ArticleCanadian Urological Association journal = Journal de l'Association des urologues du Canada2020
A drug-coated balloon treatment for urethral stricture disease: Interim results from the ROBUST I study.
Article in Canadian Urological Association journal = Journal de l'Association des urologues du Canada, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
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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
21 citing papers in PubMed, 31 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
- Innovations in the management of urethral stricture disease: emerging and regenerative strategies.The Canadian journal of urology · 2026Review
- 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 · 2026Article
- Article
- Outcomes of drug-coated balloon urethral dilation in patients with stricture recurrence after urethroplasty.Translational andrology and urology · 2025Article
- Review of the role of paclitaxel urethral balloon dilation for initial treatment of newly diagnosed short bulbar strictures.Translational andrology and urology · 2025Review
- 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
- Drug-Coated Balloon Treatment for Urethral Strictures: Is This the Future? A Review of the Current Literature.Journal of clinical medicine · 2025Review
- Evaluation of Bi-layer Silk Fibroin Grafts for Onlay Urethroplasty in a Female Porcine Model of Long Urethral Strictures.Tissue engineering and regenerative medicine · 2025Article
- BEES-HAUS preventing urethral stricture recurrence by restoring the integrity of urothelium and its further simplified version, the BHES-HAUS.Frontiers in bioengineering and biotechnology · 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
- Initial safety and efficacy of a novel drug-coated balloon for treatment of benign intestinal strictures.iGIE : innovation, investigation and insights · 2024Article
- Prospects and Challenges of Electrospun Cell and Drug Delivery Vehicles to Correct Urethral Stricture.International journal of molecular sciences · 2022Review
- 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
- Ectopic Germinal Centres with B and T Cells and Follicular Dendritic Cell Networks in Urethral Stricture Tissue: Possible Avenue for Immunological Treatments.European urology open science · 2021Article
- A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2021Article
- Recent Advances in treatment of urethral stricture disease in men.F1000Research · 2020Review
Corrections and comments
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Authors and funding
9 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionWe aimed to investigate the safety and preliminary efficacy of the Optilume™ paclitaxel-coated balloon for the treatment of recurrent urethral stricture.
methodsMen with bulbar urethral strictures ≤2 cm with 1-4 prior endoscopic treatments were enrolled at four study sites after ethics committee approvals. All subjects were treated with mechanical balloon dilation or direct visualization internal urethrotomy prior to drug-coated balloon treatment. Patients were evaluated at 2-5 days, 14 days, three, six, and 12-months post-treatment. The primary safety endpoint was serious complications through 90 days post-procedure. The preliminary efficacy endpoint was anatomic success, defined as urethral lumen ≥14 Fr at 12 months.
resultsA total of 53 subjects were enrolled and treated; 46 completed the 12-month followup. Forty-three percent of men had undergone >1 previous dilation; the mean for the overall study population was 1.7 prior dilations. There were no serious adverse events related to the treatment within 90 days. Anatomic success was achieved in 32/46 (70%; 95% confidence interval [CI] 54-82%) at 12 months. The 14 failures included seven cystoscopic recurrences, five retreatments, and two patients who exited the study early due to symptom recurrence.
conclusionsOne-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.