Versius robotic surgical system: case series of 18 robot-assisted radical prostatectomies.

OBJECTIVE: To present the results of the first series of patients treated with robot-assisted radical prostatectomy (RARP) with the use of the Versius® Surgical System (CMR Surgical Ltd., Cambridge, UK). RARP has demonstrated better perioperative outcomes compared to open RP. However, RARP remains limited by platform availability and cost-effectiveness issues. The increasing competition from new robotic surgical platforms may further drive utilisation of the robotic approach. PATIENTS AND METHODS: Data were collected prospectively for our first 18 consecutive patients with localised prostate cancer who underwent RARP at our centre over a 3-month period. We recorded parameters, including patient demographics and perioperative outcomes. We also report our optimised set-up with regard to trocar placement, bedside unit placement, and overall composition of the operating room for this procedure. Describing the incremental modifications carried out to achieve reductions in set-up and operating times to optimise utilisation of the Versius system. RESULTS: The median (interquartile range [IQR]) set-up time was 8.5 (7-10) min. The median (IQR) console time was 201 (170-242) min. The median (IQR) operative time was 213 (186-266) min. The median (IQR) total surgery time was 226 (201-277) min. Bilateral pelvic lymphadenectomy median (IQR) time was 19 (17-20) min. There were no complications and/or limitations related to the use of the Versius system including need for conversion. There were no relevant intra- or postoperative complications at the 1-month follow-up related to the use of the Versius system. Patients were discharged after a median (IQR) of 4 (3.75-5) days, and the transurethral catheter was removed after a mean (range) of 8 (7-14) days. Continence at 2 months was achieved in 72.2% of the patients. CONCLUSIONS: Performing RARP using the Versius system is feasible, safe, and easily reproducible. Our set-up enables a rapid docking approach and efficient completion of the surgery.

The use of Versius CMR for pelvic surgery: a multicentric analysis of surgical setup and early outcomes.

INTRODUCTION: Versius CMR is a novel robotic system characterized by an open surgical console and independent bedside units. The system has potentials of flexibility and versatility, and has been used in urological, gynecological, and general surgical procedure. The aim is to depict a comprehensive analysis of the Versius system for pelvic surgery. METHODS: This is a study involving two Institutions, ASST Santi Paolo and Carlo, Milan, and Apuane Hospital, Massa, Italy. All interventions performed in the pelvic area with the Versius were included. Data about indications, intra-, and post-operative course were prospectively collected and analyzed. RESULTS: A total of 171 interventions were performed with the Versius. Forty-two of them involved pelvic procedures. Twenty-two had an oncological indication (localized prostate cancer), the remaining had a non-oncological or functional purpose. The mostly performed pelvic procedure was radical prostatectomy (22) followed by annexectomy (9). No intra-operative complication nor conversion to other approaches occurred. A Clavien II complication and one Clavien IIIb were reported. Malfunctioning/alarms requiring a power cycle of the system occurred in 2 different cases. An adjustment in trocar placement according to patients' height was required in 2 patients undergoing prostatectomy, in which the trocar was moved caudally. In two cases, a pelvic prolapse was repaired concomitant with other gynecological procedures. CONCLUSIONS: Pelvic surgery with the Versius is feasible without major complications; either dissection and reconstructive steps could be accomplished, provided a proper OR setup and trocar placement are pursued. Versius can be easily adopted by surgeons of different disciplines and backgrounds; a further multi-specialty implementation is presumed and long-term oncological and functional outcomes are awaited.

Duodenal graft complications requiring duodenectomy after pancreas and pancreas-kidney transplantation.

Duodenal graft complications are poorly reported complications of pancreas transplantation that can result in graft loss. Excluding patients with early graft failure, after a median follow-up period of 126 months (range 23-198) duodenectomy was required in 14 of 312 pancreas transplants (4.5%). All patients were insulin-independent at the time of diagnosis. Reasons for duodenectomy included delayed duodenal graft perforation (n = 10, 71.5%) and refractory duodenal graft bleeding (n = 4, 28.5%). In patients with duodenal graft bleeding, a total duodenectomy was performed. In patients with duodenal graft perforation, preservation of a duodenal segment was possible in five patients but completion duodenectomy was necessary in one patient. After total duodenectomy, immediate enteric duct drainage was feasible in seven patients. In two patients, a pancreaticocutaneous fistula was created that was subsequently converted to enteric drainage in one patient. In the other patient, enteric fistulization occurred as a consequence of silent pressure perforation of the draining catheter on the ascending colon. After a mean follow-up period of 52 months (21-125), all patients were alive, well, and insulin-independent. An aggressive and timely surgical approach may permit graft rescue in patients with severe duodenal graft complications occurring after pancreas transplantation. Generalization of these results remains to be established.

