Virtue male sling for post-prostatectomy stress incontinence: a prospective evaluation and mid-term outcomes.

OBJECTIVE: To evaluate the efficacy and safety of the Virtue® male sling (Coloplast, Humlebaek, Denmark) in a cohort of patients affected by post-prostatectomy stress urinary incontinence (SUI). METHODS: All 29 consecutive patients treated with a Virtue male sling at our Institution between July 2012 and October 2013 were included in the present prospective, non-randomized study. Patients were evaluated preoperatively and at 1, 3, 6, 12, 24 and 36 months after surgery using a 24-h pad weight test, the International Consultation on Incontinence short-form questionnaire (ICIQ-SF), Urinary Symptom Profile (USP) questionnaire, a bladder diary, uroflowmetry and the Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity questionnaires. RESULTS: The mean patient age was 65.5 years. A total of 72.4% of patients had preoperative mild incontinence (1-2 pads/day), while nine patients used 3-5 pads/day. There were a total of 17 complications, which occurred in 29 patients (58.6%); all were Clavien-Dindo grade I. At 12-month follow-up patients showed a significant improvement in 24-h pad test (128.6 vs 2.5 g), number of pads per day (2 vs 0), ICIQ-SF score (14.3 vs 0.9) and USP score for SUI (4 vs 0), and outcomes remained stable at 36 months. At last follow-up, the median score on the PGI-I questionnaire was 1 (very much better). CONCLUSION: The Virtue male sling is an effective treatment option for low to moderate post-prostatectomy incontinence.

Role of Multi-Parametric Magnetic Resonance Image and PIRADS Score in Patients with Prostate Cancer Eligible for Active Surveillance According PRIAS Criteria.

OBJECTIVE: To evaluate the prognostic role of multiparametric-MRI (mp-MRI) in patients with clinically localized prostate cancer (PCa) eligible for active surveillance (AS) according to Prostate Cancer Research International: Active Surveillance (PRIAS) criteria. PATIENTS AND METHODS: We analyzed prospectively 73 patients with PCa and PRIAS criteria for low-risk disease. All patients fitted criteria for AS but optioned surgery treatment. The mp-MRI was performed to define the likelihood of malignancy according to the Prostate Imaging Reporting and Data System (PIRADS) score (1-5). Patients were divided in 2 groups: non-visible cancer lesion on MRI (PIRADS 2-3) and visible cancer (PIRADS 4-5). Preoperative clinical data (age, body mass index, prostate specific antigen (PSA) level, positive core biopsy, PSA density (PSAD)) and definitive pathological findings (staging, upgrading, unfavorable disease) were compared between groups. PIRADS score was correlated with pathological data to evaluate the prognostic role of mp-MRI; and preoperative variables and definitive pathology (upgrading, upstaging and unfavorable disease) were also assessed. RESULTS: PSAD (p = 0.04) and pathological stage (p = 0.03) were significantly associated with the presence of visible disease. Visible disease was significantly associated with upstaging (p = 0.03). Correlation between PIRADS 5 and unfavorable disease was statistically significant (p = 0.02). The mp-MRI had adequate sensibility in detecting upstaging (92%), intermediate for upgrading (76%) and unfavorable disease (76%). Negative predictive value was higher for upstaging than for upgrading or unfavorable disease (96 vs. 68% and 64%). Multivariate logistic regression revealed that PIRADS 5 was a significant predictor of upstaging (p = 0.05, OR 16.12) and unfavorable disease (p = 0.01, OR 6.53). CONCLUSION: A visible lesion on mp-MRI strongly predicts significant PCa in patients eligible for AS according to PRIAS criteria, based on upstaging and unfavorable disease. We believe that mp-MRI is an important tool and should be added to clinical selection criteria for AS.

Body mass index was associated with upstaging and upgrading in patients with low-risk prostate cancer who met the inclusion criteria for active surveillance.

