This is a single-arm, multicenter, retrospective, observational study. We identified patients who were enrolled in the previous multicenter study with post-RP ED and climacturia and/or mild SUI- 2 PADS PER DAY (PPD) and underwent inflatable penile prosthesis (IPP) insertion with simultaneous placement of a mini-jupette sling. Data were collected including current PPD, subjective improvement in climacturia/SUI, complications, need for revision of IPP or additional urinary incontinence surgery, and date of most recent follow-up. SPSS was used for statistical analysis. Results: Of the original 38 patients, 5 have since died and 10 were lost to follow-up with 23/38 (61%) patients available for evaluation of long-term outcomes. The average follow-up time was 59 months (SD =8.8) with a mean age of 69 years (SD =6.8). Most patients (n=21, 91%) had subjective improvement of SUI and climacturia. One patient with persistent bothersome incontinence underwent artificial urinary sphincter (AUS) placement in 2018 with no complications, while the other is still considering a repeat procedure due to minor but persistent SUI. The mean PPD decreased from 1.4 preoperatively to 0.4 at a mean of 5 years of follow-up. Most patients reported satisfaction in their urinary symptoms with 91% and 73% reporting improvement in SUI and climacturia respectively, compared to 86% and 93% respectively in the original series. One (4.3%) patient had an IPP revision for pump malfunction. There were no device infections reported. Conclusions: The mini-jupette sling appears to be a safe and effective procedure with durable improvements in SUI and climacturia at 5 years of follow-up.

Development and Application of a Novel and Efficient Skills Assessment Tool: A Pilot Initiative to Measure Vasectomy Competency on a Smartphone.

OBJECTIVE: To develop and evaluate a mobile phone-based skills assessment tool that measures procedural competency of urology residents learning to perform a common, non-robotic urology procedure as a means of tracking current skillset and improvement over time. METHODS: The assessment tool was a Qualtrics survey accessed via a smartphone link that breaks down a vasectomy into 6 critical steps. Level of competency was measured on a scale of '1-novice' to '5-expert.' Nine residents from Post graduate year (PGY)-1 to PGY-5 were evaluated by one instructor after completing a vasectomy (86 single-side cases recorded over a 6-month period). We compared individual trainees to each other, analyzed performance (improvement) over time, and evaluated competency against cohort and program averages. RESULTS: As an example, a single resident ('Resident 2,' N = 11 cases) was compared to cohort (PGY, M = 7.5/resident) and program (all residents, M = 7.4/resident). Results indicate similar skillfulness across Step 1 (puncturing and isolation of vas and hand positioning; P > 0.1), but marginally lower competency on Step 2 (opening of vasal sheath to expose/isolate vas; vs. cohort: P = 0.076, vs. residents: P = 0.082). Significantly lower competency on Steps 3-6 (all P < 0.04) suggests targeted teaching could improve cautery technique, fascial interposition, hemostasis, and positioning of stumps. CONCLUSION: Our mobile-based skills assessment is a low cost, novel, and efficient assessment that would support current Accreditation Council for Graduate Medical Education (ACGME) goals to increase competency-based residency training. This tool is easily created and accessed, provides real-time feedback to learners, and can be used for individual and group assessment at a single timepoint or longitudinally.

The pandemic, telemedicine, and andrology: what have we learned?

BACKGROUND: Telemedicine gained wide acceptance during the COVID-19 pandemic, as it was deemed critical for patient care when lockdowns were implemented worldwide. While there is evidence to suggest that urology patients were receptive to telemedicine, no systematic review has been done to date on andrology patients and their perception of telemedicine. METHODS: Three electronic databases, PubMed, Scopus, and Web of Science, were searched from their inception until June 2022 for relevant articles. Two independent teams reviewed abstracts and extracted data from the selected manuscripts. A meta-analysis was completed in line with PRISMA 2020 and AMSTAR Guidelines. For our study, we limited telemedicine to communication through videoconferencing or telephone encounters between patients and medical professionals. Positive response to telemedicine was defined as patients "wishing for telemedicine consultation", "preferring telemedicine over in person", "accepting the current telemedicine arrangement", "having needs addressed with teleconsultation", or "willingness to do a teleconsultation". RESULTS: Of the 1128 retrieved abstracts, 56 underwent full-text review and 12 were included in the final analysis, comprising a total cohort of >4021 cases. Video visits were evaluated in 5 studies, telephone encounters were analyzed in 2 studies, and both methods were examined in 1 randomized control study. Three studies showed that andrology and sexual medicine are compatible with telemedicine, with few 30- and 90-day in-person revisit rates. Telemedicine was shown to save an average cost of US$149-$252 per patient, and 8 studies that directly assessed andrology patient perceptions of telemedicine showed that most patients had a "positive perception."Pooled analyses of the positive responses to telemedicine were 68.7% (95% CI, 49.4%-83.1%, P = 0.057), and those of patients who recommended telemedicine were 65.1% (95% CI, 18.4%-93.9%, P = 0.577). While the percentage of patients recommending telemedicine was high among studies using videoconferencing, the percentage dropped in studies using telephone visits only. The difference between recommending video and telephone practices was statistically significant, with 84.6% pooled proportion for recommending video practice compared to 38.9% pooled proportion for recommending telephone practice, P = 0.035. In the telephone-only encounters, up to 27.1% of patients preferred in-person visits, as security and privacy of any mode of telecommunication were of concern. CONCLUSIONS: Most patients have a positive perception of telemedicine, particularly with videoconferencing and less so with telephone visits. These results suggest that telemedicine will likely continue to play a pivotal role in andrology and sexual medicine practices.