Intravesical migration of female urethral dilator: a case report of a new urologic emergency in the era of e-commerce.

BACKGROUND: The introduction of foreign bodies in the female urethra for auto-erotic stimulation or in case of psychiatric disorders is not uncommon. The occurrence of intravesical migration of these objects makes it necessary to remove it shortly after insertion, since after long term permanence complications are likely to occurr. CASE PRESENTATION: A 47-year-old white female was referred at our Urology department for migration inside the bladder of a metallic urethral dilator used for sexual stimulation. An ultrasound study and an X-ray plate of the pelvis clearly visualized the presence of an object shaped like a rifle bullet located in the bladder. Twenty-four hours later, the patient reported its spontaneous emission through the urethra during micturition. This was confirmed by US and X-ray imaging. CONCLUSIONS: The retrieval of foreign objects introduced through body orifices with purpose of sexual gratification is a known urological expertise. Curiously, in the case reported, the patient was able to manipulate the object thus facilitating its correct orientation and passage outside the bladder during micturition. To the best of our knowledge this is the first case of documented spontaneous emission through the urethra of a sizable intravesical foreign body. Sexual gratification in females though the insertion of urethral dilators is a growing practice, as demonstrated by the broad proposal of such instruments on the web. Therefore, the occurrence of accidental intravesical displacement of such kind of foreign body is increasingly likely, and the Urologists must be aware of this possibility.

Complete intraperitoneal displacement of a double J stent: a first case.

OBJECTIVES: Ureteral double-J stents are known to migrate proximally and distally within the urinary tract, while perforation and stent displacement are uncommon. Possible mechanisms of displacement are either original malpositioning with ureteral perforation or subsequent fistula and erosion of the excretory system, due to infection or long permanence of the device. We present the unique case of complete intraperitoneal stent migration in a 59-year-old caucasian male without evidence of urinary fistula at the moment of diagnosis, so far an unreported complication. MATERIALS AND METHODS: Eight months after the placement of a double-J stent for lower right ureteral stricture at a district hospital, the patient came at our observation for urosepsis and hydro-uretero-nephrosis. A CT scan demonstrated intraperitoneal migration of the stent outside the urinary tract. Cystoscopy failed to visualize the lower extremity of the stent, a percutaneous nephrostomy was placed to drain the urinary system and the stent was removed through a small abdominal incision on the right lower quadrant. RESULTS: In our case we presume that during the positioning manoeuvre the guide wire perforated simultaneously the lower ureteral wall and the pelvic peritoneum, and that once the upper end of the stent was coiled, the lower extremity was also attracted intraperitoneally. The lack of pain due to the spinal lesion concurred to this unusual complication. CONCLUSIONS: We must be aware that ureteral double J stents may be found displaced even inside the peritoneal cavity, and that the use of retrograde pyelography during placement is of paramount importance to exclude misplacement of an apparently normally coiled upper extremity of the stent.

Radical cystectomy and ileal orthotopic bladder substitution after radical retropubic prostatectomy: functional and oncological results.

Men with good functional results following radical retropubic prostatectomy (RRP) and requiring radical cystectomy (RC) for subsequent bladder carcinoma seldom receive orthotopic bladder substitution. Four patients aged 62-72 years (median 67 years), who had undergone RRP for prostate cancer of stage pT2bN0M0 Gleason score 6 (n = 1), pT2cN0M0 Gleason score 5 and 6 (n = 2) and pT3bN0M0 Gleason score 7 (n = 1) 27 to 104 months before, developed urothelial bladder carcinoma treated with RC and ileal orthotopic bladder substitution. After radical prostatectomy three were continent and one had grade I stress incontinence, and three achieved intercourse with intracavernous alprostadil injections. Follow-up after RC ranged between 27 and 42 months (median 29 months). At the 24-month follow-up visit after RC daily urinary continence was total (0 pad) in one patient, two used one pad for mild leakage, and one was incontinent following endoscopic incision of anastomotic stricture. One patient died of progression of bladder carcinoma, while the other three are alive without evidence of disease. The three surviving patients continued to have sexual intercourse with intracavernous alprostadil injections. Men with previous RRP have a reasonable chance of maintaining a satisfactory functional outcome following RC and ileal orthotopic bladder substitution.

