Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study
- 24.06.2023
- Original Article
Erschienen in:
- Verfasst von
- Merycarla Pichardo
- Edwin Rijo
- Gustavo Espino
- Ramon Rodriguez Lay
- Rafael Estrella
- Cristian Gonzalez
- Marlin Fernandez
- David Soriano
- Ingris M. Peralta
- Steven A. Kaplan
- Erschienen in
- World Journal of Urology | Ausgabe 8/2023
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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- Titel
- Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study
- Verfasst von
-
Merycarla Pichardo
Edwin Rijo
Gustavo Espino
Ramon Rodriguez Lay
Rafael Estrella
Cristian Gonzalez
Marlin Fernandez
David Soriano
Ingris M. Peralta
Steven A. Kaplan
- Publikationsdatum
- 24.06.2023
- Verlag
- Springer Berlin Heidelberg
- Erschienen in
-
World Journal of Urology / Ausgabe 8/2023
Print ISSN: 0724-4983
Elektronische ISSN: 1433-8726 - DOI
- https://doi.org/10.1007/s00345-023-04473-1
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