Long-term outcomes after treatment with Optilume BPH: Four-year results from the EVEREST study.

INTRODUCTION: The purpose of this study was to gather initial safety and efficacy data with the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). METHODS: A total of 80 men with moderate-to-severe LUTS secondary to BPH were enrolled and treated with the Optilume BPH Catheter System. Symptoms were evaluated using the International Prostate Symptom Score (IPSS) and Benign Prostatic Hyperplasia Impact Index (BPHII). Improvement in urinary flow and relief of obstruction was evaluated by way of peak urinary flow rate (Qmax) and postvoid residual urine volume (PVR). Subjects were prospectively queried for adverse events at each study visit, and relatedness to the study device were evaluated by the investigators, as well as centrally adjudicated by the study principal investigator. RESULTS: Previous reports of symptom improvement in this cohort were maintained through four-year followup, with a significant reduction in IPSS and IPSS quality of life maintained through four years (-12.1, -2.8, respectively). Clinically meaningful improvement in Qmax was maintained in the majority of subjects, with an average improvement from baseline of +5.6 mL/sec. No treatment-related adverse events were reported in the long-term followup period. CONCLUSIONS: Long-term followup through four years for subjects treated with the Optilume BPH Catheter System indicates durable outcomes in symptom improvement and functional improvement in flow rate. These results indicate the unique mechanism of action for Optilume BPH successfully achieves an immediate mechanical effect that is maintained long-term through incorporation of paclitaxel to maintain patency.

Aquablation at 4-years: Real World Data From the Largest Single-center Study With Associated Outcomes Follow-up.

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. Primary outcomes included change in IPSS score, change in Qmax, change in PVR, preservation of antegrade ejaculation, and complications. RESULTS: In this cohort of 330 men, mean prostatic volume was 110.3 mL (range 38-330 mL) at baseline. International Prostate Symptom Score (IPSS) improved from a baseline of 23.8 (SD 8.4) to 6.9 (SD 2.9) at 4 years. Mean peak urinary flow rate (Qmax) also demonstrated improvement and increased from 6.4 mL/sec (SD 4.2) to 17.4 mL/sec (SD 5.5) at 4 years. At 1 year, mean prostate volume reduction was 45.5 mL (-41.3%). Postoperative antegrade ejaculation was preserved in 249/250 men (99.6)% of men. Complications included urinary tract infection within first month after procedure in 37 (11.2%) and bleeding requiring blood transfusion in 11 (3.3%). Thirteen patients (3.9%) required a second procedure including 2 for post-operative bleeding, 1 for a bladder neck disruption and 10 (3.0%) for transurethral resection of residual anterior tissue. CONCLUSION: We demonstrate Aquablation to not only be safe but also providing durable outcomes at 4 years for men with BPH.

Two-year long-term follow-up of treatment with the Optilume BPH catheter system in a randomized controlled trial for benign prostatic hyperplasia (The PINNACLE Study).

BACKGROUND: Patient outcomes were assessed 2 years after treatment with the Optilume BPH Catheter System, a minimally invasive surgical therapy for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). METHODS: One-hundred forty-eight adult males with symptomatic BPH were enrolled and randomized in a 2:1 fashion to Optilume BPH or Sham (100 Optilume BPH; 48 Sham). Long-term measures include International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), Post-Void Residual Urine (PVR), quality of life measures and sexual function. Follow-up beyond one year was limited to those treated with Optilume BPH. RESULTS: At 2 years, 67.5% (56/83 CI 56.3%, 77.4%) of participants in the Optilume BPH arm were symptomatic responders as defined by ≥30% improvement in IPSS without medical or surgical retreatment. IPSS significantly improved from 23.4 ± 5.5 (n = 100) to 11.0 ± 7.0 (n = 74). Qmax improved by 116.8.% (8.9 ± 2.2 (n = 97) to 19.0 ± 16.3 (n = 65)), while PVR showed a slight reduction (83.7 ± 70.3 (n = 99) to 65.9 ± 74.5 (n = 65)). Improvement in uroflowmetry measures was consistent across all prostate volumes. BPH-II improved from 7.0 ± 2.9 (n = 98) to 2.3 ± 2.5 at 1 year (n = 89) and remained consistent at 2.3 ± 2.9 at the 2-years (n = 74), representing a 53.9% improvement. IPSS QoL also improved from 4.6 ± 1.3 (n = 100) at baseline to 2.2 ± 1.5 (n = 74). The most common adverse events reported in the Optilume BPH arm were hematuria and urinary tract infection (UTI). No device and/or treatment related serious adverse events were reported occurring beyond 12 months post-procedure. There was no impact to sexual function. CONCLUSIONS: In the PINNACLE study, participants treated with the Optilume BPH Catheter System demonstrated continued and durable results at 2 years, affirming tolerability, safety, and the enduring effectiveness. The Optilume BPH Catheter System provides lasting results that are comparable to the more invasive therapies, while preserving the advantages with being a minimally invasive therapy. REGISTRATION: ClinicalTrials.gov NCT04131907.

The Role of Remote Diagnostics to Better Assess Uroflow Variability: Insights From Combining at Home Uroflows and Frequency Volume Charts From 19,868 Voids Using a Novel, Hand Held, Cellular Embedded Device.

