Thulium: YAG vs continuous-wave thulium fiber laser enucleation of the prostate: do potential advantages of thulium fiber lasers translate into relevant clinical differences?

PURPOSE: To compare endoscopic enucleation of the prostate using a thulium: yttrium-aluminum-garnet (Tm:YAG) laser and a super-pulsed thulium fiber laser set in continuous-wave (CW) mode, and to evaluate whether theoretical advantages of thulium fiber lasers, related to their shorter wavelength, translate into relevant clinical differences. METHODS: In total, 110 patients suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia were randomized to undergo either thulium:YAG laser enucleation of the prostate (ThuLEP) or CW thulium fiber laser enucleation of the prostate (CW-ThuFLEP). Intraoperative and postoperative variables and complications were compared. Micturition improvement was assessed at 3-month follow-up using the International Prostate Symptom Score (IPSS), post-void residual urine (PVR) and maximum flow rate (Qmax). Erectile function was evaluated using the International Index of Erectile Function-5 (IIEF-5). RESULTS: No significant differences between the ThuLEP and CW-ThuFLEP groups were found in terms of operative time (70.69 vs 72.41 min), enucleation time (50.23 vs 53.33 min), enucleated tissue weight (40.2 vs 41.9 g), enucleation efficiency (0.80 vs 0.79 g/min), catheterization time (2.45 vs 2.57 days), hospital stay (2.82 vs 2.95 days) and hemoglobin drop (1.05 vs 1.27 g/dl). At 3-month follow-up, no significant differences were found in IPSS (5.09 vs 5.81), Qmax (26.51 vs 27.13 ml/s), PVR (25.22 vs 23.81 ml) and IIEF-5 (14.01 vs 14.54). CONCLUSION: ThuLEP and CW-ThuFLEP were equivalent in relieving patients from LUTS and improving micturition. Theoretical advantages of the TFL, such as shallower penetration depth and improved vaporization capacity, did not translate into relevant perioperative outcomes or clinical differences.

A comparison among RIRS and MiniPerc for renal stones between 10 and 20 mm using thulium fiber laser (Fiber Dust): a randomized controlled trial.

PURPOSE: We performed a prospective randomized comparison among Retrograde IntraRenal Surgery (RIRS) and MiniPerc (MP) for stones between 10 and 20 mm to evaluate outcomes with the same laser device: Fiber Dust. METHODS: Patients with a single renal stone between 10 and 20 mm were randomized to RIRS (Group A) versus MP (Group B). Exclusion criteria were age < 18 or > 75, presence of acute infection, coagulation impairments, cardiovascular or pulmonary comorbidities. In both groups, the Fiber Dust laser was used. A CT scan after 3 months was performed. A negative CT scan or asymptomatic patients with stone fragments < 3 mm and a negative urinary culture were the criteria to assess the stone-free status. A statistical analysis was carried out to assess success, complication and retreatment rates and need for auxiliary treatments. RESULTS: Between January 2021 and January 2022, 186 patients were enrolled (90 in Group A and 96 in Group B). Mean stone size was 15.8 mm and 14.9 mm in Group A and B, respectively (p = 0.23). The overall stone-free rate (SFR) was 73.3% for Group A and 84.4% for Group B. A higher SFR was reached for upper calyceal stones in Group A (90.4%) lower calyceal stones in Group B (91.6%). Retreatment rate (p = 0.31) and auxiliary procedure rate (p = 0.18) were comparable. Complication rate was 5.5% and 5.2% for Groups A and B, respectively. CONCLUSIONS: RIRS and MP are both effective to obtain a postoperative SFR with Fiber Dust. According to the stone position one treatment is superior to the other one.

Change in Postoperative Storage Symptoms and De Novo Urge Incontinence After Thulium:YAG Laser Enucleation of the Prostate: Results from a Prospective Multicenter Study.

