Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study.

The objective of this subset analysis was to evaluate and compare the efficacy and tolerability of two combination treatments for men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Data were from a real-world, open-label, prospective, and multicenter study performed in outpatient urology clinics. Men with moderate-to-severe LUTS/BPH received 6-month treatment with tamsulosin (TAM) in combination with either the hexanic extract of S. repens (HESr) or a 5-alpha-reductase inhibitor (5ARI). Changes in urinary symptoms and quality of life were measured using the IPSS and BII questionnaires, respectively. Treatment tolerability was assessed by recording adverse effects (AEs). Patients in the two study groups were matched using iterative and propensity score matching approaches. After iterative matching, data were available from 136 patients (n = 68 treated with TAM + 5ARI, n = 68 with TAM + HESr). After 6 months of treatment, mean (SD) IPSS total score improved by 7.7 (6.3) and 6.7 (5.0) points in the TAM + 5ARI and TAM + HESr groups, respectively (p = 0.272); mean BII total scores improved by 3.1 (2.9) and 2.9 (2.4) points (p = 0.751), respectively. AEs were reported by 26.5% and 10.3% of patients in the same groups, mostly affecting sexual function (p < 0.027). When used in a real-world setting to treat patients with moderate-severe LUTS/BPH, 6-month treatment with TAM + HESr was as effective as TAM + 5ARI, but with better tolerability.

Mitomycin C allergy after passive and device-assisted hyperthermia for non-muscle invasive bladder cancer treatment: A retrospective cohort from a high-volume center.

INTRODUCTION: Mitomycin C (MMC) is one of the most frequently utilized intravesical chemotherapy drugs for the management of non-muscle-invasive bladder cancer (NMIBC). Allergic reactions (Type 4 delayed hypersensitivity) are seldomly reported in the literature but not so infrequent in daily practice, its incidence has been increasing with the use of device-assisted hyperthermia. This study aims to identify the incidence, risk factors, and clinical characteristics of patients with allergic reactions to MMC. PATIENTS AND METHODS: Single-center retrospective cohort from June 2014 to August 2018. Patients with intermediate or high-risk NMIBC were included. Patients received passive MMC (4 weekly and eleven monthly instillations of 40mg of MMC) or Chemohyperthermia (CHT) with MMC (6 weekly and 6-monthly instillations, heated at 43°C [+/- 0.5°C] using Combat BRS). RESULTS: We included 258 patients (MMC = 157, CHT = 101) and found 7 (4.4%) suspected and 4 confirmed (2.4%) allergies in the passive MMC group and 11 suspected (10.9%) and 7 confirmed (6.9%) in the CHT group. The mean number of instillations received before developing the allergy was 6 in the passive MMC and 5 in the CHT group. Seven out of 18 suspected allergy cases were pseudo-allergic reactions with negative allergy tests. Early postoperative MMC instillation was associated with an increased risk of allergy (OR 2.47 [CI 1.39-4.36], P = 0.001), while neither history of atopy nor history of other medications allergy was found to increase the risk. CONCLUSION: MMC allergy risk is increased with the use of device-assisted hyperthermia with an incidence of 2.4% for passive MMC and 6.9% for CHT. History of prior allergies does not seem to increase the risk of developing MMC allergy. In this series 38% of suspected cases were found to be pseudo-allergic reactions, highlighting the need to confirm the diagnosis before definitively stopping the treatment.

Recirculating hyperthermic intravesical chemotherapy with mitomycin C (HIVEC) versus BCG in high-risk non-muscle-invasive bladder cancer: results of the HIVEC-HR randomized clinical trial.

