Serenoa repens + selenium + lycopene vs tadalafil 5 mg for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction: a Phase IV, non-inferiority, open-label, clinical study (SPRITE study).

OBJECTIVE: To compare in a randomised, open-label, non-inferiority clinical study, the efficacy and tolerability of Serenoa repens (SeR) + selenium (Se) + lycopene (Ly) (SeR-Se-Ly) therapy vs tadalafil 5 mg in men with lower urinary tract symptoms (LUTS). PATIENTS AND METHODS: From May 2015 to January 2017, 427 patients were enrolled in 21 different centres (International Standard Randomised Controlled Trial Number Register [ISRCTN] 73316039). Inclusion criteria included: age between 50 and 80 years, International Prostate Symptom Score (IPSS) ≥12, maximum urinary flow rate (Qmax ) ≤ 15 mL/s, and post-void residual (PVR) <100 mL. Patients were randomised into two groups in a 2:1 ratio: Group A (SeR-Se-Ly, 1 tablet daily for 6 months) and Group B (tadalafil 5 mg, 1 tablet daily for 6 months). The primary endpoint of the study was the non-inferior variation in the IPSS and Qmax in Group A vs Group B after 6 months of treatment. RESULTS: In all, 404 patients completed the full protocol. When comparing both therapies, Group A was statistically not inferior to Group B considering the median change in IPSS (-3.0 vs -3.0; P < 0.01), IPSS quality of life (-2.0 vs -2.0; P < 0.05), and Qmax (2.0 vs 2.0 mL/s; P < 0.01). We found statistically significant differences in the increase of at least 3 points in Qmax (38.2% vs 28.1%; P = 0.04) and of at least 30% of Qmax (39.2% vs 27.3%; P < 0.01) in Group A compared to Group B. The percentage of patients with an increase of at least 3 points in the IPSS and a decrease of at least 25% of the IPSS was not statistically different between the two groups. For adverse events, four patients in Group A (1.44%) and 10 in Group B (7.81%) (P < 0.05) reported side-effects. CONCLUSION: We have shown that treatment with SeR-Se-Ly was not inferior to tadalafil 5 mg for improving IPSS and Qmax in men with LUTS.

Risk factors for benign prostatic enlargement: The role of lifestyle habits at younger age. The #Controllati2017 initiative study group.

OBJECTIVE: The risk factors for benign prostatic enlargement (BPE) are not well understood and particularly few data are available from Italian population. MATERIALS AND METHODS: This was an observational cross sectional study aimed to examine the association between several risk factors and BPE. During the "#Controllati2017" initiative, men aged 18 years or more were invited to attend participating urologic centers for a free of charge visit for counseling about urologic or andrologic conditions. Each participating man underwent a physical examination including digital rectal examination (DRE). Further he was asked about his medical history, urologic symptoms, sexual activity and related problems. Diagnosis of BPE was made by the urologist after DRE. RESULTS: Out of the 1902 [mean age 54 years (SD 12, range 18-92)] considered men, a total of 603 subjects (31.7%) had diagnosis of BPE. The diagnosis of BPE increased from 9.3% in men aged < = 50 years, to 34.1% in those aged 51-60 years and to 58.7% among men aged > 60 years. A history of hypertension, diabetes, heart diseases, hypercholesterolemia and hypertriglyceridemia were all significantly associated with an increased risk of BPE in the total series and, although not always in a statistically significant way, in strata of age. Physical activity (PA) was significantly associated with a decreased risk of BPE. We have further analyzed the risk of BPE in men with one or more of the identified risk factors (i.e. hypertension, diabetes, heart disease, hypercholesterolemia, hypertriglyceridemia and low PA): the risk of BPE increased with number of risk factors reported by the subjects. The estimated risk were higher among younger men. CONCLUSION: In our study a history of hypertension, diabetes, heart disease, hypercholesterolemia and hypertriglyceridemia increased the risk and physical activity lowered the risk of BPE. This risk profile was observed also in men aged < 50 years.

Partial renal resection by LaparoNewPro: in vivo open and laparoscopic study in an animal model.