Objectives: To assess the change of storage symptoms (SS) and their impact on quality of life in men undergoing thulium:YAG laser enucleation of the prostate (ThuLEP) for benign prostatic hyperplasia (BPH). Materials and Methods: BPH patients requiring surgery were prospectively evaluated (April 2019-October 2020). Inclusion criteria: International Prostate Symptom Score (IPSS) ≥8, maximum urinary flow rate ≤15 mL/s, and urinary retention. Exclusion criteria: previous urethral/prostatic surgery, pelvic irradiation, bladder/prostate cancer, neurogenic bladder, concomitant transurethral surgery, and active urinary tract infection. IPSS, International Continence Society-Overactive Bladder (ICIQ-OAB) and International Continence Society-Overactive Bladder Quality of Life (ICIQ-OABq) scores were gathered before surgery and 1, 3, 6, and 12 months after surgery. Results: In total, 117 men were included. Mean age was 68.0 ± 7.7 years. Mean prostate volume was 86.6 ± 34 cc. Mean IPSS subscore was 8.7 ± 3.1 and 11.7 ± 4.7 for storage and voiding symptoms, respectively. Mean ICIQ-OAB was 29.1 ± 16.8. Mean ICIQ-OABq was 80.3 ± 30.6. Voiding IPSS decreased 72.8% at 1 month, whereas the reduction of storage IPSS was 38.0%. ICIQ-OAB decreased 49.6% at 1 month. ICIQ-OABq showed a 30.0% reduction. One year after surgery, the reduction of voiding IPSS was 94.8%, ICIQ-OAB 85.5%, storage IPSS 76.7%, and ICIQ-OABq 60.5%. Urge incontinence was present in 26.5% of men at 1 month, 15.4% at 3 months, and 4.3% at 6 months. Four (3.4%) patients complained of urge incontinence 12 months after surgery. Conclusion: Both storage and voiding lower urinary tract symptoms significantly decreased after ThuLEP, but storage symptoms showed less reduction with a significant impact on patients' quality of life, particularly during the first 3 months.

Feasibility of local anaesthesia for varicocele correction in one-day-surgery setting. A single center experience.

OBJECTIVE: In this study, we compared postoperative outcomes of patients submitted to varicocele correction under general or local anesthesia at a single center. METHODS: All patients underwent varicocele surgical treatment with the Colpi-modified Marmar subinguinal technique. They were managed with either general (Group A) or local with ileo-inguinal and ileo-hypogastric nerves block (Group B) anesthesia. The two groups were compared in terms of timing of discharge and post-operative pain as assessed with the numeric rating scale (NRS) at both rest and movement (NRSm). § Results: Overall, 63 patients were included with a mean (SD) age of 25 years ± 5 yrs. The NRS mean score was significantly lower for Group B during the first 4 days after surgery at both rest and movement (all p < 0.05). Patients receiving local anesthesia showed a faster time to first urination (210 vs. 240 min; p = 0.02), although the time to discharge was comparable between the two groups (250 vs. 250 min). CONCLUSIONS: These results suggest that local anetshesia for varicocele surgical treatment is feasible and provide better pain control and faster recovery after surgery.

Retrograde Intrarenal Surgery Through an Incision of the Ureter as a Good Treatment Option for Large Ureteropelvic Impacted Stones in Transplanted Kidneys.

Urolithiasis is a rare complication after kidney transplant. Over the years, treatment of kidney stones has evolved radically, but a standard approach for transplanted kidneys has not yet been defined. Here, we present a 69-year-old male patient who received successful treatment of nephrolithiasis of the transplanted kidney. The patient, who had received a kidney from a deceased donor, was admitted to our department following a posttransplant Doppler ultrasonography showing severe hydronephrosis of the transplanted kidney associated with acute renal function decay. Computed tomography scan confirmed the hydronephrosis of the transplanted kidney, showing a large, impacted, ureteropelvic 3-cm-diameter stone and other concretions around the ureteral stent. The patient was then treated with retrograde intrarenal surgery during an open ureterotomy. His postoperative course was uneventful, and he showed good functional reprise and a rapid decrease of serum creatinine levels. Intraoperative retrograde intrarenal surgery could be a valid option for treatment of kidney stones of the transplanted kidney during open surgery of the ureter or during ureterovesical anastomosis.

