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1.
Expert Opin Emerg Drugs ; : 1-13, 2024 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-38841744

RESUMO

INTRODUCTION: Benign prostatic hyperplasia (BPH) is a condition that affects over 50% of men as they enter their fifth decade of life, often leading to lower urinary tract symptoms (LUTS). Primary treatment options include alpha blockers, 5-alpha reductase inhibitors, and phosphodiesterase-5 inhibitors. However, these medications can have some side effects, and there is a noticeable dearth of information addressing the long-term use of these medications. Thus, the exploration of all treatment modalities helps ensure patients receive personalized and effective care. Consequently, the primary objective of this review is to identify potential emerging medications for the treatment of BPH. AREAS COVERED: We conducted an extensive review of articles discussing pharmacotherapy for BPH spanning the last 15 years. Our information gathering process involved Scopus, PubMed-MEDLINE, Cochrane, Wiley Online Library Google Scholar, ClinicalTrials.gov, and the PharmaProjects database. This approach ensures that readers gain an in-depth knowledge of the existing therapeutic agents as well as promising avenues for managing BPH. EXPERT OPINION: BPH treatment targets a patient's specific constellation of symptoms. Therefore, a broad knowledge base encompassing various treatment options is paramount in ensuring optimal treatment. Looking forward, the emphasis on personalization promises to reshape the landscape of BPH treatment and improve patient outcomes.

2.
BJUI Compass ; 5(3): 366-373, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38481667

RESUMO

Objective: The aim of this study is to report the updated 2-year results of the intervention arm of the ROBUST III randomized trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) versus standard endoscopic management of recurrent male anterior urethral stricture. Materials and Methods: Eligible patients included men with recurrent anterior urethral stricture ≤3 cm in length and ≤12Fr in diameter, International Prostate Symptom Score (IPSS) ≥11 and peak flow rate (Qmax) <15 mL/s. Patients were randomized to treatment with the Optilume DCB or standard-of-care endoscopic management. Primary efficacy endpoints measured at 2 years included freedom from re-intervention and changes in IPSS, Qmax and post-void residual (PVR). Secondary endpoint was impact on sexual function using the International Index of Erectile Function (IIEF). Primary safety endpoint was freedom from serious procedure- or device-related adverse events (AEs). Results: A total of 127 patients enrolled at 22 sites in the United States and Canada (48 randomized to standard-of-care dilation and 79 to DCB dilation). Seventy-five patients in the DCB arm entered the open-label phase after 6 months. Participants averaged 3.2 prior endoscopic interventions (range 2-10); most (89.9%) had bulbar strictures with an average stricture length of 1.63 cm (SD 0.76). Significant improvements in IPSS, average Qmax and PVR were maintained at 2 years. Freedom from repeat intervention was significantly higher in the Optilume DCB arm at 2 years versus the Control arm at 1 year (77.8% vs. 23.6%, p < 0.001). During the follow-up period, there were 15 treatment failures and two non-study-related deaths. Treatment-related AEs were rare and generally self-limited (haematuria, dysuria and urinary tract infection). Conclusion: The Optilume DCB shows sustained improvement in both objective and subjective voiding parameters at 2-year follow-up. Optilume appears to provide a safe and effective endoscopic treatment alternative for short recurrent anterior urethral strictures among men who wish to avoid or delay formal urethroplasty.

3.
Can J Urol ; 30(5): 11650-11658, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37838991

RESUMO

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.


