A review of the safety and efficacy of inflatable penile prosthesis ectopic reservoir placement.

INTRODUCTION: Patient medical and surgical history factors, such as prior prostatectomy, may lead surgeons to opt for ectopic reservoir placement rather than the standard reservoir location in the retropubic space (RPS) during inflatable penile prosthesis (IPP) placement. OBJECTIVE: To examine the safety and effectiveness of ectopic reservoir placement used with three-piece IPPs in relation to reservoir placement in the RPS. METHODS: A systematic review of MEDLINE/Pubmed and Embase databases was performed for literature between 1970 and 2022. Clinical studies and case reports describing three-piece IPP reservoir placement and clinical outcomes on AMS 700, similar products (such as Coloplast Titan), and three-piece IPPs where the manufacturer is not specified were included. RESULTS: Seventy articles were identified that reported clinical outcomes on three-piece IPP reservoir placement, which included data on 9565 patients. Of these, 67% of the reservoirs (n = 6413) were placed in ectopic locations. These locations were defined as submuscular (n = 5207), retroperitoneal (n = 405), sub-external oblique (n = 50), peritoneal (n = 42), subcutaneous (n = 10), and did not specify the ectopic location (n = 694). A total of 670 patients had ectopic placement of the AMS 700 reservoirs specifically. Overall, there were no elevated rates in safety outcomes between RPS and ectopic placement. Fourteen studies directly compared safety and/or efficacy outcomes between RPS and ectopic placement and did not report any significant differences between patient groups. CONCLUSIONS: Ectopic reservoir placement of three-piece IPPs, including AMS 700, is comparable in terms of safety, efficacy, and patient satisfaction to RPS reservoir placement. Ectopic reservoir placement of the AMS 700 device is also similarly comparable to ectopically placed reservoirs of other IPPs as reported in the literature. Surgeons should consider ectopic implantation for patients at higher risk of complications associated with reservoir placement into the RPS.

A comprehensive summary of eponymous awards and scholarships in sexual medicine.

INTRODUCTION: Numerous eponymous awards and scholarships exist within sexual medicine. This comprehensive review is intended to summarize these awards and highlight the esteemed sexual medicine experts for whom these awards are named. OBJECTIVES: To provide historical background and context for the various eponymous awards in sexual medicine. METHODS: The websites of the International Society for Sexual Medicine (ISSM) and the regional affiliate societies, including the Sexual Medicine Society of North America (SMSNA), International Society for the Study of Women's Sexual Health (ISSWSH), and various regional societies were identified, and all awards associated with a member of note were documented. In cases where no awards were identified within a regional society and a contact person was available, inquiries were made regarding the existence of awards. Several documents on the history of the ISSM were utilized for background on awards. RESULTS: A comprehensive list of current awards and their history was compiled. CONCLUSION: This is the first comprehensive history of eponymous awards and scholarships available in sexual medicine.

[Physician-led healthcare structures for patients in out-of-hospital intensive care nursing: a cross-sectional survey by the German Society for Out-of-Hospital Ventilation]. / Versorgung von Patient*innen der Außerklinischen Intensivpflege in ärztlich geleiteten Einrichtungen ­ eine Querschnitterhebung der Deutschen Interdisziplinären Gesellschaft für Außerklinische Beatmung.

BACKGROUND: Patients in out-of-hospital intensive care are usually provided with a tracheal cannula and often additionally receive mechanical ventilation. Less frequently, they receive non-invasive ventilation. Their potential to be weaned from the ventilator and to have their tracheostomy tubes removed must be evaluated twice per year from January 1, 2025 on. If there is a potential for weaning from mechanical ventilation or removal of the tracheostomy tube, referral to a specialized facility is required. OBJECTIVE: The study aimed at characterizing the specialized institutions which can evaluate the potential of patients to be weaned from the ventilator and to have their tracheostomy tubes removed, and which can perform these tasks as well. METHODS: Under the auspices of the German Interdisciplinary Society for Out-of-Hospital Ventilation (DIGAB) and with support from the Working group early neurological-neurosurgical rehabilitation (ENNR) a crosssectional online survey took place. RESULTS: Of 18 participating institutions, 11 (61.1%) were certified by professional societies representing neurorehabilitation, respiratory medicine, anaesthesiology and intensive care or paraplegiology. Most leading physicians were specialists in neurology, followed by pulmonology, anaesthesiology and paediatrics. Many professions with a variety of qualifications worked in these institutions. According to n=10 (55.6%) of the participating instituions, regional treatment capacities for patients from out-of-hospital intensive care, who need hospital admission for weaning from mechanical ventilation or a tracheal cannula, were not sufficient. About one third of the institutions offered televisits. DISCUSSION: Patients in out-of-hospital intensive care need interdisciplinary care, interconnecting out- and inpatient care structures due to medical complexity and participation restrictions. While interdisciplinary teams and a wide spectrum of diagnostic and therapeutic methods were provided in the participating institutions, their structure differed considerably. CONCLUSION: Quality criteria should be established for centres evaluating the patients' potential to be weaned from the ventilator and to have their tracheostomy tubes removed and performing weaning from mechanical ventilation and tracheal cannulas. Further research is needed to specify those criteria, to quantify inpatient treatment capacities for patients from out-of-hospital intensive care to be weaned from mechanical ventilation or tracheal cannulas,to evaluate the feasibility of weaning from mechanical ventilation and tracheal cannulas in an out-of-hospital setting and to understand the role of telemedicine in the treatment of patients in out-of-hospital intensive care.

