Publications by authors named "Anastasios D Asimakopoulos"

32 Publications

Increased risk of transurethral and suprapubic catheter self-extraction in COVID-19 patients: real-life experience.

Br J Nurs 2022 May;31(9):S24-S30

Medical Doctor, Urologist, Department of Urology, San Donato Hospital, Arezzo, Italy.

Introduction: This study evaluated the prevalence of transurethral catheter self-removal in critically-ill COVID-19 non-sedated adult patients compared with non-COVID-19 controls.

Methods: COVID-19 patients who self-extracted transurethral or suprapubic catheters needing a urological intervention were prospectively included (group A). Demographic data, medical and nursing records, comorbidities and nervous system symptoms were evaluated. Agitation, anxiety and delirium were assessed by the Richmond Agitation and Sedation Scale (RASS). The control group B were non-COVID-19 patients who self-extracted transurethral/suprapubic catheter in a urology unit (subgroup B1) and geriatric unit (subgroup B2), requiring a urological intervention in the same period.

Results: 37 men and 11 women were enrolled in group A. Mean RASS score was 3.1 ± 1.8. There were 5 patients in subgroup B1 and 11 in subgroup B2. Chronic comorbidities were more frequent in group B than the COVID-19 group (<0.01). COVID-19 patients had a significant difference in RASS score (<0.006) and catheter self-extraction events (<0.001). Complications caused by traumatic catheter extractions (severe urethrorrhagia, longer hospital stay) were greater in COVID-19 patients.

Conclusion: This is the first study focusing on the prevalence and complications of catheter self-removal in COVID-19 patients. An increased prevalence of urological complications due to agitation and delirium related to COVID-19 has been demonstrated-the neurological sequelae of COVID-19 must be considered during hospitalisation.
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http://dx.doi.org/10.12968/bjon.2022.31.9.S24DOI Listing
May 2022

The ETS Homologous Factor (EHF) Represents a Useful Immunohistochemical Marker for Predicting Prostate Cancer Metastasis.

Diagnostics (Basel) 2022 Mar 24;12(4). Epub 2022 Mar 24.

Department of Experimental Medicine, University of Rome "Tor Vergata", Via Montpellier 1, 00133 Rome, Italy.

The main aim of this study was to investigate the risk of prostate cancer metastasis formation associated with the expression of ETS homologous factor (EHF) in a cohort of bioptic samples. To this end, the expression of EHF was evaluated in a cohort of 152 prostate biopsies including primary prostate cancers that developed metastatic lesions, primary prostate cancers that did not develop metastasis, and benign lesions. Data here reported EHF as a candidate immunohistochemical prognostic biomarker for prostate cancer metastasis formation regardless of the Gleason scoring system. Indeed, our data clearly show that primary lesions with EHF positive cells ≥40% had a great risk of developing metastasis within five years from the first diagnosis. Patients with these lesions had about a 40-fold increased risk of developing metastasis as compared with patients with prostate lesions characterized by a percentage of EHF positive cells ≤30%. In conclusion, the immunohistochemical evaluation of EHF could significantly improve the management of prostate cancer patients by optimizing the diagnostic and therapeutic health procedures and, more important, ameliorating the patient's quality of life.
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http://dx.doi.org/10.3390/diagnostics12040800DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9025154PMC
March 2022

Can circumcision be avoided in adult male with phimosis? Results of the PhimoStop prospective trial.

Transl Androl Urol 2021 Nov;10(11):4152-4160

Department of Surgical Sciences, Division of Urology, University of Rome Tor Vergata, Rome, Italy.

Background: Circumcision as surgical treatment of adult phimosis is not devoid of complications. Efficacy of alternative non-surgical options is unclear. PhimoStop is a therapeutic protocol which involves the use of appropriately shaped silicone tuboids of increasing size to obtain a non-forced dilation of the prepuce. The aim of the study was to evaluate the efficacy and durability of results of PhimoStop device for the treatment of adult male phimosis.

Methods: A prospective trial was conducted between 2018 and 2020 on 85 consecutive adult male patients affected by phimosis and with an indication for circumcision. Patients were treated with PhimoStop protocol and they were evaluated at baseline and after treatment through a subjective (patient self-reported information on various domains of his sexual function) and an objective assessment (evaluation of phimosis severity grade according to the Kikiros scale pre- and post-treatment, re-assessment of indication for circumcision post-treatment and validated questionnaires scores). Primary endpoint was to avoid the scheduled circumcision in 33% of the patients enrolled.

Results: Seventy-one patients (84%) completed the device usage phase as per study protocol. Median duration of tuboid application was 60 days. Thirty-seven patients (52.1%) had no indication for circumcision after treatment. Even considering patients lost to follow-up as failures, primary endpoint was reached in 43.5% of cases. There was a significant reduction of the grade of phimosis after treatment (P<0.001). Moreover IIEF-5 showed a statistically significant improvement after treatment (P<0.001). Thirty/37 patients who met the primary endpoint (81%) still have a successful resolution of their phimosis avoiding circumcision at a median follow-up of 24 months.