INTRODUCTION: The aim of this research project was to test an incremental bipolar radiofrequency generator with open and laparoscopic inline electrode probe for partial renal resection without vascular clamping. MATERIAL AND METHODS: Sixteen polar resections with clamping and six without were performed in four pigs in the acute phase. Three pigs underwent laparoscopic polar resection and were live housed for ten days and reoperated to verify the presence of hematic and urinary collection and the condition of the renal edge. Five pigs underwent laparoscopic polar resection without clamping, and two of these were live housed and reoperated after ten days. RESULTS: Polar renal resection by our system (LaparoNewPro) turned out to be effective and safe, without cardio-respiratory complications or damage to the remaining parenchyma. Coagulation of the renal parenchyma before resection is effective and safe; at the reoperation, no complications were observed. The laparoscopic version of the probe is ergonomic and safe, with effective coagulation and a small amount of smoke produced. No complications occurred in the housed animals. No damage, local or to residual parenchyma, or thrombosis of the renal vessels were found. CONCLUSIONS: LaparoNewPro is able to deliver coagulation of the resection line effectively and independently of clamping of the vessels both in the open and laparoscopic approaches. Coagulation times are short, the automatism of the generator is reliable, and the open and laparoscopic probes are ergonomic.

Patterns of prescription and adherence to European Association of Urology guidelines on androgen deprivation therapy in prostate cancer: an Italian multicentre cross-sectional analysis from the Choosing Treatment for Prostate Cancer (CHOICE) study.

OBJECTIVE: To evaluate both the patterns of prescription of androgen deprivation therapy (ADT) in patients with prostate cancer (PCa) and the adherence to European Association of Urology (EAU) guidelines for ADT prescription. METHODS: The Choosing Treatment for Prostate Cancer (CHOICE) study was an Italian multicentre cross-sectional study conducted between December 2010 and January 2012. A total of 1 386 patients, treated with ADT for PCa (first prescription or renewal of ADT), were selected. With regard to the EAU guidelines on ADT, the cohort was categorized into discordant ADT (Group A) and concordant ADT (Group B). RESULTS: The final cohort included 1 075 patients with a geographical distribution including North Italy (n = 627, 58.3%), Central Italy (n = 233, 21.7%) and South Italy (n = 215, 20.0%). In the category of patients treated with primary ADT, a total of 125 patients (56.3%) were classified as low risk according to D'Amico classification. With regard to the EAU guidelines, 285 (26.51%) and 790 patients (73.49%) were classified as discordant (Group A) and concordant (Group B), respectively. In Group A, patients were more likely to receive primary ADT (57.5%, 164/285 patients) than radical prostatectomy (RP; 30.9%, 88/285 patients), radiation therapy (RT; 6.7%, 19/285 patients) or RP + RT (17.7%, 14/285 patients; P < 0.01). Multivariate logistic regression analysis, adjusted for clinical and pathological variables, showed that patients from Central Italy (odds ratio [OR] 2.86; P < 0.05) and South Italy (OR 2.65; P < 0.05) were more likely to receive discordant ADT. CONCLUSION: EAU guideline adherence for ADT was low in Italy and was influenced by geographic area. Healthcare providers and urologists should consider these results in order to quantify the inadequate use of ADT and to set policy strategies to overcome this risk.

Laparoscopic pretransplant nephrectomy with morcellation in autosomic-dominant polycystic kidney disease patients with end-stage renal disease.

BACKGROUND: Laparoscopic nephrectomy (LN) in end-stage autosomic-dominant polycystic kidney disease (ADPKD) requires a large abdominal incision for the specimen extraction. OBJECTIVE: The objective of this study was to describe our technique of LN for end-stage ADPKD followed by morcellation (LNM) of the specimen and extraction through a minimal abdominal incision. METHODS: The medical records of 19 consecutive patients who underwent pretransplant LNM between 2008 and 2011 by a single experienced laparoscopic surgeon were analyzed. Morcellation was performed with the Gynecare Morcellex™ Tissue morcellator, Ethicon. RESULTS AND LIMITATIONS: All cases but one were completed laparoscopically. Mean specimen weight was 1,026.8 g. Mean duration of the procedure, estimated blood loss, and hospital stay were 131.3 min, 52.1 ml, and 7.9 days, respectively. Specimens were extracted through a 12-mm trocar in 10/18 patients and through a 3-cm incision in 9/18 cases. Postoperatively, three complications were observed (Clavien grades II, I, and II). The only case of incisional hernia was observed in the converted procedure. Major limitation of the study is its retrospective design. CONCLUSIONS: In our preliminary series and in the hands of a very experienced laparoscopist, LNM for ADPKD appears as a modern, mini-invasive, and safe technique. Specimen's extraction through a small abdominal incision reduces postoperative pain and incisional hernias and guarantees the final cosmetic result of laparoscopy. The reduced overall morbidity could reduce the period between nephrectomy and transplantation.