Delayed-onset ureteral lesions due to thermal energy: an emerging condition.

OBJECTIVES: To describe the risks of ureteral damage occurring during urological and gynecological procedures utilizing energybased surgical devices (ESD) during both laparoscopic and open procedures. MATERIALS AND METHODS: During the last 20 months we observed five cases of iatrogenic ureteral lesions caused by ESD which required open surgery. There were 3 lesions of the lower ureter occurring during gynecological laparoscopic or robotic procedures, and 2 lesions of the upper ureter occurring during open enucleation of low-stage renal cell carcinomas. RESULTS: In the laparoscopic gynecological lesions the cause was attributable to monopolar cutting and bipolar coagulation: they presented with urine extravasation after 20, 15 and 15 days respectively and required ureteral reimplantation in 2 out of 3 cases. In the upper ureteral lesions the causes were bipolar coagulation and LigaSure Impact TM used for perirenal fat dissection: they presented after 2 and 4 months respectively and required uretero-ureterostomy and inferior nephropexy in one case and nephrectomy in the other. In 3 out of 5 cases there was an unsuccessful attempt at placing an ureteral double J stent, and in the 2 cases where it was placed it did not prevent the formation of subsequent stricture in one. CONCLUSIONS: The widespread diffusion of ESD has the potential drawback of inadvertent thermal energy transmission to the ureter. Delayed presentation of ureteral lesions and difficulties in ureteral stent placement were the common features of the cases observed. Inadvertent ureteral damage by different thermal energy sources is an emerging condition, requiring awareness, prompt recognition and adequate treatment with the reconstructive urology principles.

Management of an elderly patient with retention of a steel nail in the scrotum: a case report.

BACKGROUND: The retention of foreign bodies inside the body during ludic/sexual procedures or for traumatism represents one of the causes of visits to accident and emergency departments that often requires surgical removal of the foreign body. However, there are cases where the discovery of such foreign bodies takes place after many years, as in patients that are slightly compromised from a neuro-sociological point of view. CASE PRESENTATION: A 76-year-old male presented to an outpatient urological examination due to an increase in scrotal volume. At the ultrasound check, an acoustic interference from a solid object was detected, for which computed tomography was requested. The computed tomography scan revealed the presence of an elongated metal body in the perineum. The removal of the foreign body in the operating theatre was then scheduled. A 10 cm long stainless-steel nail located within an abscessed foreign body granuloma was identified and removed via a scrotal access. Four days later, a new surgical toilet was performed due to minimal necrosis of the skin flaps. The patient then performed three more dressings in the operating theatre during the following week. Healing took place by secondary intention until a perfect healing of the surgical wound was obtained. CONCLUSIONS: Removal of foreign bodies from the perineum in case of infection can be challenging. Careful attention and postoperative dressings are crucial for the success of the case.

Partial nephrectomy series using Versius robotic surgical system: technique and outcomes of an initial experience.

Partial nephrectomy (PN) represents a procedure where the use of a robot has further enabled successful completion of this complex surgery. The results of this procedure using Versius Robotic Surgical System (VRSS) still need to be evaluated. Our working group described the technique and reported the initial results of a series of PN using VRSS. We presented our setting, surgical technique and outcomes for PN, using VRSS. Between 2022 and 2023, 15 patients underwent PN performed by two surgeons in two different centers. Fifteen patients underwent PN. The median lesion size identified on preoperative imaging was 4 (IQR 2.3-5) cm. Median PADUA score was 8 (IQR 7-9). Two procedures were converted to radical nephrectomy for enhanced oncological disease control. Of the 13 nephrectomies that were completed as partial, 7 were performed clampless and 6 with warm ischemia clamping. Median clamping time was 10 (IQR 9-11) minutes. No procedure was converted to open. Median blood loss was 200 (IQR 100-250) mL. Median total operative time was 105 (IQR 100-110) minutes. Median console time was 75 (IQR 66-80) minutes. Median set-up time was 13 (IQR 12-14) minutes. No intraoperative complications were reported. The median hospitalization time was 4 (IQR 3.5-4) days. None of the patients were transfused and none of the patients required readmission. In a pathology report, one patient had a positive surgical margin. Our initial experience suggests that performing PN using VRSS is feasible with good short-term outcomes.

Prospective study on the impact of BEAM versus FEAM conditioning on occurrence of neutropenic enterocolitis and on transplant outcome in lymphoma patients.

