Risk of unfavorable outcomes after penile prosthesis implantation - results from a national registry (INSIST-ED).

Like all surgeries, penile prosthesis implantation (PPI) has the potential for both postoperative complications and suboptimal patient satisfaction. In order to assess risk factors for poor satisfaction, we reviewed patients who had been prospectively recruited in a national multi-institutional registry of penile prostheses procedures (INSIST-ED) from 2014 to 20121. Patient baseline characteristics and postoperative complications were recorded. The primary endpoint of this study was unfavorable outcomes after inflatable PPI, defined as significant postoperative complications (Clavien-Dindo ≥2) and/or Sexuality with Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) scores below the 10th percentile. A total of 256 patients were included in the study. The median age was 60 years (IQR 56-67). The most common cause of erectile dysfunction (ED) was organic (42.2%), followed by pelvic surgery/radiotherapy (39.8%) and Peyronie's disease (18.0%). Postoperative complications were recorded in 9.6%. High-grade complications (Clavien ≥2) occurred in 4.7%. At 1-year follow-up, the median QoLSPP total score was 71 (IQR 65-76). In all, 14.8% of patients were classified as having experienced unfavorable outcomes because of significant postoperative complications and/or QoLSPP scores below the 10th percentile. Logistic regression analysis demonstrated patient age to be non-linearly associated with the risk of experiencing unfavorable outcomes. A U-shaped correlation showed a lower risk for younger and older patients and a higher risk for middle-aged men. ED etiology and surgical volume were not associated with PPI outcomes. Physicians should, therefore, be aware that middle-aged men may be at higher risk of being unsatisfied following PPI compared to both younger and older patients.

Variation of inflammatory indexes in patients with chronic abacterial prostatitis treated with an herbal compound/extract.

INTRODUCTION: Inflammation is a highly prevalent finding in the prostate. Men with inflammation have higher IPSS score and increased prostate size. For men with prostatic inflammation, there is a significantly increased risk of developing acute urinary retention and the need of a surgical approach to the disease. Some laboratory tests (i.e. fibrinogen, C-reactive protein), can play a role in identifying patients at greatest risk of complications and adverse outcomes after surgery. There have been several experiences exploring the role of nutraceutical approach to the prostate inflammation. Aim of our study were to describe the variation in symptoms and inflammatory indexes in men affected by chronic abacterial prostatitis, treated with an herbal extract containing Curcuma Longa 500 mg, Boswellia 300 mg, Urtica dioica 240 mg, Pinus pinaster 200 mg and glycine max 70 mg. MATERIALS AND METHODS: A prospective multicenter study was conducted from February 2021 and March 2022. One hundred patients, with a diagnosis of Chronic Prostatitis were enrolled in a multicentric phase III observational study. They were treated with the herbal extract, one capsule per day, for 60 days. No placebo arm was included. In each patient, inflammatory indexes, PSA, prostate volume, IIEF-5, PUF, uroflowmetry (Qmax), IPSS-QoL, NIH-CPPS were registered and statistically compared at baseline and at the follow up visit. RESULTS: The variation obtained on the inflammation indexes showed a global improvement after treatment, including the PSA reduction. We also recorded a significant improvement on IPSS-QoL, NIH-CPPS, PUF and Qmax scores. CONCLUSIONS: The herbal extract considered in our study may represent a promising and safe therapeutic agent leading to a reduction of inflammation markers, and could be used in the treatment of prostatitis and benign prostatic hyperplasia.

Shockwave Therapy for Erectile Dysfunction: Which Gives the Best Results? A Retrospective National, Multi-Institutional Comparative Study of Different Shockwave Technologies.

BACKGROUND: Low-intensity shockwave therapy (Li-SWT) is a promising option for the treatment of erectile dysfunction (ED). Many devices with different characteristics in terms of generators, shockwaves, set-up parameters and procedure protocols are commercially available. In this report, we present our experience with the main shockwave technologies currently in use in clinical practice for ED treatment. METHODS: A retrospective national, multi-institutional study was performed to compare the effects of different shockwave technologies in ED patients. All of the subjects underwent 8 consecutive weekly physical treatments with SWT under either a focused or non-focused regimen: 3,000 shocks per session at 0.09 mJ/mm2 and 10,000 shocks per session at 15 Hz and 90 mJ, respectively. Efficacy was evaluated by comparing pre- and post-treatment Sexual Health Inventory in Men (SHIM) scores, International Index of Erectile Function (IIEF-5) and Erection Hardness Score (EHS). Possible relationships between type of shockwave generator, source, morphology and type of ED were investigated. RESULTS: A total of 94 men were included in the analysis. There were no significant differences in the baseline clinical characteristics or demographics. The mean (SD) increase in the scores from questionnaires evaluated at 8 weeks was clinically and statistically significant, with overall improvements of +5.49, +5.47 and +1.18 (p<0.0001) in the IIEF-5, SHIM, and EHS scores, respectively. The increases in these scores were evaluated by a multiple regression analysis, in relation to the shockwave generator, type of ED, shockwave source and morphology, but none of the factors examined predicted improvement. No side effects were reported with any device. CONCLUSIONS: SWT is a clinically effective and safe treatment for ED that is independent of the generator type, source, shockwave morphology emitted, type of ED and perhaps treatment protocol.