Prevalence of "complicated" stress urinary incontinence in female patients: can urodynamics provide more information in such patients?

INTRODUCTION AND HYPOTHESIS: The role of urodynamic investigation has been recently questioned on the basis of data from a selected population of patients with stress urinary incontinence defined as uncomplicated. The aim of this study was to determine the proportion of patients who underwent urodynamic investigation in our centre in whom the stress urinary incontinence could be defined as uncomplicated. The secondary aim was to assess the number of women in whom the urodynamic investigation added information to the preurodynamic assessment. METHODS: This was a retrospective single-centre study. The data from female patients who underwent urodynamic evaluation prior to surgery for stress urinary incontinence between 2008 and 2012 were considered. Patients were categorized as presenting with uncomplicated or complicated stress urinary incontinence according to the definitions used in the ValUE trial. Urodynamic observations were then compared with preurodynamic data. RESULTS: Data from 244 female patients were considered. Due to incomplete data, 33 of these patients were excluded from the evaluation. Only 47 patients (22.3 %) were considered to have uncomplicated stress urinary incontinence according to the definition used in the ValUE trial. The remaining 164 patients (77.7 %) were considered to have complicated stress urinary incontinence. Urodynamic observations differed from the preurodynamic data in 134 of 211 patients (63.5 %). A diagnosis of voiding dysfunction was obtained in 25.6 % of patients. CONCLUSIONS: The majority of our patients had complicated stress urinary incontinence. In a relevant percentage of these patients, a urodynamic test added some new information, including a diagnosis of voiding dysfunction. The role of urodynamic investigation needs to be explored in this patient group.

3D vs 2D laparoscopic radical prostatectomy in organ-confined prostate cancer: comparison of operative data and pentafecta rates: a single cohort study.

BACKGROUND: Currently, men are younger at the time of diagnosis of prostate cancer and more interested in less invasive surgical approaches (traditional laparoscopy, 3D-laparoscopy, robotics). Outcomes of continence, erectile function, cancer cure, positive surgical margins and complication are well collected in the pentafecta rate. However, no comparative studies between 4th generation 3D-HD vision system laparoscopy and standard bi-dimensional laparoscopy have been reported. This study aimed to compare the operative, perioperative data and pentafecta rates between 2D and 3D laparoscopic radical prostatectomy (LRP) and to identify the actual role of 3D LRP in urology. METHODS: From October 2012 to July 2013, 86 patients with clinically localized prostate cancer [PCa: age ≤ 70 years, prostate-specific antigen (PSA) ≤ 10 ng/ml, biopsy Gleason score ≤ 7] underwent laparoscopic extraperitoneal radical prostatectomy (LERP) and were followed for approximately 14 months (range 12-25). Patients were selected for inclusion via hospital record data, and divided into two groups. Their patient records were then analyzed. Patients were randomized into two groups: the former 2D-LERP (43 pts) operated with the use of 2D-HD camera; the latter 3D-LERP (43 pts) operated with the use of a 3D-HD 4th generation view system. The operative and perioperative data and the pentafecta rates between 2D-LERP and 3D-LERP were compared. RESULTS: The overall pentafecta rates at 3 months were 47.4% and 49.6% in the 2D- and 3D-LERP group respectively. The pentafecta rate at 12 months was 62.7% and 67% for each group respectively. 4th generation 3D-HD vision system provides advantages over standard bi-dimensional view with regard to intraoperative steps. Our data suggest a trend of improvement in intraoperative blood loss and postoperative recovery of continence with the respect of the oncological safety. CONCLUSIONS: Use of the 3D technology by a single surgeon significantly enhances the possibility of achieving better intraoperative results and pentafecta in all patients undergoing LERP. Potency was the most difficult outcome to reach after surgery, and it was the main factor leading to pentafecta failure. Nevertheless, further studies are necessary to better comprehend the role of 3D-LERP in modern urology.

Retzius-sparing robot-assisted laparoscopic radical prostatectomy: Critical appraisal of the anatomic landmarks for a complete intrafascial approach.

