A prospective, single-arm study on the use of the da Vinci® Table Motion with the Trumpf TS7000dV operating table.

BACKGROUND: The da Vinci® Table Motion (dVTM) comprises a combination of a unique operating table (Trumpf Medical™ TruSystem® 7000dV) capable of isocenter motion connected wirelessly with the da Vinci Xi® robotic platform, thereby enabling patients to be repositioned without removal of instruments and or undocking the robot. MATERIALS AND METHODS: Between May 2015 to October 2015, the first human use of dVTM was carried out in this prospective, single-arm, post-market study in the EU, for which 40 patients from general surgery (GS), urology (U), or gynecology (G) were enrolled prospectively. Primary endpoints of the study were dVTM feasibility, efficacy, and safety. RESULTS: Surgeons from the three specialties obtained targeting success and the required table positioning in all cases. Table movement/repositioning was necessary to gain exposure of the operating field in 106/116 table moves (91.3%), change target in 2/116 table moves (1.7%), achieve hemodynamic relief in 4/116 table moves (3.5%), and improve external access for tumor removal in 4/116 table moves (3.5%). There was a significantly higher use of tilt and tilt plus Trendelenburg in GS group (GS vs. U p = 0.055 and GS vs. G p = 0.054). There were no dVTM safety-related or adverse events. CONCLUSIONS: The dVTM with TruSystem 7000dV operating table in wireless communication with the da Vinci Xi is a perfectly safe and effective synergistic combination, which allows repositioning of the patient whenever needed without imposing any delay in the execution of the operation. Moreover, it is helpful in avoiding extreme positions and enables the anesthesiologist to provide immediate and effective hemodynamic relief to the patient when needed.

Combined bladder neck preservation and posterior musculofascial reconstruction during robotic assisted radical prostatectomy: effects on early and long term urinary continence recovery.

BACKGROUND: To evaluate the effects of combined bladder neck preservation and posterior reconstruction techniques on early and long term urinary continence in patients treated by robotic assisted radical prostatectomy (RARP). METHODS: Two-hundred ninety-two patients who previously underwent radical prostatectomy were retrospectively selected for a case-control study, excluding those with anastomotic strictures and significant perioperative complications and re-called for a medical follow-up visit after their consent to participate the study. They were divided in 3 different groups according to the surgical technique previously received: radical retropubic prostatectomy (RRP) combined with bladder neck preservation (BNP), RARP with bladder neck resection, and RARP combined with BNP and posterior musculofascial reconstruction (PRec). Functional and oncologic outcomes evaluation were integrated by a questionnaire on urinary continence status, abdominal ultrasound scan, uroflowmetry and post-void urine volume measurement. Urinary continence definition included the terms "no pad" or "safety pad". RESULTS: Two hundred thirty-two patients responded to the phone call interview and were enrolled in the study. They presented comparable age, prostate volume and BMI. Differences in comorbidities, ASA score and medications, did not influence the postoperative functional results, focused on continence outcome. Early urinary continence was achieved in 49.38% and 24.73% of patients who previously underwent RARP + BNP + PRec and simple RARP respectively (p = 0.000)as well as late 12-months urinary continence was obtained in 92.59% and 79.56% of patients.(p = 0.01). Late urinary continence in the RRP + BNP group was comparable to the result obtained in the simple RARP group. The potential effects of nerve sparing technique on urinary continence have not been evaluated. CONCLUSIONS: The combined technique of RARP + BNP + PRec seems to be effective to determine early and long term significant effects on urinary continence of patients with comparable body mass index, age and prostate volume. No statistically significant differences were found between the simple RARP and the RRP + BNP groups.

Staghorn cystine stone in a 72-year-old recurrent calcium stone former.

This case deals with the first diagnosis of Type B cystinuria with cystine nephrolithiasis in a 72-year-old male. Cystinuria is an inherited disease that consists of congenital abnormalities of renal and intestinal transport of dibasic amino acids. It often leads to frequent recurrent stone formation. Cystine stones most frequently occur in the 1st through 3rd decades of life with a decreased incidence in old age. This case shows that the first diagnosis of cystinuria may be made even in the 8th decade, without any family history, and in a patient with a history of recurrent calcium stone disease. Therefore, the chance of cystinuria must be always considered, even in older calcium stone formers.

