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

Pichardo, Merycarla; Rijo, Edwin; Espino, Gustavo; Lay, Ramon Rodriguez; Estrella, Rafael; Gonzalez, Cristian; Fernandez, M. D.; Soriano, David; Peralta, Isabel; Kaplan, Steven A.

doi:10.1007/s00345-023-04473-1

Cited by 3 publications

(3 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Early experience with this cohort of patients treated with the Optilume BPH Catheter System has been promising, showing excellent increases in flow rate and symptom improvement. 11,12 This experience was corroborated with outcomes from a randomized, sham controlled trial reporting significant increases in flow rate and durable symptom improvement through 1 year post treatment when compared to a sham procedure. 10 This report represents the first long-term follow-up for patients treated with Optilume BPH, with follow-up through 4 years.…”

Section: Discussionmentioning

confidence: 76%

See 1 more Smart Citation

Long-term outcomes after treatment with Optilume BPH

Kaplan,

Pichardo,

Rijo

et al. 2024

CUAJ

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

confidence: 76%

“…Initial experience with Optilume BPH has been reported for this cohort through 2 years. 11,12 This report includes results through 4 years of post-procedural follow-up.…”

mentioning

confidence: 99%