How much do people know about male sexual problems? A survey in a selected population sample.

OBJECTIVES: Our purpose has been to investigate by an ad hoc questionnaire the knowledge of several aspects of male sexual dysfunction in a significant sample of men and women (largely not physicians) attending an International Health Care Exhibition, held in Italy. MATERIALS AND METHODS: The survey took place during Exposanità, 2018 edition, aimed at medical and non-medical professionals. We devised as investigation tool an ad hoc anonymous questionnaire in two versions, one for each sex. Object of this report are questions addressing subject's knowledge of prevalence of erectile dysfunction (ED), ED causes, ED as early sign of coronary heart disease/myocardial infarction, available ED treatments and attitudes towards penile prosthesis, and reimbursement of ED treatments. RESULTS: As many as 1094 Convention attendees (495 men, 599 women) participated to the survey (about 4% of total attendees). Mean sample age was 40.5 years in men and 39.9 years in women. Forty-three percent of the sample worked in healthrelated professions, 5.9% being physicians. Respondents globally over-estimated the prevalence of ED. Both responding men and women rated psychologic and lifestyle factors as the most frequent ED causes. The majority of responders did not regard ED as a possible predictor of cardiovascular events. Oral pills resulted the most known ED treatment by both men (77.2%) and women (79.1%). Psychotherapy ranked as the second most known treatment approach. Other effective ED treatments (intracavernosal injections, vacuum erection device, penile prostheses) were known by a minority of men (22.2-27.9%) and women (19.2-20.2%). Roughly half of the sample (50.7% of men and 48.4% of women) were willing to choose (men) or to support (women) the penile prosthesis option in cases of severe ED; majority of both sexes (71.3% of men and 76.3% of women) expressed no resistances to the perspective of penile prosthesis use. Vast majority of men (80.3%) and women (80.4%) considered that coverage for ED treatments should be provided by the National Health System. CONCLUSIONS: The outcomes of our survey show both an elevated prevalence of misconceptions on the role of organic factors in the etiology of ED, and ignorance of the implications of ED on cardiovascular health. Knowledge of available second level ED treatments resulted scanty. Nonetheless, when confronted with the most aggressive treatment, penile prosthesis, majority of both genders responders would undergo/support this surgery, should it be the only way to solve the erectile problem. In this perspective, population appears ready and overall keen to a treatment option that too often is not addressed by majority of the medical community when counseling men with severe ED not responsive to conservative approach.

INSIST-ED: Italian Society of Andrology registry on penile prosthesis surgery. First data analysis.

OBJECTIVES: The Italian Society of Andrology, i.e. "Società Italiana di Andrologia" (S.I.A.), launched on December 2014 a prospective, multicenter, monitored and internal review board approved Registry for penile implants, the "INSIST-ED" (Italian Nationwide Systematic Inventarisation of Surgical Treatment for ED) Registry. Purpose of this first report is to present a baseline data analysis of the characteristics of penile implant surgery in Italy. MATERIAL AND METHODS: The INSIST-ED Registry is open to all surgeons implanting penile prostheses (all brands, all models) in Italy, providing anonymous patient, device, surgical procedure, outcome, follow-up data, for both first and revision surgeries. A Registry project Board overviews all the steps of the project, and a Registry Monitor interacts with the Registry implanting surgeons. RESULTS: As by April 8, 2016, 31 implanting surgeons actively joined the Registry, entering 367 surgical procedures in its database, that comprise: 310 first implants, 43 prosthesis substitutions, 14 device explants without substitution. Implanted devices account for: 288 three-component devices (81,3%), 20 two-component devices (5,4%), 45 non-hydraulic devices (12,3%). Leading primary ED etiologies in first implant surgeries resulted: former radical pelvic surgery in 111 cases (35,8%), Peyronie's disease in 66 cases (21,3%), diabetes in 39 cases (12,6%). Two intraoperative complications have been recorded. Main reasons for 57 revision surgeries were: device failure (52,6%), erosion (19,3%), infection (12,3%), patient dissatisfaction (10,5%). Surgical settings for patients undergoing a first penile implant were: public hospitals in 251 cases (81%), private environments in 59 cases (19%). CONCLUSIONS: The INSIST-ED Registry represents the first European experience of penile prosthesis Registry. This baseline data analysis shows that: three-pieces inflatable prosthesis is the most implanted device, leading etiology of erectile dysfunction (ED) in patient receiving a prosthesis is former radical pelvic surgery, primary reason for revision surgery is device failure, primary settings for first penile implant surgery are public hospitals. Evaluation of penile implant impact on recipients quality of life is presently ongoing.