PURPOSE: The purpose of the study was to compare the outcomes of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) patients treated with BCG vs recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC). METHODS: A pilot phase II randomized clinical trial was conducted including HR-NMIBC patients, excluding carcinoma in situ. Patients were randomized 1:1 to receive intravesical BCG for 1 year (once weekly for 6 weeks plus subsequent maintenance) or HIVEC with 40 mg MMC, administered using the Combat BRS system (once weekly instillations were given for 6 weeks, followed by once monthly instillation for 6 months). Total recirculating dwell time for HIVEC was 60 min at a target temperature of 43° ± 0.5 °C. Primary endpoint was recurrence-free survival. Secondary endpoints were time to recurrence, progression-free survival, cancer-specific survival, and overall survival at 24 months. Adverse events were routinely assessed. RESULTS: Fifty patients were enrolled. Mean age was 73.5 years. Median follow-up was 33.7 months. Recurrence-free survival at 24 months was 86.5% for HIVEC and 71.8% for BCG (p = 0.184) in the intention-to-treat analysis and 95.0% for HIVEC and 75.1% for BCG (p = 0.064) in the per protocol analysis. Time to recurrence was 21.5 and 16.1 months for HIVEC and BCG, respectively. Progression-free survival for HIVEC vs BCG was 95.7% vs 71.8% (p = 0.043) in the intention-to-treat analysis and 100% vs 75.1% (p = 0.018) in the per protocol analysis, respectively. Cancer-specific survival at 24 months was 100% for both groups and overall survival was 91.5% for HIVEC vs 81.8% for BCG. CONCLUSION: HIVEC provides comparable safety and efficacy to BCG and is a reasonable alternative during BCG shortages. TRIAL REGISTRATION: EudraCT 2016-001186-85. Date of registration: 17 March 2016.

Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients.

In a subset analysis of data from a 6-month, multicenter, non-interventional study, we compared change in symptoms and quality of life (QoL), and treatment tolerability, in men with moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving tamsulosin (TAM, 0.4 mg/day) or the hexanic extract of Serenoa repens (HESr, 320 mg/day) as monotherapy. Symptoms and QoL were assessed using the IPSS and BII questionnaires, respectively. Patients in the treatment groups were matched using two statistical approaches (iterative and propensity score matching). Within the iterative matching approach, data was available from a total of 737 patients (353 TAM, 384 HESr). After 6 months, IPSS scores improved by a mean (SD) of 5.0 (4.3) points in the TAM group and 4.5 (4.7) points in the HESr group (p = 0.117, not significant). Improvements in QoL were equivalent in the two groups. TAM patients reported significantly more adverse effects than HESr patients (14.7% vs 2.1%; p < 0.001), particularly ejaculation dysfunction and orthostatic hypotension. These results show that HESr is a valid treatment option for men with moderate/severe LUTS/BPH; improvements in urinary symptoms and QoL were similar to those observed for tamsulosin, but with considerably fewer adverse effects.

Quality of life and adverse events in patients with nonmuscle invasive bladder cancer receiving adjuvant treatment with BCG, MMC, or chemohyperthermia.

INTRODUCTION: Chemohyperthermia (CHT) with mitomycin C (MMC) is together with Bacillus Calmette-Guérin (BCG), and passive MMC, a treatment option for patients with non muscle-invasive bladder cancer. There are no data published about the impact of CHT in quality of life (QoL). We evaluated QoL and adverse events (AE) in this 3-arm observational study. PATIENTS AND METHODS: Prospective observational study from September 2016 to March 2017, we recruited consecutive patients that received adjuvant treatment after transurethral resection of bladder tumor. Patients received induction courses of either BCG, CHT, or passive MMC. Patients filled the questionnaires Functional assessment of cancer therapy for bladder cancer patients (FACT-Bl) and International prostate symptom score (IPSS) before, during, and after the induction course. A urologist documented AE using Common Terminology Criteria for AE (CTCAE criteria). RESULTS: A total of 56 patients, receiving a total of 296 bladder instillations (BCG n = 27, CHT n = 14 and MMC n = 15). FACT-Bl showed statistically significant differences in the fourth week in favor of CHT versus BCG, IPSS did not show statistically significant differences before, during, and after induction course in all 3 arms. All patients recovered their baseline QoL at the end of the induction treatment. Overall 55.5%, 50% and 20% of patients presented any grade of AE in the BCG, CHT and MMC groups respectively. About 7% of patients in BCG and CHT arms had to discontinue treatment due to AE. BCG and CHT showed a similar rate of AE but in CHT were mostly grade I and BCG had grade I, II, and IV. Passive MMC had the safest profile. CONCLUSION: There are no clinically significant differences between BCG, CHT, and passive MMC regarding QoL and lower urinary tract symptoms during the induction course. CHT has a more favorable AE profile when compared with BCG.

Critical analysis of a multicentric experience with holmium laser enucleation of the prostate for benign prostatic hyperplasia: outcomes and complications of 10 years of routine clinical practice.