State of the Art of Thulium Laser Enucleation and Vapoenucleation of the Prostate: A Systematic Review.

Tm:YAG laser operates at a wavelength of 1940-2013 nm in a continuous wave mode, which enables smooth incision and rapid vaporization of prostatic tissue, with a shallow penetration of only 0.2 mm. These characteristics make Tm:YAG a versatile laser, allowing the surgeon to perform resection, vaporization, and vapoenucleation. This systematic review aims to summarize the current evidence of safety and efficacy, long-term durability, impact on sexual function following Tm:YAG laser enucleation and vapoenucleation of the prostate and to compare the outcomes of these procedures vs other surgical treatments of benign prostatic hyperplasia.

Feasibility of en bloc thulium laser enucleation of the prostate in a large case series. Are results enhanced by experience?

OBJECTIVE: To provide the first large single-operator case series of patients who undergo "en bloc" thulium laser enucleation of the prostate (ThuLEP) and to demonstrate an improvement in enucleation efficacy with experience. METHODS: We prospectively evaluated a cohort of patients with symptomatic benign prostatic hyperplasia (BPH) who underwent "en bloc" ThuLEP between May 2015 and November 2017. Association between dependent variables (delivered energy and operating time) and independent variables (adenoma volume and experience) were estimated with regression analysis. The experience was calculated as the time interval between the date of the first operation of the series and the date of the operation being considered. RESULTS: A total of 100 patients were registered for the study. Median operative time was 56.5 min (interquartile range [IQR]: 40-85 min). Median enucleation time was 17.4 min (IQR: 15-21.5 min). Median enucleation index (enucleation time per adenoma gram) was 0.3 min/g (0.2-0.3 min/g). The overall operative time is not influenced by experience, but we registered a significant trend towards a reduction in the total amount of energy delivered energy normalized per adenoma gram (p = 0.0148). CONCLUSION: We believe that further attention is needed for these new "en bloc" prostatic enucleation techniques, which can facilitate some surgical steps, leading to a widespread use of laser technology for BPH surgical treatment.

Prostate MRI and transperineal TRUS/MRI fusion biopsy for prostate cancer detection: clinical practice updates.

This narrative review summarizes the current knowledge about multiparametric and biparametric magnetic resonance imaging of the prostate. This is provided from both a radiological and a urological point of view analyzing the technical aspects of fusion-targeted biopsy using the transperineal approach. We report practical considerations concerning pure cognitive and software-assisted settings, discuss the principal transperineal fusion software now available, and debate the pros and cons of choosing one approach over the other.

Are Outcomes of Thulium Laser Enucleation of the Prostate Different in Men Aged 75 and Over? A Propensity Score Analysis.

