RESUMEN
PURPOSE: To identify expert laser settings for BPH treatment and evaluate the application of preventive measures to reduce complications. METHODS: A survey was conducted after narrative literature research to identify relevant questions regarding laser use for BPH treatment (59 questions). Experts were asked for laser settings during specific clinical scenarios. Settings were compared for the reported laser types, and common settings and preventive measures were identified. RESULTS: Twenty-two experts completed the survey with a mean filling time of 12.9 min. Ho:YAG, Thulium fiber laser (TFL), continuous wave (cw) Tm:YAG, pulsed Tm:YAG and Greenlight™ lasers are used by 73% (16/22), 50% (11/22), 23% (5/22), 13.6% (3/22) and 9.1% (2/22) of experts, respectively. All experts use anatomical enucleation of the prostate (EEP), preferentially in one- or two-lobe technique. Laser settings differ significantly between laser types, with median laser power for apical/main gland EEP of 75/94 W, 60/60 W, 100/100 W, 100/100 W, and 80/80 W for Ho:YAG, TFL, cwTm:YAG, pulsed Tm:YAG and Greenlight™ lasers, respectively (p = 0.02 and p = 0.005). However, power settings within the same laser source are similar. Pulse shapes for main gland EEP significantly differ between lasers with long and pulse shape modified (e.g., Moses, Virtual Basket) modes preferred for Ho:YAG and short pulse modes for TFL (p = 0.031). CONCLUSION: Ho:YAG lasers no longer seem to be the mainstay of EEP. TFL lasers are generally used in pulsed mode though clinical applicability for quasi-continuous settings has recently been demonstrated. One and two-lobe techniques are beneficial regarding operative time and are used by most experts.
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Terapia por Láser , Láseres de Estado Sólido , Litotripsia por Láser , Hiperplasia Prostática , Masculino , Humanos , Litotripsia por Láser/métodos , Hiperplasia Prostática/cirugía , Hiperplasia Prostática/tratamiento farmacológico , Próstata , Láseres de Estado Sólido/uso terapéutico , Hipertrofia/tratamiento farmacológico , Hipertrofia/cirugía , Tulio/uso terapéutico , Terapia por Láser/métodosRESUMEN
Transperineal prostate biopsy (TPPB) is proven to be an effective diagnostic tool for prostate cancer detection. It allows satisfactory sampling of apical and anterior areas which is not well achieved with the transrectal route, without the associated risks of urinary tract infection or sepsis. The main objective of this paper is to describe the technique utilized in our institution to perform transperineal prostate biopsy under local anesthetic in the outpatient clinic setting.
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Próstata , Neoplasias de la Próstata , Masculino , Humanos , Próstata/patología , Anestésicos Locales , Pacientes Ambulatorios , Biopsia/efectos adversos , Biopsia/métodos , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/patología , Biopsia Guiada por Imagen , Perineo/patologíaRESUMEN
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
OBJECTIVE: To determine whether the addition of inhaled methoxyflurane to periprostatic infiltration of local anaesthetic (PILA) during transrectal ultrasonography-guided prostate biopsies (TRUSBs) improved pain and other aspects of the experience. PATIENTS AND METHODS: We conducted a multicentre, placebo-controlled, double-blind, randomized phase 3 trial, involving 420 men undergoing their first TRUSB. The intervention was PILA plus a patient-controlled device containing either 3 mL methoxyflurane, or 3 mL 0.9% saline plus one drop of methoxyflurane to preserve blinding. The primary outcome was the pain score (0-10) reported by the participant after 15 min. Secondary outcomes included ratings of other aspects of the biopsy experience, willingness to undergo future biopsies, urologists' ratings, biopsy completion, and adverse events. RESULTS: The mean (SE) pain scores 15 min after TRUSB were 2.51 (0.22) in those assigned methoxyflurane vs 2.82 (0.22) for placebo (difference 0.31, 95% confidence interval [CI] -0.75 to 0.14; P = 0.18). Methoxyflurane was associated with better scores for discomfort (difference -0.48, 95% CI -0.92 to -0.03; P = 0.035, adjusted [adj.] P = 0.076), whole experience (difference -0.50, 95% CI -0.92 to -0.08; P = 0.021, adj. P = 0.053), and willingness to undergo repeat biopsies (odds ratio 1.67, 95% CI 1.12-2.49; P = 0.01) than placebo. Methoxyflurane resulted in higher scores for drowsiness (difference +1.64, 95% CI 1.21-2.07; P < 0.001, adj. P < 0.001) and dizziness (difference +1.78, 95% CI 1.31-2.24; P < 0.001, adj. P < 0.001) than placebo. There was no significant difference in the number of ≥ grade 3 adverse events. CONCLUSIONS: We found no evidence that methoxyflurane improved pain scores at 15 min, however, improvements were seen in patient-reported discomfort, overall experience, and willingness to undergo repeat biopsies.
