Interim 2 Year Results for the EVEREST-I Trial Evaluating the Optilume BPH Catheter System

Chee J1, Kaplan S2, Pirchardo M3, Riio E4, Lay R5, Espino G6, Estrella R7

Research Type

Clinical

Abstract Category

Prostate Clinical / Surgical

Abstract 495
On Demand Prostate Clinical / Surgical
Scientific Open Discussion Session 32
On-Demand
Benign Prostatic Hyperplasia (BPH) New Devices Stress Urinary Incontinence
1. MURAC Health, 2. Mount Sinai Health System, New York, 3. URUS, Santo Domingo, Dominican Republic, 4. c Centro Medico Dr. Canela, La Romana, Dominican Republic, 5. Urology Royal Center Panamá City, Panamá, 6. Centro Especializado San Fernando, Panamá City, Panamá, 7. Clínica Union Medica, Santiago de los Caballeros, Dominican Republic
Presenter
Links

Abstract

Hypothesis / aims of study
The Optilume BPH Catheter System is a novel Minimally Invasive Surgical Therapy (MIST) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The Optilume BPH System utilizes mechanical dilation of the prostatic urethra to achieve an anterior commissurotomy while delivering the drug paclitaxel to maintain urethral patency. The EVEREST-I study is a prospective, single arm, multicenter study evaluating the safety and efficacy of the Optilume BPH System.
Study design, materials and methods
Key eligibility criteria included an International Prostate Symptom Score (IPSS) of ≥13, maximum flow rate (Qmax) of 5-15 mL/sec, and prostate volume 20-80g with no prior MIST or surgical intervention. Medication washouts included 3 weeks for alpha blockers and 6 months for 5 alpha-reductase inhibitors. Two-year follow up is ongoing, with 54 of 75 expected subjects with 2-year follow-up complete. The primary efficacy endpoint was responder rate, defined as the percent of subjects experiencing a ≥40% improvement in IPSS without receiving additional therapy. Other outcomes included IPSS, Qmax, and BPH Impact Index. Impact on sexual function was assessed by the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD).
Results
A total of 80 men were enrolled and treated with the Optilume BPH Catheter System at 6 centers in Panama and the Dominican Republic. Subjects were an average of 65.8 years with prostate volume of 35.9g. The responder rate was 81.8% at 2 years which was consistent with 1-year results (81.3%, 61/75). Responder rate was consistent across all device sizes used. One subject received a prostatectomy 18 months post-treatment. IPSS improved from an average of 22.3 at baseline to 7.9 at 1 year and 8.3 at 2 years. Similarly, Qmax improved from 10.9 mL/sec at baseline to 18.3 mL/sec at 1 year and 17.7 mL/sec at 2 years. The IIEF Overall Satisfaction score was 7.2 at baseline and 7.9 at 2 years. Corresponding values for MSHQ-EjD were 9.4 and 9.1. There were no reported unanticipated adverse device effects.
Interpretation of results
Subjects in the study experienced significant and clinically meaningful improvements in symptom severity and voiding function that were sustained through 2 years. Quality of life improved concurrently. The treatment had no negative impact on sexual function as measured by IIEF and MSHQ-EjD. There was no control arm in this study, however a randomized controlled trial is ongoing to evaluate the safety and efficacy of the device. Long-term follow-up is planned through 5 years to further define the durability of the treatment.
Concluding message
The Optilume BPH System exhibited a significant improvement in both objective and subjective outcomes through 2-years post treatment. This minimally invasive approach shows promise as a treatment for LUTS secondary to BPH.
Figure 1 Table 1
Disclosures
Funding Urotronic Inc Clinical Trial Yes Registration Number NCT03423979 RCT No Subjects Human Ethics Committee National Council of Bioethics in Health (CONABIOS) Helsinki Yes Informed Consent Yes
13/11/2024 22:37:03