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.

An original mininvasive corporoplasty technique for penile curvature without circumcision.

OBJECTIVE: We describe an original minimally invasive penile plication technique with scrotal or infrapubic access, not requiring circumcision, for penile curvature of different severity and types. This technique can be used to correct both congenital and acquired curvatures, mono or bidirectional deformities. MATERIALS AND METHODS: Between 2012 and 2018 we treated 134 patients suffering from congenital curvature (33) and acquired curvature from Peyronie's disease (101). The average curvature was 62.2° (± 30.4°). Preoperative evaluation included prostaglandin E1 injection with photographic documentation and measurement of penile angulation, administration of IIEF- 15, vasoactive penile Doppler ultrasound, analysis of thermal and vibratory sensitivity with Genito-Sensory-Analyzer (GSA) and assessment of nocturnal penile stiffness with Rigiscan, performed twice, for a detailed evaluation of patient's erectile function. Scrotal access was performed in patients with dorsal and/or lateral penile curvature; the infrapubic access was performed in patients with ventral curvature. After preparation and incision of Colles' fascia, penis was partially degloved and an original plication technique called "binary corporoplasty" was performed at the site or sites established at preoperative assessment, with non-resorbable synthetic multifilament (Premicron®) suture. RESULTS: Complete correction of penile curvature was achieved in 96.8 % of patients. No major complications were reported, and no patients suffered worsening in erectile function or in penile sensitivity. The average shortening of convex side was 1.65 cm (± 0.7 cm) and all patients report easy intercourse after correction. The average time of surgery was 46 minutes (± 11 min) and all procedures were performed as a day-hospital or ambulatory settings, with local anesthesia and light sedation. Overall satisfaction rate is 96%. CONCLUSIONS: This is a simple and rapid technique that perfectly corrects even the most severe and complex penile curvatures. In comparison to traditional techniques, such as Nesbit procedure, this technique is associated with low morbidity, a very low recurrence rate and a great aesthetic results. Aesthetic and functional patients' satisfaction was excellent.

Penile lenghthening original technique using a pubo-cavernous spacer. Long term results from a series of over 200 patients.

INTRODUCTION: We report our long experience in the surgical treatment of patients requesting penile lengthening by suspensory ligament release and placement of a custom-made soft silicone pubo-cavernous spacer. The aim was to show that with this surgical technique the results obtained are maintained over time. It is crucial to achieve postoperative satisfaction of these patients who show fragility and self-esteem problems. METHODS: From 1999 to 2020, we treated 245 patients with congenital or acquired penile brevity. We carefully analysed the preoperative and postoperative (at 6, 12, 24 and 48 months) penile size of the patients to evaluate whether this technique could allow the long-term maintenance of aesthetic results. We also assessed preoperative erectile function and we focused on the psychological aspects to avoid surgery in patients with dysmorphophobia. This original technique involves the section of the suspensory ligament and the implantation of a silicone spacer between the pubic symphysis and the corpora cavernosa. This spacer is conformed to the patient anatomy and maintains the relationship between the anatomical structures unchanged over time. Sexual self-esteem and patient satisfaction were assessed with the APPSSI questionnaire. RESULTS: The mean increase in penile length was about 2.5 cm in flaccid state and 1.9 cm in stretched state. There were no injuries of the neurovascular bundle or urethra, and no erectile dysfunction was noted. These results persisted at 6, 12, 24 and 48 months without significant differences. Over 80% of patients stated that they were completely satisfied with the results obtained. This satisfaction remained stable along follow up. CONCLUSION: The section of the suspensory ligament and the implant of the soft silicone spacer provide real penis elongation with satisfactory results that persist over time. This technique avoids the frequent complication of short-term shortening due to the scar adhesions of the edges of the dissected ligament. The high aesthetic satisfaction of patients is stable at controls at 6, 12, 24 and 48 months.

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.

New surgical technique for ventral penile curvature without circumcision.