New Italian guidelines on bladder cancer, based on the World Health Organization 2004 classification.

OBJECTIVE To provide evidence-based recommendations on bladder cancer management METHODS A multidisciplinary guideline panel composed of urologists, medical oncologists, radiotherapists, general practitioners, radiologists, epidemiologists and methodologists conducted a structured review of previous reports, searching the Medline database from 1 January 2004 to 31 December 2008. The milestone papers published before January 2004 were accepted for analysis. The level of evidence and the grade of the recommendations were established using the GRADE system. RESULTS In all, 15 806 references were identified, 1940 retrieved, 1712 eliminated (specifying the reason for their elimination) and 971 included in the analysis, as well as 241 milestone reports. A consensus conference held to discuss the discrepancies between the scientific evidence and the clinical practice was then attended by 122 delegates of various specialities. CONCLUSION Recommendations on bladder cancer management are provided.

Intraoperative and postoperative complications of nephron sparing surgery: prevention and possible treatments.

Conservative surgery for renal cell carcinoma has been widely diffused and performed in the last 15 years. It showed excellent oncological results in imperative and then elective indications. A greater number of small renal lesions are now being discovered, and elective partial nephrectomy has been adopted more frequently for the treatment of such tumours. However results regarding morbidity are extremely variable in the literature and the overall complication rate after NSS ranges between 4% and 30%. Fortunately, better patient selection, operating techniques, perioperative care, and surgical experience have guaranteed a significant reduction of complication in the last decade. The purpose of this review was to assess the incidence of complications of conservative renal surgery for renal cell carcinoma and to discuss treatment modalities.

Hem-o-lok clips to control both the artery and the vein during laparoscopic nephrectomy: personal experience and review of the literature.

BACKGROUND AND PURPOSE: Control and division of the renal vessels is a critical step in laparoscopic nephrectomy. Although the linear cutting stapler is easy to use, a 1.7% malfunction rate has been reported, and the consequences of this failure can be serious, including often-emergency conversion to an open procedure and even death. We reviewed the purely laparoscopic nephrectomies performed in our center, in which both the renal artery and the vein were secured using only nonabsorbable polymer ligating (NPL) clips. Our purpose was to evaluate the reliability, safety, and cost-effectiveness of this surgical approach. PATIENTS AND METHODS: We retrospectively reviewed our 31 laparoscopic nephrectomies performed from November 2002 to November 2005. In all the procedures, both the renal artery and the renal vein were secured using only NPL clips. For each patient, the operative time, estimated blood loss, early and late complications, and length of hospital stay were analyzed. Further, we performed a MEDLINE search for laparoscopic nephrectomies in which both the renal artery and the vein were secured using only Hem-o-lok clips. RESULTS: No renal vessel injuries, cases of clip dislodgement or slippage, or bleeding were recorded. Worthy of note, we achieved a meaningful reduction in the cost per procedure. To the best of our knowledge, renal-pedicle control exclusively with Hem-o-lok clips during purely laparoscopic nephrectomy has not been yet published. CONCLUSIONS: Any device or technique for vascular control is prone to malfunction in either open or laparoscopic surgery. The described approach is safe, reliable, rapid, and inexpensive.

Multicenter study on the use of gemcitabine to prevent recurrence of multiple-recurring superficial bladder tumors following intravesical antiblastic agents and/or BCG: evaluation of tolerance.