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Próstata , Neoplasias de la Próstata , Anestesia Local , Anestésicos Locales/uso terapéutico , Biopsia/efectos adversos , Biopsia/métodos , Humanos , Lidocaína/uso terapéutico , Masculino , Metoxiflurano , Dolor/tratamiento farmacológico , Dolor/etiología , Dolor/prevención & control , Dimensión del Dolor , Próstata/diagnóstico por imagen , Próstata/patología , Neoplasias de la Próstata/patología , UltrasonografíaRESUMEN
PURPOSE: As benign prostatic hyperplasia (BPH) is an age-related process, growing interest in surgical management for elderly men has emerged. Recently, Aquablation was approved for treatment of BPH associated lower urinary tract symptoms (LUTS) and utilizes robotic ultrasound guided surgeon-controlled waterjet ablation. We assessed the differences in functional and surgical outcomes between elderly and young men undergoing Aquablation for BPH/LUTS. MATERIALS AND METHODS: We retrospectively assessed prospectively collected data from the WATER I (NCT02505919) and WATER II (NCT03123250) clinical trials reporting safety and efficacy of Aquablation in the treatment of LUTS/BPH in men 45-80 years with a prostate between 30 and 80 cc, and 80 cc and 150 cc, respectively. Men ≥ 65 years were defined as elderly and men < 65 years as young. RESULTS: Of 217 patients included, 83 (38.2%) were young and 134 (61.8%) were elderly. Mean age (SD) was 59.3 (± 3.4) years and 71.2 (± 4.2) years for young and elderly men, respectively. At 3 years of follow-up compared to baseline, elderly men showed similar reductions in total IPSS (7.68 points vs 7.12 points, p > 0.05) and similar increases in Qmax (20.6 mL/s vs 19.3 mL/s, p > 0.05) compared to young men. The ejaculatory dysfunction rate was similar for both cohorts (12.0% vs 9.7%, p > 0.05). Elderly men experienced similar annual retreatment rates compared to young men (1.5% vs 0.8% p > 0.05). CONCLUSIONS: Elderly men undergoing Aquablation have similar functional and surgical outcomes as young men. Elderly patient BPH surgical counseling should, therefore, consider Aquablation as a treatment option for LUTS/BPH.
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Técnicas de Ablación , Síntomas del Sistema Urinario Inferior , Hiperplasia Prostática , Anciano , Humanos , Síntomas del Sistema Urinario Inferior/etiología , Síntomas del Sistema Urinario Inferior/cirugía , Masculino , Persona de Mediana Edad , Hiperplasia Prostática/complicaciones , Hiperplasia Prostática/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , AguaRESUMEN
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
OBJECTIVE: To compare the outcomes of Aquablation in 30-80 mL prostates with those in 80-150 mL prostates. Surgical options, especially with short learning curves, are limited when treating large prostates for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation (AquaBeam System, PROCEPT BioRobotics Inc., Redwood City, CA, USA) could solve this issue with global reproducibility, independent of prostate volume. PATIENTS AND METHODS: Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue (WATER [W-I]; NCT02505919) is a prospective, double-blind, multicentre, international clinical trial comparing Aquablation and transurethral resection of the prostate (TURP) for the treatment of LUTS/BPH in prostates between 30 and 80 mL. WATER II (W-II; NCT03123250) is a prospective, multicentre, single-arm international clinical trial of Aquablation in prostates between 80 and 150 mL. We compare baseline parameters and 12-month outcomes in 116 W-I and 101 W-II study patients. Students' t-test or Wilcoxon tests were used for continuous variables and Fisher's test for binary variables. RESULTS: The mean (SD) operative time was 33 (17) and 37 (13) min in W-I and W-II, respectively. Actual treatment time was 4 and 8 min in W-I and W-II, respectively. The mean change in the International Prostate Symptom Score was substantial averaging (at 12 months) 15.1 in W-I and 17.1 in W-II (P = 0.605). By 3 months, Clavien-Dindo grade ≥II events occurred in 19.8% of W-I patients and 34.7% of W-II patients (P = 0.468). CONCLUSION: Aquablation clinically normalises outcomes between patients with 30-80 mL prostates and patients with 80-150 mL prostates treated for LUTS/BPH, with an expected increase in the risk of complications in larger prostates. Long-term outcomes of procedure durability are needed.
