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Drug-Coated Balloon Therapy (Optilume)

The Optilume® paclitaxel-coated balloon is the cross-cutting drug-coated-balloon technology used for both bulbar urethral stricture (ROBUST III pivotal RCT) and the investigational ureteral stricture indication (ENDURE-1).

The canonical WARWIKI page lives in the cross-cutting Treatment Atlas: Drug-Coated Balloon Therapy. This urethral-reconstruction page is a pointer plus a short selection summary so readers landing from the urethral database do not hit a dead end.

For related urethral options, see DVIU and Urethral Dilation and Endoscopic Urethroplasty (Suturing Device). For the ureteral endoscopic counterpart, see Endoureterotomy.

Urethral Selection Snapshot

Best supportedLess certain / off-label
Recurrent bulbar stricture less than 3 cm after prior dilation or DVIUPenile urethral strictures
Patient wants an endoscopic bridge before urethroplastyPosterior urethral stenosis, BNC, or VUAS
Patient understands this is not urethroplasty-equivalent durabilityTreatment-naive strictures outside trials

Technique Snapshot

The operative concept is mechanical dilation plus local paclitaxel delivery. The working sequence is: confirm stricture length and location endoscopically, obtain wire access, pre-dilate enough to deploy the balloon, center the drug-coated segment across the scar, inflate per device protocol, drain briefly with catheter, and follow with symptom score, uroflow, PVR, and cystoscopy when recurrence is suspected.

Counseling Snapshot

Drug-coated balloon therapy is a better endoscopic option for selected recurrent bulbar strictures, not a replacement for substitution urethroplasty. A DCB failure should trigger reassessment of stricture length, spongiofibrosis, radiation history, lichen sclerosus, and candidacy for definitive reconstruction rather than automatic serial repeat dilation.