Partial Component Exchange of a Non-Infected Inflatable Penile Prosthesis is Associated With a Higher Complication Rate.

OBJECTIVE: To describe the infectious and non-infectious complications in men undergoing Inflatable penile prosthesis (IPP) revision with partial and complete component exchange for mechanical malfunction. METHODS: We performed a multicenter retrospective cohort study of patients who underwent IPP revision. Men undergoing procedures for implant infection were excluded. Patients were divided into those who had complete exchange of the entire device or partial exchange of only one or 2 components. Infectious and non-infectious complications were compared between groups. RESULTS: Three hundred sixty-eight men had complete exchange of the entire device and 85 had partial component exchange. Men undergoing partial exchange had a significantly higher infection rate (7.1% vs 2.2%, P = .031). The partial exchange group also was more likely to receive antifungals (51.8 vs 16.6%, P < .001), have a modified salvage washout (77.4 vs 60.2%, P = .004), and less likely to receive vancomycin and gentamicin (63.5 vs 83.7%, P < .001). Time to revision was significantly shorter in the partial exchange group (44.9 vs 168.2 months, P < .001). Mean follow-up was slightly longer in the complete exchange group (18.3 vs 13.0 months). In multivariable analysis, partial exchange surgery, vancomycin and gentamicin prophylaxis, modified salvage washout, and antifungal prophylaxis were no longer associated with postoperative infections. The partial exchange group had greater rates of non-infectious complications (21.2% vs 9.5%, P = .005) such as pump malfunction and tubing breakage. CONCLUSION: Patients undergoing partial component revision had more infectious and non-infectious complications. These findings suggest that partial component exchange increases complications in men undergoing IPP revision.

Contemporary cost-analysis comparison of direct-to-consumer vs. traditional prescriptions of phosphodiesterase-5 inhibitors.

After a focused telehealth visit, patients can now access phosphodiesterase-5 inhibitor (PDE5 inhibitor) prescriptions through online direct-to-consumer (DTC) healthcare companies. This study seeks to quantify the cost of DTC PDE5 inhibitor treatment compared to a traditional physician visit and local pharmacy prescription. Two DTC companies, two compounding pharmacies with national reach, three online Canadian pharmacies, and sixteen American pharmacy chains were queried for prices of 90-day regimens of common PDE5 inhibitors. Prices for chains were determined using their publicly available price on GoodRx® with coupon. Cost of physician visit was determined using 2020 Center for Medicare and Medicaid Services reimbursement for a level 3 new patient visit. For sildenafil 20 mg, a physician visit and local prescription cost a low of $125.45 compared to $144.35 for compounding, $169.34 for Canadian, and $195.00 for DTC. For sildenafil 100 mg, a physician visit and local prescription cost a low of $137.16 compared to $289.35 for compounding, $200.36 for Canadian, and $900.00 for DTC. For tadalafil 5 mg, a physician visit and local prescription cost a low of $125.80 compared to $169.35 for compounding, $195.34 for Canadian, and $720.00 for DTC. For tadalafil 20 mg, a physician visit and local prescription cost a low of $161.00 compared to $289.35 for compounding, $229.00 for Canadian, and $2880.00 for DTC. Thus, local pharmacies, in conjunction with online coupons, consistently provide a markedly less-expensive option for fulfillment of PDE5 inhibitor prescriptions than online DTC services.

Predictors of Curvature Improvement in Men With Peyronie's Disease Treated With Intralesional Collagenase Clostridium Histolyticum.