OBJECTIVE: To assess the perioperative outcomes of holmium laser enucleation of the prostate (HoLEP) in real-life practice and investigate the factors influencing the safety and effectiveness of the technique. PATIENTS AND METHODS: Critical analysis of patients with benign prostate hyperplasia (BPH) treated with HoLEP over 10 years of routine practice in three hospitals. Analysed variables included: preoperative characteristics (prostate size, active antiplatelet/anticoagulant therapy, blood parameters. prostate-specific antigen (PSA) level, maximum urinary flow rate [Qmax ], and International Prostate Symptom Score [IPSS]), intraoperative variables (operation time, concomitant removal of bladder calculi, and complications), early postoperative outcomes (change in blood parameters, catheterisation time, and hospital stay), and 12-month follow-up outcomes (change in IPSS, PSA level, and Qmax ). RESULTS: The analysis included 963 patients, aged 48-91 years, with a mean (range) prostate size of 91 (35-247) mL. The mean (sd) operation time was 77 (29) min, and the hospital stay and catheterisation time were 4 (2) and 1.3 (2) days, respectively. In all, 56 patients (5.6%) required concomitant removal of bladder calculi and 36 (3.7%) were converted to open prostatectomy or transurethral resection of the prostate due to intraoperative complications. Patients had a significant decrease in haemoglobin and haematocrit, but no differences were seen between patients with and without anticoagulant/antiplatelet therapy and those with prostates ≥ and <100 mL. The concomitant removal of bladder calculi and having a prostate ≥100 mL resulted in a longer operation time, but did not influence the safety and effectiveness outcomes. CONCLUSIONS: HoLEP is suitable for real-life patients with BPH, irrespective of the presence of active treatment with anticoagulant/antiplatelet, bladder lithiasis or a prostate ≥100 mL.

Factors Influencing Intraoperative Blood Loss in Patients Undergoing Holmium Laser Enucleation of the Prostate (HoLEP) for Benign Prostatic Hyperplasia: A Large Multicenter Analysis.

OBJECTIVE: To assess blood loss during holmium laser enucleation of the prostate (HoLEP) and investigate the factors influencing it. PATIENTS AND METHODS: Analysis of patients with benign prostatic hyperplasia (BPH) treated with HoLEP at 3 centers. Hemoglobin and hematocrit were measured before surgery and hospital discharge. All blood transfusions performed during and after HoLEP were recorded. Blood loss outcomes were analyzed regarding antithrombotic (antiplatelet/anticoagulant) therapies and drug treatments for BPH and other conditions. RESULTS: The analysis included 963 patients with a mean age of 72 years. Mean (range) prostate size was 102 (40-316) g; 28% of patients were receiving antiplatelets and 11% anticoagulants. Mean (range) prostate-specific antigen was 6.0 (0.3-43.5) ng/dL. Mean (range) operation time was 77 (28-178) minutes. Bladder calculi were found in 54 (5.6%) patients; all of them were successfully treated with cystolitholapaxy. Forty-eight (5%) patients required blood transfusion during or immediately after the HoLEP procedure. Overall, mean (SD) hemoglobin decreased from 14.6 (1.5) g/dL to 12.3 (2.1) g/dL (P <.001), and mean (SD) hematocrit decreased from 44.3% (4.7) to 37.7% (6.5) (P <.001). Neither hemoglobin nor hematocrit decreases were significantly different between patients receiving and not receiving antithrombotic therapy or BPH therapy. CONCLUSION: HoLEP is safe and has no remarkable impact on blood loss. Patients at high risk, such as those receiving antithrombotic therapy, had the same outcome than the rest regarding blood loss, although showed a higher transfusion rate. Operating time may influence hemoglobin decrease; therefore, it should be considered in patients with higher risk of bleeding.

Analysis of Holmium Laser Enucleation of the Prostate in a High-Volume Center: The Impact of Concomitant Holmium Laser Cystolitholapaxy.

