Citations

Abstract Introduction Vacuum erectile device (VED) is 1 of the main approved therapies for erectile dysfunction (ED). The introduction of phosphodiesterase type 5 inhibitor (PDE5i) for ED significantly changed the roles of VED in contemporary sexual medicine. Objective To provide updated clinical evidence to inform health care providers on best practices with VED. Methods A consensus panel was held with leading sexual medicine experts during the 5th International Consultation on Sexual Medicine (ICSM). Relevant peer-reviewed literature was reviewed with focus on research from the last 10 years, but not limited to the last 10 years. The expert panel generated consensus statements based on the quality of evidence and criteria of Grading of Recommendations Assessment, Development and Evaluation. Results As a primary or combination therapy for ED, VED has been shown to be successful in all populations studied, including difficult to treat cohorts, such as diabetes mellitus, spinal cord injury, and post-radical prostatectomy (RP), but long-term attrition rates are high. Available evidence has shown that VED can preserve or restore penile size for patients after RP, after incision and grafting surgery for Peyronie’s disease, before and after penile prosthesis, and after other post pelvic surgeries. However, it has not demonstrated a more rapid recovery of spontaneous erectile function after RP. VED does not increase penile length for subjective short penis. Studies with female specific VED for female sexual dysfunction are very limited. Conclusions Since the prior 4th ICSM, more evidence is available to support the new roles of VED in contemporary sexual medicine. Research into the penile pathophysiologic changes with VED therapy and clinical outcomes for various conditions are ongoing. We encourage sexual medicine clinicians to follow the 5th ICSM recommendations, but providers should also use their own judgement and adopt shared decision making with their patients/partners when considering VED for a specific disorder.

Abstract Introduction Penile prosthesis (PP) is one of the main approved therapies for erectile dysfunction (ED). Greater than 50 years of clinical use has led to considerable innovation in PP surgery and patient care. Objectives To summarize the current literature and provide updated clinical evidence to inform healthcare providers on best practices with PP. Methods A consensus panel was held with leading sexual medicine experts during the 5th International Consultation on Sexual Medicine (ICSM). Relevant peer-reviewed literature was reviewed with focus on research from but not limited to the last 10 years. The quality of each individual study was judged with Oxford levels of evidence (LOE) criteria, but overall LOE were not used as systematic review was not performed. The expert panel generated consensus statements based on the quality of evidence and criteria of GRADE (Grading of Recommendations Assessment, Development and Evaluation). Results PP provides excellent outcomes for the treatment of ED. The panel developed 35 recommendations building upon previous recommendations. Nine recommendations (4, 5, 11,13,17, 25, 26, 31, and 32) are retained without change from 2015. Twelve recommendations (1, 2, 3, 7, 9,14,16,19,21, 28, 33, and 34) change syntax to make statements more active or change details. Fourteen recommendations (6, 8, 10, 12, 15, 18, 20, 22, 23, 24, 27, 29, 30, and 35) are novel in this update. Conclusion Since the 4th ICSM, new evidence has emerged to guide PP use in modern sexual medicine. While multi-institutional studies are needed to improve outcomes, key challenges remain: reducing infections, enhancing devices, and improving awareness and accessibility. We recommend following 5th ICSM guidelines while emphasizing the importance of clinical judgment and shared decision-making for optimal PP outcomes.

Abstract Introduction A new three-piece inflatable penile prosthesis was introduced in 2019. The Rigicon Infla10® has been implanted in 26 centers by 103 physicians. Clinical investigation for FDA approval in United States will begin in late 2022. Objective We report initial survival from explantation and revision rates for infection, mechanical failure and medical problems. Data was obtained from analysis of Patient Information Forms (PIFs) submitted to the manufacturer. Patient information data was omitted prior to analysis. Methods 319 patients implanted from 1/06/2019 to 12/31/2021 were followed to analyze device durability from revision/removal and rates of reoperation for infection, mechanical failure or medical reason. Results Mean follow-up was 21.2 months with a range of 5-36 months. Mean age was 58.5. 4.38% required removal/revision. Mechanical failure was 2.5%. There were no infections reported and only two (0.6%) medical problems (component out of place). One Peyronie's patient required revision for inadequate straightening (0.03% Three patients (0.9%) requested device removal for dissatisfaction. A total of 95.6% of Rigicon Infla10® was free from explant or revision 13 months from the original implant date. Kaplan Meier analysis revealed cumulative survival of the device at 12, 24 and 36 months was 95.6%, 94.7% and 95.7% until surgical invention. Conclusions While this is a retrospective study derived from volunteered Patient Information Forms, we believe the vast majority of the early Rigicon Infla10® performed prior to 1/2022 were included in the analysis. Early results show initial durability from re-operation equivalent to contemporary, devices. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Rigicon, Boston Scientific, Coloplast.