To provide an overview of the anatomical landmarks needed to guide a retropubic (Retzius)-sparing robot-assisted laparoscopic prostatectomy (RALP), and a step-by-step description of the surgical technique that maximizes preservation of the periprostatic neural network. The anatomy of the pelvic fossae is presented, including the recto-vesical pouch (pouch of Douglas) created by the reflections of the peritoneum. The actual technique of the trans-Douglas, intrafascial nerve-sparing robotic radical prostatectomy is described. The technique allows the prostate gland to be shelled out from under the overlying detrusor apron and dorsal vascular complex (DVC-Santorini plexus), entirely avoiding the pubovesical ligaments. There is no need to control the DVC, since the line of dissection passes beneath the plexus. Three key points to ensure enhanced nerve preservation should be respected: (1) the tips of the seminal vesicles, enclosed in a "cage" of neuronal tissue; a seminal vesicle-sparing technique is therefore advised when oncologically safe; (2) the external prostate-vesicular angle; (3) the lateral surface of the prostate gland and the apex. The principles of tension and energy-free dissection should guide all the maneuvers in order to minimize neuropathy. Using robotic technology, a complete intrafascial dissection of the prostate gland can be achieved through the Douglas space, reducing surgical trauma and providing excellent functional and oncological outcomes.

Dietary treatment of urinary risk factors for renal stone formation. A review of CLU Working Group.

OBJECTIVE: Diet interventions may reduce the risk of urinary stone formation and its recurrence, but there is no conclusive consensus in the literature regarding the effectiveness of dietary interventions and recommendations about specific diets for patients with urinary calculi. The aim of this study was to review the studies reporting the effects of different dietary interventions for the modification of urinary risk factors in patients with urinary stone disease. MATERIALS AND METHODS: A systematic search of the Pubmed database literature up to July 1, 2014 for studies on dietary treatment of urinary risk factors for urinary stone formation was conducted according to a methodology developed a priori. Studies were screened by titles and abstracts for eligibility. Data were extracted using a standardized form and the quality of evidence was assessed. RESULTS: Evidence from the selected studies were used to form evidence-based guideline statements. In the absence of sufficient evidence, additional statements were developed as expert opinions. CONCLUSIONS: General measures: Each patient with nephrolithiasis should undertake appropriate evaluation according to the knowledge of the calculus composition. Regardless of the underlying cause of the stone disease, a mainstay of conservative management is the forced increase in fluid intake to achieve a daily urine output of 2 liters. HYPERCALCIURIA: Dietary calcium restriction is not recommended for stone formers with nephrolithiasis. Diets with a calcium content ≥ 1 g/day (and low protein-low sodium) could be protective against the risk of stone formation in hypercalciuric stone forming adults. Moderate dietary salt restriction is useful in limiting urinary calcium excretion and thus may be helpful for primary and secondary prevention of nephrolithiasis. A low-normal protein intake decrease calciuria and could be useful in stone prevention and preservation of bone mass. Omega-3 fatty acids and bran of different origin decreases calciuria, but their impact on the urinary stone risk profile is uncertain. Sports beverage do not affect the urinary stone risk profile. HYPEROXALURIA: A diet low in oxalate and/or a calcium intake normal to high (800-1200 mg/day for adults) reduce the urinary excretion of oxalate, conversely a diet rich in oxalates and/or a diet low in calcium increase urinary oxalate. A restriction in protein intake may reduce the urinary excretion of oxalate although a vegetarian diet may lead to an increase in urinary oxalate. Adding bran to a diet low in oxalate cancels its effect of reducing urinary oxalate. Conversely, the addition of supplements of fruit and vegetables to a mixed diet does not involve an increased excretion of oxalate in the urine. The intake of pyridoxine reduces the excretion of oxalate. HYPERURICOSURIA: In patients with renal calcium stones the decrease of the urinary excretion of uric acid after restriction of dietary protein and purine is suggested although not clearly demonstrated. HYPOCITRATURIA: The administration of alkaline-citrates salts is recommended for the medical treatment of renal stone-formers with hypocitraturia, although compliance to this treatment is limited by gastrointestinal side effects and costs. Increased intake of fruit and vegetables (excluding those with high oxalate content) increases citrate excretion and involves a significant protection against the risk of stone formation. Citrus (lemons, oranges, grapefruit, and lime) and non citrus fruits (melon) are natural sources of dietary citrate, and several studies have shown the potential of these fruits and/or their juices in raising urine citrate levels. CHILDREN: There are enought basis to advice an adequate fluid intake also in children. Moderate dietary salt restriction and implementation of potassium intake are useful in limiting urinary calcium excretion whereas dietary calcium restriction is not recommended for children with nephrolithiasis. It seems reasonable to advice a balanced consumption of fruit and vegetables and a low consumption of chocolate and cola according to general nutritional guidelines, although no studies have assessed in pediatric stone formers the effect of fruit and vegetables supplementation on urinary citrate and the effects of chocolate and cola restriction on urinary oxalate in pediatric stone formers. Despite the low level of scientific evidence, a low-protein (< 20 g/day) low-salt (< 2 g/day) diet with high hydration (> 3 liters/day) is strongly advised in children with cystinuria. ELDERLY: In older patients dietary counseling for renal stone prevention has to consider some particular aspects of aging. A restriction of sodium intake in association with a higher intake of potassium, magnesium and citrate is advisable in order to reduce urinary risk factors for stone formation but also to prevent the loss of bone mass and the incidence of hypertension, although more hemodynamic sensitivity to sodium intake and decreased renal function of the elderly have to be considered. A diet rich in calcium (1200 mg/day) is useful to maintain skeletal wellness and to prevent kidney stones although an higher supplementation could involve an increase of risk for both the formation of kidney stones and cardiovascular diseases. A lower content of animal protein in association to an higher intake of plant products decrease the acid load and the excretion of uric acid has no particular contraindications in the elderly patients, although overall nutritional status has to be preserved.

Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial).

BACKGROUND: Phytotherapy has been used to treat patients with lower urinary tract symptoms (LUTS). We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens (SeR), Lycopene (Ly), and Selenium (Se) + tamsulosin versus single therapies. METHODS: PROCOMB trial (ISRCTN78639965) was a randomized double-blinded, double-dummy multicenter study of 225 patients between 55 and 80 years old, PSA ≤ 4 ng/ml, IPSS ≥12, prostate volume ≤60 cc, Qmax ≤15 ml/sec, postvoid residual urine (PVR) <150 ml. Participants were randomized group A (SeR-Se-Ly), group B (tamsulosin 0.4 mg), group C (SeR-Se-Ly + tamsulosin 0.4 mg). The primary endpoints of the study were the reduction of IPSS, PVR, and increase of Qmax in group C versus monotherapy groups. RESULTS: The decrease for combination therapy was significantly greater versus group A (P < 0.05) and group B (P < 0.01) for IPSS and versus group A (P < 0.01) for PVR from baseline to 6 months. A greater decrease in IPSS was observed for Group C versus group A (P < 0.01) and increase in Qmax versus group B (P < 0.01), from 6 months to 12 months. At one year, the changes of IPSS and Qmax were greater for Group C versus monotherapies (each comparison <0.05). The proportions of men with a decrease of at least three points (each comparison P < 0.05) and decrease of 25% for IPSS (each comparison P < 0.01) were greater for Group C. CONCLUSION: SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS.

Robotic radical nephrectomy for renal cell carcinoma: a systematic review.

BACKGROUND: Laparoscopic radical nephrectomy (LRN) is the actual gold-standard for the treatment of clinically localized renal cell carcinoma (RCC) (cT1-2 with no indications for nephron-sparing surgery). Limited evidence is currently available on the role of robotics in the field of radical nephrectomy. The aim of the current study was to provide a systematic review of the current evidence on the role of robotic radical nephrectomy (RRN) and to analyze the comparative studies between RRN and open nephrectomy (ON)/LRN. METHODS: A Medline search was performed between 2000-2013 with the terms "robotic radical nephrectomy", "robot-assisted laparoscopic nephrectomy", "radical nephrectomy". Six RRN case-series and four comparative studies between RRN and (ON)/pure or hand-assisted LRN were identified. RESULTS: Current literature produces a low level of evidence for RRN in the treatment of RCC, with only one prospective study available. Mean operative time (OT) ranges between 127.8-345 min, mean estimated blood loss (EBL) ranges between 100-273.6 ml, and mean hospital stay (HS) ranges between 1.2-4.3 days. The comparison between RRN and LRN showed no differences in the evaluated outcomes except for a longer OT for RRN as evidenced in two studies. Significantly higher direct costs and costs of the disposable instruments were also observed for RRN. The comparison between RRN and ON showed that ON is characterized by shorter OT but higher EBL, higher need of postoperative analgesics and longer HS. CONCLUSIONS: No advantage of robotics over standard laparoscopy for the treatment of clinically localized RCC was evidenced. Promising preliminary results on oncologic efficacy of RRN have been published on the T3a-b disease. Fields of wider application of robotics should be researched where indications for open surgery still persist.

Correlation between penile cuff test and pressure-flow study in patients candidates for trans-urethral resection of prostate.