Purpose: To assess the influence of holmium laser cystolitholapaxy (HLC) concomitantly with holmium laser prostate enucleation (HoLEP) on patients with benign prostatic hyperplasia (BPH) presenting bladder calculi. Materials and Methods: We present a retrospective analysis of patients with BPH (with or without concomitant HLC) at three Spanish centers. Intraoperative variables (e.g., time and resected tissue), changes in functional parameters of the prostate, and frequency of complications (intraoperative, early postoperative, and at 12 months) in patients with and without HLC were compared. Results: The analysis included 963 patients aged 48 to 91 years, of which 54 (5.6%) underwent HLC to treat vesical lithiasis. Mean (range) prostate size (measured by transrectal ultrasound) was 79 (43-173) g and 91 (35-247) g for patients with and without concomitant HLC, respectively (p = 0.080). All bladder calculi were effectively removed. No significant differences were found regarding enucleation and morcellation times, but total operation time was significantly higher in patients with HLC: mean (standard deviation [SD]) of 78 (27) minutes vs 95 (41) minutes (p < 0.001). Three patients underwent conversion to open surgery because of bladder perforation, all of them from the group without HLC. Rates of intraoperative, early, and 12-month complications were similar in both groups. No significant differences in International Prostate Symptom Scale, maximum flow rate (Qmax), and mean flow were observed between groups 12 months after surgery. Conclusions: Simultaneous HoLEP and HLC increases the total operation time, but does not influence the risk of clinically relevant perioperative and postoperative complications.

Efficacy and safety of a hexanic extract of Serenoa repens (Permixon® ) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH): systematic review and meta-analysis of randomised controlled trials and observational studies.

OBJECTIVES: To comprehensively evaluate the efficacy and safety of the hexanic extract of Serenoa repens (HESr, Permixon® ; Pierre Fabre Médicament, Castres, France), at a dose of 320 mg daily, as monotherapy for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). MATERIALS AND METHODS: We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) and prospective observational studies in patients with LUTS/BPH identified through searches in Medline, Web of Knowledge (Institute for Scientific Information), Scopus, the Cochrane Library, and bibliographic references up to March 2017. Articles studying S. repens extracts other than Permixon were excluded. Data were collected on International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax ), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions (ADRs). Data obtained from RCTs and observational studies were analysed jointly and separately using a random effects model. A sub-group analysis was performed of studies that included patients on longer-term treatment (≥1 year). RESULTS: Data from 27 studies (15 RCTs and 12 observational studies) were included for meta-analysis (total N = 5 800). Compared with placebo, the HESr was associated with 0.64 (95% confidence interval [CI] -0.98 to -0.31) fewer voids/night (P < 0.001) and an additional mean increase in Qmax of 2.75 mL/s (95% CI 0.57 to 4.93; P = 0.01). When compared with α-blockers, the HESr showed similar improvements on IPSS (weighted mean difference [WMD] 0.57, 95% CI -0.27 to 1.42; P = 0.18) and a comparable increase in Qmax to tamsulosin (WMD -0.02, 95% CI -0.71 to 0.66; P = 0.95). Efficacy assessed using the IPSS was similar after 6 months of treatment between the HESr and 5α-reductase inhibitors (5ARIs). Analysis of all available published data for the HESr showed a mean improvement in IPSS from baseline of -5.73 points (95% CI -6.91 to -4.54; P < 0.001). HESr did not negatively affect sexual function and no clinically relevant effect was observed on prostate-specific antigen. Prostate volume decreased slightly. Similar efficacy results were seen in patients treated for ≥1 year (n = 447). The HESr had a favourable safety profile, with gastrointestinal disorders being the most frequent ADR (mean incidence of 3.8%). CONCLUSION: The present meta-analysis, which includes all available RCTs and observational studies, shows that the HESr (Permixon) reduced nocturia and improved Qmax compared with placebo and had a similar efficacy to tamsulosin and short-term 5-ARI in relieving LUTS. HESr (Permixon) appears to be an efficacious and well-tolerated therapeutic option for the long-term medical treatment of LUTS/BPH.

Supresión androgénica máxima con acetato de abiraterona en cáncer de próstata hormonosensible / Maximal androgen deprivation with abiraterone acetate in hormone sensitive prostate cancer