Introduction: Carmustine (BCNU), etoposide, cytarabine, and melphalan (BEAM) are a widely used high-dose chemotherapy regimen for autologous stem cell transplantation transplant (ASCT) in lymphoid malignancies. During BCNU shortages, some centers switched to fotemustine-substituted BEAM (FEAM). Neutropenic enterocolitis (NEC) is a life-threatening complication occurring after intestinal mucosa damage related to intensive chemotherapy. NEC mortality may be up to 30%-50%. In our study, we compared NEC incidence, symptoms, mortality, and transplant outcome in terms of overall survival (OS) and progression-free survival (PFS) in the BEAM vs. FEAM groups. Furthermore, we compared the cost of hospitalization of patients who did vs. patients who did not experience a NEC episode (NECe). Methods: A total of 191 patients were enrolled in this study (N = 129 and N = 62 were conditioned with BEAM and FEAM, respectively). All patients received bed-side high-resolution ultrasound (US) for NEC diagnosis. Results and discussion: NEC incidence and NEC-related mortality were similar in the BEAM and FEAM groups (31% and 40.3%, p = 0.653, and 5% and 8%, p = 0.627, respectively). At a median follow-up of 116 months, no difference was noted between BEAM vs. FEAM groups in terms of OS and PFS (p = 0.181 and p = 0.978, respectively). BEAM appeared equivalent to FEAM in terms of NEC incidence and efficacy. The high incidence of NEC and the low mortality is related to a timely US diagnosis and prompt treatment. US knowledge in NEC diagnosis allows to have comparable days of hospitalization of patients NECpos vs. patients NECneg. The cost analysis of NECpos vs. NECneg has been also performed.

Minimally invasive treatment of urinary fistulas using N-butyl-2-cyanoacrylate: a valid first line option.

BACKGROUND: A few single case reports and only one clinical series have been published so far about the use of N-butyl-2-cyanoacrylate in the treatment of urinary fistulas persisting after conventional urinary drainage. CASE PRESENTATION: We treated five patients with a mean age of 59.2 years presenting iatrogenic urinary fistulas which persisted following conventional drainage manouvres. There were 3 calyceal fistulas following open, laparoscopic and robotic removal of renal lesions respectively, one pelvic fistula after orthotopic ileal neobladder and a bilateral dehiscence of uretero-sigmoidostomy. We used open-end catheters of different sizes adopting a retrograde endoscopic approach for cyanoacrylate injection in the renal calyces, while a descending percutaneous approach via the pelvic drain tract and bilateral nephrostomies respectively was used for the pelvic fistulas. Fluoroscopic control was always used during the occlusion procedures. The amount of adhesive injected ranged between 2 and 5 cc and in one case the procedure was repeated. With a median follow-up of 11 months we observed clinical and radiological resolution in 4 cases (80%), while a recurrent and infected calyceal fistula after laparoscopic thermal renal damage during tumor enucleoresection required nephrectomy. No significant complications were documented. CONCLUSIONS: In an attempt to spare further challenging surgery in patients that had been already operated on recently, minimally invasive occlusion of persistent urinary fistulas with N-butyl-2-cyanoacrylate represents a valid first line treatment, justified in cases when the urinary output is not excessive and there is a favorable ratio between the length and diameter of the fistulous tract.

Ureteral reimplantation with psoas bladder hitch in adults: a contemporary series with long-term followup.

We retrospectively evaluated our experience with ureteral reimplantation and psoas bladder hitch to restore urinary tract continuity in patients with lower ureteral defects, since long-term data on the outcomes of this procedure have been relatively scarce in the last two decades. The procedure was performed in 24 patients (7 male, 17 female) with a mean age of 54.6 years. The mean ureteral defect length was 4.8 cm (range 3-10), the ureterovesical anastomosis was performed with simplified split-cuff technique in 18 patients, submucosal tunnel in 2, and direct anastomosis without antireflux technique in 2. Mean followup was 53 months (range 12-125), and there were no reinterventions. Postoperative renal imaging was normal in 22 cases (91.6%) and revealed decreased kidney size in 2, 3 patients presented intermittent flank pain, and 5 had sporadic episodes of lower tract UTI but no one pyelonephritis. Psoas hitch ureteral reimplantation can be successfully used for bridging defects of the lower ureter up to 10 cm in length in difficult clinical situations. It is relatively simple to perform, compared to other procedures of ureteral reconstruction, and it provides adequate protection of the upper urinary tract.