OBJECTIVES: The treatment of choice for superficial bladder TCC is endoscopic resection, followed or not by intravesical immuno/chemotherapy. Some patients are not responders to common intravesical therapy and are more exposed to disease progression. In this case the suitable treatment is radical cystectomy. Because gemcitabine is effective against advanced bladder cancer, we have initiated a study to evaluate the efficacy of its intravesical use to prevent relapse and disease progression, and tolerance and safety of this drug in patients with multi-treated bladders. In this preliminary study, we cite only data on tolerance. MATERIALS AND METHODS: 64 patients were selected, and 61 were evaluable (age range 39-84 years), with multiple-recurrent bladder TCC. All patients were previously treated with intravesical chemotherapy and/or immunotherapy. The protocol provided for intravesical instillation of gemcitabine (2000 mg) once per week for 8 weeks. We collected data regarding problems noted by the patients (both local and systemic). RESULTS: 53 patients out of 61 (86.9%) completed the cycle. Side effects appeared in 14 patients, 8 of these had to suspend the treatment. Severe side effects were systemic in 4 patients (1 systemic edema, 1 malaise and dysgeusia, 1 hyperthermia and severe strangury, 1 elevated transaminases and asthenia), and local in 4 patients (1 severe urinary urgency, 1 hematuria, 1 urinary incontinence, and 1 case of pelvic pain). In 6 patients we observed pelvic pain, hematuria, strangury and UTI of medium magnitude that did not require treatment interruption. CONCLUSIONS: We believe that the severe side effects requiring treatment interruption are attributable primarily to increased sensitivity in patients with multi-treated bladders. In our experience, the side effects responsible for suspension occurred at the start of treatment in 7 cases out of 8. Our study demonstrates the safety of intravesical gemcitabine in patients with recurrent and multi-treated superficial TCC of the bladder.

Penile metastasis from primary transitional cell carcinoma of the renal pelvis: first manifestation of systemic spread.

BACKGROUND: Almost one-third of all penile metastases are detected at the same time as a primary tumor, whereas the remaining two-thirds are detected a mean of 18 months after the discovery of the primary tumor. Cutaneous metastasis of transitional cell carcinoma (TCC) is extremely rare and generally accepted as the late manifestation of a systemic spread. CASE PRESENTATION: We report the first case of simultaneous penile and lung metastases from a primary TCC of the renal pelvis in a 76-year-old man, that occurred 8 years after a left nephroureterectomy. CONCLUSIONS: This case report underscores the importance of physical examinations of the skin of patients who undergo surgical procedures for TCC from bladder as well as from the upper urinary tract, including those seemingly without metastatic disease, because of the possibility of skin and penile metastatic spread.

Percutaneous nephrolithotomy of transplanted kidney.

Urinary lithiasis after renal transplantation is a relatively uncommon disease; the predisposing factors and the composition of calculi are identical to those of patients with native kidneys. We present a case of a 45-year-old woman with a staghorn stone in a left-sided transplanted kidney who was treated successfully by percutaneous nephrolithotomy (PCNL). After reviewing the literature, we conclude that PCNL in transplanted kidney is a feasible and safe procedure. The technical aspects of the procedure, such as patient position and the use of the ultrasound-guided caliceal puncture, are stressed.

Safety and antitumor efficacy of (153)Sm-EDTMP and docetaxel administered sequentially to patients with metastatic castration-resistant prostate cancer.

BACKGROUND: Bone metastases are responsible for most of the morbidity associated with metastatic castration-resistant prostate cancer (mCRPC). Bone-seeking radiopharmaceuticals have been approved for palliation of painful skeletal metastases, but their clinical use is limited by concerns of toxicities both when administered alone and especially when combined with chemotherapy agents. OBJECTIVE: We investigated whether docetaxel administered to mCRPC patients after treatment with samarium-153-labeled ethylene-diamine-tetra-methylene-phosphonic acid (Sm-EDTMP) has increased toxicity and/or reduced antitumor efficacy. MATERIALS AND METHODS: Thirty mCRPC patients with skeletal metastases were enrolled. Patients received standard therapy with docetaxel (75 mg/m intravenously every 21 days for at least six cycles) on average 6 weeks after Sm-EDTMP (37 MBq/kg). Patients were monitored for the presence of toxicities, and antitumor efficacy was assessed by changes in serum prostate-specific antigen levels. Besides standard descriptive statistical analysis, progression-free survival and overall survival were defined using the Kaplan-Meier method. RESULTS: Over 80% of the patients showed favorable biochemical responses. Median time to progression was 9.1 months (mean 9.8, 95% confidence interval 7.8-9.9), and median overall survival was 19.9 months (mean 24.5, 95% confidence interval 16.9-22.8); five patients were still alive over 5 years after enrollment. No additional hematological toxicities were observed when docetaxel was administered after Sm-EDTMP other than those expected when administering the agent alone. CONCLUSION: Prior administration of Sm-EDTMP does not cause additional toxicities for subsequent treatment with docetaxel and does not reduce the antitumor efficacy of the latter. This work justifies further investigations on the possible synergistic effects of combined strategies with the two agents.