Conclusions: PhimoStop device is effective for the treatment of adult male phimosis of Kikiros grade ≤2. The results seem to be durable in most patients at a median follow-up of 24 months. Randomized clinical trials are necessary in order to confirm our results and assess cost-efficacy.
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http://dx.doi.org/10.21037/tau-21-673DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8661253PMC
November 2021

T1 Bladder Cancer: Comparison of the Prognostic Impact of Two Substaging Systems on Disease Recurrence and Progression and Suggestion of a Novel Nomogram.

Front Surg 2021 23;8:704902. Epub 2021 Aug 23.

Urology Unit ICOT, Department of Medico-Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Latina, Italy.

The T1 substaging of bladder cancer (BCa) potentially impacts disease progression. The objective of the study was to compare the prognostic accuracy of two substaging systems on the recurrence and progression of primary pathologic T1 (pT1) BCa and to test a nomogram based on pT1 substaging for predicting recurrence-free survival (RFS) and progression-free survival (PFS). The medical records of 204 patients affected by pT1 BCa were retrospectively reviewed. Substaging was defined according to the depth of lamina propria invasion in T1 and the extension of the lamina propria invasion to T1-microinvasive (T1) or T1-extensive (T1). Uni- and multivariable Cox regression models evaluated the independent variables correlated with recurrence and progression. The predictive accuracies of the two substaging systems were compared by Harrell's C index. Multivariate Cox regression models for the RFS and PFS were also depicted by a nomogram. The 5-year RFS was 47.5% with a significant difference between T1 and T1 ( = 0.02) and between T1 and T1 ( < 0.001). The 5-year PFS was 75.9% with a significant difference between T1 and T1 ( = 0.011) and between T1 and T1 ( < 0.001). Model T1 showed a higher predictive power than T1 for predicting RFS and PFS. In the univariate and multivariate model subcategory T1e, the diameter, location, and number of tumors were confirmed as factors influencing recurrence and progression after adjusting for the other variables. The nomogram incorporating the T1 model showed a satisfactory agreement between model predictions at 5 years and actual observations. Substaging is significantly associated with RFS and PFS for patients affected by T1 BCa and should be included in innovative prognostic nomograms.
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http://dx.doi.org/10.3389/fsurg.2021.704902DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8419324PMC
August 2021

Introducing 3D printed models of the upper urinary tract for high-fidelity simulation of retrograde intrarenal surgery.

3D Print Med 2021 Jun 7;7(1):15. Epub 2021 Jun 7.

Urology Unit, Policlinico Tor Vergata Foundation, Viale Oxford 81, 00133, Rome, Italy.

Purpose: Training in retrograde intrarenal surgery for the treatment of renal stone disease is a challenging task due to the unique complexity of the procedure. This study introduces a series of 3D printed models of upper urinary tract and stones designed to improve the training process.

Methods: Six different models of upper urinary tract were algorithmically isolated, digitally optimized and 3D printed from real-life cases. Soft and hard stones in different sizes were produced from 3D printed moulds. The models were fitted onto a commercially available part-task trainer and tested for retrograde intrarenal surgery.

Results: Each step of the procedure was simulated with extraordinary resemblance to real-life cases. The unique anatomical intricacy of each model and type of stones allowed us to reproduce surgeries of increasing difficulty. As the case-load required to achieve proficiency in retrograde intrarenal surgery is high, benchtop simulation could be integrated in training programs to reach good outcomes and low complication rates faster. Our models match incredible anatomical resemblance with low production cost and high reusability. Validation studies and objective skills assessment during simulations would allow comparison with other available benchtop trainers and the design of stepwise training programs.

Conclusions: 3D printing is gaining a significant importance in surgical training. Our 3D printed models of the upper urinary tract might represent a risk-free training option to hasten the achievement of proficiency in endourology.
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http://dx.doi.org/10.1186/s41205-021-00105-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8182943PMC
June 2021

Robotic radical prostatectomy: analysis of midterm pathologic and oncologic outcomes: A historical series from a high-volume center.

Surg Endosc 2021 12 7;35(12):6731-6745. Epub 2020 Dec 7.

Department of Urology, Clinique Saint Augustin, Bordeaux, France.

Background: Identifying predictors of positive surgical margins (PSM) and biochemical recurrence (BCR) after radical prostatectomy (RP) may assist clinicians in formulating prognosis. Aim of the study was to report the midterm oncologic outcomes, to identify the risk factors for PSM and BCR and assess the impact of the PSM on BCR-free survival following robot-assisted laparoscopic radical prostatectomy (RALP).

Methods: From 2005 to 2010, 1679 consecutive patients underwent transperitoneal RALP. Data was retrospectively collected by an independent statistical company and analyzed in 2014. Median postoperative follow-up was 33.5 mo. BCR was defined as any detectable serum prostate-specific antigen (PSA) ≥ 0.2 ng/mL in two consecutive measurements. BCR-free survival was estimated using the Kaplan-Meier method. Univariate and multivariate analysis were applied to identify risk factors for PSM and BCR.