Patients' and caregivers' perception of multidimensional and palliative care in amyotrophic lateral sclerosis - protocol of a German multicentre study.

INTRODUCTION: Amyotrophic lateral sclerosis (ALS) is an inevitably fatal condition that leads to a progressive loss of physical functioning, which results in a high psychosocial burden and organizational challenges related to medical care. Multidimensional and multiprofessional care is advised to meet the complex needs of patients and their families. Many healthcare systems, including Germany, may not be able to meet these needs because non-medical services such as psychological support or social counselling are not regularly included in the care of patients with ALS (pwALS). Specialised neuropalliative care is not routinely implemented nor widely available. Caregivers of pwALS are also highly burdened, but there is still a lack of support services for them. METHODS: This project aims to assess the perceptions and satisfaction with ALS care in Germany in pwALS and their caregivers. This will be achieved by means of a cross-sectional, multicentre survey. The examination will assess, to which extend the patients' needs in the six domains of physical, psychological, social, spiritual, practical and informational are being met by current care structures. This assessment will be linked to mental well-being, subjective quality of life, attitudes toward life-sustaining measures and physician-assisted suicide, and caregiver burden. The study aims to recruit 500 participants from nationwide ALS centres in order to draw comprehensive conclusions for Germany. A total of 29 centres, mostly acquired via the clinical and scientific German Network for Motor Neuron Diseases (MND-NET), will take part in the project, 25 of which have already started recruitment. PERSPECTIVE: It is intended to provide data-based starting points on how current practice of care in Germany is perceived pwALS and their caregivers and how it can be improved according to their needs. Planning and initiation of the study has been completed. TRIAL REGISTRATION: The study is registered at ClinicalTrails.gov; NCT06418646.

Factors Affecting Implant Length in Primary Inflatable Penile Prosthesis Placement.

OBJECTIVE: To evaluate predictors of implant length for men undergoing primary IPP placement. METHODS: A multicenter, retrospective cohort study was performed for men undergoing primary IPP placement at 16 high-volume surgical centers. Patient demographics, comorbidities, operative approach, and implanted cylinder and rear-tip extender length were recorded. Associations between potential preoperative and intraoperative predictors of total device length were tested using non-parametric correlation and Kruskal-Wallis tests, followed by multiple regression. RESULTS: Of 3951 men undergoing primary IPP placement from July 2016 to July 2021, the median implant length was 20 cm (IQR: 19-22). Shorter implant length was associated with increasing age in years (ß = -0.01, P = .009), Asian ethnicity (ß = -2.34, P = .008), history of radical prostatectomy (ß = -0.35, P = .001), and use of an infrapubic surgical approach (ß = -1.02, P <.001). Black or African American ethnicity was associated with the implantation of longer devices (ß = 0.35, P <.001). No significant associations were recorded with BMI, history of intracavernosal injections, diabetes mellitus, tobacco use, radiation therapy, Peyronie's disease, priapism, or cavernosal dilation technique. CONCLUSION: The length of an implanted penile prosthesis was found to be associated with preoperative and intraoperative factors including history of radical prostatectomy and operative approach. The knowledge of these associations may assist in the preoperative counseling of patients receiving IPP and help create accurate postoperative expectations.

Variability in Methodology of Erectile Dysfunction Regenerative Therapy Trials on ClinicalTrials.gov.