Assuntos
Técnicas de Ablação , Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Humanos , Masculino , Técnicas de Ablação/efeitos adversos , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/cirurgia , Estudos Prospectivos , Próstata/cirurgia , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Hiperplasia Prostática/diagnóstico , Ressecção Transuretral da Próstata/efeitos adversos , Resultado do Tratamento , Água , Método Duplo-Cego
4.
Urology ; 181: 112-118, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37574143

RESUMO

OBJECTIVE: To analyze the impact of perioperative antithrombotic use on the bleeding outcomes following Aquablation. METHODS: One hundred sixteen men with who underwent Aquablation as part of the WATER prospective trial (NCT02505919) were assigned to 2 groups based on perioperative antithrombotic status. Antithrombotic cessation and restart timing were based on the surgeon's discretion. Methods of achieving intraoperative hemostasis consisted of no-cautery balloon tamponade or cautery. Primary endpoints included immediate postoperative hematuria rates and changes in hemoglobin. Secondary endpoints included 90-day bleeding complications and nonbleeding postoperative adverse events. RESULTS: Forty-one men took antithrombotic medications in the perioperative period while 75 men had no antithrombotic medication. Preoperative hemoglobin levels were comparable between both groups. Postoperative hemoglobin change from baseline (drop of 1.8 ± 1.5 g/dL among the antithrombotic group vs 1.8 ± 1.7 g/dL among the antithrombotic-naïve group) did not differ between both groups (P = .896). In total, 4 (9.8%) men in the antithrombotic group and 4 (5.3%) patients in the antithrombotic-naïve group experienced a Clavien-Dindo grade 1 complication (P = .451) in the 3-month postoperative period. Eight (19.5%) patients in the antithrombotic group and 11 (14.7%) patients in the antithrombotic-naïve group experienced a Clavien-Dindo grade 2 complication (P = .601), none of which is associated with bleeding in both groups. No men in either group demonstrated de novo erectile dysfunction. One patient (2.4%) in the antithrombotic group and none in the antithrombotic-naïve group required blood products (P = .353). CONCLUSION: Aquablation demonstrates comparable postoperative bleeding outcomes and other adverse effects for men with benign prostatic hypertrophy who are on antithrombotic therapy.


Assuntos
Fibrinolíticos , Hiperplasia Prostática , Masculino , Humanos , Feminino , Fibrinolíticos/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento , Hiperplasia Prostática/cirurgia , Hemorragia Pós-Operatória/epidemiologia , Hemorragia Pós-Operatória/etiologia , Hemorragia Pós-Operatória/prevenção & controle , Hemoglobinas
6.
J Urol ; 210(3): 500-509, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37555604

RESUMO

PURPOSE: The Optilume BPH Catheter System is a novel drug/device combination minimally invasive surgical therapy for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. The PINNACLE study is a prospective, randomized, double-blind, sham-controlled clinical trial evaluating the safety and efficacy of Optilume BPH against a sham surgical procedure. MATERIALS AND METHODS: Eligible patients were men 50 years or older with symptomatic benign prostatic hyperplasia and a prostate size between 20 and 80 g. Subjects were randomized 2:1 to receive treatment with Optilume BPH or a sham surgical procedure. Blinding was maintained for subjects in both arms and evaluating personnel through 1 year postprocedure. Follow-up assessments included the International Prostate Symptom Score, uroflowmetry, and other quality-of-life and sexual function assessments. RESULTS: A total of 148 men were randomized (100 active, 48 sham) at 18 centers in the U.S. and Canada. Subjects randomized to receive Optilume BPH saw a reduction in International Prostate Symptom Score of 11.5±7.8 points at 1 year posttreatment, as compared to a reduction of 8.0±8.3 points at 3 months in the sham arm. Flow rate was dramatically improved after treatment with Optilume BPH, with an improvement of +10.3 mL/s from baseline to 1 year (+125%). CONCLUSIONS: Treatment with Optilume BPH provides immediate and sustained improvements in obstructive symptoms and flow rate while preserving erectile and ejaculatory function. Treatment is well tolerated and can be done in an office or ambulatory setting.