OBJECTIVES: To describe and report on our variant of penile corporoplasty, the 'double-breasted' corporoplasty, with penoscrotal and infrapubic access not requiring circumcision. The medicolegal aspects of treatment are also discussed. PATIENTS AND METHODS: Between February 1995 and October 2012, double-breasted corporoplasty was performed in 93 patients with congenital ventral penile curvature. Preoperative assessment comprised RigiScan monitoring, prostaglandin E1 injection with photographic documentation and measurement of penile angulation, administration of the International Index of Erectile Function-5 (IIEF-5) questionnaire, and biothesiometry up until 5 years ago when it was substituted with the Genito Sensory Analyser for testing sensitivity. Dorsal infrapubic access was used in the patients with ventral curvature. After preparation and incision of Colles' fascia, the penis is degloved and double-breasted corporoplasty is performed at the site established at preoperative assessment. The tunica albuginea is prepared, an incision is made, and the cavernous tissue is isolated from the albuginea to obtain two flaps that are then overlaid and sutured asymmetrically with interrupted 2-0 polyglactin 910 (Vicryl®) sutures. After the free edge of the albuginea is sutured with a running polyglactin 910 suture, a non-absorbable monofilament and uncoated suture made of polypropylene (Premicron®) suture is placed at the point of maximum traction. RESULTS: Complete correction of penile curvature was achieved in 96% of patients; recurrence occurred in 4%. No major complications were reported, nor were there neurovascular lesions or change in erectile function. Palpable subcutaneous irregularities at the site of the corporoplasty, without functional or aesthetic impairment, were reported by 35% of patients. There was no change in the appearance of the penis as circumcision was not performed and the residual scar was barely noticeable as it was hidden in the infrapubic fold. The corporoplasty technique can adequately restore the patient's psychophysical integrity, making it, from a medicolegal perspective, one of the most reliable procedures in the surgical repair of penile curvature. CONCLUSIONS: This original technique is associated with low morbidity, a low recurrence rate and excellent aesthetic results. The results show that it is safe and effective. When indicated for the surgical treatment of penile curvature, the choice of the technique satisfies the criteria of diligence and prudence for the surgeon's conduct.

Reconstructive surgery of the sulcus of glans penis for balanopreputial adhesion due to lichen sclerosus. Our experience and medicolegal implications.

AIM: Our exeperience with the reconstructive surgery of the adhesion of the glans with the preputial skin due to lichen sclerosus. MATERIAL OF STUDY: Twentyeight patients (mean age, 44 years; range, 28-69) underwent reshaping of the balanopreputial sulcus at our institution. All patients presented with trapped penis resulting from adhesion at the sulcus of glans due to Lichen Sclerosus. The procedure entailed separating the coronal adhesion along its entire length with the use of a blunttipped forceps, then reshaping the balanopreputial sulcus. Though simple, the maneuver is delicate and requires scrupulous attention to the ventral aspect to avoid damaging the urethra. The adhesion is removed circumferentially around the glans by means of electrobistoury. RESULTS: The duration of the follow-up period was 24 months. All patients stated they were satisfied with the cosmetic results and functional outcome. Recurrence of the condition occurred in 7% of the patients and was treated medically; recurrence of adhesion occurred in 2% of the patients and was treated with repeat surgery. DISCUSSION: The indication for medical therapy in early LS is a selective criterion restricted to less severe cases; otherwise, the physician may be held responsible for treatment failure, justified claims for reimbursement, disease progression and the decidedly greater damage that may ensue. Such consequences can be averted when assessment is based on recent scientific evidence and the approach to treatment is appropriate in terms of efficacy and effectiveness. Surgical management is definitive and restores normal penile anatomy and function, including sexual and urinary function, thus enabling the patient to regain sexual confidence CONCLUSIONS: Lichen sclerosus et atrophicus is a rare disease, however, its management is not devoid of medicolegal considerations. The etiopathogenesis of the disease is unknown but progression to carcinoma of the penis has been reported in untreated cases. Consequently, timely diagnosis holds medicolegal relevance for averting delayed initiation of treatment. In cases of balanopreputial adhesion with disappearance of the sulcus of glans, we proceed with lysis and reshaping of the sulcus by means of a simple technique we have developed. The technique involves separating the coronal adhesion circumferentially around the glans using a blunt-tipped forceps, then reshaping the balanopreputial sulcus. Though very simple, the procedure is also delicate as the surgeon must be careful not to damage the urethra beneath the ventral surface.

Penile subcutaneous fibrolipoma postaugmentative phalloplasty.

Fibrolipomas are a rare subtype of lipomas. We describe a case of a man suffering from subcutaneous penile fibrolipoma, who three months earlier has been submitted to an augmentative phalloplasty due to aesthetic dysmorphophobia. After six months from the excision of the mass, the penile elongation and penile enlargement were stable, and the patient was satisfied with his sexual intercourse and sexual life. To our knowledge, this is the first reported penile subcutaneous fibrolipoma case in the literature. The diagnostics and surgical features of this case are discussed.