OBJETIVO: El tratamiento del cáncer de próstata (CP) metastático ha permanecido inalterado durante más de 70 años fundamentado en la deprivación androgénica (DA). En 2015, a raíz de los estudios CHAARTED y STAMPEDE se estableció que la adición de 6 ciclos de docetaxel a la DA se asociaba significativamente con incremento de la supervivencia. En junio de 2017 los estudios LATITUDE y el brazo G del STAMPEDE demuestran que la adición de Abiraterona junto con Prednisona (5 mg/día) a DA se asocia también a un incremento significativo de supervivencia en los pacientes metastáticos. El presente trabajo analiza estos dos estudios. RESULTADOS: LATITUDE demostró una reducción relativa del riesgo de muerte del 38% (HR=0,62, 95% IC, 0,61-0,76) patente en la práctica totalidad de subgrupos. La reducción del riesgo relativo de progresión radiológica fue del 53 % (HR=0,47,IC 95% 0,39-0,55). Los objetivos secundarios como progresión de PSA, tiempo a quimioterapia o a nuevo evento esquelético también son significativamente retrasados. STAMPEDE también demuestra que la combinación con Abiraterona+prednisolona se asocia a un incremento relativo de SV del 37% (HR=0,63;95% IC, 0,52-0,76; p < 0,001) en pacientes M1, no así en los M0. La supervivencia libre de progresión fue muy mejorada en este brazo (HR=0,29;95% IC 0,25-0,34, p < 0,001). Los efectos secundarios referidos muestran el patrón conocido de exceso mineralcorticoide con incremento de HTA, hipokaliemia y elevación de enzimas hepáticas. CONCLUSIONES: La comparación indirecta de los trabajos de docetaxel y abiraterona confirma que tanto poblaciones, como resultados, son superponibles. Dos meta-análisis indirectos comparativos (>6000 pacientes) otorgan beneficio marginal a abiraterona. A favor de Abiraterona juega el ser una medicación oral, cómoda, con buen perfil de tolerancia y efectos secundarios de fácil manejo, útil en pacientes con frecuencia añosos y frágiles en los que la QT pudiera no estar indicada, aún a costa de una exposición al fármaco es más prolongada y de su actual precio. Futuros ensayos, en curso, determinará el perfil de pacientes idóneo, su posicionamiento en el tiempo o una potencial asociación de ambos

OBJECTIVES: Prostate cancer is linked to bone disease by two different entities. On one hand, androgen deprivation therapy (ADT) usually causes osteoporosis, on the other a great number of patients with advanced prostate cancer will present bone bicametastases, that condition not only their vital prognosis but also an important quality of life deterioration. METHODS: We performed a bibliographic review on both the physiology and therapy of osteoporosis secondary to ADT and bone metastasis in prostatic neoplasias. RESULTS: Osteoporosis: Long term ADT is associated with osteopenia/osteoporosis in 80% of the patients, with a 5-20% incidence of osteoporotic fractures. We should monitor bone mineral density before starting ADT therapy and during treatment. Treatment is based on risk factors reduction, regular physical exercise, calcium and vitamin D supplements, and drugs such as biphosphonates or denosumab. Bone metastasis: Currently, both zolendronic acid and denosumab have approval for the prevention of skeletal events in patients with castration resistant prostate cancer (CPRC). Although the last one seems to be more effective, it is associated with a higher risk of hypocalcemia and jaw osteonecrosis so that the choice of drug must be individualized in every patient. The duration of treatment is not clear. Currently, the indication for the use of this drugs in earlier phases of advanced disease is not approved. CONCLUSIONS: Comprehensive management of the patient with advanced prostate cancer should include the study and treatment of osteoporosis and bone metastases. Currently, very effective therapies are available for both entities

The role of RANK-ligand inhibition in cancer: the story of denosumab.

The diagnosis of bone metastases is an event with certain consequences for the patient. They often mean pain and can also mean pathological fractures, hypercalcemia, and spinal cord compression, all synonymous with a diminished quality of life and often also hospitalization. Since the advent of the intravenous bisphosphonates, things began to look a bit brighter for patients with bone metastases-bone destruction was kept at bay a little longer. The next generation of bone metastasis treatments is well on its way in clinical development, and among them, the most advanced drug is denosumab. Denosumab is a fully human monoclonal antibody that inhibits osteoclast maturation, activation, and function by binding to receptor activator of nuclear factor kappa B ligand, with the final result being a reduced rate of bone resorption. In this review, we give an overview of relevant preclinical and clinical data regarding the use of denosumab in patients with solid tumors in general and prostate cancer in particular.

[Local anesthesia significantly improves the tolerance of prostate biopsy]. / La anestesia local mejora significativamente la tolerancia de la biopsia prostática.

