Mp56-06 the Optilume Drug Coated Balloon for Recurrent Anterior Urethral Strictures: 3-Year Results From the Robust I Study

Abstract

METHODS: A retrospective study was performed of men undergoing self UBD from 1/2011 to 6/2019. Patients with no follow-up in the clinic and those who performed UBD only a single time were excluded. Comorbidities, stricture details, need for subsequent intervention, and frequency of annual UTIs were collected. All patients were started on daily self UBD and frequency was titrated to the lowest necessary frequency. Descriptive statistics are reported.RESULTS: Forty six patients were identified with median (range) follow-up of 45.5 (2-94) months. Mean (SD) age at the start of dilations was 67.8 (10.6), and mean (SD) BMI was 32.7 (6.1). Twenty-two (47.8%) had a history of radiation treatment, 9 (19.6%) had a history of prostatectomy, 11 (23.9%) had a history of prior urethroplasty, and 45 (97.8%) reported prior endoscopic intervention in the form of dilation or DVIU. The site of stricture was bladder neck contracture in 15 (32.6%), membranous in 10 (21.7%), bulbar in 11 (23.9%), panurethral in 8 (17.4%), and fossa in 2 (4.3%). At most recent follow-up, 15 (32.6%) performed UBD daily, 3 (6.5%) performed UBD 2-3 times a week, 6 (13.0%) performed UBD weekly, 4 (8.7%) performed UBD every 2-4 weeks, and unknown in one. Seventeen (37.0%) no longer performed UBD, of which nine (52.9%) no longer required intervention for the stricture, three opted to have SP tube placed, two underwent urinary diversion, two have chronic catheters due to being moved to nursing facilities, and one is scheduled for definitive urethroplasty. Eleven (23.9%) patients failed UBD and required a definitive intervention. Transient urethrorrhagia was reported by 14 (30.4%) patients. Thirty seven (80.4%) patients reported 0-1 UTIs per year, 6 (13.0%) reported 2-3 per year, and 3 (6.5%) reported > 3 annual UTIs. No patients required hospitalization for complications related to the UBD or secondary to infections. CONCLUSIONS: Self urethral balloon dilation offers patients with complex strictures, particularly those with a history of radiation, an opportunity to avoid surgical intervention which can be associated with many adverse effects. Risks are low and include infection, mild urethrorrhagia, and need for further intervention.

Economic evaluation of Optilume, a drug‐coated balloon for recurrent anterior male urethral stricture

“…From the ROBUST III, our analyses estimated the probability of stricture recurrence and safety of Optilume compared with endoscopic management. The results of this trial are supported by a single arm study of Optilume looking over a longer 3‐year time period, the ROBUST I 12 . These key model assumptions were then extensively explored via sensitivity analyses.…”

“…The results of this trial are supported by a single arm study of Optilume looking over a longer 3-year time period, the ROBUST I. 12 These key model assumptions were then extensively explored via sensitivity analyses.…”