Novel drug-coated balloon catheter now available in Europe to treat urethral strictures

September 23, 2020

The Optilume drug-coated balloon catheter system has been approved for use in European patients with urethral strictures.

The Optilume drug-coated balloon catheter system has been granted Conformité Européene (CE) Mark approval, making the technology available for the treatment of European patients with urethral strictures.1

The clinical activity of Optilume in this setting was demonstrated in the ROBUST I pilot study (NCT03014726), in which 70%(32/46) of patients met the primary end point of achieving a ≥50%improvement in International Prostate Symptom Score (IPSS) at 2 years.2 The mean IPSS score improved from 25.2 at baseline to 6.9 at 24 months (P <.0001).

There were also significant improvements in post-void residual urine volumes, flow rate, and overall quality of life. Regarding safety, no serious treatment-related adverse events occurred at 2 years’ follow-up.

"There has been a significant need for new and alternative treatments for urethral stricture disease. We continually need to challenge how to deliver the most cost-effective treatments for men with de novo or recurrent strictures. Novel therapies should match patient expectations regarding success alongside accelerated care pathways and recovery where possible. Exciting early data suggest that Optilume can significantly improve success rates including improved durability and potentially fewer side effects over conventional endoscopic dilatation or urethrotomy techniques in men," Oliver Kayes, MBBS, MSc, MD(Res), FRCS(Urol), consultant urologist, Leeds Teaching Hospitals NHS Trust, United Kingdom, stated in a press release.1

The Optilume drug coated balloon (Urotronic, Inc.) is a "guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation," according to

ROBUST I enrolled and treated 53 patients with recurrent bulbar strictures ≤2 cm who had received 1 to 4 previous endoscopic treatments. There were 46 patients who completed the 2-year follow-up. The mean number of prior dilations was 1.7, with 43% of patients having received 1 or more previous dilations.

Building on ROBUST I, the ongoing prospective, multicenter, adaptive sample size ROBUST III trial (NCT03499964) is randomizing patients in a 2:1 ratio to Optilume or a control device.3 The assigned treatment in the control arm may be either a rod, uncoated balloon, or direct vision internal urethrotomy (DVIU), depending on which approach is considered to be the best standard of care for the patient.

Eligible patients for the trial must have stricture that is visually confirmed through cystoscopy or urethrogram; an IPSS score ≥11; and at least 2 prior dilation treatments of the same stricture (this must include DVIU, but previous urethroplasty is not allowed). The primary efficacy outcome measure is the stricture-free rate at 6 months.


1. New Treatment for Urethral Strictures, Optilume®, Receives CE Approval. Posted September 23, 2020. Accessed September 23, 2020.

2. Mann RA, Virasoro R, DeLong JM, et al. A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study [published online July 27, 2020]. Can Urol Assoc J. doi: 10.5489/cuaj.6661

3. ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease (ROBUST-III). NIH US National Library of Medicine: Posted April 17, 2018. Accessed September 23, 2020.