Results: In pN0/pNx cancers, pathologic stage was pT2 in 1186 patients (71.8%), pT3 in 455 patients (27.6%), and pT4 in 11 patients (0.6%). PSM rate was 17.4% and 36.9% of pT2 and pT3 cancers, respectively. Pathologic Gleason score was < 7, = 7 and > 7 in 42.1%, 53% and 4.9% of the patients, respectively. Overall BCR-free survival was 73.1% at 5 years; the 5-year BCR-free survival was 87.9% for pT2 with negative surgical margins. PSA, Gleason score (both bioptic and pathologic), pathologic stage (pT) and surgeon's volume were significant independent predictors of PSM. PSA, pathologic Gleason score, pT and PSM were significant independent predictors of BCR-free survival. Seminal vesicle-sparing, nerve-sparing approach and the extent of nerve-sparing (intra vs interfascial dissection) did not negatively affect margin status or BCR rates.

Conclusions: PSMs are a predictor of BCR. Being the only modifiable factor influencing the PSM rate, surgical experience is confirmed as a key factor for high-quality oncologic outcomes.
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http://dx.doi.org/10.1007/s00464-020-08177-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8599245PMC
December 2021

Retzius-sparing versus standard robot-assisted radical prostatectomy: a prospective randomized comparison on immediate continence rates.

Surg Endosc 2019 07 13;33(7):2187-2196. Epub 2018 Nov 13.

Department of Urology, Usl Toscana Sud Est, San Donato Hospital, Arezzo, Italy.

Background: Post-prostatectomy urinary incontinence is an adverse event leading to significant distress. Our aim was to evaluate immediate urinary continence (UC) recovery in a single-surgeon prospective randomized comparative study between the traditional robot-assisted laparoscopic radical prostatectomy (TR-RALP) and the Retzius-sparing RALP (RS-RALP), for the treatment of the clinically localized prostate cancer (PCa).

Methods: 102 consecutive PCa patients were prospectively randomized to TR-RALP (57) or RS-RALP (45). Postoperative continence was defined as patient-reported absence of leakage or use of 0 pads/day. The immediate continence rate and 95% confidence interval (CI 95%) were calculated for each treatment. Univariable and multivariate logistic regressions were used to assess predictors of immediate continence following RALP. Continence rates from 1 to 6 months were calculated by Kaplan-Meier curves; log-rank test was used for the curve comparison. Two analyses were performed, considering a per-protocol (PP) population regarding all randomized patients that received nerve-sparing RALP and an Intention-To-Treat (ITT) population regarding all randomized patients that received RALP.

Results: In the PP analysis, the rates of immediate continence were 12/40 (30%) (CI 95% 17-47%) for the TR-RALP and 20/39 (51.3%) (CI 95% 35-68%) for the RS-RALP (p = 0.05). In the ITT analysis, the corresponding rates were 12/57 (21%) (CI 95% 11-34%) for the TR-RALP and 23/45 (51%) (CI 95% 36-66%) for the RS-RALP (p = 0.001). Median time to continence was 21 days for the TR-RALP and 1 day for RS-RALP, respectively (p = 0.02). The relative Kaplan-Meier curves regarding continence resulted statistically different when compared with the log rank test (p = 0.02). In the multivariate analysis, lower age and the Retzius-sparing approach were significantly associated to earlier continence recovery.

Conclusions: The Retzius-sparing approach significantly reduces time to continence following RALP. Further studies are required to confirm the reproducibility of our results and investigate the role of the RS-RALP as an additional "protective" factor for postoperative continence in the elderly population.
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http://dx.doi.org/10.1007/s00464-018-6499-zDOI Listing
July 2019

Nerve Sparing, Robot-Assisted Radical Cystectomy with Intracorporeal Bladder Substitution in the Male.

J Urol 2016 11 15;196(5):1549-1557. Epub 2016 Jul 15.

Department of Urology, Clinique Saint-Augustin, Bordeaux, France.

Purpose: We provide a step-by-step description of our technique of nerve and seminal vesicle sparing robot-assisted radical cystectomy with an orthotopic neobladder. We also present preliminary oncologic and functional outcomes.

Materials And Methods: Nerve and seminal vesicle sparing robot-assisted radical cystectomy with a modified Y-shaped orthotopic neobladder was performed by the same surgeon in 40 men with clinically localized bladder cancer from January 2011 to September 2014. Operative, perioperative and pathological data as well as continence and erectile function outcomes are presented.