OBJECTIVE: To evaluate the outcomes of thulium laser enucleation of the prostate (ThuLEP) in men aged ≥75 years compared to youngers. Traditional surgery has increased and significant morbidity in older men. Lasers have been introduced as an alternative approach to overcome the morbidity of traditional surgery. MATERIAL: We retrospectively evaluated 412 men who underwent en bloc ThuLEP. Inclusion criteria were lower urinary tract symptoms refractory to medical therapy, maximum urinary flow rate (Qmax) ≤15 mL/s, International Prostate Symptom Score (IPSS) ≥8 and absolute indications for surgery. Prostate volume, prostate specific antigen, IPSS, and Qmax, antiplatelet/anticoagulant therapy, ASA score, operation time, length of catheterization, discharge day, early complications, and reoperations were gathered. Differences between groups were estimated using propensity scores, by fitting a stepwise logistic regression model with age group as the dependent variable. RESULTS: One hundred twenty-nine patients were aged ≥75 years (Group 2). Mean age was 65.6 ± 6.0 years in Group 1 and 79 ± 3.7 years in Group 2. Propensity scores retrieved 206 patients. Median operation, catheterization time, and hospital stay were similar in both groups (55 minutes, 2 and 3 days). Overall, 85.9% of men had no complications, with no differences between the groups (82.5% in Group 1 and 89.3% in Group 2). The incidence of Clavien grade III-IV complications was comparable (3.8% in Group 1, 1% in Group 2). By 1 year, there were no statistically significant differences in IPSS, Qmax, QoL, or reoperation rate between the groups. CONCLUSION: En bloc ThuLEP is a safe and effective treatment even in men aged ≥75 years old.

Pretransplant Nephrectomy for Large Polycystic Kidneys in ADPKD (Autosomal Dominant Polycystic Kidney Disease) Patients: Is Peritoneal Dialysis Recovery Possible after Surgery?

The choice of modality for renal replacement therapy in patients with ADPKD varies, often based on patient choice, physician-related factors, and resource availability. For a long time peritoneal dialysis (PD) was considered as relative contraindication due to the possible limited intraperitoneal space. In recent years, some studies suggested it is a valid option also in patients with ADPKD to be considered as a first line treatment in potentially fit patients. Diuresis volume lowering and potential permanent damage of peritoneal integrity, both leading to a necessary switch to haemodialysis, are the two most important dangers after nephrectomy, especially if bilateral, in PD patients. We performed a retrospective analysis of patient underwent native polycystic kidney nephrectomy in order to state the possibility to recover peritoneal dialysis after surgery.

En Bloc Thulium Laser Enucleation of the Prostate: A Step-by-Step Guide to Improve Enucleation Time and Efficiency for Endoscopic Enucleation of Prostatic Adenoma.

OBJECTIVE: To present a reproducible step-by-step approach to en bloc thulium laser enucleation of the prostate (ThuLEP) for benign prostatic hyperplasia surgical treatment. Laser adenoma enucleation is nowadays a recognized surgical treatment for benign prostatic enlargement. Some variants to the classical 3-lobes laser technique have been proposed, in order to overcome the main concerns regarding the original procedure.1-4 After a vast experience with the 3-lobes ThuLEP, we developed our own en bloc enucleation technique. METHODS: The capsular plane is identified only once, at the level of the prostatic apex, at 5 o'clock; this plane is followed ascending towards the bladder neck, separating the left lobe from the prostatic capsule from 5 to 11 o'clock. The right and median lobes are then enucleated following the same plane clockwise and the 2 planes are joined anteriorly at 11 o'clock. Finally, enucleation is completed by incising the remaining mucosal flap from 10 to 2 o'clock. We have already proved the clear advantages provided by this technique compared to the "3-lobes" enucleation.5 RESULTS: Our single-center experience with this technique includes 140 procedures performed up to June 2018. Mean prostatic adenoma volume was 66.7 mL (range 20-220 ± 32.85 standard deviation [SD]). Mean total surgical time was 60.93 minutes (25-133 ± 23.6 SD); mean enucleation time was 18.3 minutes (8.2-36.53 ± 5.62 SD), mean enucleation time normalized per adenoma gram was 0.32 min/g (0.12-0.8 ± 0.15 SD) and mean energy needed for the enucleation normalized per adenoma gram was 1852.13 J/g (689-6129 ± 862.4 SD). Only 1 case of reintervention for clot evacuation (Clavien grade IIIb) was necessary. CONCLUSION: En bloc ThuLEP provides an anatomical approach for endoscopic enucleation of prostatic adenoma. We believe that this sequence optimizes efficiency and efficacy in a reproducible way.

Holmium laser versus thulium laser enucleation of the prostate: a matched-pair analysis from two centers.