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Técnicas de Ablación/métodos , Endoscopía , Síntomas del Sistema Urinario Inferior/cirugía , Próstata/patología , Hiperplasia Prostática/patología , Hiperplasia Prostática/cirugía , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Humanos , Síntomas del Sistema Urinario Inferior/etiología , Masculino , Persona de Mediana Edad , Tamaño de los Órganos , Estudios Prospectivos , Hiperplasia Prostática/complicaciones , AguaRESUMEN
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
Here, we review the evolution of prostate enucleation in chronological order based on energy technology starting first with holmium laser, then bipolar electrocautery, followed by thulium laser and finally greenlight and diode laser enucleation of the prostate.
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Terapia por Láser , Hiperplasia Prostática , Resección Transuretral de la Próstata , Humanos , Masculino , Prostatectomía , Hiperplasia Prostática/cirugía , Resultado del TratamientoRESUMEN
PURPOSE: We performed a clinical feasibility trial to evaluate the safety and efficacy of a fully implanted, primary battery powered, nickel sized and shaped neuromodulation device called the eCoin® for tibial nerve stimulation to treat refractory urgency urinary incontinence. MATERIALS AND METHODS: This prospective, single arm, open label study included 46 participants with refractory urgency urinary incontinence. It was performed at multiple sites in the United States and New Zealand. The device was implanted in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality of life instruments were collected 3 and 6 months after activation and compared to baseline values. RESULTS: The mean ± SD age of participants was 63.4 ± 11.5 years and 45 (98%) were female. Episodes of urgency urinary incontinence were reduced a relative median of 71% after 3 months of treatment (4.2 vs 1.7 daily episodes at 3 months, p = 0.001). A 50% or greater decrease in reported episodes of urgency urinary incontinence was observed in 32 of 46 participants (69.6%) at 3 months with more than 20% dry at 3 and 6 months. I-QOL (Incontinence Quality of Life) scores improved an average of 25.9 points and 33 of 46 patients (72%) indicated improvement in symptoms. A single serious adverse event secondary to wound care resolved with intravenous antibiotics. CONCLUSIONS: The implantable neuromodulation device was a safe and effective treatment of urgency urinary incontinence associated with overactive bladder syndrome with a significant reduction or resolution of symptoms and no significant safety concerns.
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Terapia por Estimulación Eléctrica/instrumentación , Terapia por Estimulación Eléctrica/métodos , Electrodos Implantados , Calidad de Vida , Nervio Tibial , Incontinencia Urinaria de Urgencia/terapia , Anciano , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Níquel , Estudios Prospectivos , Medición de Riesgo , Resultado del Tratamiento , Incontinencia Urinaria de Urgencia/diagnóstico , Incontinencia Urinaria de Urgencia/psicologíaRESUMEN
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
AIMS: This paper presents 4-year follow-up results for patients enrolled in a pivotal study conducted to support an FDA premarket approval application (PMAA). The study evaluated the safety and efficacy of the ProACT Adjustable Continence Therapy for the treatment of post-prostatectomy stress urinary incontinence (SUI). METHODS: The clinical study involved 11 clinical sites and enrolled 160 subjects, all male. A total of 124 subjects met study criteria and 123 were implanted with ProACT. Baseline and outcomes for 68 patients who completed 4-year follow-up visits are reported. Endpoints included 24-h pad weight, Incontinence Quality of Life Questionnaire (I-QOL), UCLA Prostate Cancer Index-Urinary Function (PCI-UF), residual volume, and incidence and severity of device or procedure-related adverse events. RESULTS: Statistically significant improvements during follow-up were observed in 24-h pad weight, for which the mean pre-implant urine loss was 293 g, which was reduced at 4 years to 73 g (P < 0.001). Reductions in pad weight were observed across all levels of pre-implant SUI severity. Significant improvements were also seen in quality of life as measured by the I-QOL (P < 0.001) as well as measures of urinary function and pad use. One procedure-related SAE (retention) was reported among the 68 subjects; the SAE was resolved without clinical meaningful sequalae. CONCLUSIONS: These results confirm the long-term safety and efficacy of this newly FDA-approved therapy, showing significant improvements in both objective and subjective measures of SUI in mild, moderate, and severely incontinent male patients. The implant procedure is minimally invasive, and complications are generally mild and easily resolvable.