Two-step surgery for a unique case of idiopathic female pseudohermaphroditism. Surgical treatment in an exceptional combined uro-genital malformation.

A 15 years-old patient was brought to our attention in June 2010 with a complex genito-urinary malformation: fusion of the labia majora and a partial union of labia minora, common urinary and vaginal meatus and clitoromegaly. The patient had a normal sexual feminine hormonal development. After diagnostic iter the patient underwent surgery twice. No signs of hormonal deficency was shown authorizing us to approach the disease as a congenital malformation due to an abnormality of intrauterine development. So surgical treatment was carried out, considering it as the gold standard for this type of malformations. It's considerable to emphasize that the association between clitoromegaly and fusion of the lower third of the urethra with the vagina has not been previously reported in the literature.

Lichen sclerosus in patients with squamous cell carcinoma. Our experience with partial penectomy and reconstruction with ventral fenestrated flap.

INTRODUCTION: The vast majority of penile malignant tumors are squamous cell carcinomas (SCCs). After histological diagnosis of penile carcinoma, when possible, more conservative procedures are performed, otherwise it is necessary to perform a total penectomy. MATERIAL AND METHODS: Ten patients, from 2006 to 2008, underwent to partial penectomy and reconstruction with ventral fenestrated flap technique; five of these patients had lichen sclerosus. All tumors were staged as T2N0M0, involving the corpus spongiosum and cavernosum. Patients were evaluated both the aesthetical and the sexual satisfaction, the first one by patient aesthetical self-assessment score, the second one by the International Index of Erectile Function (IIEF). Patients underwent follow-up for forty months. RESULTS: Of the ten patients, no one encountered severe complications. The average aesthetic satisfaction one month postoperatively was of 2 points, 40 months postoperatively it was of 3 points (scoring scale: 1= complete dissatisfaction, 5 = complete satisfaction). The average IIEF score in the preoperative period was 21.6 points, one month postoperatively it was 13 points, 40 months postoperatively it was 19.7 points (mild erectile dysfunction). DISCUSSION: The technique we presented, compared to other techniques, allows a reduction in operating time and is a one step technique without risk of non-engraftment. The ventral fenestrated flap technique did not result in metal stenosis in our ten patients series. CONCLUSIONS: The use of a ventral fenestrated flap in the closure of the defect due to partial penectomy has numerous advantages. Aesthetics is highly accepted by patients who are satisfied and report satisfactory sexual activity despite the reduction in penis length.

Original technique for penile girth augmentation through porcine dermal acellular grafts: results in a 69-patient series.

INTRODUCTION: Although different techniques for augmentation phalloplasty have been reported in the medical literature, this issue is still highly controversial, and none of the proposed procedures has been unanimously approved. AIMS: The aim of this study is to describe an innovative surgical technique for penile girth augmentation with porcine dermal acellular grafts, through a small transverse incision at the penile base, along the penopubic junction. METHODS: Between 2000 and 2009, 104 patients were referred to our institution for penile enhancement. After a preoperative psychosexual consultation and a general medical assessment, 69 patients were deemed suitable good candidates for surgery. The average penis circumference was measured at the mid-length of the penis and was 8.1 cm (5.4-10.7 cm) and 10.8 cm (6.5-15.8 cm) during flaccidity and erection, respectively. All patients received penile augmentation with porcine dermal acellular grafts. MAIN OUTCOME MEASURES: Results evaluation of an innovative technique for penile girth augmentation through exogenous porcine grafts and small penobubic incision. RESULTS: Postoperative measurements were performed at 6 and 12 months. At the 1-year follow-up, the average penis circumference was 11.3 cm (8.2-13.2 cm, 3.1 cm mean increase) during flaccidity and 13.2 cm (8.8-14.5 cm, 2.4 cm mean increase) during erection. No major complications occurred in the series. Minor complications were resolved with conservative treatment within 3 weeks. Sexual activity was resumed from 1 to 2 months after surgery. The psychosexual impact of the operation was beneficial in the majority of cases. CONCLUSION: Penile girth enlargement with acellular dermal matrix grafts has several advantages over augmentation with autogenous dermis-fat grafts: the elimination of donor site morbidity and a significantly shorter operation time. With this approach, through a short dorsal incision at the base of the penis, the scar is concealed in a crease covered by pubic hair and thus hardly visible.