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INTRODUCTION: To report the 5-year efficacy and safety of Aquablation compared with transurethral resection of the prostate for the management of lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with prostate volumes 50-80 mL. MATERIALS AND METHODS: In a large double-blinded, multicenter, and prospective randomized controlled trial, 96 randomized men with 50-80 mL prostates who underwent Aquablation or transurethral prostate resection were prospectively identified for subgroup analysis. Follow up was performed for up to 5 years. The primary efficacy endpoint was the reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo (CD) postoperative complications grade 1 persistent and grade 2 or higher at 3 months. RESULTS: Both groups had comparable baseline characteristics. Reduction in IPSS score was significantly higher in the Aquablation group across 5 years of follow up (-14.1 vs. -10.8, p = 0.02). The Aquablation group achieved a significantly lower rate of CD1P and CD2 or higher events at 3 months follow up (risk difference of -23.1%). Among recorded adverse events, de novo postoperative ejaculatory dysfunction was notably lower in Aquablation (risk difference of -21.9%), while the risk of bleeding remained similar after 6 months. The surgical and medical retreatment rate at 6 months was also lower in Aquablation (risk difference of -14.4%). CONCLUSIONS: In the 50-80 mL prostate volume subgroup, Aquablation yields superior long-term symptom relief and lower complication rates than standard transurethral resection, with notably lower rates of ejaculatory dysfunction. This further supports the adoption of Aquablation for men with medium-sized prostates.
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Técnicas de Ablación , Síntomas del Sistema Urinario Inferior , Hiperplasia Prostática , Resección Transuretral de la Próstata , Humanos , Masculino , Técnicas de Ablación/efectos adversos , Síntomas del Sistema Urinario Inferior/etiología , Síntomas del Sistema Urinario Inferior/cirugía , Estudios Prospectivos , Próstata/cirugía , Hiperplasia Prostática/complicaciones , Hiperplasia Prostática/cirugía , Hiperplasia Prostática/diagnóstico , Resección Transuretral de la Próstata/efectos adversos , Resultado del Tratamiento , Agua , Método Doble CiegoRESUMEN
INTRODUCTION: A common indication for benign prostate hyperplasia (BPH) therapies is failure to improve with medical therapy. However, pivotal Federal Drug Administration (FDA) registered randomized clinical trials (RCTs) for minimally invasive surgical therapies (MISTs) are designed to be compared to either sham or placebo while off medical therapy at baseline, and as an alternative to medical therapy. There are few if any RCTs reporting the MISTS efficacy in patients with true medical therapy failure. We report on the efficacy of robotic water jet ablation therapy (RWT) and TURP in patients who have failed to improve with medical therapy. MATERIALS AND METHODS: Data was obtained from the WATER and WATER II clinical trials. Both clinical trials did not implement a drug washout period. Only patients with reported BPH medical therapy such as alpha-blockers (AB) and 5-alpha-reductase inhibitors (5-ARIs) usage were included. Functional outcomes as post-void residual volume (PVR), peak urinary flow rate (Qmax), internal prostate symptom score (IPSS), and quality of life score (QoL) were analyzed. RESULTS: AB and/or 5-ARIs usage at baseline were reported in 146 and 39 patients who underwent RWT (prostate sizes up to 150 cc) and transurethral resection of the prostate (TURP, prostate sizes up to 80 cc) respectively. Baseline median (IQR) IPSS, QoL, Qmax and PVR were 24 (18,28), 5 (4,5), 8.9 (6.4,11.5), and 95 (36,172), respectively. Functional outcomes did not statistically differ between Aquablation and TURP at baseline and at 36-month. In cohort of true medical failure, both RWT and TURP demonstrated group statistical improvements in PVR, Qmax, IPSS, and QoL at 36-month compared to baseline. CONCLUSIONS: RWT and TURP are effective BPH therapy in patients who truly failed medical therapy, and RWT demonstrated this in a much broader prostate size range.
