Evidence map›Paper›PMID 39213367›Full record

ArticleThe Journal of urology2025

Long-Term Outcomes of Recurrent Bulbar Urethral Stricture Treatment With the Optilume Drug-Coated Balloon: Five-Year Results From the ROBUST I Study.

Jessica DeLong, Ramón Virasoro, Merycarla Pichardo, Rafael Estrella, Ramón Rodríguez Lay, Gustavo Espino, Sean Elliott

Abstract readClinical Trial, Phase I
In one paragraph

Article in The Journal of urology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
–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

32 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Single-center prospective experience with OptilumeInternational urology and nephrology · 2026
    Article
  10. Article
  11. Paclitaxel Drug-Coated Balloon (OptilumeMedicina (Kaunas, Lithuania) · 2026
    Review
  12. Case - Novel approach to complex female urethral stricture using paclitaxel-coated balloon dilation.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2026
    Article
  13. Article
  14. Article
  15. Drug-Coated Balloon (OptilumeAdvances in urology · 2026
    Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Surgical management of vesicourethral anastomotic stenosis.Investigative and clinical urology · 2025
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Jessica DeLongMultiCare Urology, Puyallup, Washington.ORCID 0000-0002-4938-6915
Ramón VirasoroUniversity of Colorado, Colorado Springs, Colorado.
Merycarla PichardoURUS, Santiago, Dominican Republic.
Rafael EstrellaClinica Unión Medica, Santiago de los Caballeros, Dominican Republic.
Ramón Rodríguez LayRoyal Center, Panama City, Panama.
Gustavo EspinoCentro Especializado San Fernando, Panama City, Panama.
Sean ElliottDepartment of Urology, University of Minnesota, Minneapolis, Minnesota.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe report the 5-year study closeout results for the ROBUST I trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) for men with short, recurrent bulbar urethral strictures. MATERIALS AND

methodsAdult men with recurrent bulbar urethral strictures ≤ 2 cm long and lumen < 12F were included in the study and treated with the Optilume DCB. Outcome measures included symptom questionnaires, maximum urinary flow rate, postvoid residual, and freedom from repeat intervention. Functional success was defined as improvement in International Prostate Symptom Score ≥ 50% without re-treatment.

resultsFifty-three men were enrolled and treated, and 31 subjects completed all follow-up. Functional success was achieved in 58% (25/43) patients at 5 years. Average International Prostate Symptom Score improved from a mean of 25.2 at baseline to 7.2 at 5 years (

conclusionsIn this challenging cohort of men with failed prior endoscopic treatment, the Optilume DCB shows sustained improvement in subjective and objective voiding parameters at 5 years. Optilume is a safe and effective treatment option for appropriately selected men with recurrent bulbar urethral stricture who wish to avoid urethroplasty. Results are in line with the ROBUST III randomized controlled trial that will continue follow-up through 5 years.

Indexed as

RecurrenceUrethral StrictureAdultAgedCoated Materials, BiocompatibleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesTime FactorsTreatment OutcomeCoated Materials, Biocompatibleclinical triallower urinary tract symptomspaclitaxelurethral dilationurethral stricture

Identifiers

PMID39213367
PMCPMC12708045

What OpenQuestion holds

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Registered trials

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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.