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. 2023 Dec 18;5(3):366-373.
doi: 10.1002/bco2.312. eCollection 2024 Mar.

Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial

Maia E VanDyke  1 , Allen F Morey  1 , Karl Coutinho  2 , Kaiser J Robertson  3 , Richard D'Anna  4 , Kent Chevli  5 , Christopher H Cantrill  6 , Michael J Ehlert  7 , Alexis E Te  8 , Jeffrey Dann  9 , Jessica M DeLong  10 , Ramón Virasoro  11 , Judith C Hagedorn  12 , Richard Levin  13 , Euclid DeSouza  14 , David DiMarco  15 , Brad A Erickson  16 , Carl Olsson  17 , Sean P Elliott  18
Affiliations

Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial

Maia E VanDyke et al. BJUI Compass. .

Abstract

Objective: The aim of this study is to report the updated 2-year results of the intervention arm of the ROBUST III randomized trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) versus standard endoscopic management of recurrent male anterior urethral stricture.

Materials and methods: Eligible patients included men with recurrent anterior urethral stricture ≤3 cm in length and ≤12Fr in diameter, International Prostate Symptom Score (IPSS) ≥11 and peak flow rate (Qmax) <15 mL/s. Patients were randomized to treatment with the Optilume DCB or standard-of-care endoscopic management. Primary efficacy endpoints measured at 2 years included freedom from re-intervention and changes in IPSS, Qmax and post-void residual (PVR). Secondary endpoint was impact on sexual function using the International Index of Erectile Function (IIEF). Primary safety endpoint was freedom from serious procedure- or device-related adverse events (AEs).

Results: A total of 127 patients enrolled at 22 sites in the United States and Canada (48 randomized to standard-of-care dilation and 79 to DCB dilation). Seventy-five patients in the DCB arm entered the open-label phase after 6 months. Participants averaged 3.2 prior endoscopic interventions (range 2-10); most (89.9%) had bulbar strictures with an average stricture length of 1.63 cm (SD 0.76). Significant improvements in IPSS, average Qmax and PVR were maintained at 2 years. Freedom from repeat intervention was significantly higher in the Optilume DCB arm at 2 years versus the Control arm at 1 year (77.8% vs. 23.6%, p < 0.001). During the follow-up period, there were 15 treatment failures and two non-study-related deaths. Treatment-related AEs were rare and generally self-limited (haematuria, dysuria and urinary tract infection).

Conclusion: The Optilume DCB shows sustained improvement in both objective and subjective voiding parameters at 2-year follow-up. Optilume appears to provide a safe and effective endoscopic treatment alternative for short recurrent anterior urethral strictures among men who wish to avoid or delay formal urethroplasty.

Keywords: anterior urethral strictures; bladder outlet obstruction; lower urinary tract symptoms; urethral dilation; urethral stricture.

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Conflict of interest statement

VanDyke: None. Morey: Coloplast, Boston Scientific. Coutinho: Urotronic. Robertson: None. D'Anna: None. Chevli: None. Cantrill: None. Ehlert: Coloplast, Medtronic, Valencia Technologies. Te: Biobot, Boston Scientific, Meditate, Procept, Urotronic, Olympus, Zenflo. Dann: Urotronic. DeLong: Laborie, Urovant. Virasoro: Laborie. Hagedorn: None. Levin: Boston Scientific. DeSouza: None. DiMarco: None. Erickson: Boston Scientific. Olsson: Exilixis Corp. Elliott: Boston Scientific, Laborie, Percuvision, Urotronic.

Figures

FIGURE 1
FIGURE 1
Participant timeline. Reasons for discontinuation between visits are as follows: atreatment failure (1); badverse event (1: urethritis and recurrent stricture, considered a treatment failure), withdrew consent (1), death (1: intestinal infarction); ctreatment failure (5), withdrew consent (1), lost to follow‐up (1); dtreatment failure (8), withdrew consent (3), investigator discretion (2), lost to follow‐up (1), death (1: lung cancer).
FIGURE 2
FIGURE 2
Kaplan–Meier curve for freedom from repeat intervention.
See this image and copyright information in PMC

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