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Hiperplasia Prostática , Procedimientos Quirúrgicos Robotizados , Resección Transuretral de la Próstata , Masculino , Humanos , Hiperplasia Prostática/cirugía , Resección Transuretral de la Próstata/efectos adversos , Agua , Próstata/cirugía , Resultado del Tratamiento , Calidad de VidaRESUMEN
INTRODUCTION: To determine if Aquablation therapy can maintain long term effectiveness in treating men with moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with a baseline prostate volume between 30 and 80 mL at 5 years compared to TURP. MATERIALS AND METHODS: In a double-blinded, multicenter prospective randomized controlled trial, 181 patients with moderate to severe LUTS secondary to BPH underwent TURP or Aquablation. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo persistent Grade 1 or Grade 2 or higher operative complications at 3 months. The assessments included IPSS, Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function (IIEF) and uroflow (Qmax). The patients were followed for 5 years. RESULTS: The primary safety endpoint was successfully achieved at 3 months where the Aquablation group had a lower event rate than TURP (26% vs. 42%, p = .0149 for superiority). Procedure-related ejaculatory dysfunction was lower for Aquablation (7% vs. 25%, p = .0004). The primary efficacy endpoint was successfully achieved at 6 months, where the mean IPSS decreased from baseline by 16.9 points for Aquablation and 15.1 points for TURP; the mean difference in change score at 6 months was 1.8 points larger for Aquablation (p < .0001 for non-inferiority, p = .1346 for superiority). At 5 years, IPSS scores improved by 15.1 points in the Aquablation group and 13.2 points in TURP (p = .2764). However, for men with larger prostates (≥ 50 mL), IPSS reduction was 3.5 points greater across all follow up visits in the Aquablation group compared to the TURP group (p = .0123). Improvement in peak urinary flow rate was 125% and 89% compared to baseline for Aquablation and TURP, respectively. The risk of patients needing a secondary BPH therapy, defined as needing BPH medication or surgical intervention, up to 5 years due to recurrent LUTS was 51% less in the Aquablation arm compared to the TURP arm. CONCLUSIONS: The improvement in net health outcomes from Aquablation therapy outweigh those offered by a TURP when considering the efficacy benefit along with the lower risk of needing a secondary BPH therapy and avoiding retrograde ejaculation. Following Aquablation therapy, symptom reduction and uroflow improvement at 5 years have shown to be durable and consistent across all years of follow up compared to TURP. Larger prostates (≥ 50 mL) demonstrated a larger safety and efficacy benefit for Aquablation over TURP.
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Técnicas de Ablación , Síntomas del Sistema Urinario Inferior , Hiperplasia Prostática , Resección Transuretral de la Próstata , Técnicas de Ablación/efectos adversos , Técnicas de Ablación/métodos , Humanos , Síntomas del Sistema Urinario Inferior/etiología , Síntomas del Sistema Urinario Inferior/cirugía , Masculino , Estudios Prospectivos , Hiperplasia Prostática/complicaciones , Hiperplasia Prostática/cirugía , Resección Transuretral de la Próstata/efectos adversos , Resección Transuretral de la Próstata/métodos , Resultado del TratamientoRESUMEN
PURPOSE: To compare the safety and durability of transurethral resection of the prostate (TURP) and Laser prostatectomy (LP) among multi-morbid and elderly patients. METHODS: Using data retrieved from the New York State Department of Health Statewide Planning and Research Cooperative System and the California Office of Statewide Health Planning and Development, we selected cohorts of 1) multi-morbid (Charlson comorbidity index ≥ 3) and 2) elderly (aged ≥ 75) patients with benign prostatic hyperplasia who underwent laser coagulation, vaporization, enucleation, or TURP between January 2005 and December 2016. We assessed the post-operative incidence of hospital readmission and ER visit at 30 days and 90 days, complications at 90 days, and reoperation and the development of urethral stricture at 6 months or longer. RESULTS: We found 12,815 and 29,806 patients in the multi-morbid and elderly cohort, respectively. Compared to LP, TURP was associated with lower odds of 90-day hospital readmission and ER visit in the multi-morbid cohort (OR 0.92, 95% CI 0.85-1.00) and higher odds in the elderly cohort (OR 1.07, 95% CI 1.01-1.14). The multi-morbid cohort showed lower odds of urinary tract infections (Ref: LP, OR 0.83, 95% CI 0.73-0.93). The elderly cohort showed higher odds of experiencing hematuria (OR 1.28, 95% CI 1.03-1.59) post TURP. TURP was associated with a 19% (95% CI 0.66-1.00) and 20% (95% CI 0.71-0.91) reduced hazard of reoperation at 6 months or longer for multi-morbid and elderly cohorts, respectively. CONCLUSION: Compared to LP, TURP was associated with higher complication rates for the multi-morbid and elderly cohorts overall but a lower hazard of reoperation, supporting its durability.
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Prostatectomía/métodos , Hiperplasia Prostática/complicaciones , Hiperplasia Prostática/cirugía , Factores de Edad , Anciano , Anciano de 80 o más Años , Humanos , Terapia por Láser , Masculino , Prostatectomía/efectos adversos , Estudios Retrospectivos , Resección Transuretral de la Próstata/efectos adversos , Resultado del TratamientoRESUMEN
Introduction: Clinical trial manuscripts commonly report results of individual endpoints. However, durability of a medical treatment may be difficult to determine when evaluating endpoint outcomes individually. We reviewed pivotal trial manuscripts of two minimally invasive benign prostatic hyperplasia (BPH) treatments and estimated the rate of treatment durability using a composite, symptom-centric metric.Methods: Data were derived from published pivotal trial reports of two minimally invasive BPH treatments - water vapor thermal therapy (WVTT) and prostatic urethral lift (PUL). We estimated the risk of medical or surgical retreatment using life-table methods, and the number of patients achieving the minimal clinically important difference (MCID) for the International Prostate Symptom Score (IPSS) using z-score methods. Treatment durability was defined as a MCID on the IPSS at the 4-year follow-up visit while free from medical or surgical retreatment.Results: Comparing WVTT to PUL, the rate of medical or surgical retreatment was 10.6% vs. 31.8%, the IPSS MCID was achieved in 82.2% vs. 79.5%, and treatment durability rates were 71.8% vs. 51.7%.Conclusions: Utilization of a composite treatment durability metric derived from endpoints commonly reported in the BPH literature may allow patients and their providers to make better informed treatment decisions.