BACKGROUND: Aim of this study was to make a comparison between penile cuff test (PCT) and standard pressure-flow study (PFS) in the preoperative evaluation of patients candidates for trans-urethral resection of prostate (TURP) for benign prostatic obstruction (BPO). METHODS: We enrolled male patients with lower urinary tract symptoms candidates for TURP. Each of them underwent a PCT and a subsequent PFS. A statistical analysis was performed: sensitivity (SE), specificity (SP), positive predictive value (PPV), negative predictive value (NPV), likelihood ratio and ratio of corrected classified were calculated. Fisher exact test was used to evaluate relationships between PCT and maximal urine flow (Qmax): a p-value < 0.05 was considered statistically significant. RESULTS: We enrolled 48 consecutive patients. Overall, at PCT 31 patients were diagnosed as obstructed and 17 patients as unobstructed. At the subsequent PFS, 21 out of 31 patients diagnosed as obstructed at PCT were confirmed to be obstructed; one was diagnosed as unobstructed; the remaining 9 patients appeared as equivocal. Concerning the 17 patients unobstructed at PCT, all of them were confirmed not to be obstructed at PFS, with 10 equivocal and 7 unobstructed. The rate of correctly classified patients at PCT was 79% (95%-CI 65%-90%). About detecting obstructed patients, PCT showed a SE of 100% and a SP of 63%. The PPV was 68%, while the NPV was 100%. CONCLUSIONS: PCT can be an efficient tool in evaluating patients candidates for TURP. In particular, it showed good reliability in ruling out BPO because of its high NPV, with a high rate of correctly classified patients overall. Further studies on a huger number of patients are needed, including post-operative follow-up as well.

Partial nephrectomy using radiofrequency incremental bipolar generator with multi electrode probe: experimental study in bench pig kidneys.

BACKGROUND: The aim of this research project was the realization of an incremental bipolar radiofrequency generator with inline 4-electrode probe for partial renal resection without clamping of the vessels. METHODS: The experimentation was carried out across two phases: the preliminary realization of a specific generator and an inline multielectrode probe for open surgery (Phase 1); system testing on 27 bench kidneys for a total of 47 partial resection (Phase 2). The parameters evaluated were: power level, generator automatisms, parenchymal coagulation times, needle caliber, thickness of the coagulated tissue "slice", charring, ergonomy, feasibility of the application of "bolster" stitches. RESULTS: The analysis of the results referred to the homogeneity and thickness of coagulation, energy supply times with reference to the power level and caliber of the needles. The optimal results were obtained by using needles of 1.5 mm caliber at power level 5, and with coagulation times of 54 seconds for the first insertion and 30 seconds for the second. CONCLUSIONS: The experimentation demonstrated that the apparatus, consisting of a generator named "LaparoNewPro" and fitted with a dedicated probe for open surgery, is able to carry out a coagulation of the line of resection of the renal parenchyma in a homogeneous manner, in short times, without tissue charring, and with the possibility of stitching both on coagulated tissue and the caliceal system. The generator automatism based on the flow of the current supplied by each electrode is reliable, and the cessation of energy supply coincides with optimal coagulation.

Laparoscopic versus robot-assisted bilateral nerve-sparing radical prostatectomy: comparison of pentafecta rates for a single surgeon.

BACKGROUND: This study aimed to compare the pentafecta rates between laparoscopic radical prostatectomy (LRP) and robot-assisted radical prostatectomy (RALP) and to identify prognostic factors predicting the pentafecta for each technique. METHODS: This prospective comparative study enrolled 248 consecutive male patients 70 years of age or younger with clinically localized prostate cancer [PCa: age ≤ 70 years, prostate-specific antigen (PSA) ≤ 10 ng/ml, biopsy Gleason score ≤ 7] who were fully continent, potent, and candidates for bilateral nerve-sparing (BNS) LRP or RALP. The pentafecta rates between LRP and RALP were compared. A logistic regression model was created to evaluate independent factors for achieving pentafecta. RESULTS: In the final analysis, 91 LRP and 136 RALP patients were evaluated. The median follow-up period was 21 months for the 91 LRP patients and 18 months for the 136 RALP patients (p = 0.07). Of the 227 patients, 87 reached pentafecta [25 LRP patients (27.5 %) vs 62 RALP patients (45.6 %), p = 0.006]. Of the 140 patients who failed pentafecta, 90 (64.3 %) missed a single parameter. In these cases, erectile deficit was the leading cause of pentafecta failure, with a significant [corrected] difference between groups (80 % LRP cases that missed potency recovery [corrected] vs 53.3 % RALP, p = 0.007). Lower age, lower pathologic stage, and RALP are significantly associated with pentafecta as independent factors. For the pT3 disease, the two techniques did not differ significantly. CONCLUSIONS: Patients submitted to BNS RP have low possibilities of achieving pentafecta. Use of the robotic platform by a single surgeon significantly enhances the possibility of achieving pentafecta independently of age and pathologic stage. Potency was the most difficult outcome to reach after surgery, and it was the main factor leading to pentafecta failure. LRP and RALP provide equivalent pentafecta rates for the pT3 disease and similar "tetrafecta" outcomes when potency recovery is not included among the postoperative expectations of the patient.