[Endoscopic resection. Aspects of technique and optimization of outcomes. Current indications to PDD-guided resection]. / Resezione endoscopica. Elementi di tecnica e ottimizzazione dei risultati. Indicazioni attuali alla resezione guidata in PDD.

Trans-Urethral Resection (TUR) of bladder tumors is the gold standard to make the correct diagnosis and remove all visible lesions. The strategy of resection depends on the size of the lesion. Small tumors can be resected en bloc, while larger tumors should be resected separately in fractions to obtain a correct pathological diagnosis. Random biopsies from normal-looking mucosa should be performed in patients with positive urinary cytology and absence of visible tumor in the bladder. As a standard procedure, cystoscopy and TUR are performed using white light. Photodynamic diagnosis (PDD) is most useful for detecting CIS, and therefore should be restricted to those patients with a suspected high-grade tumor.

An open, randomised, multicentre, phase 3 trial comparing the efficacy of two tamoxifen schedules in preventing gynaecomastia induced by bicalutamide monotherapy in prostate cancer patients.

BACKGROUND: Bicalutamide monotherapy is a valuable option for prostate cancer (PCa) patients who wish to avoid the consequences of androgen deprivation; however, this treatment induces gynaecomastia and mastalgia in most patients. Tamoxifen is safe and effective in preventing breast events induced by bicalutamide monotherapy without affecting antitumor activity, but possible interference between bicalutamide and tamoxifen remains a matter of concern. To reduce the exposure to tamoxifen, we considered the putative advantages of weekly administration. OBJECTIVE: To compare the efficacy of two different schedules of tamoxifen in preventing breast events. Toxicity, prostate-specific antigen behaviour, and sexual-functioning scores were also evaluated. DESIGN, SETTING, AND PARTICIPANTS: This was a noninferiority trial. From December 2003 to February 2006, 80 patients with localised/locally advanced or biochemically recurrent PCa who were also candidates for bicalutamide single therapy were randomised to receive two different schedules of tamoxifen: daily (n=41) and weekly (n=39). Median follow-up was 24.2 mo. INTERVENTION: Daily bicalutamide (150 mg) plus daily tamoxifen 20mg continuously (daily group) or the same but with tamoxifen at 20mg weekly after the first 8 wk of daily treatment (weekly group). Three patients in the weekly group and one in the daily group were discontinued for adverse events. MEASUREMENTS: For gynaecomastia, we used ultrasonography. For mastalgia and sexual functioning, we used questionnaires. RESULTS AND LIMITATIONS: Gynaecomastia developed in 31.7% of patients in the daily group and in 74.4% of patients in the weekly group (p<0.0001), and it was more severe in patients who switched to weekly tamoxifen (p=0.001). Mastalgia occurred in 12.2% and 46.1% of patients, respectively (p=0.001). There were no major differences among treatment schedules relative to sexual functioning scores and incidence and severity of adverse events. No differences between groups in PSA behaviour and disease progression have been detected so far. CONCLUSIONS: This study demonstrated that tamoxifen 20mg/wk is inferior to tamoxifen 20mg/d in preventing the incidence and severity of bicalutamide-induced breast events. The safety and efficacy of tamoxifen at the common daily dose of 20mg for the prophylaxis of bicalutamide-induced breast events were confirmed.

Vascular air embolism complicating percutaneous nephrolithotomy: medical malpractice or fatal unforeseeable complication?

Vascular air embolism (VAE) can be a lethal complication of surgical approaches, and it has been documented in various urologic procedures. A case of VAE complicating a percutaneous nephrolithotomy in a 47-year-old man is presented, well documented by immunohistochemical examination of lung samples and three-dimensional imaging of histologic sections with confocal laser scanning microscopy.

Major invasive surgery for urologic cancer in octogenarians with comorbid medical conditions.