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Ensayos Clínicos como Asunto , Procedimientos Quirúrgicos Mínimamente Invasivos , Hiperplasia Prostática/cirugía , Anciano , Simulación por Computador , Humanos , Hipertermia Inducida , Síntomas del Sistema Urinario Inferior , Masculino , Persona de Mediana Edad , Método de Montecarlo , Próstata/cirugía , Calidad de Vida , Factores de Riesgo , Vapor , Resultado del Tratamiento , Uretra/cirugíaRESUMEN
INTRODUCTION: To compare 3-year efficacy and safety after prostate resection with Aquablation therapy or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostate hyperplasia (BPH). MATERIALS AND METHODS: One hundred and eighty-one patients assigned to either Aquablation therapy or TURP were followed for 3 years postoperatively. Patients and follow up assessors were blinded to treatment. Assessments included International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire (MSHQ-EjD), International Index of Erectile Function (IIEF) and uroflow. RESULTS: Over 3 years of treatment, improvements in IPSS scores were statistically similar across groups. Mean 3-year improvements were 14.4 and 13.9 points in the Aquablation and TURP groups, respectively (difference of 0.6 points, 95% CI -3.3-2.2, p = .6848). Similarly, 3-year improvements in Qmax were 11.6 and 8.2 cc/sec (difference of 3.3 [95% CI -0.5-7.1] cc/sec, p = .0848). At 3 years, PSA was reduced significantly in both groups by 0.9 and 1.1 ng/mL, respectively; the reduction was similar across groups (p = .5983). There were no surgical retreatments for BPH beyond 20 months for either Aquablation or TURP. CONCLUSIONS: Three-year BPH symptom reduction and urinary flow rate improvement were similar after TURP and Aquablation therapy. No subjects required surgical retreatment beyond 20 months postoperatively. (ClinicalTrials.gov number, NCT02505919).
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Técnicas de Ablación/métodos , Síntomas del Sistema Urinario Inferior/cirugía , Prostatectomía/métodos , Hiperplasia Prostática/cirugía , Anciano , Método Doble Ciego , Humanos , Síntomas del Sistema Urinario Inferior/etiología , Masculino , Persona de Mediana Edad , Hiperplasia Prostática/complicaciones , Factores de Tiempo , Resección Transuretral de la Próstata , Resultado del Tratamiento , AguaRESUMEN
Introduction and Objectives: After transurethral prostatectomy, erectile dysfunction and ejaculatory dysfunction are significant concerns for patients. We compared ejaculatory hood-sparing technique in patients who underwent photoselective vaporization of the prostate using the GreenLight Laser (EjS-PVP) with the ejaculatory hood-sparing technique in patients who underwent bipolar button plasma vaporization of the prostate (EjS-BPVP) in the surgical management of benign prostatic hyperplasia (BPH). Materials and Methods: Twenty-seven patients were randomized to either undergo EjS-PVP or EjS-BPVP from August 2016 to March 2018. All of the patients were sexually active with antegrade ejaculation before prostatectomy. We evaluated International Prostate Symptom Score (IPSS), quality of life (QoL), peak flow rate (Qmax), postvoid residual volume (PVR), International Index of Erectile Function and ejaculatory function by the Male Sexual Health Questionnaire (MSHQ). Men were evaluated preoperatively and at 1, 3, and 6 months postoperatively. The primary outcome was ejaculation preservation measured as no change or preservation in antegrade ejaculate at the last follow-up visit by MSHQ (6 months). Results: Twenty-seven patients with a mean age of 65.6 ± 8.4 years underwent either EjS-BPVP or EjS-PVP (Table 1). There were no differences in baseline characteristics between the two groups. Improvements in IPSS, QoL, Qmax, and PVR were durable throughout the study period in both groups. There was no difference in outcomes between groups. Postoperatively, there was no change in ejaculatory function with EjS-BPVP utilizing either 180 W EjS-PVP or bipolar energy. The change in MSHQ Ejaculation Scale was -2.1 and -5.4 at 6 months in both arms. The 6-month ejaculatory preservation rate was 85% in the EjS-PVP group and 78% in the EjS-BPVP group. Conclusions: EjS GreenLight photoselective vaporization and bipolar plasma button vaporization is a safe and effective method for treating men with lower urinary tract symptoms secondary to BPH with maintenance of antegrade ejaculation.