UNLABELLED: Transrectal biopsy is one of the most frequent procedures in urological practice. Generally, transrectal biopsies have been practiced without anesthesia, because of a supposed good tolerance. Nevertheless, it is not infrequent to find patients with a high level of pain and adverse effects attributable to such procedure. OBJECTIVES: In the present article the effect of transrectal local anesthesia in order to significantly diminish the perception of pain by the patient is evaluated. METHODS: A total of 131 consecutive patients undergoing transrectal prostate biopsy are included in the study. After randomization, 76 patients were biopsiated with anesthesia and 55 represent the control group. Cases and control groups do not differ in age or prostate volume. Anesthesia consisted on a periprostatic nerve blockage with injection of 5 cc of 1% mepivacaine solution in the angle between prostate and seminal vesicles bilaterally. A visual analogical scale for pain was used; it was given to the patient at the end of the procedure. RESULTS: Mean pain value was 2.41 with a median of 2.0 in the group with anesthesia, and 4.02 with a median of 4 in the control group. A Student's t test comparing the means showed a statistically significant difference of 1.61 (p < 0.0001). Pain in the scale was 66% greater in the control group. CONCLUSION: The use of anesthesia in the performance of transrectal biopsies significantly diminishes the perception of pain by patients. This effect, along with the tendency to increase the number of biopsies, will result in short time in a more generalized use of local anesthesia.

La anestesia local mejora significativamente la tolerancia de la biopsia prostática / Local anesthesia significantly improves the tolerance of prostate biopsy

La biopsia transrectal es uno de los procedimientos mas frecuentes en la práctica urológica. Usualmente las biopsias transrectales se han practicado sin administrarse anestesia, ante la consideración de una buena tolerancia. Sin embargo no es infrecuente encontrarnos ante pacientes con un nivel del dolor alto e incluso efectos adversos atribuibles al mismo. OBJETIVO: Se evalúa en el presente trabajo si la anestesia local transrectal puede disminuir significativamente la percepción del dolor por el paciente. MÉTODOS: Se incluyen en el siguiente estudio 131 pacientes consecutivos y sometidos a biopsia transrectal. Efectuándose la randomización 76 pacientes fueron biopsiados con anestesia y 55 representan el grupo control. Casos y controles no difieren en edad ni volumen prostático. La anestesia se efectuó administrándose 10 cc del anestésico mepivacaína al 1%, 5 cc en cada lado en el ángulo entre la próstata y las vesículas seminales. Se empleó una escala analógica y visual del dolor que se suministró al paciente una vez acabado el procedimiento. RESULTADOS: En el grupo de pacientes anestesiados la media de valoración del dolor fue de 2,41 con una mediana de 2 y en el grupo control se obtuvo una media de 4,02 con una mediana de 4. Se realizó test de comparación de medias (t de Student), obteniéndose entre los grupos una diferencia estadísticamente significativa de 1,61 (< 0,0001). Porcentualmente encontramos una diferencia en la escala del dolor de un 66 % más en el grupo control. CONCLUSIÓN: La utilización de anestesia en la realización de las biopsias transrectales disminuye significativamente la percepción del dolor por los pacientes. Este efecto junto a la tendencia en incrementar el número de biopsias, generalizará en poco tiempo el empleo de la anestesia local

Transrectal biopsy is one of the most frequent procedures in urological practice. Generally, transrectal biopsies have been practiced without anesthesia, because of a supposed good tolerance. Nevertheless, it is not infrequent to find patients with a high level of pain and adverse effects attributable to such procedure. OBJECTIVES: In the present article the effect of transrectal local anesthesia in order to significantly diminish the perception of pain by the patient is evaluated. METHODS: A total of 131 consecutive patients undergoing transrectal prostate biopsy are included in the study. After randomization, 76 patients were biopsiated with anesthesia and 55 represent the control group. Cases and control groups do not differ in age or prostate volume. Anesthesia consisted on a periprostatic nerve blockage with injection of 5 cc of 1% mepivacaine solution in the angle between prostate and seminal vesicles bilaterally. A visual analogical scale for pain was used; it was given to the patient at the end of the procedure. RESULTS: Mean pain value was 2.41 with a median of 2.0 in the group with anesthesia, and 4.02 with a median of 4 in the control group. A Student´s t test comparing the means showed a statistically significant difference of 1.61 (p<0.0001). Pain in the scale was 66% greater in the control group. CONCLUSION: The use of anesthesia in the performance of transrectal biopsies significantly diminishes the perception of pain by patients. This effect, along with the tendency to increase the number of biopsies, will result in short time in a more generalized use of local anesthesia