BACKGROUND: The aim of our study was to compare perioperative and functional outcomes of two different prostatic laser enucleation techniques performed in two high-volume centers: 100 W holmium laser enucleation of the prostate (HoLEP) (Lyon, France) and 110 W thulium laser enucleation of the prostate (ThuLEP) (Varese, Italy). MATERIALS AND METHODS: A nonrandomized, observational, retrospective and matched-pair analysis was performed on two homogeneous groups of 117 patients that underwent prostate laser enucleation in the HoLEP or ThuLEP centers between January 2015 and April 2017, following the classical 'three lobes' enucleation technique. The American Society of Anesthesiologists (ASA) score and prostate volume were the main parameters considered for matching the patients between the two groups. Patients on anticoagulant therapy, with documented detrusor hypoactivity or hyperactivity or with the finding of concurrent prostate cancer were excluded from the study. Follow up was assessed at 3, 6 and 12 months after surgery. RESULTS: Median enucleation and morcellation time was 75.5 and 11.5 min, respectively, in the HoLEP group versus 70.5 and 12 min, respectively, in the ThuLEP group (p = 0.001 and 0.49, respectively). Enucleated adenoma weight was comparable (44 g versus 45.6 g, p = 0.60). Energy index (3884.63 versus 4137.35 J/g, p = 0.30) and enucleation index (0.57 versus 0.6 g/min, p = 0.81) were similar in the two groups. Catheterization time was comparable (1 versus 1 day; p = 0.14). The International Prostate Symptom Score and Quality of Life score significantly decreased, as well as maximal urinary flow rate. Median prostate-specific antigen (PSA) drop 1 year after surgery was 2.1 ng/ml in the HoLEP group (-52.83%) versus 1.75 ng/ml in the ThuLEP group (-47.85%) (p = 0.013). CONCLUSION: Both HoLEP (100 W) and ThuLEP (110 W) relieve lower urinary tract symptoms in a comparable way with high efficacy and safety, with negligible clinical differences.

Comparison Between Two Different En Bloc Thulium Laser Enucleation of the Prostate: Does Technique Influence Complications and Outcomes?

OBJECTIVE: To evaluate whether 2 similar en bloc thulium laser enucleation of the prostate (ThuLEP) techniques can influence surgical complications and outcomes. MATERIAL: Within 2 institutional databases 164 men who underwent 2 different en bloc ThuLEP techniques were compared using propensity scores. With the first technique prostatic lobes were all enucleated en bloc, whereas, with the second the median lobe was enucleated first and the lateral lobes were enucleated en bloc thereafter. All patients were evaluated at baseline and 6 months after surgery with PSA, Qmax, and self-administrated IPSS. Operative data and 30-day postoperative complications were gathered. RESULTS: Surgical time and 24-hour blood loss were similar between 2 groups (55 vs 55 minutes, P .97288; -0.9 vs -1.3 g/dL, P .112 respectively). Median hospital stay after surgery was 3 days in both groups (P .3251). IPSS and Qmax improved equally in both groups (median 3 vs 3, P .941; 19.17 vs 20.63 mL/s, P .8232 respectively). Early complications were mild to moderate (Clavien I 12.2% vs 12.2%; Clavien II 3.6% vs 4.84%; Clavien IIIb 1.2% vs 2.4%). CONCLUSION: Our results show that en bloc ThuLEP approaches appear feasible, have similar complications and outcomes and can be considered surgeon-independent techniques. En bloc ThuLEP may be proposed even for laser-naïve urologists as an alternative to the original 3-lobe technique.

En Bloc Thulium Laser Enucleation of the Prostate: Surgical Technique and Advantages Compared With the Classical Technique.

