ArticleCanadian Urological Association journal = Journal de l'Association des urologues du Canada2021
A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study.
Article in Canadian Urological Association journal = Journal de l'Association des urologues du Canada, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
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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.
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.
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Who cites it
16 citing papers in PubMed, 25 citations in OpenAlex.
- One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the OptilumeThe Journal of urology · 2022Trial
- A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST I Study.Research and reports in urology · 2022Trial
- Paclitaxel Drug-Coated Balloon (OptilumeMedicina (Kaunas, Lithuania) · 2026Review
- Economic evaluation of urethroplasty vs. repeated endoscopic dilation in short bulbar urethral stricture management.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2026Article
- Article
- Optilume, a minimally invasive solution for BPH and urethral stricture: what we know, what we need? an EAU endourology scoping review.BMC urology · 2025Article
- Long-term prognosis of urethral balloon dilation for urethral strictures: experience from a tertiary care center in China.Translational andrology and urology · 2025Article
- Drug-Coated Balloon (Optilume®) for the Management of Bulbar Urethral Stricture, Our Experience.Urology research & practice · 2025Article
- Long-Term Outcomes of Recurrent Bulbar Urethral Stricture Treatment With the Optilume Drug-Coated Balloon: Five-Year Results From the ROBUST I Study.The Journal of urology · 2025Article
- Recent Advancements in Prostate Catheters and Stents for Management of Benign Prostatic Hyperplasia.Current urology reports · 2024Review
- A single-institution experience with the Optilume Urethral Drug Coated Balloon for management of urethral stricture disease.Translational andrology and urology · 2024Article
- Development and initial clinical experience with a paclitaxel-coated balloon for the treatment of benign difficult esophageal strictures.iGIE : innovation, investigation and insights · 2023Article
- Male Urethral Stricture in Patients with Metabolic Syndrome.Urology research & practice · 2023Article
- Inhibition of urethral stricture by a catheter loaded with nanoparticle/ pirfenidone complexes.Frontiers in bioengineering and biotechnology · 2023Article
- Long-Term Experience with Balloon Dilation for Short Bulbar and Membranous Urethral Strictures: Establishing a Baseline in the Active Drug Treatment Era.Journal of clinical medicine · 2022Article
- Optilume® drug-coated balloon dilation in complex female urethral stricture.Urology case reports · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionMechanical balloon dilation and direct visualization internal urethrotomy (DVIU) are the most widely used treatments for urethral stricture disease in the U.S., but recurrence rates are high, especially after re-treatment. This study investigates the safety and efficacy of the Optilume™ paclitaxel-coated balloon for the treatment of recurrent strictures.
methodsMen with recurrent bulbar strictures ≤2 cm with 1-4 prior endoscopic treatments were treated with the Optilume™ drug-coated balloon. Patients were evaluated within 14 days, three, six, 12, and 24 months post-treatment. The primary safety endpoint was serious urinary adverse events. The primary efficacy endpoint was ≥50% improvement in International Prostate Symptom Score (IPSS) at 24 months. Secondary outcomes included quality of life, erectile function, flow rate, and post-void residual urine volume.
resultsA total of 53 subjects were enrolled and treated; 46 completed the 24-month followup. Forty-three percent of men had undergone >1 previous dilations, with a mean of 1.7 prior dilations. There were no serious adverse events related to treatment at two years. Success was achieved in 32/46 (70%), and baseline IPSS improved from a mean of 25.2 to 6.9 at 24 months (p<0.0001). Quality of life, flow rate, and post-void residual urine volumes improved significantly from baseline. There was no impact on erectile function.
conclusionsTwo-year data indicates the Optilume™ paclitaxel-coated balloon is safe for the treatment of recurrent bulbar urethral strictures. Early efficacy results are encouraging and support further followup of these men through five years, as well as further investigation with a randomized trial.
Identifiers
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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.