Glans reconstruction with the use of an inverted urethral flap after distal penile amputation for carcinoma.

Restoration of adequate cosmesis and preservation of sexual and urinary function are the main goals of penile reconstructive surgery following amputation for carcinoma. Split thickness skin grafts and oral mucosa grafts have been widely used for the creation of a pseudoglans with excellent cosmetic and functional results. The main drawbacks associated with the use of grafts are donor site morbidity, the lack of engorgement of the pseudoglans and the risk of poor graft take, which may lead to contracture and poor cosmetic results. In the present series the long term cosmetic and functional outcomes of glans reconstruction with an inverted distal urethral flap are described.

Does current scientific and clinical evidence support the use of phosphodiesterase type 5 inhibitors for the treatment of premature ejaculation? a systematic review and meta-analysis.

INTRODUCTION: Premature ejaculation (PE) is a highly prevalent and complex syndrome that remains poorly defined and inadequately characterized. Pharmacotherapy represents the current basis of lifelong PE treatment. AIM: The goal of this study was to assess the role of phosphodiesterase type 5 inhibitors (PDE5-Is) in the treatment of patients with PE without associated erectile dysfunction (ED). MAIN OUTCOME MEASURE: The posttreatment intravaginal ejaculatory latency time was used as the primary end point of efficacy. METHODS: A systematic review of the literature was performed by electronically searching the MedLine database for peer-reviewed articles regarding the mechanism of action and the clinical trials of PDE5 in the management of PE. A meta-analysis of these clinical studies was performed to pool the efficacy. RESULTS: Twenty-nine articles that examined the supposed mechanisms of action and 14 articles that reported data from clinical studies were reviewed. The PDE5 may exert their influence by increasing the levels of nitric oxide both centrally (reducing sympathetic drive) and peripherally (leading to smooth-muscle dilatation of the seminal tract). These drugs may also induce peripheral analgesia to prolong the duration of the erection, increase confidence, improve the perception of ejaculatory control and overall sexual satisfaction, and decrease the postorgasmic refractory time for achieving a second erection after ejaculation. Concerning the efficacy, the meta-analysis shows an overall positive effect for the use of PDE5 as monotherapy or as components of a combination regimen in the treatment of PE. The major limitations of the published literature included poor study design, the absence of solid methodology, which was characterized by the lack of a unique PE definition, and the lack of appropriate endpoints for outcome evaluation of a placebo control arm and of Institutional Review Board approval. CONCLUSION: There is inadequate, partial basic, and clinical evidence to support the use of PDE5 for the treatment of PE.

Simultaneous penile lengthening and penile prosthesis implantation in patients with Peyronie's disease, refractory erectile dysfunction, and severe penile shortening.

INTRODUCTION: Due to loss of length, patients who had penile prosthesis implantation for Peyronie's disease (PD) show a statistically significant reduction in their levels of satisfaction when compared with the general implant population. AIM: The aim of this study is to report our experience of penile lengthening with circumferential graft during penile prosthesis implantation in patients with PD and severe penile shortening. METHODS: Between March 2006 and February 2008, 23 patients with PD, refractory erectile dysfunction, and severe penile shortening underwent penile lengthening with circumferential graft and concomitant implantation of an inflatable penile prosthesis. MAIN OUTCOME MEASURES: Surgical outcome and complications have been recorded during postoperative follow-up. Patients' satisfaction has been assessed 6 months postoperatively with the administration of the modified Erectile Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire. RESULTS: After an average follow-up of 22 months (range 6-36), 20 patients attended all the postoperative follow-up visits and returned the EDITS questionnaire. An average length gain of 2.8 cm (range 2.2-4.5) was recorded, and all patients were able to cycle the device and engage in penetrative sexual intercourse. Patient recorded complications included diminished glans sensitivity in four (20%) and persistent dorsal curvature of less than 15° in three (15%). Overall, 18 patients (90%) were satisfied with the cosmetic and functional result of surgery. CONCLUSION: Penile lengthening with circumferential graft during penile prosthesis implantation in patients with PD represents a safe and reproducible technique that yields higher satisfaction rates than penile prosthesis implantation alone in patients with severe penile shortening.

