Evidence map›Paper›PMID 37354260›Full record

ArticleWorld journal of urology2023

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

Merycarla Pichardo, Edwin Rijo, Gustavo Espino, Ramon Rodriguez Lay, Rafael Estrella, Cristian Gonzalez, Marlin Fernandez, David Soriano, Ingris M Peralta, Steven A Kaplan

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in World journal of urology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03423979 (Evaluation of Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter in the Treatment of Moderate-to-Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 7% of its field
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.

NCT03423979 phase2completednot on this map

Evaluation of Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter in the Treatment of Moderate-to-Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

TypeinterventionalSponsorUrotronic Inc.Ran2017 to 2024Enrolled80ConditionsBenign Prostatic Hyperplasia, Benign Prostatic HypertrophyArmsOptilume™ BPH Prostatic DCB Dilation Catheter, Paclitaxel
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Long-term outcomes after treatment with Optilume BPH Four-year results from the EVEREST study.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2024
    Article
  8. Review
  9. A critical evaluation of OptilumeTranslational andrology and urology · 2024
    Article
  10. Review
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

10 authors at 3 institutions in 2 countries.

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.
Cristian GonzalezURUS, Santo Domingo, Dominican Republic.
Marlin FernandezURUS, Santo Domingo, Dominican Republic.
David SorianoURUS, Santo Domingo, Dominican Republic.
Ingris M PeraltaURUS, Santo Domingo, Dominican Republic.
Steven A KaplanDepartment of Urology, Icahn School of Medicine at Mount Sinai, 625 Madison Avenue, 2nd Floor, New York, NY, 10065, USA. steven.kaplan@mountsinai.org.ORCID http://orcid.org/0000-0003-2558-7306
Icahn School of Medicine at Mount Sinai · USUnión Médica Clínica UniversitariaUniversidad Especializada de las Américas · PA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo 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).

methodsThis 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 (Q

resultsSubjects 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 Q

conclusionsThe 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.

Indexed as

Lower Urinary Tract SymptomsProstatic HyperplasiaHumansMaleTreatment OutcomeBenign prostatic hyperplasiaLower urinary tract symptomsMinimally invasive surgical procedureProstatic hypertrophy

Identifiers

PMID37354260
OpenAlexW4381856477

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.