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Trastorno Bipolar , Terapia por Láser , Hiperplasia Prostática , Resección Transuretral de la Próstata , Anciano , Eyaculación , Humanos , Masculino , Persona de Mediana Edad , Plasma , Hiperplasia Prostática/cirugía , Calidad de Vida , Resultado del Tratamiento , VolatilizaciónRESUMEN
This review provides a brief overview of and commentary on currently available technology for the surgical treatment of obstructive benign prostatic hyperplasia causing lower urinary tract symptoms. This review provides references relevant to review and understand current technology that is clinically available.
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Prostatectomía , Hiperplasia Prostática/cirugía , Humanos , Síntomas del Sistema Urinario Inferior/etiología , Masculino , Hiperplasia Prostática/complicacionesRESUMEN
OBJECTIVE: To report long-term safety and efficacy data on middle lobe only-transurethral resection of the prostate (TURP) (MLO-TURP). MATERIALS AND METHODS: We evaluated: (1) efficacy: International Prostate Symptom Score, Quality of Life, peak flow rate (Qmax), postvoid residual urine, International Index of Erectile Function and ejaculatory function, which was assessed by the Male Sexual Health Questionnaire. Men were evaluated at 1 month, 6 months, and yearly thereafter. RESULTS: A total 312 men (mean age 61.3 ± 8.6) with significant lower urinary tract symptoms (nâ¯=â¯147) or urinary retention (nâ¯=â¯175 were treated with MLO-TURP from 2005 to 2017. Mean baseline prostate volume was 79.8 g (30-178 g); mean baseline intravesical-prostatic protrusion was 13.6. Improvements in International Prostate Symptom Score, Quality of Life, Qmax and postvoid residual urine were durable throughout the study period. There was no difference in outcomes between monopolar and bipolar MLO-TURPs. Postoperatively, the incidence of ejaculatory dysfunction was 2.6% (Nâ¯=â¯8) and there was 1 case of new onset ED (0.3%). There were modest improvement in bother due to ejaculatory function (baseline: 2.4 and at 5 years: 1.27). CONCLUSION: MLO-TURP is a safe and effective treatment for men with lower urinary tract symptoms. Patients experience long-term improvement of symptoms and preserve antegrade ejaculation. In select men with prominent middle lobes, MLO-- should be considered a therapeutic, ejaculation-sparing option.
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Eyaculación , Terapia por Láser , Hiperplasia Prostática/cirugía , Resección Transuretral de la Próstata/métodos , Anciano , Anciano de 80 o más Años , Disuria/etiología , Estudios de Seguimiento , Humanos , Terapia por Láser/efectos adversos , Síntomas del Sistema Urinario Inferior/etiología , Síntomas del Sistema Urinario Inferior/cirugía , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias , Próstata/cirugía , Calidad de Vida , Resección Transuretral de la Próstata/efectos adversos , Cateterismo Urinario , Retención Urinaria/cirugía , Infecciones Urinarias/etiologíaRESUMEN
INTRODUCTION: To compare 2-year safety and efficacy outcomes after Aquablation or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostate hyperplasia (BPH). METHODS: One hundred eighty-one patients with BPH were assigned at random (2:1 ratio) to either Aquablation or TURP. Patients and follow-up assessors were blinded to treatment. Assessments included the International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function and uroflow. The focus of analysis was 2-year outcomes. RESULTS: At 2 years, IPSS scores improved by 14.7 points in the Aquablation group and 14.9 points in TURP (p = .8304, 95% CI for difference - 2.1 to 2.6 points). Two-year improvements in maximum flow rate (Qmax) were large in both groups at 11.2 and 8.6 cc/s for Aquablation and TURP, respectively (p = 0.1880, 95% CI for difference - 1.3 to 6.4). Sexual function as assessed by MSHQ was stable in the Aquablation group and decreased slightly in the TURP group. At 2 years, PSA was reduced significantly in both groups by 0.7 and 1.2 points, respectively; the reduction was similar across groups (p = 0.1816). Surgical retreatment rates after 12 months for Aquablation were 1.7% and 0% for TURP. Over 2 years, surgical BPH retreatment rates were 4.3% and 1.5% (p = 0.4219), respectively. CONCLUSION: Two-year efficacy outcomes after TURP and Aquablation were similar, and the rate of surgical retreatment was low and similar to TURP. TRIAL REGISTRATION: ClinicalTrials.gov no. NCT02505919. FUNDING: PROCEPT BioRobotics.
