Trial reportResearch and reports in urology2022
A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST I Study.
Trial report in Research and reports in urology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06827210 (Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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.
Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- Balloon dilation for the treatment of male urethral strictures: a systematic review and meta-analysis.BMJ open · 2024Pooled it
- The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.The Journal of urology · 2023Trial
- Multicentric Preliminary Experience and Clinical Outcomes of Female Urethral Dilation Using a Paclitaxel-Coated Balloon.International urogynecology journal · 2026Article
- 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
- Applications and challenges of paclitaxel- coated balloons beyond coronary atherosclerotic heart disease.World journal of clinical cases · 2025Review
- 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
- 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 Loss at Arterial Bends Can Dominate Off-Target Drug Delivery by Paclitaxel-Coated Balloons.Pharmaceutics · 2025Article
- Construction of a nomogram to predict urethral stricture after transurethral resection of the prostate: A retrospective cohort study.PloS one · 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
- Off-label use of drug-coated balloon (Optilume™) for urethral stricture in a 16-year-old boy: the FIRST pediatric case report.Frontiers in pediatrics · 2025Article
- Review
- Deep Phenotyping the Anterior Urethral Stricture: Characterizing the Relationship Between Inflammation, Fibrosis, Patient History, and Disease Pathophysiology.The Journal of urology · 2024Article
- Therapeutic adjuncts in the endoscopic management of urethral stricture disease: past, present, and future.Frontiers in urology · 2024Review
- Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study.World journal of urology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: Endoscopic management of male anterior urethral stricture disease is common; however, repeat treatment is associated with high recurrence rates. Here, we report the 3-year results of the ROBUST I trial, which evaluated the safety and efficacy of the Optilume Methods: Adult men with recurrent bulbar urethral strictures ≤2 cm in length and 1-4 prior endoscopic interventions were treated with the Optilume DCB. Functional success was defined as ≥50% reduction in International Prostate Symptom Score (IPSS) without need for retreatment. Other outcomes included quality of life, maximum flow rate, post-void residual urine volume, erectile function, and freedom from repeat intervention. Results: Of the 53 enrolled and treated men, 33 completed the 3-year visit, with 10 patients experiencing clinical failures at previous visits, giving a total of 43 subjects evaluable for the functional success endpoint. Functional success was achieved in 67% (29/43) and freedom from retreatment in 77% (33/43). Average IPSS improved from 25.2 at baseline to 5.5 at 3 years (p<0.0001). Significant improvements were observed in quality of life, flow rate, and post-void residual urine volume. Erectile function was not affected by treatment. Device-related adverse events were mild or moderate in nature and resolved quickly after onset. There were no serious treatment-related adverse events. Conclusion: Symptomatic improvement after treatment with the Optilume DCB was maintained through 3 years in a population highly susceptible to recurrent urethral stricture disease. This minimally invasive therapy is safe with no negative impact on sexual function.
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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.