Results: Median followup was 26.5 months (range 8 to 52). A soft tissue positive surgical margin was found in a patient with pT3a disease. A global rate of 30% early and 32.5% late complications was observed. However, the grade III or higher complication rate was low in both settings at 2.5% and 5%, respectively. There was 1 cancer related death 23 months after surgery. Of the 40 patients 30 (75%) gained daytime continence (0 pad) within 1 month postoperatively. The 12-month nocturnal continence rate was 72.5% (29 of 40 patients). Mean preoperative IIEF-6 (International Index of Erectile Function-6) score was 24.4. Erectile function returned to normal, defined as an IIEF-6 score greater than 17, in 31 of 40 patients (77.5%) within 3 months while 29 of 40 patients (72.5%) returned to the preoperative IIEF-6 score within 12 months.

Conclusions: In the hands of an experienced surgeon nerve and seminal vesicle sparing robot-assisted radical cystectomy with intracorporeal reconstruction of the neobladder seems feasible and safe. It provides short-term oncologic efficacy and promising functional outcomes. Yet comparative, long-term followup studies with standard open cystectomy are required.
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http://dx.doi.org/10.1016/j.juro.2016.04.114DOI Listing
November 2016

Robotic partial nephrectomy performed with Airseal versus a standard CO pressure pneumoperitoneum insufflator: a prospective comparative study.

Surg Endosc 2017 04 5;31(4):1583-1590. Epub 2016 Aug 5.

Department of Experimental Medicine and Surgery, UOC of Urology, University of Rome Tor Vergata, Policlinico Casilino, Viale Oxford 81, 00133, Rome, Italy.

Background: Airseal represents a new generation of valveless and barrier-free surgical trocars that enable a stable pneumoperitoneum with continuous smoke evacuation and carbon dioxide (CO) recirculation during surgery. The aim of the current study was to evaluate the potential advantages of the Airseal compared to a standard CO insufflator in the field of robotic partial nephrectomy (RPN).

Methods: Between October 2012 and April 2015, two cohorts of 122 consecutive patients with clinically localized renal cell carcinoma underwent RPN by a single surgeon, with the use of a standard CO pressure insufflator (Group A, 55 patients) or Airseal (Group B, 67 patients) and were prospectively compared.

Results: The two groups were similar in baseline, preoperative characteristics. The mean dimension of the lesion, as evaluated by contrast-enhanced CT scan, was 30 (median 28; IQR 2) and 39 mm (median 40; IQR 2) for Groups A and B, respectively (p < 0.05). The complexity of the treated tumors was similar, as indicated by the mean RENAL nephrometry score. Positive surgical margins rate was similar in both groups (3.6 vs 4.5 %, p = 0.8) as well as the need for postoperative blood transfusion (9.1 vs 4.5 %, p = 0.3) and the development of postoperative acute kidney injury (16.4 vs 10.4 %, p = 0.3). Mean operative time and warm ischemia time were significantly shorter in Group B. Moreover, a significant increase in the cases performed as "zero ischemia" was observed in Group B (7.3 vs 30 %, p < 0.01).

Conclusions: This is the first study comparing the Airseal with a standard CO insufflator system in the field of the RPN. The preliminary outcomes in terms of overall operative time, warm ischemia time and cases performed as "zero ischemia" are better with respect to standard insufflators. The feasibility, safety and efficacy of combining laser tumor enucleation with the valve-free insufflation systems should be evaluated.
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http://dx.doi.org/10.1007/s00464-016-5144-yDOI Listing
April 2017

The influence of environmental conditions on the incidence of renal colic in Rome.

Urologia 2016 May 14;83(2):77-82. Epub 2016 Apr 14.

Urology Unit, Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Rome - Italy.

Introduction: The aim of this study was to investigate the effect of three major environmental variables (temperature, humidity, air pressure) on the probability of onset of renal colic (RC) in a large cohort of patients in Rome.

Methods: The records of 2682 patients discharged by the Emergency Department (ED) of the University Hospital of Tor Vergata, Rome, from January 2007 to November 2009 with the main diagnosis of reno-ureteric colic associated with a proven calculus, were retrospectively evaluated. The climatic parameters (average humidity, average air pressure and daily minimum, medium and maximum temperature) were recorded in a second, independent database. RC events were grouped by weeks and months and analysed for a total period of 35 months and 153 weeks.

Results: Two thousand five hundred and fourteen patients out of 2682 had a proven urolithiasis. RC events were observed more likely in the warmer months, from the second half of June to the first half of September, compared with the colder months. Although the weekly model showed a positive correlation (R2 = 0.134) between the average increase of environmental temperature and RC incidence, the monthly model was much more convincing (R2 = 0.373). We found no statistically significant correlation between humidity and air pressure and the incidence of RC.

Conclusions: This study demonstrates that an increase in average environmental temperature is associated with a significant increase in the number of episodes of RC seen in the ED at both weekly and monthly time intervals. The average humidity and air pressure were not found to be associated with an increased incidence of RC.
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http://dx.doi.org/10.5301/uro.5000170DOI Listing
May 2016

Holmium Laser Enucleation of the Prostate and Iatrogenic Arteriovenous Fistula Treated by Superselective Arterial Embolization.