BACKGROUND: Obesity is associated with an increased risk of high-grade prostate cancer (PCa). The effect of body mass index (BMI) as a predictor of progression in men with low-risk PCa has been only poorly assessed. In this study, we evaluated the association of BMI with progression in patients with low-risk PCa who met the inclusion criteria for the active surveillance (AS) protocol. METHODS: We assessed 311 patients who underwent radical prostatectomy and were eligible for AS according to the following criteria: clinical stage T2a or less, prostate-specific antigen level < 10 ng/ml, 2 or fewer cores involved with cancer, Gleason score ≤ 6 grade, and prostate-specific antigen density < 0.2 ng/ml/cc. Reclassification was defined as upstaged (pathological stage > pT2) and upgraded (Gleason score ≥ 7; primary Gleason pattern 4) disease. Seminal vesicle invasion, positive lymph nodes, and tumor volume ≥ 0.5 ml were also recorded. RESULTS: We found that high BMI was significantly associated with upgrading, upstaging, and seminal vesicle invasion, whereas it was not associated with positive lymph nodes or large tumor volume. At multivariate analysis, 1 unit increase of BMI significantly increased the risk of upgrading, upstaging, seminal vesicle invasion, and any outcome by 21%, 23%, 27%, and 20%, respectively. The differences between areas under the receiver operating characteristics curves comparing models with and without BMI were statistically significant for upgrading (P = 0.0002), upstaging (P = 0.0007), and any outcome (P = 0.0001). CONCLUSIONS: BMI should be a selection criterion for inclusion of patients with low-risk PCa in AS programs. Our results support the idea that obesity is associated with worse prognosis and suggest that a close AS program is an appropriate treatment option for obese subjects.

Intraoperative frozen pathology during robot-assisted laparoscopic radical prostatectomy: can ALEXIS™ trocar make it easy and fast?

OBJECTIVE: To describe the first series of robot-assisted laparoscopic radical prostatectomy (RALP) using the ALEXIS™ trocar device when removal of the specimen is necessary for intraoperative frozen-section pathology. MATERIALS AND METHODS: Consecutive RALP using the ALEXIS were prospectively catalogue. Perioperative data, including preoperative oncologic diagnosis, operative time, estimated blood loss (EBL), size of incision for umbilical trocar, complications related to trocar, and length of hospital stay, were analyzed. RESULTS: One hundred twenty-eight patients were analyzed. The mean operative time was 216 minutes, mean time to trocar placement was 4 minutes, and mean EBL was 172 mL. The incision size for a trocar was 2-3 cm in 117 patients and 1 incisional hernia was observed. The mean hospital stay was 3 days and mean follow-up was 4 months. CONCLUSION: The ALEXIS trocar provides an easy and fast intraoperative removal of the specimen for frozen pathology during RALP, even for large prostates. Safe and cosmetic results with a low intraoperative complication rate are acquired with the wound retractor.

Robot-assisted simple prostatectomy (RASP): does it make sense?

UNLABELLED: Study Type - Therapy (case series) Level of Evidence 4. What's known on the subject? and What does the study add? The open simple prostatectomy (OSP) is the 'gold standard' for high-volume prostate adenomas. It shows very good functional results despite its invasiveness. Minimally invasive approaches, e.g. laparoscopy or holmium laser enucleation of the prostate, have been 'tested' but none have proved a substitute for the OSP. The robot-assisted approach provides optimal functional results and is easy to perform for experienced robotic surgeons. Extending the indication of robotics to low-incidence pathologies can take advantage of the opportunity to 'see the procedure' using available information technology, e.g. Youtube™ that presents as an unexpectedly useful tool. OBJECTIVE: • To evaluate the outcome, feasibility and reproducibility of a robot-assisted (RA) approach for simple prostatectomy (SP) in cases of high-volume symptomatic benign prostatic hyperplasia (HVS-BPH). PATIENTS AND METHODS: • In all, 35 consecutive patients underwent RASP for HVS-BPH using a previously described technique. • The mean prostate volume on preoperative transrectal ultrasonography was 106.6 mL. • All but two patients (with bladder calculi) had an adenoma volume of >65 mL and 27 (77.1%) >80 mL. Nine patients (25.7%) had an indwelling catheter. • The mean International Prostate Symptom Score (IPSS) was 28. RESULTS: • The median operative duration was 180 min and the mean hospital stay was 3.17 days. • The mean catheter duration was 7.4 days and discontinuous or continuous catheter irrigation was required in two and seven patients, respectively (25.1%). • In all, 10 patients (28.6%) had practically no blood loss. No patients had a transfusion. • The mean postoperative peak urinary flow was 18.9 mL/s (P < 0.001), while the mean IPSS was 7 (P < 0.001). • For costs, while superficially RASP appeared more expensive than open SP (OSP), when considering the higher costs of hospitalisation for OSP, RASP was cheaper. Also, bipolar-TURP costs in patients with large-volume prostates had rather similar costs to RASP. CONCLUSIONS: • RASP is a feasible and reproducible procedure with outcome advantages when compared with the open or with other minimally invasive techniques (laser or laparoscopy). As a result, a RA approach is worth considering in cases of high-volume prostate adenomas. • Extending the indication of the RA approach, to the SP, requires firstly that the surgeon be proficient in RA surgery and secondly that as the incidence rate of HVS-BPH is low, the surgeon has had the opportunity to 'see the procedure'.

