Satisfaction rate at 1-year follow-up in patients treated with penile implants: data from the multicentre prospective registry INSIST-ED.

OBJECTIVES: To investigate scores and predictors of patient satisfaction at 1 year after penile prosthesis implantation (PPI) using the validated Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire. PATIENTS AND METHODS: Analyses were performed for 142 patients prospectively included in the national multicentre registry Italian Nationwide Systematic Inventarization of Surgical Treatment for Erectile Dysfunction (INSIST-ED), which provided 1-year follow-up data. Postoperative patient satisfaction was assessed using the validated QoLSPP tool. Linear logistic regression analyses assessed predictors of QoLSPP total and single domain scores, including age at surgery, erectile dysfunction aetiology, type of prosthesis, surgical approach, surgeon experience and complications. Locally weighted regression methods were used to explore the relationship between surgeon experience and QoLSPP scores. RESULTS: Overall, high median functional, relational, social, personal and total QoLSPP scores were reported at 1 year after PPI. Patients implanted with hydraulic devices had higher functional (23 vs 21.5; P = 0.01) and total scores (68 vs 65.5; P = 0.03) than those with a malleable prosthesis. Surgeon experience emerged as the only independent predictor of higher satisfaction scores, depicting a non-linear association with both QoLSPP total and single domain scores (all P < 0.03). Data suggested that the higher the number of procedures per year, the greater the satisfaction scores, reaching a plateau after l5 procedures/year. CONCLUSIONS: This study reports high functional and patient satisfaction scores at 1 year after PPI surgery using a dedicated tool for the first time. Better outcomes should be expected for patients treated by surgeons with greater experience.

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.

A questionnaire for the evaluation of quality of life after penile prosthesis implant: quality of life and sexuality with penile prosthesis (QoLSPP): to what extent does the implant affect the patient's life?

INTRODUCTION: Penile prosthesis implantation is considered to be a satisfactory treatment for erectile dysfunction. Previous studies have assessed mainly prosthesis function and perioperative complications and have measured satisfaction only with regard to sexual performance. Very little, if anything, has been reported on the most relevant question: To what extent does the implant affect the patient's life? AIM: To develop and validate the pathology-specific Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire, which evaluates patients' quality of life after penile prosthesis implantation. METHODS: Sixty-nine patients aged 32-82 years who received a three-component hydraulic prosthesis between 1997 and 2009 participated in the study; 47 participated in the retest of the instrument. The QoLSPP questionnaire was developed to examine general and sexual quality of life in four domains: functional, personal, relational, and social. All psychometric properties of the QoLSPP were validated. Internal validity was assessed by means of exploratory factor analysis. Cronbach's alpha was used to evaluate the internal consistency of the items within each factor. Paired-sample t-tests were used to investigate metric stability. Independent-samples t-tests and nonparametric tests were used to evaluate the sensitivity. MAIN OUTCOME MEASURES: The main outcome measure for the questionnaire was quality of life as biological and psychosocial-relational well-being. Main outcome measures for validation were internal validity, metric stability, and sensitivity of the QoLSPP. RESULTS: The QoLSPP met the psychometric requirements of internal validity and reliability. Metric stability and sensitivity were tested and confirmed. Respondents reported high satisfaction levels in all quality of life domains. All domains were significantly and positively correlated; the functional domain was most predictive of overall quality of life. More than half of respondents perceived their partners to be very satisfied. CONCLUSIONS: Prosthesis implantation was correlated with high quality of life in recipients and high perceived quality of couple relationships; partner satisfaction affected patients' quality of life, self-image, relation to the outside world, and satisfaction with implant function.

Pseudo-capsule "coffin effect": how to prevent penile retraction after implant of three-piece inflatable prosthesis.

OBJECTIVE: Following three-component implantation of a penile prosthesis, some patients are dissatisfied with their penile length. This may be due to the procedure by itself or pre-existing risk factors or psychological reasons. We supposed that formation of a restricted pseudo-capsule due to a late prosthesis activation can inhibit later system expansion. We aimed to identify the presence or absence of penile retraction after implant and to prevent it by immediate prosthesis activation after implantation. MATERIAL AND METHODS: Forty-six patients operated with three-piece inflatable penile prosthesis (AMS 700 CX o LGX) were enrolled. In 27 patients prosthesis was first activated four weeks after surgery (NEA group) and in 19 patients prosthesis was activated immediately after surgery (DEA group). Length and girth of the penis was evaluated before (in DEA group) and after the surgical procedure. RESULTS: The average post implant dorsal length of the erect penis in group NEA was found 3.28 cm shorter than in group with early activation (DEA). In DEA group there was no lenght difference between pre-operative stretching (14.57 cm) and post operative erection (14.98 cm). When early activation was not performed, the clinical result was a smaller penis in erect phase. CONCLUSION: Reduced lenght of the penis after implantation can be caused by the presence of a pseudo-capsule that limits the elongation of the prosthesis and of the penis ("coffin effect"). Timing of first activation seems to be the key in order to prevent the risk of penile retraction after implantation. Early activation is identified as the best measure to maintain the length of the pre implant erect penis after the prosthetic hydraulic implant.

Use of a Non-cross-linked Xenograft (Xenform) in Surgical Treatment of Peyronie's Disease.

OBJECTIVE: To evaluate the effectiveness in Peyronie's disease surgical treatment using Xenform, a non-cross-linked graft derived from dermal bovine tissue, to close the defect obtained after plaque incision, without penile prosthesis implant. A further objective is to evaluate the satisfaction of patients. MATERIALS AND METHODS: We treated with plaque incision 28 patients with a stable penile curvature ≥60° hindering penetration and with erectile function conserved. International Index of Erectile Function-15 and a not-validated questionnaire constituted of 7 questions about their satisfaction were administered after 1 year of follow-up. Furthermore, specific questions were relative about penile straightening, penile postoperative length, glandular sensitivity, and feeling palpability. RESULTS: Graft is resulted compatible with albugineal features, like thickness, consistency, and elasticity; it is waterproof, allowing the visualization of complete correction of the curvature after the suture. No severe complications were observed except 1 hematoma requiring surgical revision. Sixteen patients were seen after at least 1 year of follow-up. Curvature improvement was obtained in all cases, with the complete straightening in 75%; we did not observe any retraction of the graft and any recurrence on the curvature. Significant reduced glans sensibility and erectile dysfunction were the more frequent postoperative complications, resulting in 43.8% and 25%, respectively. All patients are satisfied with the straightening. Only 2 patients are dissatisfied about the overall result. CONCLUSION: Plaque incision corporoplasty with Xenform graft is an effective and safe surgical treatment. Xenform is a secure and a reliable albugineal substitute, comparable to other heterologous graft. We have not observed any retraction. Patient's satisfaction is linked to the treatment result and to sexual life.