Case Rep Urol 2016 28;2016:4918081. Epub 2016 Feb 28.

Department of Experimental Medicine and Surgery, UOC of Urology, University of Rome Tor Vergata, Policlinico Casilino, Via Casilina 1049, 00169 Rome, Italy.

Iatrogenic pelvic pseudoaneurysm with concomitant arteriovenous fistula has been described as a rare and challenging complication, which may occur during transurethral resection of the prostate. We provide the first report of this complication after holmium laser enucleation of the prostate for the treatment of benign prostatic hyperplasia. The attempt to control the bleeding by conversion to open surgery and placement of haemostatic stitches into the prostatic fossa failed. Angiography with superselective arterial embolization proved to be a modern, quick, safe, and efficient treatment of this uncommon complication.
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http://dx.doi.org/10.1155/2016/4918081DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4789036PMC
March 2016

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

Clin Anat 2015 Oct 21;28(7):896-902. Epub 2015 Jul 21.

Department of Urology, Clinique Saint-Augustin, Bordeaux, France.

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.
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http://dx.doi.org/10.1002/ca.22576DOI Listing
October 2015

Measurement of post-void residual urine.

Neurourol Urodyn 2016 Jan 22;35(1):55-7. Epub 2014 Sep 22.

Unit for Functional Urology, Policlinico Tor Vergata, Department of Experimental Medicine and Surgery, Tor Vergata University of Rome, Rome, Italy.

Aims: To present the teaching module "Measurement of Post-void residual urine."

Methods: This module has been prepared by a Working Group of the ICS Urodynamics Committee. The methodology used included comprehensive literature review, consensus formation by the members of the Working Group, and review by members of the ICS Urodynamics Committee core panel.

Results: In this ICS teaching module the evidence for and relevance of PVR measurement in patients with lower urinary tract dysfunction (LUTD) is summarized; in short: The interval between voiding and post-void residual (PVR) measurement should be of short duration and ultrasound bladder volume measurement is preferred to urethral catheterization. There is no universally accepted definition of a significant residual urine volume. Large PVR (>200-300 ml) may indicate marked bladder dysfunction and may predispose to unsatisfactory treatment results if for example, invasive treatment for bladder outlet obstruction (BOO) is undertaken. PVR does not seem to be a strong predictor of acute urinary retention and does not indicate presence of BOO specifically. Although the evidence base is limited, guidelines on assessment of LUTS generally include PVR measurement.

Conclusion: Measurement of PVR is recommended in guidelines and recommendations on the management of LUTS and urinary incontinence, but the level of evidence for this measurement is not high. This manuscript summarizes the evidence and provides practice recommendations for teaching purposes in the framework of an ICS teaching module.
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http://dx.doi.org/10.1002/nau.22671DOI Listing
January 2016

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

BMC Urol 2014 Sep 18;14:75. Epub 2014 Sep 18.

UOC of Urology, Department of Experimental Medicine and Surgery, University of Tor Vergata, Policlinico Casilino, Rome, Italy.

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.
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http://dx.doi.org/10.1186/1471-2490-14-75DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4171399PMC
September 2014

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

Surg Endosc 2015 Jan 15;29(1):236-44. Epub 2014 Aug 15.

UOC of Urology, Department of Surgery, University of Rome Tor Vergata, Policlinico Casilino, Viale Oxford 81, 00133, Rome, Italy,

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.
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http://dx.doi.org/10.1007/s00464-014-3663-yDOI Listing
January 2015

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

Surg Endosc 2013 Nov 27;27(11):4297-304. Epub 2013 Jun 27.

UOC of Urology, Department of Surgery, University of Tor Vergata, Policlinico Casilino, Rome, Italy,

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.
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http://dx.doi.org/10.1007/s00464-013-3046-9DOI Listing
November 2013

Robot-assisted laparoscopic radical prostatectomy with intrafascial dissection of the neurovascular bundles and preservation of the pubovesical complex: a step-by-step description of the technique.

J Endourol 2012 Dec 16;26(12):1578-85. Epub 2012 Oct 16.

Department of Surgery, University of Tor Vergata, Rome, Italy.

The preservation of sexual potency after radical prostatectomy has always been the topic of much anxiety and debate. While cancer control and urinary continence are of supreme importance, the preservation of sexual function completes the trifecta that both patient and surgeon strive to achieve. The introduction of robotic assistance to modern laparoscopic surgery has provided many advantages, the two greatest being improved three-dimensional magnified vision and wristed instrumentation. These technical enhancements provide the surgeon with improved surgical tools that have the potential to facilitate a more precise surgical approach. One of the potential advantages during robot-assisted laparoscopic prostatectomy (RALP) is improving visualization, control, and dissection of the neurovascular bundle (NVB). With this article, we provide the description of our current technique of intrafascial, tension and energy-free dissection of the NVB during RALP, aiming to maximize the preservation of the periprostatic neuronal network and improve erectile function outcomes. A step-by-step description of the preservation of the pubovesical complex is also provided.
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http://dx.doi.org/10.1089/end.2012.0405DOI Listing
December 2012

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

Urol Int 2012 25;89(3):275-82. Epub 2012 Jul 25.