OBJECTIVE: To examine how representative 24-hour data collection is of the overall patient experience utilizing a home uroflow device in men with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: Home uroflow data were collected with the iO Urology CarePath device from men at a single urology clinic and retrospectively analyzed. Void characteristics were summarized for data collected over 24 hours compared to data collected over several days or weeks with the device (overall study excludes the 24-hour data). A linear mixed-effects model was used to evaluate differences in average Qmax from voids collected during a single 24-hour period compared to the overall study. RESULTS: A total of 486 men (mean age 67.4) used the device resulting in 465 included in the analysis with a total of 15,521 voids in the overall study and 4347 voids in the single-day analysis. Average Qmax from the model was 11.2 mL/s (95% CI: 10.80, 11.65) and 11.2 mL/s (95% CI: 10.81, 11.64) in the 24-hour and overall study groups, respectively. Both groups had similar between (20.3% vs 20.4%) and within-subject (12.0% vs 11.9%) variance. The difference in Qmax was not significantly different (P = .970). A subgroup analysis including voids >150 mL yielded similar results. CONCLUSION: Data show variability in voiding parameters, but similar average Qmax collected in 24 hours as compared to several days/weeks. The combination of home uroflowmetry with frequency-volume chart information can provide objective data and a unique perspective on uroflow variability (UFV) for clinician review to support the development of individualized patient treatment plans.

Ejaculation sparing of classic and minimally invasive surgical treatments of LUTS/BPH.

BACKGROUND: The surgical landscape for Lower Urinary Tract Symptoms (LUTS) and Benign Prostatic Hyperplasia (BPH) has evolved with the introduction of Minimally Invasive Surgical Therapies (MISTs), recognizing the impact of sexual function on patients' well-being, and prioritizing ejaculation-sparing approaches. METHODS: This systematic review explored ejaculation sparing after classic endoscopic procedures and MISTs (iTind, Rezum, Urolift, Aquablation, and TPLA) and a literature search yielded 41 studies. RESULTS: While all procedures demonstrated efficacy in improving LUTS/BPH symptoms (IPSS, QoL, Qmax), a subset of studies evaluated ejaculatory function. Positive outcomes were noted, challenging the historical association of BPH surgeries with ejaculatory dysfunction. Variations in study design, patient cohorts, and limited long-term data present challenges. Notably, the lack of baseline specificity, use of alpha-blockers, and non-specific sexual function assessments underscore potential biases. CONCLUSIONS: Despite limitations, the review tentatively concluded that MISTs, including iTind, Rezum, Urolift, Aquablation, and TPLA, appear comparable in sparing ejaculation. Long-term studies are essential to validate sustainability, and comparative research should assess trade-offs between MISTs and traditional surgeries. Incorporating patient-reported outcomes and quality of life assessments will enhance future investigations, refining MISTs as standard therapeutic options for LUTS/BPH.

Aquablation versus TURP: 5-year outcomes of the WATER randomized clinical trial for prostate volumes 50-80 mL.

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.

Improved nursing home end-stage renal disease patient participation in physical therapy with onsite, more frequent dialysis.

INTRODUCTION: For end-stage renal disease (ESRD) patients residing in skilled nursing facilities (SNFs), the logistics and physical exhaustion of life-saving hemodialysis therapy often conflict with rehabilitation goals. Integration of dialysis care with rehabilitation programs in a scalable and cost-efficient manner has been a significant challenge. SNF-resident ESRD patients receiving onsite, more frequent hemodialysis (MFD) have reported rapid post-dialysis recovery. We examined whether such patients have improved Physical Therapy (PT) participation. METHODS: We conducted a retrospective electronic medical records review of SNF-resident PT participation rates within a multistate provider of SNF rehabilitation care from January 1, 2022 to June 1, 2022. We compared three groups: ESRD patients receiving onsite MFD (Onsite-MFD), ESRD patients receiving offsite, conventional 3×/week dialysis (Offsite-Conventional-HD), and the general non-ESRD SNF rehabilitation population (Non-ESRD). We evaluated physical therapy participation rates based on a predefined metric of missed or shortened (<15 min) therapy days. Baseline demographics and functional status were assessed. FINDINGS: Ninety-two Onsite-MFD had 2084 PT sessions scheduled, 12,916 Non-ESRD had 225,496 PT sessions scheduled, and 562 Offsite-Conventional-HD had 9082 PT sessions scheduled. In mixed model logistic regression, Onsite-MFD achieved higher PT participation rates than Offsite-Conventional-HD (odds ratio: 1.8, CI: 1.1-3.0; p < 0.03), and Onsite-MFD achieved equivalent PT participation rates to Non-ESRD (odds ratio: 1.2, CI: 0.3-1.9; p < 0.46). Baseline mean ± SD Charlson Comorbidity score was significantly higher in Onsite-MFD (4.9 ± 2.0) and Offsite-Conventional-HD (4.9 ± 1.8) versus Non-ESRD (2.6 ± 2.0; p < 0.001). Baseline mean self-care and mobility scores were significantly lower in Onsite-MFD versus Non-ESRD or Offsite-Conventional-HD. DISCUSSION: SNF-resident ESRD patients receiving MFD colocated with rehabilitation had higher PT participation rates than those conventionally dialyzed offsite and equivalent PT participation rates to the non-ESRD SNF-rehabilitation general population, despite being sicker, less independent, and less mobile. We report a scalable program integrating dialysis and rehabilitation care as a potential solution for ESRD patients recovering from acute hospitalization.

The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

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.