OBJECTIVES: We retrospectively reviewed the records of the octogenarian patients who underwent major surgery for urologic cancer at two institutions. The aims of our study were to assess intra- and postoperative morbidity and mortality rates, and to identify potential risk factors that can predict postoperative complications and, as a consequence, surgical outcome. METHODS: Fifty-five patients (median age: 83 yr) underwent major surgery for urologic cancer. Radical nephrectomy was performed in 27 patients, radical cystectomy with urinary diversion was done in 20 patients, and nephroureterectomy was performed in the remainder. Significant comorbidity was present in 51 patients. RESULTS: The perioperative mortality rate was 9%. The overall mortality rate was 69%; cancer-specific mortality was 28%. Intraoperative complications occurred in 11% of patients. Postoperative intensive care monitoring was required in 29% of patients. The early postoperative complication rate was 33%. Only the presence of more than two comorbidities (p<0.05) and chronic obstructive lung disease (COLD) (p=0.017) resulted in independent prognostic factors for morbidity. Sixteen percent of patients developed a late postoperative complication within the first 6 mo. Median hospital stay was 14 d (range: 6-55), and hospital stays were significantly longer among patients with complications (p<0.05). The 3-yr and 5-yr overall survival rates were 36% and 26%, respectively; these rates were significantly lower in patients with COLD (p<0.01). There was no significant difference between cancer-specific and non-cancer-specific survival rates. CONCLUSIONS: Major surgery for urologic malignancies can be safely performed in selected octogenarian patients.

Alterations in sperm motility after acute oral administration of sildenafil or tadalafil in young, infertile men.

OBJECTIVE: To evaluate the acute effect of sildenafil and tadalafil on seminal parameters in young, infertile patients. DESIGN: Prospective, randomized, double-blind, crossover clinical investigation on semen parameters after the administration of a single dose of sildenafil (50 mg) or tadalafil (20 mg). SETTING: An academic hospital as well as a male infertility center and clinical andrology laboratories. PATIENT(S): Eighteen young, infertile men. INTERVENTION(S): Oral administration of a single dose of sildenafil (50 mg) or tadalafil (20 mg) in a blind, randomized order. The semen samples were collected 1 or 2 hours after each treatment. MAIN OUTCOME MEASURE(S): Changes in sperm parameters after sildenafil and tadalafil administration, compared with the basal conditions. RESULT(S): A significant increase in sperm progressive motility (median value, 37.0% vs. 28.5%) was observed after sildenafil administration as compared with baseline; in contrast, a significant decreased value was observed after tadalafil (median value, 21.5% vs. 28.5%). CONCLUSION(S): These preliminary results indicate that sperm motility appears to be acutely affected in young, infertile patients by a single dose of sildenafil and tadalafil, with opposite effects: stimulatory by the former and inhibitory by the latter.

Clinical benefit of bone-targeted radiometabolic therapy with 153Sm-EDTMP combined with chemotherapy in patients with metastatic hormone-refractory prostate cancer.

BACKGROUND: Bone metastases are responsible for most of the morbidity associated with hormone-refractory prostate cancer (HRPC). 153Sm-ethylenediaminetetramethylene phosphonate (153Sm-EDTMP) has been approved for palliation of painful skeletal metastases. We retrospectively investigated the possible synergistic effect on survival of 153Sm-EDTMP (given to HRPC patients for bone pain palliation) and chemotherapy. METHODS: Forty-five HRPC patients were evaluated, with a median age of 71 years. The number of metastatic bone sites was 10 in 20 patients. Median serum PSA was 224 ng/ml. Bone pain was mild in 6 patients, moderate in 16, severe in 22 and intolerable in 1. Fifteen patients were only treated with 153Sm-EDTMP (group A), while 30 patients also received chemotherapy (estramustine phosphate or mitoxantrone plus prednisone) at variable times: between 3 and 5 months after 153Sm-EDTMP (14 patients, group B) or within 1 month after 153Sm-EDTMP (16 patients, group C). RESULTS: Haematological toxicities observed after either regimen were in general mild, consistent with common observations after either 153Sm-EDTMP or chemotherapy, and without any additive adverse effects in the patients receiving both 153Sm-EDTMP and chemotherapy. Bone pain palliation to some degree was induced by 153Sm-EDTMP in 32/45 patients (71.1%), the proportion of patients with a favourable clinical response being significantly higher in group C than in group A (87.5% vs 53.3%, p = 0.0388). Also in terms of biochemical response (serum PSA levels), patients of group C performed significantly better than patients of group A (p = 0.0235). Overall median survival from the time of administration of 153Sm-EDTMP was 15 months in the total cohort of 45 patients, and was significantly longer in group C than in either group B (30 months vs 11 months, p = 0.023) or group A (30 months vs 10 months, p = 0.008). CONCLUSION: The results of this study confirm that 153Sm-EDTMP is effective in terms of pain relief and PSA response, with minimal toxicity. When it was administered in combination with chemotherapy, prolonged survival indicated actual clinical benefit, while there were no additive toxicities. These results provide the rationale for future prospective evaluation of combined therapeutic strategies.

