URINARY CONTINENCE RESTORATION THROUGH AN ENDOURETHRAL DEVICE: A 3-MONTH PILOT STUDY ON TEN PATIENTS.

BACKGROUNDː Stress urinary incontinence (SUI) is a widespread and frustrating condition that affects millions of people worldwide, with severe consequences on patients' quality of life and healthcare systems' costs. Currently, the most severe cases of SUI are treated using implanted (and rather invasive) extraurethral artificial sphincters. The authors propose an innovative, minimally invasive endourethral device for the treatment of SUI. METHODSː Ten patients with SUI were enrolled in three Italian centers and underwent device implantation. After 10, 30, 60 and 90 days, correct device position was confirmed by ultrasonography. Improvements in continence and quality of life were evaluated through a 24 h pad-test, an International Consultation on Incontinence Questionnarie- Short Form (ICI-Q) and a custom checklist. The device was explanted after 90 days. RESULTSː The proposed device was successfully implanted and explanted in 8 out of 10 patients. The results of the pad-test, ICI-Q and custom checklist demonstrated remarkable improvements in continence (median improvement: 82% with respect to the initial condition) and quality of life (mean reduction of the impact of urine losses on the quality of life: 61%). No major pain or discomfort was reported. CONCLUSIONSː The results demonstrate the efficacy of the proposed endourethral artificial sphincter in addressing SUI. The proposed device was successfully implanted and explanted in a short time (~ 10 min) without intrinsic side effects and without triggering pain or discomfort.

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.

Loss of nuclear p27(kip1) and α-dystroglycan is a frequent event and is a strong predictor of poor outcome in renal cell carcinoma.

Expression levels of p27(kip1) , a negative regulator of the G1 phase of the cell cycle, and 8-hydroxydeoxyguanosine (8-OHdG), a marker of oxidative DNA damage, were assessed by immunostaining in a series of renal cell carcinomas (RCCs) and their prognostic significance was evaluated. Expression of p27(kip1) as well as of the α-subunit of the dystroglycan (DG) complex, previously reported to be altered in RCC, was also evaluated by western blot analysis. Nuclear expression of p27(kip1) was reduced in a significant fraction of tumors and low p27(kip1) staining correlated with higher tumor grade (P < 0.01). Recurrence and death from clear cell RCCs were significantly more frequent in p27(kip1) -low expressing tumors and Kaplan-Meier curves showed a significant separation between high vs low expressor groups for both disease-free (P = 0.011) and overall (P = 0.002) survival. Low nuclear expression of p27(kip1) as well as loss of α-DG were confirmed to be independent prognostic parameters at a multivariate analysis and the simultaneous loss of both molecules defined a "high-risk" group of patients with increased risk of recurrence (RR = 28.7; P = 0.01) and death (RR = 12.9; P = 0.03). No significant correlation with clinical or pathological parameters was found for 8-OHdG staining. Western blot analyses suggested a post-translational mechanism for the loss of α-DG expression and demonstrated that cytoplasmic dislocation of the protein contributes to the loss of active nuclear p27(kip1) . Loss of nuclear p27(kip1) is a frequent event in human RCCs and is a powerful predictor of poor outcome which, in combination with low DG expression, could help to identify high-risk patients with clear cell RCC.

Prostate cancer metastases to bone: observational study for the evaluation of clinical presentation, course and treatment patterns. Presentation of the METAURO protocol and of patient baseline features.

