Evidence map›Paper›PMID 41318833›Full record

ArticleInternational urology and nephrology2026

Single-center prospective experience with Optilume

Antonio Cretì, Mauro Ragonese, Pierluigi Russo, Nazario Foschi, Giovanni Battista Filomena, Antonio Silvestri, Fabrizio Fantasia, Vincenzo Cavarra, Eros Scarciglia, Francesco Pio Bizzarri and 3 more

Abstract read
In one paragraph

Article in International urology and nephrology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Paclitaxel Drug-Coated Balloon (OptilumeMedicina (Kaunas, Lithuania) · 2026
    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

13 authors.

Antonio CretìDepartment of Urology, Fondazione Policlinico Agostino Gemelli IRCSS, Largo Agostino Gemelli 1, 00167, Rome, Italy. antoniocreti@icloud.com.
Mauro RagoneseDepartment of Urology, Fondazione Policlinico Agostino Gemelli IRCSS, Largo Agostino Gemelli 1, 00167, Rome, Italy.
Pierluigi RussoDepartment of Urology, Fondazione Policlinico Agostino Gemelli IRCSS, Largo Agostino Gemelli 1, 00167, Rome, Italy.
Nazario FoschiDepartment of Urology, Fondazione Policlinico Agostino Gemelli IRCSS, Largo Agostino Gemelli 1, 00167, Rome, Italy.
Giovanni Battista FilomenaDepartment of Urology, Fondazione Policlinico Agostino Gemelli IRCSS, Largo Agostino Gemelli 1, 00167, Rome, Italy.
Antonio SilvestriDepartment of Urology, Fondazione Policlinico Agostino Gemelli IRCSS, Largo Agostino Gemelli 1, 00167, Rome, Italy.
Fabrizio FantasiaDepartment of Urology, C.Ur.E.-Centro Urologico Europeo, Mater Olbia Hospital, Olbia, OT, Italy.
Vincenzo CavarraDepartment of Urology, Fondazione Policlinico Agostino Gemelli IRCSS, Largo Agostino Gemelli 1, 00167, Rome, Italy.
Eros ScarcigliaDepartment of Urology, Fondazione Policlinico Agostino Gemelli IRCSS, Largo Agostino Gemelli 1, 00167, Rome, Italy.
Francesco Pio BizzarriDepartment of Urology, Fondazione Policlinico Agostino Gemelli IRCSS, Largo Agostino Gemelli 1, 00167, Rome, Italy.
Mariachiara SighinolfiDepartment of Urology, Fondazione Policlinico Agostino Gemelli IRCSS, Largo Agostino Gemelli 1, 00167, Rome, Italy.
Bernardo Maria Cesare RoccoDepartment of Urology, Fondazione Policlinico Agostino Gemelli IRCSS, Largo Agostino Gemelli 1, 00167, Rome, Italy.
Francesco PintoDepartment of Urology, Fondazione Policlinico Agostino Gemelli IRCSS, Largo Agostino Gemelli 1, 00167, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUrethral stricture disease remains a challenging condition in urology, particularly in cases with recurrent anterior urethral narrowing following prior endoscopic treatments. Traditional options such as dilation and direct vision internal urethrotomy (DVIU) are limited by high failure rates. The Optilume

objectiveTo evaluate the short-term functional outcomes and safety of Optilume DESIGN, SETTING, AND

participantsThis was a prospective single-center study including 35 male patients with anterior urethral strictures ≤ 3 cm and at least one prior endoscopic treatment. Outcomes were assessed at 1, 3, and 6 months post-procedure. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcomes included changes in Qmax (uroflowmetry), post-void residual (PVR), IPSS, and erectile function (IIEF-5). Recurrence was defined as symptomatic deterioration, Qmax < 10 mL/s, or need for retreatment. Paired t-tests were used for pre- and post-treatment comparisons, with p < 0.05 considered statistically significant. As this was an exploratory pilot study, no formal sample size calculation was performed; analyses were descriptive and hypothesis-generating. RESULTS AND LIMITATIONS: Mean Qmax improved from 10.2 ± 4.9 to 21.6 ± 3.1 mL/s (p < 0.001), and PVR decreased from 74.6 ± 36.3 to 24.8 ± 16.0 mL (p < 0.001). IPSS improved from 21.8 ± 4.8 to 8.7 ± 2.0 (p < 0.0001), and IIEF-5 scores increased from 13.7 ± 7.7 to 18.5 ± 7.6 (p = 0.012). The recurrence rate at 6 months was 8.6% (3/35). Minor adverse events included transient hematuria and dysuria. No Clavien-Dindo grade ≥ 2 complications were recorded. Study limitations include its single-arm, non-randomized design and relatively short follow-up, limiting direct comparison with DVIU, urethroplasty, or emerging minimally invasive surgical therapies (MISTs).

conclusionsOptilume

Indexed as

DilatationPaclitaxelUrethral StrictureAdultAgedHumansMaleMiddle AgedProspective StudiesRecurrenceTreatment OutcomePaclitaxelDrug coated balloonPaclitaxelRecurrent urethral stenosis

Identifiers

PMID41318833
PMCPMC13194215

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.