OBJECTIVE: To report a new technique for thulium laser enucleation of the prostate, which we called "en bloc" ThuLEP. METHODS: A full anatomic description of the technique is provided. We assessed operative variables of a 50-patient series, treated with the new "en bloc" ThuLEP, and compared them with another series of 50 patients (who had the same preoperative parameters) operated with the classical "3-lobe" technique, to assess the feasibility of the new one. All procedures were carried out by the same surgeon. RESULTS: In our experience, "en bloc" ThuLEP permits an easier enucleation of the adenoma, reduces operating time, and reduces the amount of energy delivered per adenoma gram compared with the classical technique. Further studies are needed to validate this technical evolution of prostatic enucleation and verify the reduction of postoperative irritative symptoms. CONCLUSION: "En bloc" ThuLEP may represent a valid alternative for prostatic adenoma enucleation, mostly in medium-sized prostates.

Impact of Thulium Laser Enucleation of the Prostate on Erectile, Ejaculatory and Urinary Functions.

OBJECTIVE: To test the impact of Thulium laser enucleation of the prostate (ThuLEP) on erectile and ejaculatory functions, on lower urinary tract symptoms and on quality of life (QoL). METHODS: From July 2013 to May 2015, we prospectively evaluated 177 patients with LUTS related to benign prostatic hyperplasia. All patients were assessed with the International Index of Erectile Function (IIEF-5), Male Sexual Health Questionnaire-Ejaculatory Disease (MSHQ-EjD), International Prostate Symptom Score (IPSS), QoL, PSA and uroflowmetry before and at 4 and 8 months after surgery. RESULTS: Erectile function did not show variation with IIEF-5 preoperative score 22.49 ± 1.8 and postoperative score 22.14 ± 3.1 (p = 0.195) and 22.18 ± 3.2 (p = 0.26) at 4 and 8 months after treatment. The ejaculatory function on the MSHQ-EjD test indicated the reduction of ejaculation, changing from 14.90 ± 6.88 to 5.51 ± 4.17 (p < 0.0001) and 5.38 ± 3.93 (p < 0.0001) at 4 and 8 months follow-up. IPSS score decreased from preoperative 21.12 ± 5.81 to 3.14 ± 3.16 (p < 0.0001) and 3.08 ± 3.12 (p < 0.0001) 4 and 8 months after surgery. PSA decreased from 4.50 ± 3.72 to 1.39 ± 1.04 (p < 0.0001) and 1.47 ± 1.14 ng/ml (p < 0.0001) at 4 and 8 months follow-up, while QoL score improved from 5.41 ± 0.69 to 0.57 ± 0.84 (p < 0.0001) and 0.51 ± 0.80 (p < 0.0001) at 4 and 8 months follow-up. CONCLUSIONS: ThuLEP does not affect erectile function and determines the resolution of LUTS with improvement of QoL. Loss of ejaculation did not impair the sexual intercourse activities of the patients.

Evaluation of the learning curve for thulium laser enucleation of the prostate with the aid of a simulator tool but without tutoring: comparison of two surgeons with different levels of endoscopic experience.

BACKGROUND: The aim of this study was to determine the learning curve for thulium laser enucleation of the prostate (ThuLEP) for two surgeons with different levels of urological endoscopic experience. METHODS: From June 2012 to August 2013, ThuLEP was performed on 100 patients in our institution. We present the results of a prospective evaluation during which we analyzed data related to the learning curves for two surgeons of different levels of experience. RESULTS: The prostatic adenoma volumes ranged from 30 to 130 mL (average 61.2 mL). Surgeons A and B performed 48 and 52 operations, respectively. Six months after surgery, all patients were evaluated with the International Prostate Symptom Score questionnaire, uroflowmetry, and prostate-specific antigen test. Introduced in 2010, ThuLEP consists of blunt enucleation of the prostatic apex and lobes using the sheath of the resectoscope. This maneuver allows clearer visualization of the enucleation plane and precise identification of the prostatic capsule. These conditions permit total resection of the prostatic adenoma and coagulation of small penetrating vessels, thereby reducing the laser emission time. Most of the complications in this series were encountered during morcellation, which in some cases was performed under poor vision because of venous bleeding due to surgical perforation of the capsule during enucleation. CONCLUSIONS: Based on this analysis, we concluded that it is feasible for laser-naive urologists with endoscopic experience to learn to perform ThuLEP without tutoring. Those statements still require further validation in larger multicentric study cohort by several surgeon. The main novelty during the learning process was the use of a simulator that faithfully reproduced all of the surgical steps in prostates of various shapes and volumes.