Combination of perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block for pain control during transrectal ultrasound guided prostate biopsy: a randomized, controlled trial.

PURPOSE: To our knowledge the optimal analgesia during prostate biopsy remains undetermined. We tested the efficacy and safety of combined perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block during transrectal ultrasound guided prostate biopsy. MATERIALS AND METHODS: A total of 280 patients were randomized to receive combined perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block (group 1), perianal-intrarectal lidocaine-prilocaine cream alone (group 2), periprostatic nerve block alone (group 3) or no anesthesia (group 4) before transrectal ultrasound guided prostate biopsy. Pain was evaluated with a 10-point visual analog scale at subsequent procedural steps, including perianal-intrarectal substance administration, prostate transrectal ultrasound, periprostatic nerve block and sampling. Complications were assessed by self-administered questionnaire and telephone interview. RESULTS: The groups were comparable in patient age, prostate volume, pathology results and visual analog scale perianal-intrarectal substance administration. Visual analog scale results for transrectal ultrasound were lower in groups 1 and 2 vs 3 and 4 (mean 1.5 and 1.41 vs 5.37 and 5.31, p <0.001) and results for periprostatic nerve block were lower in group 1 vs 3 (mean 1.03 vs 3.74, p <0.001). Results for sampling were lower in groups 1 to 3 vs 4 (mean 0.77, 1.27 and 1.27 vs 4.33, p <0.001) and in group 1 vs 2 and 3 (p <0.001). Stratified analysis showed that visual analog scale sampling was lower in group 1 vs 2 and 3 in patients 65 years old or younger, those with a prostate greater than 49 cc and those with lower anorectal compliance (visual analog scale results for perianal-intrarectal substance administration greater than 2) (p = 0.006, <0.001 and 0.003, respectively). The overall complication rate was similar in all 4 groups (p = 0.87). CONCLUSIONS: Our findings suggest that the combination of perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block provides better pain control than the 2 modalities alone during the sampling part of transrectal ultrasound guided prostate biopsy with no increase in the complication rate. The magnitude of this effect is higher in younger men, men with a larger prostate and men with lower anorectal compliance.

The role and extension of lymphadenectomy in bladder cancer: a review of the current literature.

Radical cystectomy (RC) with pelvic lymph node dissection (LND) is the gold standard for high grade and muscle invasive bladder cancer. Although consensus exists on the need for node dissection, its extent and role are still matter of debate. However, an ever-growing body of data supports an extended dissection since it may provide a survival advantage in both node positive and node negative patients without significantly increasing morbidity and mortality. Besides dissection extent, the modality of specimen submission and node retrieval have a key role in the quality of node assessment. Moreover the stage of primary bladder tumor, the total number of lymph nodes removed, the lymph node tumor burden, the extracapsular extension and the lymph node density have been demonstrated to be important prognostic variables in patients undergoing cystectomy with node metastases and could be useful to accurately stratify patient risk in order to identify those who may benefit from adjuvant therapies. Even if evidence from the literature is only based on retrospective studies, an extended dissection at the time of cystectomy appears to provide a more accurate staging and enhance survival; future prospective studies taking into account the new prognostic factors are needed.

Clinical reappraisal and state of the art of nephropexy.

The diffusion of minimally invasive techniques for renal surgery has prompted a renewed interest in nephropexy which is indicated to prevent nephroptosis in symptomatic patients and to mobilize the upper ureter downward in order to bridge a ureteral defect. Recent publications have been reviewed to present the state of the art of the diagnosis and management of these two challenging conditions and to try to foresee the next steps. The evaluation of patients with mobile kidney can be made relying on diagnostic criteria such as ultrasound with color Doppler and measurement of resistive index, conventional upright X-ray frames after a supine uro-computerized tomography scan and both static and dynamic nuclear medicine scans, always with evaluation in the sitting or erect position. Laparoscopic nephropexy emerges as the current treatment option combining both objectively controlled repositioning of the kidney and resolution of symptoms with minimal invasiveness, low morbidity, and short hospital stay. The use of robotics is presently limited by its higher cost, but may increase in the future. Downward renal mobilization and nephropexy is a safe and versatile technique which has been adopted as a unique strategy or more often in combination with other surgical maneuvers in order to cope with complex ureteral reconstruction.

Granular cell tumour of the urinary bladder: a case report and review of the literature.

