Urethral Drug-Coated Balloon for Urethral Stricture and Benign Prostatic Hyperplasia

Urethral stricture disease is a fibrotic narrowing of the urethral lumen, most commonly involving the anterior (bulbar) urethra, that obstructs urine flow and produces obstructive lower urinary tract symptoms (LUTS). Endoscopic treatments, namely direct visual internal urethrotomy (DVIU) and dilation, are minimally invasive but carry high recurrence rates, whereas urethroplasty is the definitive, reference-standard surgical repair. Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate that causes bladder outlet obstruction and LUTS; management ranges from pharmacotherapy through minimally invasive surgical therapies (MISTs) to transurethral resection of the prostate (TURP). The Optilume drug-coated balloon (DCB) platform (Urotronic, Inc., now part of Laborie) combines mechanical balloon dilation with localized delivery of paclitaxel, an antiproliferative agent intended to inhibit the fibroblastic and collagen-remodeling response responsible for re-narrowing after dilation. Two related products are addressed in this review: the Optilume Urethral DCB, for adult men with anterior urethral stricture; and the Optilume BPH Catheter System, a double-lobe DCB that performs an anterior commissurotomy while delivering paclitaxel to the prostatic urethra, for LUTS secondary to BPH.