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.

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.

Feasibility study for interspecialistic collaboration in active research of urothelial neoplasms of professional origin.

INTRODUCTION: In Italy only a small fraction of cancer is reported to the supervisory body and recognised as professional by the insurance institution. Among the causes of this sub-notification, especially for lowgrade etiologic fractional cancers such as bladder cancers are the lack of knowledge of carcinogenicity in the occupational field and the consequent incomplete medical history collections. OBJECTIVES: Diagnosis of occupational bladder neoplasms and activation of systematic surveillance of tumors of professional origin through an "active research" program. METHODS: From July 2010 to July 2017, all patients diagnosed with Bladder Cancer in the departments of Urology of Area Vasta 3 ASUR Marche underwent a first interview and a further anamnestic study in selected cases.When an occupational exposure was recognised, more information for preventive, social security and criminal justice has been acquired. RESULTS: The study highlighted 18 cases of bladder tumors due to occupational exposure to aromatic amines and polycyclic aromatic hydrocarbons, which are the most important risk factor for BC after tobacco smoking. CONCLUSIONS: Our study confirmed that active research is an useful tool both for the activation of epidemiological surveillance and for the regional registration of professional tumors. In addition active research of occupational exposure allow obtaining information that can be used for preventive purposes, for criminal justice and for the initiation of medico-legal actions and improvement of working conditions aimed at guaranteeing workers' rights.

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.

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.

Salvage Procedure in Case of Urethrocavernous Fistula after Revision Surgery for Malfunctioning Three-Piece Penile Prosthesis.

Urethrocavernous fistula is a rare complication of penile prosthesis. Literature lacks any materials regarding this complication's treatment. We report our experience with a 66-year-old man who developed urethrocavernous fistula after penile prosthesis implant. Our technique involves the careful closure of urethral and corpus cavernosum defects with application of TachoSil (®) above the sutures. After the salvage procedure, no recurrence of fistula occurred and patient was able to have sexual intercourse. We believe that our technique may be successfully used in case of urethrocavernous fistula after penile prosthesis implant.

Testicular sparing surgery in small testis masses: A multinstitutional experience.

INTRODUCTION: The incidence of benign testicular tumors is increasing in particular in small lesion incidentally found at scrotal ultrasonography. Primary aim of this study was to perform radical surgery in malignant tumor. Secondary aim was to verify the efficacy of the diagnostic-therapeutic pathway recently adopted in management of small masses with testis sparing surgery in benign lesions. MATERIALS AND METHODS: In this multicenter study, we reviewed all patients with single testis lesion less than 15 mm at ultrasound as main diameter. We applied the diagnostic-therapeutic pathway described by Sbrollini et al. (Arch Ital Urol Androl 2014; 86:397) which comprises: 1) testicular tumor markers, 2) repeated scrotal ultrasound at the tertiary center, 3) surgical exploration with inguinal approach, intraoperative ultrasound, and intraoperative pathological examination. Definitive histology was reviewed by a dedicated uro-pathologist. RESULTS: Twenty-eight patients completed this clinical flowchart. The mean lesion size was 9.3 mm (range 2.5-15). Testicular tumor markers were normal except in a case. Intraoperative ultrasound was necessary in 8/28 cases. We treated 11/28 (39.3%) with immediate radical orchiectomy and 17/28 (60.7%) with testis-sparing surgery. Definitive pathological results were: malignant tumor in 6 cases (seminoma), benign tumor in 10 cases (5 Leydig tumors, 2 Sertoli tumors, 1 epidermoid cyst, 1 adenomatoid tumor, 1 angiofibroma), benign disease in 11 (8 inflammation with haemorragic infiltration, 2 tubular atrophy, 1 fibrosis), and normal parenchyma in 1 case. We observed a good concordance between frozen section examination and definitive histology. Any malignant tumor was treated conservatively. Any delayed orchiectomy was necessary based on definitive histology. CONCLUSIONS: The incidence of benign lesions in 60% of small testis lesions with normal tumor markers makes orchiectomy an overtreatment. Testicular sparing surgery of single testicular nodules below 15 mm is a safe option, but requires a standardized pathway in diagnosis. Our pathway has shown good reliability and security profile to be applied in a multicenter management for small scrotal masses. Our study has shown the reliability of the diagnostic-therapeutic pathway in the management of single testicular masses. The higher incidence of benign lesions in 60% of patients makes often orchiectomy an overtreatment.

Rare presentation of a testicular angiofibroma treated with testis sparing surgery.

INTRODUCTION: Testicular benign tumors are very rare (< 5%). Testicular Angiofibroma (AF) is one of those, however the gold standard of treatment and follow-up is still unclear. CASE REPORT: A 47 years-old man with only one functioning testis was referred to our clinic for a palpable right testicular mass and atrophic contralateral testis. Patient underwent testis-sparing surgery with inguinal approach and intraoperative frozen sections examination with diagnosis of AF. Final histology confirmed AF. Post-operative follow-up was uneventful. Clinical and ultrasonographic follow-up was negative after 8 months. CONCLUSION: We report a conservative surgery in a patient with AF of the solitary testis. AF is a benign para-testicular fibrous neoplasm that could be misinterpreted as malignant tumor and treated with orchiectomy. Testis-sparing surgery is recommended in this case with intraoperative pathological examination. The excision of the mass is enough but in front of a possible recurrence a long follow-up is advisable.

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.

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.

[Transrectal prostatic biopsy with "end-fire" endovaginal probe]. / Biopsia prostatica transrettale con sonda endovaginale "end-fire".

OBJECTIVE: Sextant ultrasound-guided biopsy is still the standard way for the diagnosis of prostate cancer, although there have been several modifications. We report our experience using a 7.5 MHz endovaginal "end-fire" probe in patients undergoing prostate biopsy because of clinical findings suggestive of prostate cancer (abnormal digital rectal examination and/or elevated prostate specific antigen). MATERIALS AND METHODS: Since June 1999 to December 2001, we performed 262 ultrasound-guided transrectal 18G core biopsies with a 7.5 MHz endovaginal "end-fire" probe, using different schemes according to the presence or not of suspicious areas on ultrasound (a modified sextant biopsies plus two cores from the transitional zone with multiple cores from and around suspected lesions in case of abnormal findings on ultrasound). RESULTS: We obtained a detection rate of about 44%. Complications were mild: 5 cases (1.9%) of urosepsis and 4 cases (1.5%) of urinary retention. Both haematuria and rectal bleeding were not significant. CONCLUSIONS: The endovaginal "end-fire" probe allows us to obtain core biopsies in both longitudinal and transverse view. This means an optimal sampling of the prostate gland, in particular a better and safer sampling of transitional zone avoiding the prostatic urethra and the choice of the best plane in order to sample more peripheral zone and its lateral aspects. Furthermore, with the "end-fire" probe it is quite simple to obtain cores biopsies from every portion of the prostate gland and, consequently, it is possible to make an accurate staging of the disease prior to surgery.