ArticleBJUI compass2024
Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial.
Article in BJUI compass, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 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
35 citing papers in PubMed.
- Multicentric Preliminary Experience and Clinical Outcomes of Female Urethral Dilation Using a Paclitaxel-Coated Balloon.International urogynecology journal · 2026Article
- Article
- Urological injuries in major pelvic trauma; the experience of a national major trauma centre. An eight patient case series.Irish journal of medical science · 2026Article
- Innovations in the management of urethral stricture disease: emerging and regenerative strategies.The Canadian journal of urology · 2026Review
- Paclitaxel Drug-Coated Balloon (OptilumeMedicina (Kaunas, Lithuania) · 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
- Paclitaxel-Coated Balloon Dilation for Adults With Recurrent Bulbar Urethral Stricture: A Health Technology Assessment.Ontario health technology assessment series · 2026Article
- Article
- Applications and challenges of paclitaxel- coated balloons beyond coronary atherosclerotic heart disease.World journal of clinical cases · 2025Review
- Prophylactic adjuvant therapy for postoperative recurrence of urethral stricture: a narrative review.Translational andrology and urology · 2025Review
- Does Optilume drug-coated balloon dilation compromise female sphincter function?International urology and nephrology · 2025Article
- Optilume drug-coated balloon dilation for treatment of post-prostate cancer ablative therapy urethral stricture: a case series.Translational andrology and urology · 2025Article
- Surgical management of vesicourethral anastomotic stenosis.Investigative and clinical urology · 2025Review
- Article
- Review of the role of paclitaxel urethral balloon dilation for initial treatment of newly diagnosed short bulbar strictures.Translational andrology and urology · 2025Review
- Outcomes of drug-coated balloon urethral dilation in patients with stricture recurrence after urethroplasty.Translational andrology and urology · 2025Article
- Outcomes of drug-coated balloon dilation in patients with radiation-related urethral stenosis.Translational andrology and urology · 2025Article
- Efficacy and Mid-Term Outcomes of Paclitaxel-Coated Balloon (OptilumeJournal of clinical medicine · 2025Article
- Optilume, a minimally invasive solution for BPH and urethral stricture: what we know, what we need? an EAU endourology scoping review.BMC urology · 2025Article
Corrections and comments
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: The aim of this study is to report the updated 2-year results of the intervention arm of the ROBUST III randomized trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) versus standard endoscopic management of recurrent male anterior urethral stricture. Materials and Methods: Eligible patients included men with recurrent anterior urethral stricture ≤3 cm in length and ≤12Fr in diameter, International Prostate Symptom Score (IPSS) ≥11 and peak flow rate (Qmax) <15 mL/s. Patients were randomized to treatment with the Optilume DCB or standard-of-care endoscopic management. Primary efficacy endpoints measured at 2 years included freedom from re-intervention and changes in IPSS, Qmax and post-void residual (PVR). Secondary endpoint was impact on sexual function using the International Index of Erectile Function (IIEF). Primary safety endpoint was freedom from serious procedure- or device-related adverse events (AEs). Results: A total of 127 patients enrolled at 22 sites in the United States and Canada (48 randomized to standard-of-care dilation and 79 to DCB dilation). Seventy-five patients in the DCB arm entered the open-label phase after 6 months. Participants averaged 3.2 prior endoscopic interventions (range 2-10); most (89.9%) had bulbar strictures with an average stricture length of 1.63 cm (SD 0.76). Significant improvements in IPSS, average Qmax and PVR were maintained at 2 years. Freedom from repeat intervention was significantly higher in the Optilume DCB arm at 2 years versus the Control arm at 1 year (77.8% vs. 23.6%, Conclusion: The Optilume DCB shows sustained improvement in both objective and subjective voiding parameters at 2-year follow-up. Optilume appears to provide a safe and effective endoscopic treatment alternative for short recurrent anterior urethral strictures among men who wish to avoid or delay formal urethroplasty.
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