INTRODUCTION: Penile curvature is the most common abnormality that is observed by men with Peyronie's disease (PD). Collagenase Clostridium histolyticum (CCH) has become a standard treatment for PD patients. AIM: To identify predictor factors associated with improvements of penile curvature outcomes in men with PD treated with CCH. METHODS: We retrospectively collected the data of patients with PD treated with CCH up to 8 injections divided into 4 cycles between January 2014 and July 2020. Per protocol, penile curvature was assessed at baseline, and after the second and ford CCH cycle. If after cycle 2, curvature demonstrated no improvement, or penile curvature was significantly improved and the patient was happy, no further treatment was recommended. However, if penile curvature was significantly improved and the patient remained dissatisfied, 4 cycles were completed. Three categories of response were evaluated: improvement (≥10 degrees or ≥20%, either 1 happens), unchanged (±10 degrees or ±20%) or worsened (≥10 degrees or ≥20%, either 1 happens). Logistic regression analyses were performed to evaluate predictive factors associated with penile curvature improvements. OUTCOMES: Degrees of the curvature changes between the baseline and after the cycles of CCH. RESULTS: A total of 114 patients underwent CCH treatment. Median age was 57 years. Median PD duration was 11 months. At baseline, mean curvature was 47 degrees, 65% had dorsal curvature, 53% mid-shaft location, and 15% calcification. After CCH treatment, the mean final curvature was 40 degrees. A total of 44% improved the curvature, 39% had no change while 17% worsened after CCH treatment. Of men who had penile curvature improvement with CCH treatment, the mean curvature decreasing in degrees and percentage were 22 degrees and 41%, respectively. Men with baseline curvature ≤ 30, 31-59, and ≥ 60 degrees, the percentage curvature improvement were 29%, 43%, and 60%, respectively. Baseline curvature was the only significant predictor of penile curvature improvement after CCH (OR 1.33, 95% CI = 1.1, 1.7). CLINICAL IMPLICATIONS: We confirmed baseline penile curvature is the most important predictive factor, and this is the first report describing proportions of penile curvature improvement with CCH treatment. STRENGTHS AND LIMITATIONS: This study has several strengths, including the use of validated instruments. Nonetheless, there are limitations: the retrospective nature of the study, a single institution; and modelling device was not controlled. CONCLUSION: Penile curvature improvement was significantly more common in patients with greater baseline curvature, reaching up to 60% for patients with ≥ 60 degrees. Flores JM, Nascimento B, Punjani N, et al. Predictors of Curvature Improvement in Men With Peyronie's Disease Treated With Intralesional Collagenase Clostridium Histolyticum. J Sex Med 2022;19:1680-1686.

The Lack of Sexual Health Education in Medical Training Leaves Students and Residents Feeling Unprepared.

BACKGROUND: Despite physicians frequently caring for patients with sexual health issues, only 50% of United States medical schools require formal education in sexual medicine, and there are currently no guidelines pertaining to this with research which found that medical trainees are ill-equipped to provide sexual healthcare. AIM: This study aims to identify areas to improve sexual health training in order to increase physician confidence and competence in evaluating and training patients with sexual health problems. METHODS: A prospective survey was sent via REDCap to medical students (n = 190, 68.6%), residents (n = 75, 27.1%), and fellows (n = 11, 3.9%) via a known listserv. Participants (N = 276, ∼15% response rate) were asked to provide demographic information, whether they received sexual health training during medical school and rate their confidence in addressing patients' sexual health concerns. OUTCOMES: Medical students and residents currently do not receive sufficient education on sexual health and medicine, particularly in fields outside of OB-GYN and Urology, leaving them underqualified and less confident than needed for adequate patient care. RESULTS: 65.6% of trainees reported receiving formal sexual health education, while 13.9% received informal education, and 20.6% received no education during medical school. Although trainees desire to understand a patients' sexual health (P < .001), only residents in a relevant field (Urology, OB-GYN) felt confident in their ability to assist patients with a sexual health issue (P = .013). All other trainees lacked confidence in attending to sexual health concerns (P < .001), regardless of training level (P > .1). CLINICAL IMPLICATIONS: More efforts should be made to integrate sexual health education into medical school curriculum. STRENGTHS & LIMITATIONS: The strength of this study includes specific evaluation of medical student and resident confidence level with 15 individual sexual health topics. The limitations include that the demographic was regionally confined to the Midwest of the United States and women were more strongly represented among medical students. CONCLUSION: Due to the lack of standardized education, medical trainees (except for Urology and OB-GYN residents) feel unprepared to treat patients with sexual health issues, and medical schools should make sexual health education mandatory. Beebe S, Payne N, Posid T, et al. The Lack of Sexual Health Education in Medical Training Leaves Students and Residents Feeling Unprepared. J Sex Med 2021;18:1998-2004.

Development and Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI).

