The Optilume drug-coated balloon catheter system was approved in the EU in September 2020 for the treatment of patients with urethral stricture.
The first European patient has been successfully treated for urethral stricture with the Optilume drug-coated balloon catheter system, according to Laborie Medical Technologies.1
The patient was treated on January 22, 2021, by Georgi Tosev, MD, a urologist at Mannheim Urology in Germany. The device was granted Conformité Européene (CE) Mark approval for this indication in September 2020.2
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.3 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.
"In the last few decades, there has been stagnation in the treatment of urethral strictures. We're very excited to add this new treatment to our range of minimally invasive specialty procedures," Tosev stated in a press release. "I think that Optilume will become a game changer in the treatment of the urethral strictures."
The Optilume drug coated balloon 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 ClinicalTrials.gov.4
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.4 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.
"Patients have frequent relapses after direct visualization internal urethrotomy. Many of them fear a more invasive therapy in the sense of an open urethroplasty. The balloon seems to be a good compromise; in fact, this treatment offers better success rates than conventional balloon dilatation and is less invasive than urethroplasty," Tosev added in the press release.
Laborie has a strategic partnership with Urotronic, the company that created Optilume. Urotronic has ongoing trials designed to support US FDA approval of Optilume for patients with urethral strictures. The technology is also being explored as a device for patients with benign prostatic hyperplasia.
1. Laborie Medical Technologies, in Partnership with Urotronic Inc., Announces Completion of First Optilume® Procedure in Europe. Posted February 2, 2021. Accessed February 2, 2021. https://prn.to/3cxnh9l.
2. New Treatment for Urethral Strictures, Optilume®, Receives CE Approval. Posted September 23, 2020. https://www.prnewswire.com/news-releases/new-treatment-for-urethral-strictures-optilume-receives-ce-approval-301136116.html. Accessed February 2, 2021.
3. 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
4. ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease (ROBUST-III). NIH US National Library of Medicine: ClinicalTrials.gov. Posted April 17, 2018. https://clinicaltrials.gov/ct2/show/NCT03499964. Accessed February 2, 2021.