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Técnicas de Ablación/métodos , Síntomas del Sistema Urinario Inferior/cirugía , Hiperplasia Prostática/cirugía , Resección Transuretral de la Próstata/métodos , Agua , Anciano , Humanos , Masculino , Persona de Mediana EdadRESUMEN
OBJECTIVE: To test the hypothesis that benign prostatic hyperplasia (BPH) robotic surgery with aquablation would have a more pronounced benefit in certain patient subgroups, such as men with more challenging anatomies (e.g. large prostates, large middle lobes) and men with moderate BPH. METHODS: We conducted prespecified and post hoc exploratory subgroup analyses from a double-blind, multicentre prospective randomized controlled trial that compared transurethral resection of the prostate (TURP) using either standard electrocautery vs surgery using robotic waterjet (aquablation) to determine whether certain baseline factors predicted more marked responses after aquablation as compared with TURP. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo persistent grade 1 or grade ≥2 surgical complications. RESULTS: For men with larger prostates (50-80 g), the mean IPSS reduction was four points greater after aquablation than after TURP (P = 0.001), a larger difference than the overall result (1.8 points; P = 0.135). Similarly, the primary safety endpoint difference (20% vs 46% [26% difference]; P = 0.008) was greater for men with large prostate compared with the overall result (26% vs 42% [16% difference]; P = 0.015). Postoperative anejaculation was also less common after aquablation compared with TURP in sexually active men with large prostates (2% vs 41%; P < 0.001) vs the overall results (10% vs 36%; P < 0.001). Exploratory analysis showed larger IPSS changes after aquablation in men with enlarged middle lobes, men with severe middle lobe obstruction, men with a low baseline maximum urinary flow rate, and men with elevated (>100) post-void residual urine volume. CONCLUSIONS: In men with moderate-to-severe lower urinary tract symptoms attributable to BPH and larger, more complex prostates, aquablation was associated with both superior symptom score improvements and a superior safety profile, with a significantly lower rate of postoperative anejaculation. The standardized, robotically executed, surgical approach with aquablation may overcome the increased outcome variability in more complex anatomy, resulting in superior symptom score reduction.
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Técnicas de Ablación , Síntomas del Sistema Urinario Inferior/fisiopatología , Hiperplasia Prostática/fisiopatología , Resección Transuretral de la Próstata , Procedimientos Quirúrgicos Urológicos/métodos , Anciano , Método Doble Ciego , Humanos , Síntomas del Sistema Urinario Inferior/terapia , Masculino , Persona de Mediana Edad , Hiperplasia Prostática/patología , Hiperplasia Prostática/terapia , Resultado del TratamientoRESUMEN
OBJECTIVES: To describe peri-operative results, functional outcomes and complications of laser photoselective vaporization, using the GreenLight system, of prostate glands ≥200 mL in volume. METHODS: Retrospective analysis of a prospectively maintained multicentre database was performed to select a subgroup of patients with very large prostates (volume ≥200 mL) treated with the GreenLight XPS laser. A subgroup of patients with prostate volumes 100-200 mL was used for comparison. International Prostate Symptom Score, maximum urinary flow rate, postvoid residual urine volume and prostate-specific antigen levels were measured at 6, 12, 24, 36 and 48 months. Durability was evaluated using benign prostatic hyperplasia re-treatment rate at 12, 24 and 36 months. Additionally, complications were recorded using Clavien-Dindo classification. RESULTS: A total of 33 patients (38%) had prostates ≥200 mL. Baseline characteristics were similar between patients with prostates ≥200 mL and those with prostates 100-200 mL. Patients with very large prostates (≥200 mL) had longer operating times (129 vs 93 min), less energy delivered, a greater number of fibres used (3 vs 2) and a higher conversion rate to transurethral resection of the prostate (16% vs 4%). In terms of complications and functional outcomes, we did not find any differences between the groups. Retreatment rate was also comparable. CONCLUSIONS: Our results show that PVP GreenLight XPS-180W is an acceptable technique for very large prostates (≥200 mL); however, operating times, energy delivery, fibres used and conversion to TURP are a concern in this particular subgroup. This should be used for patient counselling and surgery planning.