Division of Urology, Department of Surgery, Policlinico Tor Vergata Foundation, University of Tor Vergata, Rome, Italy.

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.
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http://dx.doi.org/10.1159/000339716DOI Listing
April 2013

Radiofrequency versus ultrasonic energy in laparoscopic colorectal surgery: a metaanalysis of operative time and blood loss.

Surg Endosc 2012 Oct 12;26(10):2917-24. Epub 2012 May 12.

Department of Surgical Sciences, University of Rome Tor Vergata, Policlinico Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.

Background: Various energy sources are available for tissue dissection and vessel sealing in laparoscopic colorectal surgery. The electrothermal bipolar vessel sealing system (EBVS) and ultrasonic energy (UE) devices are widely used to provide hemostatic dissection in laparoscopic procedures. Nevertheless, available evidenced-based data comparing their operative results still are scarce. This study conducted a metaanalysis of controlled clinical trials comparing EBVS and UE in terms of operative time and intraoperative blood losses in laparoscopic colorectal surgery.

Methods: The MEDLINE and Embase databases were searched using medical subject headings and free text words. All randomized controlled trials (RCTs) and controlled clinical trials using EBVS and UE in laparoscopic colorectal surgery were considered for inclusion in the study. Random effects models were used in case of heterogeneity to obtain summary statistics for the overall difference in operating time and blood loss between instruments.

Results: Four studies comparing EBVS with UE for 397 patients (200 EBVS vs. 197 UE patients) were included in the study. The findings showed that EBVS was associated with a significantly shorter operative time and less intraoperative blood loss than UE (p < 0.05).

Conclusions: The metaanalysis indicated that EBVS is associated with a shorter operative time and less blood loss than UE in laparoscopic colorectal surgery. However, these results should be interpreted with caution due to the high heterogeneity of the included trials and the limited number of studies with a high level of evidence. More adequately designed RCTs with a larger number of patients are required to confirm the results of this metaanalysis.
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http://dx.doi.org/10.1007/s00464-012-2285-5DOI Listing
October 2012

The surgical treatment of a large prostatic adenoma: the laparoscopic approach--a systematic review.

J Endourol 2012 Aug 27;26(8):960-7. Epub 2012 Apr 27.

UOC of Urology, Department of Surgery, University of Tor Vergata, Policlinico Casilino, Rome, Italy.

Purpose: To present a critical overview of the current literature on the role of laparoscopy for the surgical treatment of patients with large prostatic adenomas.

Materials And Methods: A MedLine search for peer-reviewed studies on laparoscopic simple prostatectomy (LSP) was performed. The clinical studies that reported most of the following information were included: number of patients, prostate volume, operative time, blood loss, hospital stay, and the duration of catheterization, as well as functional outcomes and complications. Articles reporting a mean total prostate volume of <80 mL or a mean prostatic adenoma of <60 mL were excluded. The review was performed according to the PRISMA statement.

Results: Fourteen articles on LSP were included in this systematic review with a total of 626 patients treated. Both transperitoneal and extraperitoneal approaches, as well as transvesical and transcapsular routes, have been described. Eleven articles were case-series and three were comparative retrospective nonrandomized studies. When compared with open simple prostatectomy (OP), LSP is associated with a less blood loss and a reduced irrigation requirement, a shorter postoperative catheterization period, and a shorter hospital stay, at the expense of an extended operative time. The limited number of patients treated, the selection biases due to the retrospective nature of several published articles on LSP, and the short follow-up periods are evident limits of the literature. I-square test demonstrated a high heterogeneity (93%) and consequently a high variability in the intervention effects in terms of maximum urinary flow rate (Qmax).

Conclusions: Even if LSP seems feasible and safe, there is still limited evidence regarding its long-term outcomes compared with OP.
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http://dx.doi.org/10.1089/end.2012.0055DOI Listing
August 2012

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.

J Sex Med 2012 Sep 16;9(9):2404-16. Epub 2012 Jan 16.

UOC of Urology, Department of Surgery, University of Tor Vergata, Policlinico Casilino, Rome, Italy.

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.
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http://dx.doi.org/10.1111/j.1743-6109.2011.02628.xDOI Listing
September 2012

Laparoscopic extravesical ureteric re-implantation.

BJU Int 2011 Dec;108(11):1918-32

Department of Surgery, Division of Urology, University Tor Vergata, Rome, Italy.

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http://dx.doi.org/10.1111/j.1464-410X.2011.10745.xDOI Listing
December 2011

Randomized comparison between laparoscopic and robot-assisted nerve-sparing radical prostatectomy.

J Sex Med 2011 May 16;8(5):1503-12. Epub 2011 Feb 16.