Assuntos
Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Masculino , Humanos , Feminino , Hiperplasia Prostática/terapia , Hiperplasia Prostática/cirurgia , Estudos Prospectivos , Ereção Peniana , Ejaculação , Método Duplo-Cego , Resultado do Tratamento
7.
Neurourol Urodyn ; 42(7): 1563-1568, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37395472

RESUMO

INTRODUCTION: Practice patterns around the use of urodynamic evaluation (UDS) for benign prostatic hyperplasia (BPH) surgery are largely undefined. As such, we investigated factors associated with the use of UDS for BPH. METHODS: We used American Board of Urology case log data from 2008 to 2020, to compare patient- and surgeon-sided factors associated with UDS utilization and BPH surgeries. We performed logistic regression models to identify factors independently associated with UDS usage for BPH. RESULTS: Among urologists performing UDS, the majority (80%) self-identified as general urologists and practiced in a private practice group (69%). Compared with urologists who performed no UDS, urologists who performed any UDS for BPH were more likely to be from the Mid-Atlantic (20.3% vs. 10.6%, p < 0.01) and practice in regions with populations of >1 000 000 (34.7% vs. 28.5%, p < 0.01). Overall, UDS utilization declined over time (odds ratio [OR]: 0.95 year-to-year, 95% confidence interval [CI]: 0.91-0.99). In adjusted analyses, the odds of performing UDS was higher among male (OR: 2.19, 95% CI: 1.17-4.09), older (OR: 1.05, 95% CI: 1.03-1.06), and female pelvic medicine and reconstructive surgery subspecialty (OR: 3.23, 95% CI: 2.01-5.2) urologists. Additionally, performing UDS for BPH was associated with higher BPH surgical case volume (OR: 1.004, 95% CI: 1.001-1.008). CONCLUSION: There is a significant practice variation in use of UDS for BPH. Although overall BPH surgeries are increasing, urologists are increasingly less likely to perform UDS for BPH. Specifically, urologists who perform UDS have significantly higher BPH case volume than those who do not perform UDS, suggesting that UDS usage may not factor into BPH surgery decision-making.


Assuntos
Hiperplasia Prostática , Urologia , Humanos , Masculino , Feminino , Hiperplasia Prostática/cirurgia , Urodinâmica , Padrões de Prática Médica , Urologistas
8.
Can J Urol ; 30(3): 11568-11573, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37344470

RESUMO

Benign prostatic hyperplasia (BPH) is a common and progressive disease affecting aging men which has a significant impact on quality of life. The Optilume BPH Catheter System (Optilume BPH) is a prostatic dilation system that combines balloon dilation with a localized transfer of paclitaxel to maintain long term patency. Optilume BPH can be deployed using standard rigid cystoscopy without general anesthesia in an office setting. Prospective data indicate that Optilume BPH has favorable functional and sexual patient outcomes. Readers will familiarize themselves with Optilume BPH, significant historical studies and the technique for deploying Optilume BPH.


Assuntos
Catéteres , Hiperplasia Prostática , Humanos , Masculino , Estudos Prospectivos , Próstata , Hiperplasia Prostática/terapia , Qualidade de Vida
9.
Urology ; 175: 157-162, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36863599

RESUMO

OBJECTIVE: To use American Board of Urology (ABU) case log data to elucidate practice patterns for benign prostatic hyperplasia (BPH) surgery. Several surgical modalities have been introduced in recent decades causing significant practice variation. MATERIALS AND METHODS: We retrospectively analyzed ABU case logs from 2008-2021 to assess trends in BPH surgery. We created logistic regression models to identify surgeon-sided factors associated with utilization of each surgical modality. RESULTS: We identified 6,632 urologists who logged 73,884 surgeries for BPH. Transurethral resection of the prostate (TURP) was the most commonly performed BPH surgery in all but 1 year, and odds of performing a TURP increased year-over-year (OR 1.055, 95% CI [1.013,1.098], P = .010). The use of holmium laser enucleation of the prostate (HoLEP) did not change over time. HoLEP was more likely to be performed by urologists with higher BPH surgical volume (OR 1.017, CI [1.013, 1.021], P < .001) and with endourology subspecialization (OR 2.410, CI [1.45, 4.01], P = .001). Prostatic urethral lift (PUL) utilization increased significantly since its introduction in 2015 (OR 1.663, CI [1.540, 1.796], P < .001). PUL currently comprises over one third of all BPH surgeries logged. CONCLUSION: In the face of newer technologies, TURP remains the most common surgery for BPH in the United States. PUL has been rapidly adopted while HoLEP comprises a consistent minority of cases. Surgeon age, patient age, and urologist subspecialization were associated with use of certain BPH surgical approaches.