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Prostatectomía/efectos adversos , Prótesis e Implantes , Incontinencia Urinaria de Esfuerzo/cirugía , Anciano , Anciano de 80 o más Años , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Periodo Posoperatorio , Estudios Prospectivos , Neoplasias de la Próstata/cirugía , Calidad de Vida , Encuestas y Cuestionarios , Resultado del Tratamiento , Incontinencia Urinaria de Esfuerzo/etiologíaRESUMEN
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
AIMS: This paper presents 18-month follow-up results for patients enrolled in a pivotal study conducted to support an FDA premarket approval application (PMAA). The trial evaluated the safety and efficacy of the ProACT Adjustable Continence Therapy for the treatment of post-prostatectomy stress urinary incontinence (SUI). METHODS: The clinical study involved 11 clinical sites and enrolled 160 subjects. A total of 124 subjects met study criteria and 123 underwent ProACT implantation from July 2005 through June 2007, of whom 98 completed 18-month follow-up. Endpoints included 24-h pad weight, Incontinence Quality of Life Questionnaire (I-QOL), UCLA Prostate Cancer Index-Urinary Function (PCI-UF), residual volume, and device or procedure-related adverse events (AEs). RESULTS: The mean surgical time was 32 min. Statistically significant improvements during follow-up were observed in 24-h pad weight, for which the cohort mean pre-implant urine loss was 399 g, which was reduced at 18 months to 160 g (P < 0.001). Reductions in pad weight were observed across all levels of pre-implant SUI severity. Significant improvements were also seen in quality of life as measured by the I-QOL (P < 0.001) as well as measures of urinary function and pad count. One procedure-related serious adverse event (SAE), retention, was reported among the 124 subjects; the SAE was resolved without clinical meaningful sequalae. CONCLUSIONS: These results demonstrate the safety and efficacy of this newly FDA-approved therapy, showing significant improvements in objective and subjective measures of SUI in mild, moderate, and severely incontinent male patients. The duration of the implant procedure is short, and complications are mild and easily resolvable.
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Complicaciones Posoperatorias/cirugía , Prostatectomía/efectos adversos , Prótesis e Implantes , Incontinencia Urinaria de Esfuerzo/cirugía , Anciano , Anciano de 80 o más Años , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Estudios Prospectivos , Neoplasias de la Próstata/cirugía , Calidad de Vida , Encuestas y Cuestionarios , Resultado del Tratamiento , Incontinencia Urinaria de Esfuerzo/etiologíaRESUMEN
Intravesical bacillus Calmette-Guérin has been the standard of care for high-risk non-muscle-invasive bladder cancer for 40 years. It remains one of the most successful immunotherapies ever used. Bacillus Calmette-Guérin shows superior efficacy to alternative intravesical treatments, and has an established role in reducing both recurrence and progression in non-muscle-invasive bladder cancer. It remains relatively safe, and has acceptable tolerability of both local and systemic side-effects. The present review provides insights into the role of bacillus Calmette-Guérin compared with alternative treatments both in primary and refractory settings.
Asunto(s)
Vacuna BCG/uso terapéutico , Inmunoterapia/métodos , Recurrencia Local de Neoplasia/prevención & control , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Administración Intravesical , Vacuna BCG/farmacología , Progresión de la Enfermedad , Humanos , Inmunoterapia/efectos adversos , Invasividad Neoplásica/inmunología , Invasividad Neoplásica/prevención & control , Recurrencia Local de Neoplasia/inmunología , Recurrencia Local de Neoplasia/patología , Resultado del Tratamiento , Vejiga Urinaria/efectos de los fármacos , Vejiga Urinaria/inmunología , Vejiga Urinaria/patología , Neoplasias de la Vejiga Urinaria/inmunología , Neoplasias de la Vejiga Urinaria/patologíaRESUMEN
PURPOSE: We sought to establish the safety and effectiveness of aquablation, a novel, image guided, robotic assisted, water jet tissue ablation technology, for the treatment of benign prostatic hyperplasia. MATERIALS AND METHODS: We performed a prospective, single arm, multicenter trial at a total of 3 centers in Australia and New Zealand with 1-year followup. Participants were men 50 to 80 years old with moderate to severe lower urinary tract symptoms as determined by urodynamics. All patients underwent aquablation under image guidance. Primary end points included procedural and perioperative safety. The main clinical end point was the change from baseline in I-PSS (International Prostate Symptom Score). Other secondary end points included uroflow measures, prostate volume on transrectal ultrasound and detrusor pressure. Detrusor pressure at maximum flow was only measured at 6 months. RESULTS: A total of 21 men underwent aquablation at a mean age of 69.7 years (range 62 to 78). Prostate volume was 57.2 ml (range 30 to 102). Procedural duration averaged 38 minutes with a mean aquablation treatment time of 5 minutes. All but 1 subject were catheterized for 1 day only and 19 of 21 were discharged home the day after the procedure. Detrusor pressure at maximum flow decreased from 65 cm H2O at baseline to 39 cm H2O at 6 months (p <0.0027). Prostate volume decreased from 57 ml at baseline to 35 ml (p <0.0001). Mean I-PSS score improved from 23.0 at baseline to 6.8 at 12 months (p <0.0001) and maximum urinary flow increased from 8.7 to 18.3 ml per second (p <0.0001). There were no important perioperative adverse events. No urinary incontinence developed and sexual function was preserved postoperatively. CONCLUSIONS: This phase II study provides early evidence to support the safety and effectiveness of aquablation for symptomatic benign prostatic hyperplasia.
