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.

Which patient may benefit the most from penile prosthesis implantation?

BACKGROUND: Penile prosthesis implantation has been associated with overall good functional outcomes. Of relevance, some patients reported higher level of satisfaction and quality of life. AIM: We investigated the profile of the patients who may benefit the most from penile prosthesis implantation. MATERIALS AND METHODS: Data from a national multi-institutional registry of penile prostheses including patients treated from 2014 to 2017 in Italy (Italian Nationwide Systematic Inventarization of Surgical Treatment for Erectile Dysfunction) were analyzed. All data have been prospectively recorded by 45 surgeons on a dedicated website (www.registro.andrologiaitaliana.it) and revised by a single data manager. Patients' baseline characteristics were recorded. In order to simultaneously evaluate perceived penile prosthesis function and quality of life, all patients were re-assessed at 1-year follow-up using the validated questionnaire Quality of Life and Sexuality with Penile Prosthesis. High quality of life after surgery was defined as a score higher than the 75th percentile in each of the subdomains of the Quality of Life and Sexuality with Penile Prosthesis questionnaire. Logistic regression analysis tested the association between clinical characteristics and high quality of life after penile prosthesis implantation. RESULTS: Follow-up data were available for 285 patients (median age 60 years; interquartile range: 56-67) who underwent penile prosthesis implantation. Erectile dysfunction etiology was organic in 40% (114), pelvic surgery/radiotherapy in 39% (111), and Peyronie's disease in 21% (60) of the cases. Patients showed good overall Quality of Life and Sexuality with Penile Prosthesis scores at 1-year follow-up for functional (22/25), personal (13/15), relational (17/20), and social (13/15) domains. Overall, 27.0% (77) of patients achieved scores consistent with the high quality of life definition. These patients did not differ in terms of median age (60 vs. 62), type of prosthesis (inflatable penile prostheses: 95% in both of the cases), and post-operative complications (10% vs. 14%) than those with lower quality of life score (all p > 0.1). At logistic regression analysis, erectile dysfunction etiology was the only factor independently associated with high quality of life at 1 year after surgery (p = 0.02). Patients treated for Peyronie's disease (odds ratio: 2.62; p = 0.01; 95% confidence interval: 1.20-5.74) were more likely to report better outcomes after accounting for age, post-operative complications, and surgical volume. CONCLUSION: Penile prosthesis implantation is associated with an overall good quality of life. The subset of patients affected by erectile dysfunction secondary to Peyronie's disease seemed to benefit the most from penile prosthesis implantation in terms of functional outcomes, relationship with their partners and the outside world, and perceived self-image. The systematic use of validated questionnaires specifically addressed at evaluating quality of life and satisfaction after penile prosthesis implantation should be further implemented in future studies to better define the predictors of optimal satisfaction after penile prosthesis implantation.

Cyber pornography use and masturbation outburst. Considerations on 150 italian patients complaining erectile dysfunction and trying to solve it.

OBJECTIVE: We aimed to verify the rate of masturbation (Mst) in a group of 150 Italian patients complaining Erectile Dysfunction (ED). MATERIALS AND METHODS: Our diagnostic protocol for penile and sexual problems included the collection of the patient's history, general and local clinical examination, and metabolic and hormonal analyses. Selected patients were also submitted to nocturnal penile tumescence test (Rigiscan), Duplex ultrasound of the penis, Magnetic Resonance Imaging, neurological tests and cardiological examination. A group of 150 Italian males (aged between 20 and 86 years) who complained ED and who presented to our Andrological Center to research the possibility of correcting their ED and being able to recover adequate sexual erectile activity were included in this study. In this group of patients suffering from ED we decided to evaluate the practice of Mst by asking specific questions: 1. Do you sometimes practice Mst? 2. How often in a week? 3. Is Mst hidden or known by the partner? 4. What do you use as a masturbatory sexual stimulus? The frequency of Mst was assessed according to a Likert scale as follow: a: No Mst; b:1-2/week; c: 2-3/week; d: > 3/week; e: daily or more. We also asked if it was possible to have penetrative marital intercourse on the same day as Mst (1-10 hours). We also asked what they used as a triggering sexual stimulus: press magazines, TV movies, the WEB. RESULTS: Only 5/150 patients did not report Mst while 27/145 pts (aged 20-30 years) reported it more than 3 times a week; 44/145 (aged 31-50 years) 1-3 times a week and 27/145 (51-86 years) 1-2 times a week. Almost all patients used WebPorn as a stimulus for Mst. A group of patients over the age of 50 said they were quite satisfied with the physical results of Mst even though they would prefer to have sex as part of a couple relationship. CONCLUSIONS: The outburst of Mst in this web-dominated era could affect the sexual activity of individual males and couples.

The woman and the penile prosthetic implant. Primary or secondary role? Personal experiences on 355 implanted patients.