Assuntos
Terapia a Laser , Lasers de Estado Sólido , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Masculino , Humanos , Hiperplasia Prostática/cirurgia , Hiperplasia Prostática/complicações , Estudos Retrospectivos , Próstata , Endoscopia , Lasers de Estado Sólido/uso terapêutico , Resultado do Tratamento
10.
Can J Urol ; 30(1): 11408-11413, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36779946

RESUMO

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.


Assuntos
Hiperplasia Prostática , Procedimentos Cirúrgicos Robóticos , Ressecção Transuretral da Próstata , Masculino , Humanos , Hiperplasia Prostática/cirurgia , Ressecção Transuretral da Próstata/efeitos adversos , Água , Próstata/cirurgia , Resultado do Tratamento , Qualidade de Vida
11.
World J Urol ; 41(1): 179-188, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36463348

RESUMO

BACKGROUND: There are growing interests for minimally invasive surgical techniques (MISTs) for the treatment of benign prostatic hyperplasia (BPH)-associated lower urinary tract symptoms (LUTS). Prostatic artery embolization (PAE) uses selective angioembolization of prostatic arteries, thereby reducing size to improve LUTS/BPH. However, real-world data comparing surgical outcomes between MISTs and tissue resective techniques are lacking. We assessed the differences in surgical outcomes between PAE, transurethral resection of the prostate (TURP), and prostatic urethral lift (PUL) in a real-world population for LUTS/BPH. METHODS: We present an observational population-based study of 12,902 men with BPH in New York State who received PAE, TURP, and PUL in outpatient and ambulatory surgery settings from 2014 to 2018. For short-term outcomes, we report 30-day and 90-day risks of readmission to inpatient and emergency room (ER) with/without complications and compared them across groups using χ2 tests and mixed-effect logistic regressions. For long-term outcomes, we report surgical retreatment and stricture rates using Kaplan-Meier failure curves and compared them using Log rank tests and Cox regression models. RESULTS: Of 12 902 men, 335 had PAE, 11,205 had TURP, and 1362 had PUL. PAE patients had the highest 30-day (19.9%) and 90-day (35.6%) risks of readmission to inpatient or ER (p < 0.01). Non-specific abdominal pain was the main diagnosis associated with 30-day and 90-day readmissions to inpatient or ER after PAE (14.3% and 26.8%, respectively). After 2 years of follow-up, PAE patients had the highest retreatment rate of 28.5% (95%CI 23.7-34.2%) compared to TURP (3.4% (95%CI 3.1-3.8%)) and PUL (8.5% (95%CI 5.6-12.9%)) (p < 0.001). CONCLUSION: In a real-world population, PAE was associated with the most frequent 30-day and 90-day readmission to inpatient or ER and the highest retreatment rate among all surgical techniques even when controlled for individual patient comorbidities and surgical volume.


Assuntos
Embolização Terapêutica , Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Masculino , Humanos , Próstata/cirurgia , Próstata/irrigação sanguínea , Ressecção Transuretral da Próstata/métodos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Embolização Terapêutica/efeitos adversos , Resultado do Tratamento , Sintomas do Trato Urinário Inferior/epidemiologia , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/cirurgia , Artérias
12.
World J Urol ; 40(12): 2991-2999, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36219230