OBJECTIVE: To evaluate the variability in the criteria of erectile dysfunction (ED) regenerative therapy trials registered on ClinicalTrials.gov. METHODS: Interventional trials on ClinicalTrials.gov with the keywords "erectile dysfunction" and variations of "shockwave," "platelet rich plasma," "stem cell," "regenerative," and "restorative" were examined. Inclusion/exclusion criteria and primary/secondary outcomes were compared between extracorporeal shockwave therapy (ESWT), platelet rich plasma and stem cell injections (PRP/SC), and other regenerative therapies (ORT) groups. RESULTS: Of the 92 trials analyzed, International Index of Erectile Function (IIEF) score was the most common primary outcome (72%), with a higher prevalence in ESWT trials than PRP/SC or ORT trials (89% vs 44% and 58%, P <.001). Safety/tolerability was a primary outcome for 44% of PRP/SC trials and 25% of ORT trials but no ESWT trials (P <.001). ESWT trials more frequently had sexual/romantic relationship-based inclusion criteria and cancer treatment-related exclusion criteria than PRP/SC and ORT trials. CONCLUSION: There is substantial variability in the inclusion/exclusion criteria and outcome measures among ED regenerative therapy trials. ESWT trials most frequently utilized IIEF and had the strictest inclusion/exclusion criteria, suggesting more rigorous and functional outcome-based studies. Conversely, PRP/SC and ORT trials, but not ESWT trials, had safety/tolerability as a primary outcome, likely due to the experimental nature of these therapies. The variability in inclusion/exclusion criteria and outcome measures limits comparison of the various ED regenerative therapies.

Short-term revision rate of Rigicon Testi10TM testicular prosthesis in adolescents and adults: a retrospective chart review.

Testicular prosthesis implantation is a valuable solution for the physical, cosmetic, and psychological challenges associated with testicular loss which may affect males of any age. We evaluated the safety and reliability of the new Rigicon Testi10TM testicular prosthesis in adults and adolescents by performing an IRB-approved retrospective study of data drawn from Patient Information Forms (PIFs). A total of 427 patients (382 adults and 45 adolescents) had at least one testicular prosthesis implanted. Only one adult patient required revision surgery due to rupture of the Rigicon Testi10 TM saline-filled prosthesis. A 40-year-old patient was found to have a leaking prosthesis approximately one week postoperatively, which was suspected to be due to inadvertently punctured by the surgeon during the sterile saline filling process. There were no post-implantation revisions required for adolescent patients. According to our results, Kaplan-Meier calculation of survival from removal or revision was 99.8% for all patients at 54 months (99.7% for adults and 100% for adolescents). The complication rates among patients in this study are lower than those reported in previous published studies. Our study underscores the generally safe nature of testicular prosthesis implantation, as well as the very rare incidence of revision surgery for this new device.

Penoscrotal inflatable penile prosthesis recipients often fully recover from pain at two weeks following placement.

The symptoms and duration of pain following inflatable penile prosthesis (IPP) surgery remains poorly understood. We characterize postoperative pain following penoscrotal 3-piece inflatable penile prosthesis placement in patients managed with a standardized pain management protocol. This is a single-center prospective analysis of 96 virginal penoscrotal 3-piece IPP recipients (9/2019 to 9/2021) excluding patients with chronic pain, IPPs performed with alternative approaches or concomitantly with other surgeries and those with infections. Standardized pain questionnaire was performed by phone on post-operative day (POD) 2, 7, 14, and 30. The primary outcome was self-reported pain scores, measured by pain score 0-10 (0 = no pain, 10 = unbearable, "worst pain you have ever felt") at various locations (incision, penile, scrotal, abdominal) over the first 30 days postoperatively. A majority of pain reported was outside the scrotal area with 67.6% of complaints in the shaft, glans, abdomen and incision. From POD2 to POD30, there was a significant decrease in severe pain from 46.2 to 11.1% (p = 0.05) with an increase in mild pain from 23.1 to 62.4% (p = 0.05). Roughly half of the participants (47.9%, n = 46) reported no pain by POD14. Penoscrotal IPP recipients often fully recover from pain at the two-week period following surgery and those with lingering discomfort predominantly complain of penile shaft and glans pain.

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.

5qSMA: standardised retrospective natural history assessment in 268 patients with four copies of SMN2.

Newborn screening for 5qSMA offers the potential for early, ideally pre-symptomatic, therapeutic intervention. However, limited data exist on the outcomes of individuals with 4 copies of SMN2, and there is no consensus within the SMA treatment community regarding early treatment initiation in this subgroup. To provide evidence-based insights into disease progression, we performed a retrospective analysis of 268 patients with 4 copies of SMN2 from the SMArtCARE registry in Germany, Austria and Switzerland. Inclusion criteria required comprehensive baseline data and diagnosis outside of newborn screening. Only data prior to initiation of disease-modifying treatment were included. The median age at disease onset was 3.0 years, with a mean of 6.4 years. Significantly, 55% of patients experienced symptoms before the age of 36 months. 3% never learned to sit unaided, a further 13% never gained the ability to walk independently and 33% of ambulatory patients lost this ability during the course of the disease. 43% developed scoliosis, 6.3% required non-invasive ventilation and 1.1% required tube feeding. In conclusion, our study, in line with previous observations, highlights the substantial phenotypic heterogeneity in SMA. Importantly, this study provides novel insights: the median age of disease onset in patients with 4 SMN2 copies typically occurs before school age, and in half of the patients even before the age of three years. These findings support a proactive approach, particularly early treatment initiation, in this subset of SMA patients diagnosed pre-symptomatically. However, it is important to recognize that the register will not include asymptomatic individuals.