BACKGROUND: No validated English language patient-reported outcome (PRO) currently exists that assesses satisfaction with inflatable penile prosthesis (IPP). Satisfaction data have been largely based primarily on surgeon assessment of patients or using questionnaires that have not been designed for this purpose. AIM: To develop an English-language validated PRO that assesses patient satisfaction after IPP surgery. METHODS: Initially, a literature review and discussions with experts defined domains important to IPP satisfaction (pain, appearance, function, overall satisfaction). The initial 35-item Satisfaction Survey for Inflatable Penile Implant (SSIPI) was developed. Cognitive interviews were then performed with IPP patients (n = 12) to gain feedback on the SSIPI domains and items. These data were used to modify SSIPI with the addition of 2 questions for a final item number of 37. Patients from 4 centers, who were between 6 months and 5 years after IPP, were administered the questionnaire through RedCap. Reliability statistics and content analysis were used to winnow questions to yield the final 16-item version of the SSIPI. Internal consistency was assessed via Cronbach's alpha and item-total correlation. Test-retest reliability was assessed via intraclass correlation coefficients using baseline and 2-week data. For convergent validity, the Erectile Dysfunction Inventory of Treatment Satisfaction and the Self-Esteem and Relationship (SEAR) questionnaire were used. For discriminant validity, the International Prostate Symptom Score (IPSS) was used. Confirmatory factor analysis was used to assess the factor structure of the SSIPI. OUTCOMES: Internal consistency, test-retest reliability, convergent and discriminant validity, and confirmatory factor analysis were assessed. RESULTS: 118 men were surveyed. Mean age was 66.8 ± 9.5 years. The 16-item SSIPI showed high internal consistency with an overall Cronbach's Alpha of 0.97 (domains 0.85-0.89). Item-total correlations for individual items to subscales ranged from 0.60 to 0.91. The overall test-retest reliability was 0.94 (domains 0.87-0.93). Erectile Dysfunction Inventory of Treatment Satisfaction and Self-Esteem and Relationship had correlations of 0.84 overall (domains 0.57-0.79) and 0.47 overall (domains 0.34-0.44), respectively. International Prostate Symptom Score (discriminant validity) had correlations of -0.29 overall (domains -0.17 to -0.31). CLINICAL IMPLICATIONS: SSIPI is the first English-language validated IPP satisfaction PRO. This will enable clinicians to collect satisfaction data in a standardized way. STRENGTHS AND LIMITATIONS: As strengths we have used a rigorous psychometric process and have no industry sponsorship. Limitations include small numbers of specific subpopulations. CONCLUSION: The SSIPI has demonstrated robust psychometric properties. Salter CA, Bach PV, Jenkins L, et al. Development and Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI). J Sex Med 2021;18:1641-1651.

The Prevalence and Predictors of Penile Pain in Men with Peyronie's Disease.

INTRODUCTION: Penile pain is one of the most stressful symptoms in men with Peyronie's disease (PD). AIM: To evaluate the prevalence, clinical presentation and risk factors associated with penile pain in men with PD as well as to assess the psychosocial impact. METHODS: We revised our institution's database of men diagnosed with PD. The information collected included penile pain assessments, and the scores of the PD Questionnaire (PDQ), Self-Esteem and Relationship Questionnaire (SEAR) and Center for Epidemiologic Studies Depression Scale Questionnaire (CES-D). Descriptive and comparative statistics were used. Logistic regression analyses were performed to evaluate predictive factors associated with penile pain. MAIN OUTCOME MEASURES: Penile pain descriptive assessment and factors associated with penile pain in men with PD. Comparison of SEAR, CES-D and PDQ domain scores of men with and without penile pain. RESULTS: 431 men with PD were included for this analysis with a mean age of 55.9 years. Penile pain was reported by 36.7%; 65.2% of those had painful erection, 7% pain with flaccid state only, and 20% in both stages. The median pain severity was 3 with erection and 1 with flaccid stage. After adjusted logistic regression analyses, advanced age was associated with less pain (OR 0.94, P ≤ 0.001). Men with penile pain had no significant difference in CES-D and SEAR mean scores compared to men without penile pain. The PDQ scores for the physical/psychological symptoms domain and the bother domain were significantly higher in men with penile pain (12 vs 8.7; P < 0.01 and 9 vs 7.1; P < 0.01 respectively). Men with penile pain had a higher rate of clinically significant bother scores than men without penile pain (52% vs 35%, P ≤ 0.001). CONCLUSION: Penile pain is common in men with PD. It was more common in young men and was associated with physical and psychological bothers in this population. Flores JM, Salter CA, Nascimento B, et al. The Prevalence and Predictors of Penile Pain in Men with Peyronie's Disease. Sex Med 2021;9:100398.