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Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study

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World Journal of Urology Aims and scope Submit manuscript

Abstract

Purpose

To evaluate the safety and efficacy of the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Methods

This open-label, single-arm study enrolled eighty subjects with LUTS secondary to BPH who were treated with the Optilume BPH Catheter System. Symptoms were recorded utilizing the International Prostate Symptom Score (IPSS) and Benign Prostatic Hyperplasia Impact Index (BPH-II). Functional improvement was measured utilizing peak urinary flow rate (Qmax) and post-void residual urine volume (PVR). Adverse events were systematically captured and reported at each follow-up visit.

Results

Subjects treated with the Optilume BPH Catheter System experienced a significant improvement in LUTS from baseline through 2 years of follow-up, as measured by IPSS (22.3 vs 8.2, p < 0.001) and BPH-II (6.9 vs 2.3, p < 0.001). Functional improvement was also significant, with Qmax improving from an average of 10.9 mL/s at baseline to 17.2 mL/s at the 2-year follow-up and PVR improving from 63.1 to 45.0 mL. Treatment-related adverse events were typically minor, with none occurring between 1- and 2-year post-treatment.

Conclusions

The Optilume BPH Catheter System is a unique minimally invasive surgical therapy that combines mechanical and pharmaceutical aspects for the treatment of BPH. The functional and symptomatic improvements seen after treatment are significant and have been sustained through 2 years in this early feasibility study.

Registration

NCT03423979, registered February 6, 2018.

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Funding

This study was funded by Urotronic, Inc, the manufacturer of the Optilume BPH Catheter System.

Author information

Authors and Affiliations

  1. URUS, Santo Domingo, Dominican Republic

    Merycarla Pichardo, Cristian Gonzalez, Marlin Fernandez, David Soriano & Ingris M. Peralta

  2. Centro Médico Dr. Canela SRL, La Romana, Dominican Republic

    Edwin Rijo

  3. Centro Especializado San Fernando, Panama City, Panama

    Gustavo Espino

  4. Edificio Royal Center, Panama City, Panama

    Ramon Rodriguez Lay

  5. Clínica Unión Medica, Santiago de los Caballeros, Dominican Republic

    Rafael Estrella

  6. Department of Urology, Icahn School of Medicine at Mount Sinai, 625 Madison Avenue, 2nd Floor, New York, NY, 10065, USA

    Steven A. Kaplan

Authors
  1. Merycarla Pichardo
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  2. Edwin Rijo
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  3. Gustavo Espino
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  4. Ramon Rodriguez Lay
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  5. Rafael Estrella
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  6. Cristian Gonzalez
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  7. Marlin Fernandez
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  8. David Soriano
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  9. Ingris M. Peralta
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  10. Steven A. Kaplan
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Contributions

MP contributed to data collection, data analysis, and manuscript writing/editing. ER contributed to data collection, data analysis, and manuscript writing/editing. GE contributed to data collection, data analysis, and manuscript writing/editing. RRL contributed to data collection, data analysis, and manuscript writing/editing. RE contributed to data collection, data analysis, and manuscript writing/editing. CG contributed to data collection and manuscript writing/editing. MF contributed to data collection and manuscript writing/editing. IMP contributed to data collection and manuscript writing/editing. SAK contributed to protocol development, data analysis, and manuscript writing/editing.

Corresponding author

Correspondence to Steven A. Kaplan.

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Conflict of interest

SAK is the principal investigator of multiple Urotronic sponsored studies. The other authors declare no conflicts.

Ethics approval and consent to participate

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Ethics committee approval was obtained before conducting study activities. Written informed consent was obtained from all individual participants included in the study.

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Pichardo, M., Rijo, E., Espino, G. et al. Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study. World J Urol 41, 2209–2215 (2023). https://doi.org/10.1007/s00345-023-04473-1

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  • DOI: https://doi.org/10.1007/s00345-023-04473-1

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