In a group of 355 pts  submitted to Penile Prosthesis Implant (PPI) we recorded data on their relationships with the woman (wife, partner, girlfriend, lover); the aspects of their sexual life; if they were married, divorced or widowed; if they had a lover; if they frequented brothels; if they were satisfied of their actual couple's life; after operation we recorded data concerning if they had some difficulties utilizing the PPI and their level of satisfaction. After operation most pts (93%) confirmed their satisfaction. Relational aspects:  Unmarried pts: 6 pts (21-30 years old) who weren't able to penetrate their girlfriends managed to have regular sex with PPI and could marry. 42/46 unmarried pts after PPI decided to marry.  In the group of married pts 3 pts weren't able to penetrate  their wives; after PPI  they  managed to have regular intercourses and pregnancies. 15 widowers and 23 divorced  pts decided to have a PPI for possible sexual encounters or stable relationships. 96/271 (28,2%) married pts declared a stable extramarital relation that could represent the main reason for having a PPI.  The results of PPI are commonly accepted. Until now PPI may re-establish  penile rigidity and maintenance. In our opinion the simple act of penetrate and ejaculate in vagina, without considering the importance of personal, relational, emotional factors  often well linked to the specific woman, cannot be considered the ideal target of PPI.

Penile prosthesis and complications: Results from 577 implants.

OBJECTIVE: Penile Prosthetic Surgery is already well characterized but the problems connected with possible complications still need to be evaluated and discussed. MATERIAL AND METHODS: The Authors revaluated their experience in Penile Prosthetic Surgery involving 577 patients (18 - 86 years, mean age 51.3 years) operated by the same surgeon since 1984. We implanted 199 silicone-semi-rigid (Small Carrion, Implantal, Eurogest, Subrini, SSDA GS), 200 malleable (Jonas, Omniphase, Duraphase, AMS600, MentorColoplast Genesis, Vedise) and 178 inflatable (Mentor: Mark II, Alpha I, Titan OTR; AMS: mono-component Hydroflex, Dynaflex; bi-component Ambicor; multicomponent: 700 Ultrex, 700 CX, 700 LGX) prostheses. Operative, postoperative, infectious and malfunctioning complications have been recorded. A total of 156 patients drop out at follow-up and we may not exclude possible late complications treated at different hospitals. RESULTS: The recorded complications and the therapeutic modalities utilized to treat them are examined. Operative complications were recorded in 2 malleable prostheses (MPP) and in one inflatable prosthesis (IPP). Postoperative complications have been recorded in three cases of MPP (1.5%) and in 9 IPP (5.0%) and were strictly connected to general medical co-morbidities as diabetes mellitus (DM), coronary artery dysfunction (CAD), and Peyronie's disease (PD). In three cases of IPP implantation, hematomas were related to the blunt surgical maneuvers utilized to insert the reservoir or the scrotal pumps. Infectious complications were mostly observed in patients with DM: 4 patients with MPP (1.0%) and 15 patients with IPP (8.4%). Malfunction rate of the prostheses in our series was really disappointing considering that 13/17 cases (77%) of mono-component IPP broke while in patients with multicomponent IPP the percentage of malfunction has been of 13/161 (8%) and malfunction was observed in only one case of MPP. We were forced to explant the prostheses in 2 patients with MPP (0.5%) and 40 with IPP (22%). However, after excluding 17 mono-component IPPs, the percentage of explants of multicomponent IPP (23 patients, 4.2%) is in line with other significative experiences. CONCLUSION: The number of complications of PPS are similar to those reported by well qualified urological institutions. In our experience a scrupulous antibiotic therapeutic schedule, avoiding direct contact between the prostheses and the patient's skin, reduced time of surgery with surgeon's experience positively influenced the results.In a limited number of patients medical treatment or minimal surgical acts allowed to solve the complications preserving the prostheses and avoiding the prosthetic explant.

Preputial circumcision performed with a new mechanical stapling tool. The "langhe disposable circumcision suture device". Preliminary experiences.

The Authors present their preliminary clinical experiences in performing preputial circumcision utilizing a new stapling tool.

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.

500 penile prostheses implanted by a surgeon in Italy in the last 30 years.

OBJECTIVES: The aim of our study was to report our experience with patients affected by Erectile Dysfunction (ED) and undergoing penile prosthetic implantation (PPI) in a single center by a single surgeon. MATERIAL AND METHODS: We retrospectively evaluated the clinical outcome of 500 patients (mean age: 51.5 years, range: 20-86 years) affected by ED and referred to our private andrological center from January 1984 to December 2013 who underwent penile prosthesis implantation, including the reported level of patient satisfaction. RESULTS: 182 silicone, 180 malleable, 18 monocomponent hydraulic and 120 multicomponents hydraulic prostheses were implanted by the same experienced surgeon. All patients were hospitalized for the procedure. All patients were evaluated immediately, 1 month (496 patients) and, for the great majority, every year after implantation. One hundred twenty five patients were lost to follow-up. Twenty two patients underwent revision surgery for complications in the postoperative period. The most serious postoperative complications were mechanical problems (45 patients, 9.0%) and infection (15 patients, 3%). Forty two (8.4%) prostheses were explanted. Overall, 80% (400/500) of patients were able to have sexual intercourse and were fully satisfied with the results. CONCLUSIONS: In our experience prosthetic surgery should be considered a good solution for men affected by ED and not responsive to other therapeutic solutions. Prosthetic surgery can be performed not only in large public hospitals but also in smaller private facilities.