Asunto(s)
Técnicas de Ablación/métodos , Prostatectomía/métodos , Hiperplasia Prostática/cirugía , Procedimientos Quirúrgicos Robotizados , Cirugía Asistida por Computador , Técnicas de Ablación/instrumentación , Anciano , Anciano de 80 o más Años , Australia , Humanos , Masculino , Persona de Mediana Edad , Nueva Zelanda , Estudios Prospectivos , Factores de Tiempo , Resultado del Tratamiento , AguaRESUMEN
BACKGROUND: Radical prostatectomy is the most common treatment for localised prostate cancer in New Zealand. Active surveillance was introduced to prevent overtreatment and reduce costs while preserving the option of radical prostatectomy. This study aims to evaluate the cost-effectiveness of active surveillance compared to watchful waiting and radical prostatectomy. METHODS: Markov models were constructed to estimate the life-time cost-effectiveness of active surveillance compared to watchful waiting and radical prostatectomy for low risk localised prostate cancer patients aged 45-70 years, using national datasets in New Zealand and published studies including the SPCG-4 study. This study was from the perspective of the Ministry of Health in New Zealand. RESULTS: Radical prostatectomy is less costly than active surveillance in men aged 45-55 years with low risk localised prostate cancer, but more costly for men aged 60-70 years. Scenario analyses demonstrated significant uncertainty as to the most cost-effective option in all age groups because of the unavailability of good quality of life data for men under active surveillance. Uncertainties around the likelihood of having radical prostatectomy when managed with active surveillance also affect the cost-effectiveness of active surveillance against radical prostatectomy. CONCLUSIONS: Active surveillance is less likely to be cost-effective compared to radical prostatectomy for younger men diagnosed with low risk localised prostate cancer. The cost-effectiveness of active surveillance compared to radical prostatectomy is critically dependent on the 'trigger' for radical prostatectomy and the quality of life in men on active surveillance. Research on the latter would be beneficial.
Asunto(s)
Neoplasias de la Próstata/epidemiología , Anciano , Terapia Combinada/economía , Terapia Combinada/métodos , Análisis Costo-Beneficio , Progresión de la Enfermedad , Costos de la Atención en Salud , Humanos , Masculino , Cadenas de Markov , Persona de Mediana Edad , Estadificación de Neoplasias , Nueva Zelanda/epidemiología , Probabilidad , Prostatectomía , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/cirugía , Calidad de Vida , Espera VigilanteRESUMEN
Aquablation is a novel technique for the surgical management of bladder outlet obstruction secondary to benign prostatic hyperplasia. Following first-in-man studies, a multicenter trial was conducted with results now out to 1 year. Aquablation resulted in a mean International Prostate Symptom Score improvement of 16 points (p < 0.01) and a mean maximum urinary flow rate increase from 8.7 to 18.3 ml/s (p < 0.01) at 12 months. Due to the precise prostate mapping, aquablation has also demonstrated favorable sexual and urinary outcomes with no new erectile dysfunction, retrograde ejaculation, or urinary incontinence as often experienced with other techniques. These improvements in functional outcomes at 12 months confirm that aquablation is a safe and effective alternative for BPH treatment.
Asunto(s)
Técnicas de Ablación/métodos , Cistoscopía/métodos , Próstata/cirugía , Hiperplasia Prostática/cirugía , Obstrucción del Cuello de la Vejiga Urinaria/cirugía , Humanos , Masculino , Presión , Hiperplasia Prostática/complicaciones , Procedimientos Quirúrgicos Robotizados , Obstrucción del Cuello de la Vejiga Urinaria/etiología , AguaRESUMEN
Since its first report in the 1870s, control of bleeding after transurethral resection of the prostate (TURP) has remained a concern. Foley's initial report of a urinary catheter involved placement of the balloon into the prostatic fossa following TURP. Removal of prostate tissue with a high-velocity saline stream (Aquablation) is a recently reported alternative to TURP. As Aquablation is heat-free, alternatives to non-thermal hemostasis were sought to optimize the procedure. We report use of a balloon catheter in the prostatic fossa after Aquablation as a post-resection hemostatic method.