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. 2025 Jan 16:17:17562872241312522.
doi: 10.1177/17562872241312522. eCollection 2025 Jan-Dec.

Efficacy of the Optilume paclitaxel drug-coated balloon after urethroplasty: short-term results from a multicenter study

Maia VanDyke  1 , Eshan Joshi  2 , Brian Ceballos  3 , Adam Baumgarten  3 , Ethan Matz  2 , Kayla S Graham  4 , Maxim J McKibben  4 , Ahmad Imam  5 , Lucas Wiegand  6 , Bryce Franzen  2 , Steven Hudak  2
Affiliations

Efficacy of the Optilume paclitaxel drug-coated balloon after urethroplasty: short-term results from a multicenter study

Maia VanDyke et al. Ther Adv Urol. .

Abstract

Background: The Optilume® paclitaxel drug-coated balloon (DCB) is a relatively new-to-market alternative in the management of male anterior urethral stricture disease. The pivotal trial excluded patients with a history of urethroplasty, although these strictures may be amenable to endoscopic management. Therefore, we sought to assess the efficacy of the DCB in the management of recurrent strictures following urethroplasty.

Methods: A retrospective, multi-institutional review of male patients undergoing DCB dilation from 1/1/2022 to 11/1/2023 by five surgeons at four institutions was performed. Patients were stratified by history of urethroplasty; demographics, stricture characteristics, and outcomes (surgical success, time to recurrence). Success was defined as freedom from re-intervention in patients with at least 3 months of follow-up.

Results: Among the 122 cases assessed, 33 (27.0%) had previously undergone urethroplasty. Patients in the urethroplasty group were younger than those in the control group (51.6 vs 58.8 years, p = 0.022). The two groups were otherwise similar with regard to background characteristics and comorbidities. Patients in both groups had similar stricture characteristics with short bulbar strictures being the most common. When compared to the control group, those with a history of prior urethroplasty had a greater median number of interventions prior to DCB treatment (3 vs 1, p < 0.001). Postoperative cystoscopy was performed in 37 cases, with similar patency rates between groups (p > 0.999). Early success rates were similarly high in both groups (80.0% post-urethroplasty vs 88.9% control, p = 0.338), although follow-up was limited to a median of 3.5 months in the urethroplasty group and 2.9 months in the control group (p = 0.069).

Conclusion: Despite a greater number of prior surgical interventions, patients with a history of urethroplasty achieve similarly high success rates after treatment with DCB compared to those without a history of urethroplasty.

Keywords: balloon dilation; urethral stricture; urethroplasty.

Plain language summary

Efficacy of a new drug-coated dilation balloon in the treatment of recurrent urethral stricture after previous urethroplasty surgery The Optilume drug coated balloon (DCB) is a dilating balloon coated in the medication paclitaxel, which helps to inhibit scar formation. It has recently been approved by the FDA to be used to treat men to have urethral stricture (scar tissue) disease. The initial studies did not include patients who had undergone surgical treatment via a urethroplasty in the past, and thus our goal was to assess how well this new technology performs in this setting. We looked at 122 patients who underwent treatment with the DCB, 33 of whom had undergone urethroplasty in the past and 89 who had not. The two groups were similar with regards to things like age, other medical problems, and the location and length of their stricture. We found that patients who had urethroplasty in the past did similarly well after dilation with the DCB: 80% of people in the urethroplasty group were successfully treated compared to 89% of those who had not had urethroplasty. One limitation of the study is that the follow-up is short; that is, patients have not been seen for a long time after surgery to make sure they are still doing well. Another is that there were relatively few patients considered. A strength of the study is that the study includes patients from different hospitals treated by different urologists which makes the results more likely to be applicable to the general population. This is an early study and we will need to continue to follow these patients over time to see how they do long-term.

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Conflict of interest statement

Drs. VanDyke, Wiegand, and Baumgarten have served as consultants for Laborie.

Figures

Figure 1.
Figure 1.
Study inclusion/exclusion flowsheet. *One patient was excluded due to an unknown location of stricture. One patient was excluded as the case was dilation of stenosed perineal urethrostomy. DCB, drug-coated balloon.
See this image and copyright information in PMC

References

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