Neuroendocrine differentiation in castration-resistant prostate cancer: a systematic diagnostic attempt.

BACKGROUND: Assessing the neuroendocrine (NE) pattern in castration-resistant prostate cancer (CRPC) may prove useful in selecting potential responders to target therapies such as somatostatin analogues. The aim of this study was to define a panel of markers or examinations appropriate to characterize NE differentiation (NED). METHODS: Forty-seven patients with CRPC underwent a systematic diagnostic attempt to characterize the NE phenotype using a plasma blood test for chromogranin A (CgA) and immunohistochemical staining of needle biopsy-obtained specimens (CgA, somatostatin receptor 2 [SSTR2], Ki-67, and androgen receptors). In a subgroup of 26 patients, somatostatin receptor scintigraphy using (111)In-DTPA-d-Phe octreotide (octreotide scintigraphy; Octreoscan, Covidien, Hazelwood, MO) was also performed. RESULTS: NED was found in 85.1% of patients (if serum CgA, tissular CgA, and tissular SSTR2 were considered separately: 54%, 67%, and 58%, respectively). Only 15% of the 26-patient subgroup had an abnormal octreotide scintigraphy result. Although p-CgA and t-CgA were associated with more aggressive disease with a worse prognosis, patients with positive tissular SSTR2 staining had longer overall survival (OS). CONCLUSION: This systematic approach to explore the NED in a quite homogeneous group of patients with CRPC seems reproducible and appropriate. Further investigations are required to validate this panel and better characterize potential responders to targeted therapy.

Robotic vs open prostatectomy in a laparoscopically naive centre: a matched-pair analysis.

OBJECTIVE: To compare the early oncological, perioperative and functional outcomes of robotic-assisted radical prostatectomy (RARP) vs open retropubic RP (RRP) in a laparoscopically naive centre, as robotic assistance aids the laparoscopically naive surgeon in minimally invasive prostate surgery, by offering magnification and superior dexterity. PATIENTS AND METHODS: From 1 November 2006 to 31 December 2007, 120 patients had RARP; this group was followed prospectively and evaluated for early oncological, perioperative and functional outcomes (measured at 3, 6 and 12 months after surgery), and compared to a historical control group of consecutive patients who had RRP from 20 May 2004 to 28 February 2007. All patients were operated by the same laparoscopically naive surgeons. The comparison was by matched-pair analysis. RESULTS: The baseline characteristics of the two groups were equivalent, although there was a higher percentage of patients with pT3/pT4 disease in the RRP group. As a proxy for oncological outcome, positive surgical margins were equivalent in the two groups (22% RARP vs 25% RRP, P = 0.77). The overall mean (range) surgical duration was significantly longer in RARP group, at 215 (165-450) min vs 160 (90-240) min in the RRP group (P < 0.001). However, RARP had a statistically significant advantage over RRP for estimated blood loss, of 200 vs 800 mL (P < 0.001), duration of catheterization (6 vs 7 days P < 0.001) and length of stay (3 vs 6 days, P < 0.001) The 3, 6 and 12-month continence rates were 70%, 93% and 97% vs 63%, 83% and 88% after RARP and RRP, respectively (P = 0.15, 0.011 and 0.014). The 3, 6 and 12 month overall potency recovery rate was 31%, 43% and 61% vs 18%, 31% and 41%, after RARP and RRP, respectively (P = 0.006, 0.045 and 0.003). CONCLUSION: Our initial experience showed the feasibility of RARP in a laparoscopically naive centre. RRP seems to be a faster procedure, whereas RARP provided better results in terms of estimated blood loss, hospitalization and functional results. The early oncological outcome seemed to be equivalent in the two groups.