RESUMO

PURPOSE: To create a prospective, multicenter coordinated registry network (CRN) of robust "real world" data for benign prostatic hyperplasia (BPH) that links surgical practices to objective and subjective outcomes of patients who undergo surgery for the improvement in lower urinary tract symptoms (LUTS) secondary to BPH. METHODS: We gathered a group of BPH experts from various institutions to identify the minimum core data elements needed to assess BPH procedures. To achieve consensus on the data elements, we used a Delphi method adaptation, in which a series of surveys were answered by the expert panel individually and anonymously. Survey results were collected and analyzed. Questions for the following round were based on response analysis from the prior survey. This process was repeated until consensus was achieved. RESULTS: Participation rates in the first and second rounds were 100% and 90%, respectively. The expert panel reached consensus on 148 data elements out of the 182 proposed, capturing patient medical and surgical history, procedure, discharge, short- and long-term follow-up, device factors, surgery, and surgeon factors. CONCLUSION: We have successfully developed a set of core data elements to support the study of BPH surgical therapies by gathering an expert panel on BPH and using the Delphi method. These data elements influence provider decisions about treatment and include important outcomes related to efficacy and safety.


Assuntos
Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Masculino , Humanos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Hiperplasia Prostática/diagnóstico , Estudos Prospectivos , Sintomas do Trato Urinário Inferior/cirurgia , Sintomas do Trato Urinário Inferior/complicações , Sistema de Registros , América do Norte
13.
Urology ; 169: 167-172, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-35863498

RESUMO

OBJECTIVE: To determine whether existing data support the use of multiple passes in Aquablation for LUTS due to BPH. METHODS: Data were obtained from 2sources. The WATER trial (NCT02505919) is a prospective, multicenter, double-blind, randomized controlled trial of Aquablation vs TURP in prostate volumes of 30 - 80 ml. The WATER II trial (NCT03123250) is a prospective single-arm multicenter trial of Aquablation in prostate volumes of 80-150ml. The number of passes was determined by the procedural data collected and the video recordings of all study cases. RESULTS: In total, 127 Aquablation subjects underwent a single pass, 90 underwent multiple passes (80 had 2passes and 10 underwent 3passes), and 65 underwent TURP (in WATER only). Men undergoing 2or more passes with Aquablation had larger prostates but few differences in other baseline parameters, including prostate size range. Compared to a single pass, the use of 2or more passes during Aquablation resulted in lower IPSS scores (by ∼4 points, P = .0002) and lower IPSS QoL scores (by ∼0.7 points, P = .0096) at the later timepoints of 24 and 36 months. Similarly, 36-month Qmax values were higher (by ∼5 ml/sec, P = .0220) in those with 2or more passes than in those with 1pass. There was no statistically significant difference in ejaculatory dysfunction between groups. CONCLUSION: Independent of prostate volume, a multiple treatment pass protocol led to improved voiding outcomes and IPSS improvement.


Assuntos
Técnicas de Ablação , Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Masculino , Humanos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/cirurgia , Estudos Prospectivos , Qualidade de Vida , Técnicas de Ablação/efeitos adversos , Técnicas de Ablação/métodos , Ressecção Transuretral da Próstata/efeitos adversos , Ressecção Transuretral da Próstata/métodos , Água , Resultado do Tratamento
14.
Can J Urol ; 29(1): 10960-10968, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-35150215

RESUMO

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.


Assuntos
Técnicas de Ablação , Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Técnicas de Ablação/efeitos adversos , Técnicas de Ablação/métodos , Humanos , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/cirurgia , Masculino , Estudos Prospectivos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Ressecção Transuretral da Próstata/efeitos adversos , Ressecção Transuretral da Próstata/métodos , Resultado do Tratamento
15.
Urology ; 165: 256-260, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35139413

RESUMO

OBJECTIVE: To assess the outcomes of a "less is more" treatment approach consisting of a single water vapor treatment per prostate lobe for benign prostatic hyperplasia (BPH). METHODS: Retrospective cohort study in a single urologic clinic of men with moderate to severe symptomatic BPH with and without median lobes undergoing thermal water vapor therapy. Single injection of thermal water vapor was given in each prostate lobe. The primary endpoint compared maximum urine flow rate (Qmax), post-void residual (PVR), International Prostatism Symptom Score (IPSS), and the IPSS Quality of Life scale (IPSS QoL) at baseline and at 1, 3, 6, and 12 months. RESULTS: The study included 52 men with mean prostate volume and IPSS of 52.8cc and 20.3cc, respectively. IPSS was reduced by -3.95 ± 7.5 at 3 months (P = .02875), -8.5 ± 9.3 at 6 months (P = .01767), and -11.63 ± 8.4 at 12 months (P = .005908). IPSS QoL improved by -1.75 ± 1.2 t 12 months (P = .003799) and QMax by 5.36 ± 3.7 mL/s at 12 months (P = .008445). Time to post-operative catheter removal was 3.5 ± 1.3 days. One patient reported ejaculatory dysfunction. All other adverse events were mild to moderate in severity and resolved quickly. CONCLUSION: Thermal water vapor therapy with single injection per lobe is both an effective and safe treatment for BPH that provides comparable improvements in lower urinary tract symptoms and quality of life to the traditional approach that employed variable number of injections by prostate volume.