EAU guidelines on pain management.

Pain is the most common symptom of any illness; the physician's therapeutic task is twofold: to discover and treat the cause of pain and the pain itself, whether or not the underlying cause is treatable, to provide relief and reduce the suffering caused by pain. Although we use the term of pain to define all sensations that hurt or are unpleasant, actually two quite different kinds of pain exist. The first (nociceptive) is associated with tissue damage or inflammation, the second (neuropathic) results from a lesion to the peripheral or central nervous systems. Pain can also be divided in acute and chronic. Caregivers are to face pain in two main settings: after surgery and in cancer patients. These tasks require a multidisciplinary team, able to properly assess and treat pain. Postoperative pain is to be treated early and aggressively. Several drug options are available, to be tailored on the surgical procedure and the patient. Pain in cancer patients consists of different aspects: it can be caused by the cancer itself or may be secondary to muscular spasm or cancer treatments. The management involves mainly pharmacotherapy, but also primary treatments as surgery, radiochemotherapy or even antibiotics can provide an adequate relief. Analgesics are to be employed according to an ascending scale, but other options can be combined to improve the outcome when a satisfactory balance between relief and side effects is not achieved; they include invasive techniques, physical and psychological therapy. The mainstay of pain management entails a interdisciplinary cooperation; it requires a full knowledge of the methods of evaluation and treatment of this condition.

Gemcitabine plus epirubicin in patients with advanced urothelial carcinoma who are not eligible for platinum-based regimens.

BACKGROUND: The objective of this study was to evaluate the efficacy and toxicity of gemcitabine plus epirubicin in previously untreated patients with advanced urothelial carcinoma who were not eligible for cisplatin-based regimens. METHODS: Patients with advanced urothelial carcinoma and at least one of the following characteristics were eligible: impaired renal function (creatinine clearance < 60 mL per minute), an Eastern Cooperative Oncology Group performance status (PS) >or= 2, and age >or= 75 years. The treatment included epirubicin 70 mg/m(2) as an intravenous bolus on Day 1 and gemcitabine 1000 mg/m(2) over 30 minutes on Days 1 and 8 of a 21-day cycle. RESULTS: Thirty-eight patients entered the study, and a total of 152 cycles were administered, with a median of 4 cycles per patient (range, 1-6 cycles per patient). The following Grade 3-4 hematologic toxicities were reported (percent of cycles): neutropenia, 22.4%; anemia, 11.2%; and thrombocytopenia, 6.5%. No cardiac, renal, or hepatic toxicities were observed. Dose intensities of epirubicin and gemcitabine were 19.6 mg/m(2) per week (84%) and 532.2 mg/m(2) per week (80%), respectively. There were 2 complete responses (5.3%), 13 partial responses (34.2%), 11 patients with stable disease (28.9%), and 12 patients with progressive disease (31.6%), for an overall response rate of 39.5% (95% confidence interval, 25.1-55.1). The median progression free survival (PFS) and overall survival (OS) rates were 4.8 months and 8.0 months, respectively. The 1-year survival rate was 38%, and the median PFS and OS were 6.4 months and 16.4 months, respectively, in patients with PS 0-1. Thirty patients were symptomatic: Seventeen patients (56.7%) achieved a complete response, and 5 patients (16.7%) achieved a partial symptomatic response. CONCLUSIONS: At the doses given in this study, gemcitabine and epirubicin had a good tolerability profile with interesting activity in patients with advanced urothelial carcinoma who were not fit for cisplatin-based regimens.