Objective To analyse data from patient information forms (PIFs) submitted to the manufacturer of a new three‐piece inflatable penile prosthesis (IPP), the Rigicon Infla10®, to summarize early outcomes. Methods A retrospective review of PIFs from 319 patients implanted with the IPP between 6 January 2019 and 31 December 2021 was performed to assess device durability and rates of reoperation for infection, mechanical failure or medical reasons. Results The mean ± sd (range) follow‐up was 21.2 ± 11 (5–36) months and the mean ± sd patient age was 58.5 ± 8.7 years. Of the total, 4.4% of devices required removal or revision. Complications included mechanical failure (2.5%) and component migration (0.7%). No infections were observed in this series. One patient (0.4%) required revision for inadequate straightening of Peyronie's disease. Three patients (0.9%) requested device removal because of dissatisfaction. A total of 95.6% of the Rigicon Infla10 devices were free from explant or revision 21 months after the original implant date. Kaplan–Meier analysis showed the rates of cumulative survival of the device at 12, 24, 36 months were 95.6%, 94.7% and 93.7%, respectively. Conclusions The vast majority of the early Rigicon Infla10 IPPs implanted prior to January 2022 were included in this retrospective analysis of volunteered PIFs. These early results demonstrate initial durability from reoperation equivalent to that of other contemporary devices.

ABSTRACT Introduction Literature concerning corporotomy location in multi-component inflatable penile prosthetic surgery via a penoscrotal approach is scarce if not non-existent. However, corporotomy location represents an important issue that may influence immediate and long-term outcomes regarding patient and partner satisfaction as well as device durability. Objective To report practices in low- and high-volume penile implant centers regarding corporotomy location. Methods Data from 18 (13 European and 5 American) implant centers were collected retrospectively between September 1st, 2018 and August 31st, 2019. Variables included: intraoperative proximal and distal corpus cavernosum length measurement, total corporal length measurement, total penile implant cylinder length, and length of rear tip extenders. Additionally, patient characteristics, indication for penile implant, operative time, type of implant utilized, reservoir characteristics and short term complications were reported. Results 809 virgin penile implant cases were included in the analysis. Mean age of participants was 61.5 +/- 9.6 years old. In total, 299 AMS 700TM (Boston Scientific) and 510 Coloplast Titan® devices were implanted. The mean proximal/distal corporal measurement ratio during corporotomy was 0.93 +/- 0.29. A statistically significant correlation between lower proximal /distal measurement ratio and higher age (p=0.0013), lower BMI (p<0.0001), use of rear tip extenders (RTE) (p=0.04), lower RTE length (p<0.0001) and absence of diabetes (p=0.0004) was reported. In a 3-month follow up period 49 complications and 37 revision procedures were reported. Conclusions This is the first study reporting and evaluating the current practices regarding corporotomy location during IPP placement in a multicenter cohort, particularly when including such a high number of patients. Nevertheless, the retrospective design limits the study outcomes. Even in experienced hands proximal length measurement in relation to distal length measurement in penoscrotal IPP surgery is in many cases sub-optimal, particularly when the tubing-cylinder connection of each device is taken into account. Disclosure No