Department of Surgery, University of Tor Vergata, Policlinico Tor Vergata, Rome, Italy.

Introduction: Lack of randomized controlled trials (RCTs) that compare pure laparoscopic radical prostatectomy (LRP) with robot-assisted laparoscopic radical prostatectomy (RALRP) is an important gap of the literature related to the surgical treatment of the clinically localized prostate cancer (PCa).

Aim: To provide the first prospective randomized comparison on the functional and oncological outcomes of LRP and RALRP for the treatment of the clinically localized PCa.

Methods: Between 2007 and 2008, 128 consecutive male patients were randomized in two groups and treated by a single experienced surgeon with traditional LRP (Group I-64 patients) or RALRP (Group II-64 patients) in all cases with intent of bilateral intrafascial nerve sparing.

Main Outcome Measures: Primary end point was to compare the 12 months erectile function (EF) outcomes. Complication rates, continence outcomes, and oncological results were also compared. The sample size of our study was able, with an adequate power (1-beta > 0.90), to recognize as significant large differences (above 0.30) between incidence proportions of considered outcomes.

Results: No statistically significant differences were observed for operating time, estimated blood loss, transfusion rate, complications, rates of positive surgical margins, rates of biochemical recurrence, continence, and time to continence. However, the 12-month evaluation of capability for intercourse (with or without phosphodiesterase type 5 inhibitors) showed a clear and significant advantage of RALRP (32% vs. 77%, P < 0.0001). Time to capability for intercourse was significantly shorter for RALRP. Rates of return to baseline International Index of Erectile Function (IIEF-6) EF domain score questionnaires (questions 1-5 and 15) (25% vs. 58%) and to IIEF-6 > 17 (38% vs. 63%) were also significantly higher for RALRP (P = 0.0002 and P = 0.008, respectively).

Conclusions: Our study offers the first high-level evidence that RALRP provides significantly better EF recovery than LRP without hindering the oncologic radicality of the procedure. Larger RCTs are needed to confirm if a new gold-standard treatment in the field of RP has risen.
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http://dx.doi.org/10.1111/j.1743-6109.2011.02215.xDOI Listing
May 2011

HIFU as salvage first-line treatment for palpable, TRUS-evidenced, biopsy-proven locally recurrent prostate cancer after radical prostatectomy: a pilot study.

Urol Oncol 2012 Sep 2;30(5):577-83. Epub 2011 Feb 2.

Division of Urology, Department of Surgery, Fondazione Policlinico Tor Vergata, University of Tor Vergata, Rome, Italy.

Objective: To test high-intensity focused ultrasound (HIFU) as salvage first-line treatment for palpable, TRUS-evidenced, biopsy-proven locally recurrent prostate cancer (CaP) after radical prostatectomy (RP).

Materials And Methods: Nineteen patients with palpable, TRUS-evidenced, biopsy-proven local recurrence of CaP after RP, unwilling to undergo salvage radiotherapy (SRT), underwent HIFU as a single-session procedure. Pre-, intra-, and postoperative data including early and late complications, and oncologic outcomes (PSA nadir, biochemical recurrence (BCR)-free survival, and need of secondary adjuvant treatment) were prospectively evaluated. Success was defined as PSA nadir ≤0.1 ng/ml obtained within 3 months from HIFU. In case of PSA nadir >0.1 ng/ml or PSA increase ≥1 ng/ml above the PSA nadir, a biopsy of the treated lesion was performed, and if negative, maximum androgen blockade (MAB) was adopted. In case of positive biopsy, RT was performed. Failure was defined as use of secondary adjuvant treatment (MAB or RT).

Results: Median follow-up was 48 months. All cases were performed as overnight procedure. No case of urethrorectal fistula or anastomotic stricture was observed. Two cases of acute urinary retention were resolved with prolonged urethral catheterization. Four cases of stress urinary incontinence were observed; 2 (mild incontinence) were resolved after pelvic floor exercises within 6 months, while 2 cases of severe incontinence required surgical minimally invasive treatment;17/19 patients (89,5%) were classified as success. Two patients failed to show a PSA nadir <0.1 ng/ml. During follow-up, 8/17 patients (47%) were classified as failure, with consequent total rate of failures 10/19 (52.6%). A statistically significant difference was observed in pre-HIFU median PSA (2 vs. 5.45 ng/ml, respectively, P = 0.013) and Gleason score of the RP specimen (P = 0.01) between the success and failure group.

Conclusions: Salvage first-line HIFU for palpable, TRUS-evidenced, biopsy-proven local recurrence of CaP is a feasible, minimally invasive day-case procedure, with an acceptable morbidity profile. It seems to have a good cancer control in the short- and mid-term. Patients with lower pre-HIFU PSA level and favorable pathologic Gleason score presented better oncologic outcomes. A prospective randomized trial with an adequate recruitment and follow-up is necessary to confirm our preliminary oncologic results.
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http://dx.doi.org/10.1016/j.urolonc.2010.08.019DOI Listing
September 2012

Complete periprostatic anatomy preservation during robot-assisted laparoscopic radical prostatectomy (RALP): the new pubovesical complex-sparing technique.