Long-term efficacy and safety of nusinersen in adults with 5q spinal muscular atrophy: a prospective European multinational observational study.

Background: Evidence for the efficacy of nusinersen in adults with 5q-associated spinal muscular atrophy (SMA) has been demonstrated up to a period of 16 months in relatively large cohorts but whereas patients reach a plateau over time is still to be demonstrated. We investigated the efficacy and safety of nusinersen in adults with SMA over 38 months, the longest time period to date in a large cohort of patients from multiple clinical sites. Methods: Our prospective, observational study included adult patients with SMA from Germany, Switzerland, and Austria (July 2017 to May 2022). All participants had genetically-confirmed, 5q-associated SMA and were treated with nusinersen according to the label. The total Hammersmith Functional Motor Scale Expanded (HFMSE) and Revised Upper Limb Module (RULM) scores, and 6-min walk test (6 MWT; metres), were recorded at baseline and 14, 26, and 38 months after treatment initiation, and pre and post values were compared. Adverse events were also recorded. Findings: Overall, 389 patients were screened for eligibility and 237 were included. There were significant increases in all outcome measures compared with baseline, including mean HFMSE scores at 14 months (mean difference 1.72 [95% CI 1.19-2.25]), 26 months (1.20 [95% CI 0.48-1.91]), and 38 months (1.52 [95% CI 0.74-2.30]); mean RULM scores at 14 months (mean difference 0.75 [95% CI 0.43-1.07]), 26 months (mean difference 0.65 [95% CI 0.27-1.03]), and 38 months (mean difference 0.72 [95% CI 0.25-1.18]), and 6 MWT at 14 months (mean difference 30.86 m [95% CI 18.34-43.38]), 26 months (mean difference 29.26 m [95% CI 14.87-43.65]), and 38 months (mean difference 32.20 m [95% CI 10.32-54.09]). No new safety signals were identified. Interpretation: Our prospective, observational, long-term (38 months) data provides further real-world evidence for the continuous efficacy and safety of nusinersen in a large proportion of adult patients with SMA. Funding: Financial support for the registry from Biogen, Novartis and Roche.

[Certification by the German Society for Neurorehabiliation, DGNR : Performance and quality of the "Centers for weaning from a ventilator in early neurological and neurosurgical rehabilitation"]. / Zertifizierung der Deutschen Gesellschaft für Neurorehabilitation e. V., DGNR : Leistung und Qualität der "Zentren für Beatmungsentwöhnung in der neurologisch-neurochirurgischen Frührehabilitation".

BACKGROUND: Certification of centers for weaning from a ventilator in neurological neurosurgical early rehabilitation (NNER) by the German Society for Neurorehabilitation (DGNR) is possible since 1 October 2021. OBJECTIVE: The results of certification of facilities in the first year after starting the procedure are presented. MATERIAL AND METHODS: As part of the certification process 28 criteria are assessed including a set of mandatory characteristics of the facility. The criteria are divided into structural criteria (i = 7), diagnostic criteria (i = 6), personnel criteria (i = 3), internal organization criteria (i = 7), and quality management criteria (i = 5). RESULTS: A total of 13 centers were certified in the first year, with a combined total of 283 beds for weaning from a ventilator in the NNER and served 2278 persons to be weaned from a ventilator in the year before certification, with a median of 134 per facility (range 44-414). Only rarely was weaning unsuccessful, requiring conversion to home mechanical ventilation before discharge (invasive home mechanical ventilation median per facility 10 persons, range 2-25; non-invasive home mechanical ventilation median 0 persons, range 0-57). A high level of process and structural quality was documented for the certified centers: across all areas of assessment, the individual certification criteria were met in the vast majority of cases (median degree of complete fulfilment 86%) or met with improvement potentials documented by the auditors (median 11%). CONCLUSION: Successful weaning in NNER and a high level of process and structural quality can be demonstrated by the certification results of centers that follow this integrative approach to weaning from a ventilator in a NNER setting.