Hypothesis / aims of study
Urethral stricture is a common urological condition that significantly impact patients' quality of life. Traditional treatments, including dilation, internal urethrotomy, and open surgical reconstruction, often have variable success rates and recurrence rates. A novel minimally invasive treatment, the Optilume drug-coated balloon (DCB), has emerged as a promising alternative. Optilume is designed to combine mechanical dilation with localized drug delivery, utilizing a paclitaxel-coated balloon to inhibit cellular proliferation and reduce fibrosis, thereby minimizing stricture recurrence. This systematic review evaluates the efficacy and safety of the Optilume DCB in the management of urethral strictures.
Study design, materials and methods
A comprehensive literature search was conducted across multiple databases, including PubMed, Scopus, and clinical trial registries, to identify relevant studies assessing Optilume’s clinical outcomes. The primary outcome measures included the success rate, which was assessed through improvements in the International Prostate Symptom Score (IPSS) and maximum urinary flow rate (QMax) scores. Secondary outcomes examined were the rates of stricture recurrence and complications.
Results
A total of seven studies with 457 participants were analyzed, including one randomized controlled trial (ROBUST III trial), three prospective cohort studies, and three retrospective cohort studies. Follow-up durations ranged from three months to five years.
Optilume treatment resulted in a significant mean reduction of 13 points in IPSS scores (95% CI: -15.8 to -10.3; p < 0.0001), indicating substantial relief in urinary symptoms. The ROBUST III trial further demonstrated that Optilume provided greater improvements in IPSS compared to standard endoscopic management over two years.
Urinary flow rates also showed significant improvement, with a mean QMax increase of 10.11 mL/s (95% CI: +7.8 to +12.4; p < 0.0001), reinforcing the efficacy of Optilume in alleviating obstructive symptoms. The ROBUST III trial demonstrated superior QMax outcomes in the Optilume group compared to conventional treatments. Recurrence rates were analyzed across all studies, revealing a mean recurrence rate of 19.17% (95% CI: 15.2% to 23.1%; p < 0.0001), translating to an approximately 80.83% recurrence-free rate. In the ROBUST III trial, the Optilume group exhibited a 77.8% recurrence-free rate at two years, significantly outperforming the control group’s 23.6% recurrence-free rate.
Complication rates, reported across five studies, showed a weighted average of 9.5%. Most complications were mild, including transient dysuria, hematuria, urinary tract infections, and temporary urinary retention, with no severe complications observed. Funnel plots and Egger’s tests were used to assess publication bias, with no significant evidence of bias detected.
Interpretation of results
The findings suggest that Optilume offers a significant advantage over traditional urethral stricture treatments by combining mechanical dilation with localized drug delivery, leading to improved symptom relief, increased urinary flow, and reduced recurrence rates. The dual-action mechanism of mechanical expansion and paclitaxel-coated drug delivery appears to enhance urethral patency while mitigating fibrosis, a key factor in stricture recurrence. The substantially lower recurrence rate compared to standard interventions highlights Optilume’s potential for durable long-term outcomes.
The low rate of complications further supports its safety profile, making it a promising alternative to existing treatments. Given that conventional endoscopic approaches, such as dilation and internal urethrotomy, often have high recurrence rates, Optilume presents a novel strategy that may redefine the standard of care for urethral strictures. However, while current evidence is promising, larger randomized controlled trials with extended follow-up are necessary to confirm these findings, optimize patient selection, and establish long-term efficacy across diverse populations.