Evidence map›Paper›PMID 38976898›Full record

ArticleCanadian Urological Association journal = Journal de l'Association des urologues du Canada2024

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

Steven A Kaplan, Merycarla Pichardo, Edwin Rijo, Gustavo Espino, Ramon Rodriguez Lay, Rafael Estrella

Abstract read
In one paragraph

Article in Canadian Urological Association journal = Journal de l'Association des urologues du Canada, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Single-center prospective experience with OptilumeInternational urology and nephrology · 2026
    Article
  3. Review
  4. Article
  5. Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Steven A KaplanDepartment of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY, United States.
Merycarla PichardoURUS, Santo Domingo, Dominican Republic.
Edwin RijoCentro Médico Dr. Canela SRL, La Romana, Dominican Republic.
Gustavo EspinoCentro Especializado San Fernando, Panama City, Panama.
Ramon Rodriguez LayEdificio Royal Center, Panama City, Panama.
Rafael EstrellaClínica Unión Medica, Santiago de los Caballeros, Dominican Republic.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe purpose of this study was to gather initial safety and efficacy data with the Optilume

methodsA 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 (BPH-II). 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 was evaluated by the investigators, as well as centrally adjudicated by the study principal investigator.

resultsPrevious 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.

conclusionsLong-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.

Identifiers

PMID38976898
PMCPMC11534392

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.