Eur Urol 2010 Sep 18;58(3):407-17. Epub 2010 May 18.

Division of Urology, Department of Surgery, Policlinico Tor Vergata, University of Tor Vergata, Rome, Italy.

Background: Puboprostatic ligament preservation has been proposed as a method to accelerate continence recovery after radical prostatectomy (RP). However, these ligaments present anatomic continuity with the bladder, and there must be interruption at some point to expose the prostatourethral junction.

Objectives: To describe the surgical steps of pubovesical complex (PVC)-sparing robot-assisted laparoscopic RP (RALP) and present the preliminary results of our technique.

Design, Setting, And Participants: Thirty PVC-sparing RALP procedures were performed in patients <60 yr with clinically localised prostate cancer between 2007 and 2009 by the same surgeon.

Surgical Procedure: The principles of bladder neck preservation, tension and energy-free dissection of the bundles as well as seminal vesicle sparing are applied. Ventrally, a plane of dissection is developed between the detrusor apron and the prostate. The soft connective tissue between Santorini's plexus and the prostate is blandly dissected, leaving the plexus intact and in place.

Measurements: The rates and location of positive surgical margins (PSM) as well as functional outcomes are presented.

Results And Limitations: Three of 30 patients (10%) had a PSM (two apical margins and one on the left posterolateral side). At catheter removal, 24 of 30 patients (80%) were dry (0 pads), and 6 of 30 patients (20%) needed one security pad. After 3 mo, 22 of 30 patients (73%) presented an International Index of Erectile Function score >17 (with or without phosphodiesterase type 5 inhibitors). Thirteen of 22 potent patients had an Erection Hardness Score of 3, and 9 of 22 patients had a score of 4. Small sample size, low mean age of enrolled patients (52 yr), and the absence of diseases that could impair the continence and potency recovery are some of the limitations of the study. Moreover, it is difficult to quantify the effect of each applied continence-sparing technique.

Conclusions: The holistic preservation of the PVC during RALP is technically feasible. It leads towards an absolute preservation of the periprostatic anatomy that may enhance early functional outcomes. Further studies are needed to confirm our results.
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http://dx.doi.org/10.1016/j.eururo.2010.04.032DOI Listing
September 2010

Significance of focal proliferative atrophy lesions in prostate biopsy cores that test negative for prostate carcinoma.

Urol Oncol 2011 Nov-Dec;29(6):690-7. Epub 2010 May 7.

Division of Urology, Department of Surgery, Policlinico Tor Vergata, University of Tor Vergata, Rome, Italy.

Objectives: To evaluate the prevalence and short-term follow-up of focal proliferative atrophy lesions, either with or without the presence of inflammation (PIA/PA), and its correlation with the PSA levels, focusing on the prostate biopsy cores that test negative for prostate adenocarcinoma (PCa).

Methods: Five hundred fifty consecutive patients who had undergone a transrectal ultrasound-guided transperineal prostate biopsy were evaluated retrospectively for the presence and follow-up of focal proliferative atrophy lesions. PIA/PA were defined according to De Marzo. The prevalence of atrophy in PCa and negative biopsy cores was compared by means of χ(2). After logarithmic transformations of the PSA values, t-test and ANOVA were applied for the comparison of the means. Incidence of newly diagnosed PCa during follow-up (mean 33.7 months) in patients with or without focal proliferative atrophy was compared by means of χ(2).

Results: A focal atrophic lesion resulted in 161/339 negative biopsies. PIA was observed in 93/161 patients (57.8%), while PA was observed in the remaining 68/161 (42.2%). Among the negative biopsy cases, the difference in PSA values were not statistically significant according to the presence or absence of atrophy (P = 0.120). The group of negative biopsies with PIA was similar in terms of PSA characteristics with the benign (PA P = 0.738; non-atrophy P = 0.342), and cancer subgroups (P = 0.094); 245/339 (72.3%) patients were successfully followed-up. Biopsy was repeated in 24/71 (33.8%) patients with PIA, in 14/50 (28%) with PA and in 27/124 (21.7%) with no atrophy lesions at initial biopsy. The incidence of newly diagnosed PCa in the 3 groups was not statistically different (χ(2), P = 0.81).

Conclusions: Focal proliferative atrophy lesions are a common finding in biopsy specimens negative for PCa. Patients with negative biopsy associated with PIA presented similar PSA characteristics as patients with biopsy-proven PCa. However, the incidence of PCa at short-term follow-up did not differ significantly between patients with PIA, PA, or no atrophic lesions at initial biopsy. Based on our findings, early repeat biopsy does not seem to be necessary after an initial diagnosis of PIA/PA, although a longer follow-up is mandatory for definitive conclusions.
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http://dx.doi.org/10.1016/j.urolonc.2010.01.010DOI Listing
March 2012
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