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Terapia por Láser , Próstata/cirugía , Hiperplasia Prostática/cirugía , Anciano , Anciano de 80 o más Años , Humanos , Terapia por Láser/efectos adversos , Terapia por Láser/métodos , Terapia por Láser/estadística & datos numéricos , Masculino , Tamaño de los Órganos , Complicaciones Posoperatorias , Próstata/patología , Hiperplasia Prostática/patología , Reoperación , Estudios Retrospectivos , Resección Transuretral de la Próstata/estadística & datos numéricos , Resultado del TratamientoRESUMEN
PURPOSE: We compared the safety and efficacy of Aquablation and transurethral prostate resection for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. MATERIALS AND METHODS: In a double-blind, multicenter, prospective, randomized, controlled trial 181 patients with moderate to severe lower urinary tract symptoms related to benign prostatic hyperplasia underwent transurethral prostate resection or Aquablation. The primary efficacy end point was the reduction in International Prostate Symptom Score at 6 months. The primary safety end point was the development of Clavien-Dindo persistent grade 1, or 2 or higher operative complications. RESULTS: Mean total operative time was similar for Aquablation and transurethral prostate resection (33 vs 36 minutes, p = 0.2752) but resection time was lower for Aquablation (4 vs 27 minutes, p <0.0001). At month 6 patients treated with Aquablation and transurethral prostate resection experienced large I-PSS improvements. The prespecified study noninferiority hypothesis was satisfied (p <0.0001). Of the patients who underwent Aquablation and transurethral prostate resection 26% and 42%, respectively, experienced a primary safety end point, which met the study primary noninferiority safety hypothesis and subsequently demonstrated superiority (p = 0.0149). Among sexually active men the rate of anejaculation was lower in those treated with Aquablation (10% vs 36%, p = 0.0003). CONCLUSIONS: Surgical prostate resection using Aquablation showed noninferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction. Larger prostates (50 to 80 ml) demonstrated a more pronounced superior safety and efficacy benefit. Longer term followup would help assess the clinical value of Aquablation.
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Técnicas de Ablación/métodos , Electrocoagulación/métodos , Hiperplasia Prostática/cirugía , Procedimientos Quirúrgicos Robotizados/métodos , Resección Transuretral de la Próstata/métodos , Técnicas de Ablación/efectos adversos , Anciano , Método Doble Ciego , Eyaculación/fisiología , Electrocoagulación/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/fisiopatología , Estudios Prospectivos , Próstata/cirugía , Hiperplasia Prostática/diagnóstico , Procedimientos Quirúrgicos Robotizados/efectos adversos , Índice de Severidad de la Enfermedad , Disfunciones Sexuales Fisiológicas/epidemiología , Disfunciones Sexuales Fisiológicas/etiología , Disfunciones Sexuales Fisiológicas/fisiopatología , Resección Transuretral de la Próstata/efectos adversos , Resultado del Tratamiento , AguaRESUMEN
OBJECTIVES: To assess the effect of energy density (kJ/mL) applied on adenoma during photoselective vaporization of the prostate (PVP) treatment for benign prostate hyperplasia (BPH) on functional outcomes, prostate-specific antigen (PSA) reduction and complications. PATIENTS AND METHODS: After exclusions, a total of 440 patients who underwent GreenLight (tm) laser XPS-180W lithium triborate PVP for the treatment of BPH were retrospectively reviewed. Data were collected from seven different international centres (Canada, USA, UK and France). Patients were stratified into four energy density groups (kJ/mL) according to intra-operative energy delivered and prostate volume as determined by preoperative transrectal ultrasonography (TRUS): group 1: <3 kJ/mL; group 2: 3-5 kJ/mL; group 3: 5-7 kJ/mL; and group 4: ≥7 kJ/mL. Energy density groups were chosen arbitrarily. PSA reduction and functional outcomes (International Prostate Symptom Score, quality of life, post-void residual urine volume, maximum urinary flow rate) were compared at 6, 12 and 24 months. Peri-operative complications and retreatment rates were also compared among the groups. RESULTS: The PSA reduction rates at 24 months after the procedure were 51, 61, 79 and 83% for the energy density groups <3, 3-5, 5-7 and ≥7 kJ/mL, respectively (P ≤ 0.01). This held true after accounting for baseline confounders. Energy density was not associated with higher complication rates, including haematuria, stricture formation, incontinence, refractory urinary retention, urinary tract infection and conversion to transurethral resection of the prostate. Functional outcomes at 2 years of follow-up were equivalent among the groups (P > 0.05 for all) and similar retreatment rates were observed (P = 0.36). CONCLUSION: Higher energy usage per cc of prostate was associated with a more significant reduction in PSA level (>50%) at 6, 12 and 24 months, suggesting increased vaporization of adenoma tissue; however, this did not translate into differences in functional outcomes at 2-year follow-up.
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Fuentes Generadoras de Energía , Terapia por Láser/métodos , Hiperplasia Prostática/cirugía , Resección Transuretral de la Próstata/métodos , Anciano , Boratos , Humanos , Compuestos de Litio , Masculino , Persona de Mediana Edad , Tamaño de los Órganos , Próstata/patología , Hiperplasia Prostática/patología , Estudios RetrospectivosRESUMEN
INTRODUCTION AND HYPOTHESIS: Overactive bladder (OAB) affects a considerable proportion of men and women in the United States and is associated with significant costs and quality of life (QoL) reduction. While medication remains a mainstay of treatment, there is increasing interest in the use of alternative medicine in the form of acupuncture. We reviewed the literature on the role of acupuncture in managing OAB. METHODS: A narrative review was compiled after searching electronic databases (PubMed, MEDLINE, Scopus, and EMBASE) for clinical studies involving acupuncture in treating OAB. Databases were searched from the time of inception through September 2015 by a clinician for articles reporting the results related to the use of acupuncture in OAB. Key search terms were acupuncture, overactive bladder, bladder instability, urgency, urinary incontinence. Articles in English or translated into English were included. RESULTS: Initial animal studies suggest several biochemical mechanisms of action underlying the effect of acupuncture on OAB suppression. The experience in humans includes two case series and six comparative trials. All studies demonstrated subjective improvement in OAB symptoms, and some reported objective improvement in urodynamic studies. Notably, some comparative trials showed the benefit of acupuncture to be comparable with antimuscarinic treatment. CONCLUSION: Despite their limitations, existing studies serve as a promising foundation for suggesting a role for acupuncture as an alternative therapy for OAB. Further well-designed studies are required to investigate optimal technique and their outcomes.
