Background: The Optilume benign prostatic hyperplasia (BPH) catheter system is a novel minimally invasive paclitaxel-coated dilation system that has demonstrated substantial and durable results in urinary flow and symptoms.
Aim: We now assess the impact of Optilume BPH procedure on sexual function.
Methods: Prior published results have described the methods of data collection during the PINNACLE study, which demonstrated durable improvement in urinary symptoms.
Objective: To report real-world experience of 4-year safety and efficacy outcomes of Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia (BPH).
Methods: This is a prospective single-center, observational study evaluating the outcomes of robotic-assisted Aquablation therapy for moderate-to-severe BPH between December 2019 and December 2023. Patient-level data included age, prostate volume, IPSS score, peak urinary flow rate (Qmax), post-void residual (PVR) were evaluated at 3 M, 6 M, and Years 1-4.
Expert Opin Emerg Drugs
September 2024
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.
View Article and Find Full Text PDFObjective: 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.
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.
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.
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.
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.
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.
View Article and Find Full Text PDFObjective: 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.
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.
View Article and Find Full Text PDFBackground: 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.
View Article and Find Full Text PDFPurpose: 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.
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.
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.
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.
BMJ Surg Interv Health Technol
June 2021
Objectives: To evaluate functional outcomes following Aquablation in various prostate volume and anatomical subgroups.
Design: A meta-analysis with individual patient data undergoing Aquablation therapy from four prospective, global, clinical studies that have been conducted with Aquablation; WATER, WATER II, FRANCAIS WATER and OPEN WATER.
Setting: Australia, Canada, Lebanon, Germany, New Zealand, UK and the USA.
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.
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.
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.