Abstract Rationale Patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) typically undergo frequent clinical evaluation. The incidence and outcomes of coronavirus disease (COVID-19) and its impact on routine management for patients with pulmonary vascular disease is currently unknown. Objectives To assess the cumulative incidence and outcomes of recognized COVID-19 for patients with PAH/CTEPH followed at accredited pulmonary hypertension centers, and to evaluate the pandemic's impact on clinic operations at these centers. Methods A survey was e-mailed to program directors of centers accredited by the Pulmonary Hypertension Association. Descriptive analyses and linear regression were used to analyze results. Results Seventy-seven center directors were successfully e-mailed a survey, and 58 responded (75%). The cumulative incidence of COVID-19 recognized in individuals with PAH/CTEPH was 2.9 cases per 1,000 patients, similar to the general U.S. population. In patients with PAH/CTEPH for whom COVID-19 was recognized, 30% were hospitalized and 12% died. These outcomes appear worse than the general population. A large impact on clinic operations was observed including fewer clinic visits and substantially increased use of telehealth. A majority of centers curtailed diagnostic testing and a minority limited new starts of medical therapy. Most centers did not use experimental therapies in patients with PAH/CTEPH diagnosed with COVID-19. Conclusions The cumulative incidence of COVID-19 recognized in patients with PAH/CTEPH appears similar to the broader population, although outcomes may be worse. Although the total number of patients with PAH/CTEPH recognized to have COVID-19 was small, the impact of COVID-19 on broader clinic operations, testing, and treatment was substantial.

Purpose There are sparse data defining the dose response of radiation therapy (RT) to the hypothalamus and pituitary in pediatric and young adult patients with brain tumors. We examined the correlation between RT dose to these structures and development of endocrine dysfunction in this population. Materials and Methods Dosimetric and clinical data were collected from children and young adults (< 26 years of age) with brain tumors treated with proton RT on three prospective studies (2003 to 2016). Deficiencies of growth hormone (GH), thyroid hormone, adrenocorticotropic hormone, and gonadotropins were determined clinically and serologically. Incidence of deficiency was estimated using the Kaplan-Meier method. Multivariate models were constructed accounting for radiation dose and age. Results Of 222 patients in the study, 189 were evaluable by actuarial analysis, with a median follow-up of 4.4 years (range, 0.1 to 13.3 years), with 31 patients (14%) excluded from actuarial analysis for having baseline hormone deficiency and two patients (0.9%) because of lack of follow-up. One hundred thirty patients (68.8%) with medulloblastoma were treated with craniospinal irradiation (CSI) and boost; most of the remaining patients (n = 56) received involved field RT, most commonly for ependymoma (13.8%; n = 26) and low-grade glioma (7.4%; n = 14). The 4-year actuarial rate of any hormone deficiency, growth hormone, thyroid hormone, adrenocorticotropic hormone, and gonadotropin deficiencies were 48.8%, 37.4%, 20.5%, 6.9%, and 4.1%, respectively. Age at start of RT, time interval since treatment, and median dose to the combined hypothalamus and pituitary were correlated with increased incidence of deficiency. Conclusion Median hypothalamic and pituitary radiation dose, younger age, and longer follow-up time were associated with increased rates of endocrinopathy in children and young adults treated with radiotherapy for brain tumors.

ABSTRACT Introduction Despite recent advances in our knowledge and treatment strategies in Peyronie's Disease (PD), much remained unknown about this disease. Aim To provide a clinical framework and key guideline statements to assist clinicians in an evidence-based management of PD. Methods A systematic literature search was conducted to identify published literature relevant to PD. The search included all relevant articles published up to June 2015, including preclinical studies and published guidelines. References used in the text were assessed according to their level of evidence, and guideline recommendations were graded based on the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Owing to the paucity of larger series and randomized placebo-controlled trials with regard to surgical intervention, guideline statements are provided as clinical principle or expert opinion. Main Outcome Measures This literature was discussed at a panel meeting, and selected articles with the highest evidence available were used to create consensus guideline statements for the Fourth International Consultation on Sexual Medicine guidelines on PD. Results In addition to existing Third International Consultation on Sexual Medicine guidelines on PD, seven new summary recommendations were created. Conclusion A greater understanding of the scientific basis of PD is greatly needed to address our understanding of the pathophysiology, clinical epidemiology, psychosocial, and diagnostic assessment as well as treatment strategies.