Granular cell tumor of the urinary bladder is an exceedingly rare disease, with only 10 cases reported so far in literature. We report a case of granular cell neoplasm of the bladder incidentally found in a 44-year-old woman during an abdominal ultrasound examination for evaluation of stress urinary incontinence. The patient underwent a transurethral resection of the mass and histological examination revealed the presence of a granular cell tumor. Immunohistochemical staining for neuron-specific enolase and S100 protein was positive. At a 6-month follow-up the patient is free of bladder recurrence.

Multifocal and bilateral renal oncocytoma: a case report and review of the literature.

A 78-year-old man presenting with synchronous, multifocal and bilateral renal oncocytomas underwent a staged nephron-sparing surgery with removal of six lesions. At 14-month follow-up the renal function was preserved and no recurrent disease was evident. A literature review demonstrated 17 similar cases, treated either with watchful waiting or with complete surgical removal. Reasons to prefer the surgical option are herein substantiated.

Early and late ureteral complications after renal transplant.

BACKGROUND: Ureteral strictures occur in approximately 3-8% of kidney transplant (KTx) recipients. They are usually a late event which needs surgical re-intervention with a subsequent increased risk of graft loss. This retrospective study presents a single-centre experience in managing ureteral complications using firstly a minimally invasive approach. METHODS: Between January 2000 and November 2012, 838 patients underwent KTx with Lich-Gregoire uretero-vesical anastomosis. Ureteral complications consisting in 6 fistulas and 18 strictures were observed in 24 grafts, with an overall incidence of 2.6%. The retrograde placement of a double J stent was attempted first in 16 grafts and succeeded in 12 (75%); the remaining 4 cases underwent open repair with anastomosis to the native ureter. Antegrade/combined ureteral stenting via a percutaneous nephrostomy was attempted in 8 grafts and succeeded in 4 (50%); the remaining 4 (2 fistulas and 2 strictures) underwent open repair with anastomosis to the native ureter. RESULTS: After an average period of 8.36 months (range 1-36) the double J stents were removed and the ureters were unobstructed in 11 (45.8%), while open surgical treatment was necessary in the remaining 5. Repeated cystoscopic stent changes were successfully performed in 13 patients. Early onset ureteral stenoses were found in 10 out of 19 patients and successfully treated by a mini-invasive approach in 50% of the cases. Three renal grafts were lost, but this was not due to ureteral complications. CONCLUSIONS: Minimally invasive procedures are recommended in early complications, although open reconstructive surgery maintains a role in late severe obstructions after KTx.

Lidocaine-prilocaine administration during transrectal ultrasound-guided prostatic biopsy: a randomized, single-blind, placebo-controlled trial.

BACKGROUND AND PURPOSE: As many as 96% of patients report some kind of discomfort/pain during transrectal ultrasonography (TRUS)-guided prostate biopsy, and when pain is severe, it may be necessary to decrease the planned number of biopsies or interrupt the procedure. Various modalities have been recommended to alleviate the pain, but reports on efficacy are contradictory. We assessed the possible benefit of intrarectal and perianal lidocaine-prilocaine (EMLA) cream. PATIENTS AND METHODS: A series of 98 patients without active anal and prostatic conditions underwent TRUS and, 10 to 31 days later, TRUS-guided biopsy. They were asked to grade their discomfort/pain using a 10- point linear visual analog pain scale (VAS). After TRUS, patients were divided into three groups on the basis of the VAS scores. Group 1 (N = 8) had pain scores or=5 (severe pain/discomfort). Each group was then randomized to receive local anesthesia with intrarectal and anal EMLA cream (subgroup A) or intrarectal and anal ultrasound gel as placebo (subgroup B). Pain scoring was repeated after the biopsy. RESULTS: In group 1, there were no significant differences in pain scores between subgroups A and B. In group 2, we could not complete the biopsy in one patient of subgroup B. A statistically significant difference was noticed between the VAS scores of subgroup A and subgroup B (P < 0.0001). In group 3, we were not able to complete biopsy in 5 patients of subgroup B. We noticed significantly higher VAS scores in subgroup B between TRUS and prostate biopsy (P < 0.0001), whereas similar scores were observed in subgroup A (P = NS). A statistically significant difference (P < 0.0001) was noticed between subgroup A and subgroup B scores during biopsy. CONCLUSIONS: In patients with high tolerance for simple TRUS, needle trauma does not significantly alter tolerability, and anesthetic provides little benefit for prostatic biopsy. However, the opposite is true in patients presenting moderate to significant pain/discomfort at TRUS, who may benefit from intrarectal/anal administration of EMLA during prostate biopsy.