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Terapia por Acupuntura/métodos , Vejiga Urinaria Hiperactiva/terapia , Puntos de Acupuntura , Animales , Femenino , Humanos , Masculino , Resultado del TratamientoRESUMEN
PURPOSE: We evaluated photoselective vaporization of the prostate using the GreenLight™ XPS™ 180 W system for benign prostatic hyperplasia treatment in a large multi-institutional cohort at 2 years. We particularly examined safety, outcomes and the re-treatment rate in larger prostates, defined as a prostate volume of 80 cc or greater, to assess the potential of photoselective vaporization of the prostate as a size independent procedure. MATERIALS AND METHODS: A total of 1,196 patients were treated at 6 international centers in Canada, the United States, France and England. All parameters were collected retrospectively, including complications, I-PSS, maximum urinary flow rate, post-void residual urine, prostate volume, prostate specific antigen and the endoscopic re-intervention rate. Subgroup stratified comparative analysis was performed according to preoperative prostate volume less than 80 vs 80 cc or greater on transrectal ultrasound. RESULTS: Median prostate size was 50 cc in 387 patients and 108 cc in 741 in the prostate volume groups less than 80 and 80 cc or greater, respectively. The rate of conversion to transurethral prostate resection was significantly higher in the 80 cc or greater group than in the less than 80 cc group (8.4% vs 0.6%, p <0.01). I-PSS, quality of life score, maximum urinary flow rate and post-void residual urine were significantly improved compared to baseline at 6, 12 and 24 months of followup without significant differences between the prostate size groups. The re-treatment rate at 2 years reported in 5 of 411 patients was associated with the delivery of decreased energy density (2.1 vs 4.4 kJ/cc) in the group without re-treatment. CONCLUSIONS: Photoselective vaporization of the prostate using the XPS 180 W system is safe and efficacious, providing durable improvement in functional outcomes at 2 years independent of prostate size when treated with sufficient energy.
Asunto(s)
Endosonografía/métodos , Terapia por Láser/instrumentación , Próstata/diagnóstico por imagen , Hiperplasia Prostática/cirugía , Resección Transuretral de la Próstata/métodos , Anciano , Anciano de 80 o más Años , Diseño de Equipo , Humanos , Masculino , Tamaño de los Órganos , Hiperplasia Prostática/diagnóstico por imagen , Calidad de Vida , Recto , Estudios Retrospectivos , Resultado del Tratamiento , VolatilizaciónRESUMEN
PURPOSE: Sacral neuromodulation with the InterStim® has been done to treat urinary and bowel control. There are limited data in the literature on use trends of sacral neuromodulation. We explored disparities in use among Medicare beneficiaries. MATERIALS AND METHODS: We queried a 5% national random sample of Medicare claims for 2001, 2004, 2007 and 2010. All patients with an ICD-9 diagnosis code representing a potential urological indication for sacral neuromodulation were included. Patients who underwent device implantation were identified using CPT-4 codes. Statistical analysis was done with the chi-square and Fisher tests, and multivariate logistic regression using software. RESULTS: A total of 2,322,060 patients were identified with a diagnosis that could potentially be treated with sacral neuromodulation. During the 10-year study period the percent of these patients who ultimately underwent implantation increased from 0.03% to 0.91% (p <0.0001) for a total of 13,360 (0.58%). On logistic regression analysis women (OR 3.85, p <0.0001) and patients younger than 65 years (OR 1.00 vs 0.29 to 0.39, p <0.0001) were more likely to be treated. Minority patients (OR 0.38, p <0.0001) and those living in the western United States (OR 0.52, p <0.0001) were less likely to receive treatment. CONCLUSIONS: Sacral neuromodulation use significantly increased among Medicare beneficiaries in a 10-year period. Patients were more likely to be treated with sacral neuromodulation if they were female, white, younger (younger than 65 years) and living outside the western United States.