Renal cell carcinoma with venous neoplastic thrombosis: a ten years review.

PURPOSE: To review the 10-year experience of our urological unit in the surgical management of renal cell carcinoma (RCC) with neoplastic tumor thrombosis focusing on postoperative survival. MATERIALS AND METHODS: We underwent a retrospective analysis of the patients treated for this pathology during the last decade 2002-2012, stratifying them by tumor thrombus level and histological subtype. Kaplan-Meyer curves were used to assess survival. RESULTS: Overall, 67 patients underwent surgery for RCC with neoplastic tumoral thrombosis in the period under review. 60 were clear cell RCC, 4 were urothelial papillary tumors of the renal pelvis and 3 were rare histotypes, as a nefroblastoma, a spinocellular tumor of the renal pelvis and an unclassifiable renal carcinoma. Thrombus level was I in 40 cases, II in 17, III in 2 and IV in 8 patients. We report the main postoperative complications and our survival data, with mean follow up of 36 months. Tumor stage is the most important variable in predicting survival. Patients with N0M0 disease had 70% survival at 36 months, instead of 20% for those with primitive metastatic tumor. CONCLUSION: Our survival results fit with the main reports in literature and our surgical management was completely in keeping with international guidelines. We did not observe relevany post-operative complications, except of hemorrhagic ones that occurred in 6 patients (9% of total) and were always successfully managed. Eighteen patients (26.87% of total) underwent caval filter positioning, without evidence of complications during its positioning or removal. Life expectancy was particularly low for the cases of RCC without clear cell histotype (7 cases in our series, 10.4% of total) that always was less than one year from surgery.

Does needle calibre affect pain and complication rates in patients undergoing transperineal prostate biopsy? A prospective, randomized trial.

Transperineal prostate biopsy is a procedure that can be used to obtain histological samples from the prostate. To improve both the quality of the biopsy core samples and prostate cancer detection, we are currently performing a prospective, randomized trial comparing prostate biopsy samples obtained using an 18 G-needle to those obtained using a 16 G needle. The aim of this preliminary study was to evaluate pain and complication rates in both groups in order to assess whether performing a prostate biopsy with a larger calibre needle is a feasible procedure. One hundred and eighty-seven patients undergoing transperineal prostate biopsy were prospectively evaluated and divided into two groups. The first group (94 patients, Group A) received a transperineal prostate biopsy using a 16 G-needle and the second group (93 patients, Group B) underwent transperineal prostate biopsy with an 18 G-needle. Anaesthesia was obtained with a single perineal injection at the prostatic apex in all subjects. A visual analogue scale (VAS) and facial expression scale (FES) were used to assess pain during multiple steps of the procedure in each group. A detailed questionnaire was used to obtain information about drug use because it could potentially influence the pain and complications that patients experienced. Two weeks after the procedure, early and late complications were evaluated. Statistical analysis was carried out using non-parametric tests. Prostate Specific Antigen (PSA) and drug use were similar at baseline between the two groups. Pain during prostate biopsy, which was measured with both the VAS and FES instruments, did not differ significantly between the 18- and 16 G-needle groups, and no significant differences were found in early or late complication rates between the groups. Transperineal prostate biopsy with a 16 G-needle is a feasible procedure in terms of pain and complication rates. Further studies with larger patient populations are required to assess whether or not this procedure can improve prostate cancer detection rates.