Simultaneous total corporal reconstruction and implantation of a penile prosthesis in patients with erectile dysfunction and severe fibrosis of the corpora cavernosa.

INTRODUCTION: Implantation of a penile prosthesis in severely scarred corporal bodies represents a great challenge as fibrosis can compromise dilatation and subsequent closure of the corpora cavernosa and limit size, type, and function of the device. AIM: The aim of this study is to report our experience of simultaneous corporeal reconstruction and penile prosthesis implantation in patients with severe penile contracture consequence of diffuse fibrosis. METHODS: Between March 2006 and February 2010, 18 patients with severe penile contracture and coporeal fibrosis underwent simultaneous corporeal reconstruction and placement of a penile prosthesis. MAIN OUTCOME MEASURES: Surgical outcome and complications have been recorded during postoperative follow-up. Patients' satisfaction has been assessed 6 months postoperatively with the administration of the modified erectile dysfunction index of treatment satisfaction questionnaire. RESULTS: Although the dilatation of the corpora was extremely difficult due to the severe fibrosis, a penile prosthesis has been implanted in all patients. A malleable penile prosthesis has been inserted in four patients and a three-piece inflatable device in the remainder. After an average follow-up of 26 months (range 6-36), revision surgery was required in four patients (elective exchange to three-piece inflatable device in three patients and upsizing of the implant in one patient). Although all patients were able to achieve penetrative sexual intercourse, four patients were partially dissatisfied because of significant penile shortening. CONCLUSION: In expert hands, simultaneous penile prosthesis implantation and corporal reconstruction of severely scarred corpora yield satisfactory results. Patients must be warned that complication rate in presence of severe fibrosis is significantly higher than in virgin cases and that downsized cylinders might be required due to the contracture of the tunica albuginea.

Cryopreserved penile tunica albuginea for allotransplantation: a morphological and ultrastructural investigation.

INTRODUCTION: Peyronie's disease, a connective tissue disorder of penile tunica albuginea (TA) associated with penile deformity, curvature, pain, and erectile dysfunction, is best managed surgically, but suitable graft biomaterials are not available. AIM: To establish whether cryopreservation affects human TA in view of its use in allotransplants. METHODS: The effects on TA samples of the two most widely used tissue cryopreservation methods were investigated using an ad hoc panel of histochemical, immunohistochemical, and ultrastructural tests. Apoptotic cells were evaluated using the terminal deoxynucleotidyl transferase method of end labeling (TUNEL) assay. MAIN OUTCOME MEASURES: Assessment of tissue integrity and arrangement of collagen and elastic fibers in thawed TA. RESULTS: Both cryofixation methods provided TA tissue suitable for use as graft material. Significant ultrastructural changes, namely, a greater diameter of collagen fibrils, were detected in sections preserved in liquid nitrogen; nonetheless, such increase never exceeded the normal range. The comprehensive panel of assays used proved suitable to characterize the thawed tissue. CONCLUSION: Human TA is suitable for cryopreservation; freezing at -80 °C provides better results than preservation in liquid nitrogen.

Morphological evaluation of the male external urethral sphincter complex by transrectal ultrasound: feasibility study and potential clinical applications.

INTRODUCTION: Previous measurement of the male external urethral sphincter complex (EUSC) length by magnetic resonance imaging and urethral pressure profilometry did not consider the intraprostatic portion, although its role for urinary continence has been demonstrated. The aim of our study was to verify the feasibility of a morphological evaluation of the EUSC by transrectal ultrasound (TRUS). MATERIALS AND METHODS: Data from 52 men that underwent TRUS were prospectively collected. The EUSC was identified in the midline sagittal plane. Total and intraprostatic EUSC length and prostate volume were measured. RESULTS: EUSC appears as a hypoechoic area surrounding the urethra. The proximal end was identified between the verumontanum and the prostate apex by the net change in prostate echo patterns, while the distal end was identified by voluntary contraction of the external anal sphincter. Mean total and intraprostatic EUSC lengths were 20.17 and 3.78 mm, respectively. Total EUSC length presented a weak correlation with prostate volume (r = 0.41; p = 0.003), while the intraprostatic portion had a stronger correlation (r = 0.60; p = 0.001). CONCLUSIONS: The evaluation of the EUSC is feasible by TRUS, and length measurement should include the intraprostatic portion. Potential clinical application should be the preoperative assessment of the risk of urinary incontinence in men undergoing radical prostatectomy.