Single-center prospective experience with Optilume® drug-coated balloon for recurrent urethral strictures: preliminary functional and safety outcomes

Background: Urethral stricture disease remains a challenging condition in urology, particularly in cases with recurrent anterior urethral narrowing following prior endoscopic treatments. Traditional options such as dilation and direct vision internal urethrotomy (DVIU) are limited by high failure rates. The Optilume® drug-coated balloon (DCB) delivers mechanical dilation combined with localized paclitaxel delivery, aiming to reduce restenosis and improve durability. Objective: To evaluate the short-term functional outcomes and safety of Optilume® DCB in patients with recurrent urethral strictures. Design, setting, and participants: This was a prospective single-center study including 35 male patients with anterior urethral strictures ≤ 3 cm and at least one prior endoscopic treatment. Outcomes were assessed at 1, 3, and 6 months post-procedure. Outcome measurements and statistical analysis: Primary outcomes included changes in Qmax (uroflowmetry), post-void residual (PVR), IPSS, and erectile function (IIEF-5). Recurrence was defined as symptomatic deterioration, Qmax < 10 mL/s, or need for retreatment. Paired t-tests were used for pre- and post-treatment comparisons, with p < 0.05 considered statistically significant. As this was an exploratory pilot study, no formal sample size calculation was performed; analyses were descriptive and hypothesis-generating. Results and limitations: Mean Qmax improved from 10.2 ± 4.9 to 21.6 ± 3.1 mL/s (p < 0.001), and PVR decreased from 74.6 ± 36.3 to 24.8 ± 16.0 mL (p < 0.001). IPSS improved from 21.8 ± 4.8 to 8.7 ± 2.0 (p < 0.0001), and IIEF-5 scores increased from 13.7 ± 7.7 to 18.5 ± 7.6 (p = 0.012). The recurrence rate at 6 months was 8.6% (3/35). Minor adverse events included transient hematuria and dysuria. No Clavien-Dindo grade ≥ 2 complications were recorded. Study limitations include its single-arm, non-randomized design and relatively short follow-up, limiting direct comparison with DVIU, urethroplasty, or emerging minimally invasive surgical therapies (MISTs). Conclusions: Optilume® DCB treatment demonstrated significant improvements in urinary flow and symptoms with a low recurrence and complication rate at 6 months. It may serve as a minimally invasive alternative for patients unsuitable or unwilling to undergo urethroplasty. Further prospective evaluation is warranted, including its potential role in bladder neck sclerosis and benign prostatic obstruction.