Assuntos
Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Prostatismo , Humanos , Sintomas do Trato Urinário Inferior/terapia , Masculino , Projetos Piloto , Hiperplasia Prostática/complicações , Hiperplasia Prostática/diagnóstico , Hiperplasia Prostática/terapia , Qualidade de Vida , Estudos Retrospectivos , Vapor , Resultado do Tratamento
17.
J Urol ; 207(4): 866-875, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-34854748

RESUMO

PURPOSE: The Optilume® drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single-blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures. MATERIALS AND METHODS: Eligible patients were adult males with anterior strictures ≤12Fr in diameter and ≤3 cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11 and maximum flow rate <15 ml per second. A total of 127 subjects were enrolled at 22 sites. The primary study end point was anatomical success (≥14Fr by cystoscopy or calibration) at 6 months. Key secondary end points included freedom from repeat treatment, International Prostatic Symptom Score and peak flow rate. The primary safety end point included freedom from serious device- or procedure-related complications. RESULTS: Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7 cm. Anatomical success for Optilume DCB was significantly higher than control at 6 months (75% vs 27%, p <0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequent adverse events included urinary tract infection, post-procedural hematuria and dysuria. CONCLUSIONS: The results of this randomized controlled trial support that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. The Optilume DCB may serve as an important alternative for men who have had an unsuccessful direct vision internal urethrotomy/dilation but want to avoid or delay urethroplasty.


Assuntos
Dilatação/métodos , Paclitaxel/administração & dosagem , Estreitamento Uretral/cirurgia , Adulto , Materiais Revestidos Biocompatíveis , Dilatação/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Método Simples-Cego , Resultado do Tratamento
19.
World J Urol ; 39(12): 4405-4412, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34232353

RESUMO

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.


Assuntos
Prostatectomia/métodos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Humanos , Terapia a Laser , Masculino , Prostatectomia/efeitos adversos , Estudos Retrospectivos , Ressecção Transuretral da Próstata/efeitos adversos , Resultado do Tratamento
20.
Curr Urol Rep ; 22(8): 40, 2021 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-34115242

RESUMO

PURPOSE OF REVIEW: The goal of this paper is to review retreatment management after failed minimally invasive treatment (MIST) of various technologies. RECENT FINDINGS: A failed MIST can be defined by the return, persistence, or worsening of LUTS, as documented by symptom scores. Persistence, development, or recurrence of comorbidities such as recurrent urinary tract infection (UTI), retention, stones, hematuria, and incontinence can also signal a failed MIST. The common etiology for MIST failure is the preoperative consequence of long-term bladder outlet obstruction (BOO) on the bladder function. Close monitoring of therapies with antimuscarinics or beta-agonists can be empirically utilized if post-void bladder residual (PVR) is low. If there is a high PVR, urodynamic studies and cystoscopy can be used to determine overactive bladder (OAB), BOO, or necrosis. Depending on the timing of the observed BOO/OAB, subsequent retreatments involving transurethral debridement, medical and behavioral therapies, or repeat surgical debulking can be employed.


Assuntos
Procedimentos Cirúrgicos Minimamente Invasivos , Retratamento , Infecções Urinárias/cirurgia , Procedimentos Cirúrgicos de Citorredução , Humanos , Recidiva , Falha de Tratamento
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