AIM: The aim of the present study is to describe the research protocol and preliminary results of an observational survey on presentation patterns of prostate cancer metastasis to bone (METAURO), involving urology departments in several Italian hospitals. MATERIALS AND METHODS: The study design was observational and inclusion criteria required subjects with prostate cancer patients who were first diagnosed with metastatic bone disease not more than 18 months before. For each patient recruited to the study, a retrospective evaluation and a prospective surveillance were undertaken. RESULTS: One hundred and ninety-nine patients were enrolled at 32 urological centers in Italy. The median age of participants at first visit was 72.7 years (SD = 7.8). Mean PSA at onset was 323.6 (SD = 1058.3) and these values strongly correlated with Gleason score (Spearman r = 0.228; p = 0.003). The main cause for suspicion of bone metastasis was routine follow up (53%), followed by pathological fracture (31%). Main metastasis sites were located at femur (43.2%), lumbar sacral spine (39.7%), cervical spine (38.2%) and ribs (33.7%). With regard to the main types of bone metastases identified, 27.6% were sclerotic, 5% were lytic and 21.1% were mixed. The specialist who most frequently suspected bone metastasis and referred patients for diagnostic assessment was an urologist (84.9%). CONCLUSIONS: The present survey is a multicentric study with the main aim to identify features of prostate cancer patients with bone metastases. This survey confirmed that suspicion of bone metastasis is motivated by pain symptoms only in a small percentage of patients with prostate cancer, which testifies to both the difficulty of diagnosis and the need and usefulness of accurate regular follow up.

Expression of dystroglycan correlates with tumor grade and predicts survival in renal cell carcinoma.

The dystroglycan (DG) complex is a transmembrane glycoprotein that forms a continuous link from the extracellular matrix to the actin cytoskeleton. Deregulated expression of DG has been reported in a variety of human malignancies and related to tumor aggressiveness. In this study expression of the DG subunit was evaluated by immunostaining in a series of renal epithelial cancers and its relation with traditional prognostic indicators and with the clinical outcome of the patients was evaluated. alphaDG expression was undetectable in a significant fraction of tumors (54%). In renal cell carcinomas (RCC) loss of alpha-DG staining correlated with higher tumor grade (p = 0.02) but not with tumor stage nor tumor size. In clear cell RCC patients loss of alphaDG staining correlated with an increased risk of recurrence (p = 0.002 by log-rank test) and death (p = 0.004) also when patients with lower grade or stage tumors were analyzed separately. In a multivariate analysis loss of DG staining confirmed to be and independent predictor of shorter disease-free (p = 0.001; RR = 4.9) and overall (p = 0.009; RR = 4.9) survival stronger than tumor grade and size. These findings demonstrate that loss of alphaDG expression, which correspond to loss of a functional DG complex, is a frequent event in human renal tumorigenesis and is an independent predictor of early recurrence and death for patients with clear cell RCC.

Quality of life evaluation by the EORTC QLQ-C30 questionnaire in patients treated with hormonal treatment in Italy. A QuABIOS group study.

OBJECTIVES: An observational study was planned by the QuABIOS group, to survey the hormonal treatment administered to prostate cancer patients in Italy within a time window of 12 months. We report here a prospective quality of life (QOL) evaluation over time and by hormonal treatment modalities. METHODS: Patients with diagnosis of prostate cancer and treated with hormonal therapy were eligible for this study. The EORTC QLQ-C30 v.3 questionnaire was administered at enrolment, after 6 months and after 12 months from enrolment. RESULTS: 587 patients were enrolled by 33 urological centers. When 1518 visits were considered together independently of time, antiandrogen monotherapy was associated with a significantly better QOL than LHRH-analogue containing treatment modalities in almost all functional scales; cyproterone acetate demonstrated a better physical function and general health status than bicalutamide. When QOL was analyzed in a prospective 12-month window, a worsening of physical function and general health status was observed, notwithstanding, antiandrogens remained significantly associated to a better QOL than LHRH-analogue therapies also over time: a favourable physical function and general health status appeared again to be related to cyproterone acetate than bicalutamide. CONCLUSIONS: Androgen deprivation therapy is associated with decline in QOL, particularly in the domains of physical function, energy, and general health status. This survey demonstrated that antiandrogens had a better QOL profile than LHRH-analogue containing therapies;furthermore, a more favourable tolerability for cyproterone acetate as compared to bicalutamide is suggested.