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Terapia por Estimulación Eléctrica/instrumentación , Electrodos Implantados , Incontinencia Fecal/terapia , Plexo Lumbosacro , Medicare/economía , Vejiga Urinaria Hiperactiva/terapia , Anciano , Anciano de 80 o más Años , Terapia por Estimulación Eléctrica/economía , Incontinencia Fecal/economía , Femenino , Humanos , Masculino , Estudios Retrospectivos , Estados Unidos , Vejiga Urinaria Hiperactiva/economíaRESUMEN
INTRODUCTION: There has been a significant change in surgical treatment of benign prostatic hypertrophy (BPH) over the last two decades. Most importantly, laser surgery (coagulation, vaporization, or enucleation) has been growing in popularity as an alternative to standard transurethral prostatectomy (TURP) or other procedures. Our goal was to analyze the trends of BPH surgeries and compare outcomes of laser surgery to TURP, the two most common alternative surgeries. MATERIALS AND METHODS: We used the New York Statewide Planning and Research Cooperation System (SPARCS) data to identify patients diagnosed as having BPH who underwent BPH-related surgery from October 2000 to December 2011. Age, insurance, individual comorbidities, and average hospital volumes were assessed. Bivariate and multivariate regression models were used to analyze predictors of laser use. In-hospital outcomes were then compared between laser and TURP in a balanced propensity-matched cohort. RESULTS: Ninety thousand six hundred seventy patients underwent BPH surgery. Laser surgery usage increased from 6.4% to 44.5% over 10 years (p<0.0001). TURP declined significantly from 72.2% to 48.3% (p<0.0001). Patients with Medicaid were less likely to undergo laser therapy than those with private insurance (odds ratio [OR]: 0.58, 95% confidence interval [CI]: 0.48, 0.69). Mid- and high-volume institutions were more likely to use laser treatment than low-volume centers (OR: 2.26, 95% CI: 1.22, 4.2; OR: 4.07, 95% CI: 1.75, 9.46, respectively). In the matched cohort, both laser and TURP patients had similar complication rates with more frequent electrolyte disorders in TURP patients (2.9% vs 2.3%, p=0.001). CONCLUSIONS: TURP remains the most common procedure. However, the rate of use has declined over time. In contrast, laser use has significantly increased. Laser treatment was utilized more in younger patients, in those privately insured, in hospitals with high volumes of BPH procedures, and in patients with fewer comorbid conditions. Both surgeries are safe with no differences in terms of occurrences of morbidity and complications.
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Procedimientos Quirúrgicos Ambulatorios/estadística & datos numéricos , Terapia por Láser/estadística & datos numéricos , Evaluación de Resultado en la Atención de Salud , Pautas de la Práctica en Medicina/estadística & datos numéricos , Hiperplasia Prostática/cirugía , Resección Transuretral de la Próstata/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Procedimientos Quirúrgicos Ambulatorios/métodos , Humanos , Terapia por Láser/métodos , Masculino , New York , Pautas de la Práctica en Medicina/tendencias , Resección Transuretral de la Próstata/métodosRESUMEN
BACKGROUND AND PURPOSE: Transurethral laser enucleation of the prostate (TLEP) using the potassium-titanyl-phosphate (KTP) laser offers an alternative technique to traditional photovaporization. The study objective was to determine the comparative efficacy between transurethral photovaporization of the prostate (PVP) with a TLEP technique using the 80W 532 nm KTP laser. PATIENTS AND METHODS: A series of 97 vs 170 patients who underwent PVP vs TLEP, respectively, with the KTP laser system at Weill Cornell Medical College from September 2001 to May 2009 was studied retrospectively. Outcome measures included laser time, prostate volume lased per unit time, International Prostate Symptom Score (IPSS), postvoid residual (PVR), and maximum flow rate (Qmax). Statistical analyses were performed using the Shapiro-Wilk, Mann-Whitney, Wilcoxon, and unpaired t tests. RESULTS: Baseline parameters were similar between groups, although volume was greater in the TLEP group (83 vs 63 cc, P=0.04). Median laser time was longer in the TLEP group (90 vs 50 min, P<0.001) with a higher median energy used (308 vs 165 kJ, P<0.001). The volume lased per unit time was shorter, however, for TLEP (0.92 cc/min) than for PVP (1.26 cc/min). A greater median number of fibers were used in TLEP (2.5 vs 2.0, P=0.001). Improvements in median IPSS and PVR were seen in the TLEP group (5.0, P<0.001; 55.5, P=0.02, respectively) but not in the PVP group (P=0.40 and 0.30). Median Qmax and prostate-specific antigen (PSA) level improved similarly in both groups. Final IPSS was lower for the TLEP group (P<0.001), but other final parameters were statistically equivalent. CONCLUSIONS: In our series, both PVP and TLEP techniques were safe and effective. Although changes in Qmax and PSA were similar between the two techniques, improvement in urinary symptoms and PVR was superior with the TLEP technique. The TLEP technique was a more efficient method for laser prostatectomy.