One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume®Drug-Coated Balloon for Anterior Urethral Strictures

Sean P. Elliott; Karl Coutinho; Kaiser J. Robertson; Richard D'Anna; Kent Chevli; Serge Carrier; Melanie Aube-Peterkin; Christopher H. Cantrill; Michael J. Ehlert; Alexis E. Te; Jeffrey Dann; Jessica M. Delong; Steven B. Brandes; Judith C. Hagedorn; Richard Levin; Amy Schlaifer; Euclid Desouza; David Dimarco; Brad A. Erickson; Richard Natale; Douglas A. Husmann; Allen Morey; Carl Olsson; Ramón Virasoro

doi:10.1097/JU.0000000000002346

One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume^®Drug-Coated Balloon for Anterior Urethral Strictures

Sean P. Elliott, Karl Coutinho, Kaiser J. Robertson, Richard D'Anna, Kent Chevli, Serge Carrier, Melanie Aube-Peterkin, Christopher H. Cantrill, Michael J. Ehlert, Alexis E. Te, Jeffrey Dann, Jessica M. Delong, Steven B. Brandes, Judith C. Hagedorn, Richard Levin, Amy Schlaifer, Euclid Desouza, David Dimarco, Brad A. Erickson, Richard NataleDouglas A. Husmann, Allen Morey, Carl Olsson, Ramón Virasoro

Research output: Contribution to journal › Article › peer-review

22 Scopus citations

Abstract

Purpose:The Optilume® drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single-blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures.Materials and Methods:Eligible patients were adult males with anterior strictures ≤12Fr in diameter and ≤3 cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11 and maximum flow rate <15 ml per second. A total of 127 subjects were enrolled at 22 sites. The primary study end point was anatomical success (≥14Fr by cystoscopy or calibration) at 6 months. Key secondary end points included freedom from repeat treatment, International Prostatic Symptom Score and peak flow rate. The primary safety end point included freedom from serious device- or procedure-related complications.Results:Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7 cm. Anatomical success for Optilume DCB was significantly higher than control at 6 months (75% vs 27%, p <0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequent adverse events included urinary tract infection, post-procedural hematuria and dysuria.Conclusions:The results of this randomized controlled trial support that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. The Optilume DCB may serve as an important alternative for men who have had an unsuccessful direct vision internal urethrotomy/dilation but want to avoid or delay urethroplasty.

Original language	English (US)
Pages (from-to)	866-874
Number of pages	9
Journal	Journal of Urology
Volume	207
Issue number	4
DOIs	https://doi.org/10.1097/JU.0000000000002346
State	Published - Apr 1 2022

Keywords

lower urinary tract symptoms
urethral stricture
urinary bladder neck obstruction

ASJC Scopus subject areas

Urology

Access to Document

10.1097/JU.0000000000002346

Cite this

Elliott, S. P., Coutinho, K., Robertson, K. J., D'Anna, R., Chevli, K., Carrier, S., Aube-Peterkin, M., Cantrill, C. H., Ehlert, M. J., Te, A. E., Dann, J., Delong, J. M., Brandes, S. B., Hagedorn, J. C., Levin, R., Schlaifer, A., Desouza, E., Dimarco, D., Erickson, B. A., ... Virasoro, R. (2022). One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume^®Drug-Coated Balloon for Anterior Urethral Strictures. Journal of Urology, 207(4), 866-874. https://doi.org/10.1097/JU.0000000000002346

Elliott, SP, Coutinho, K, Robertson, KJ, D'Anna, R, Chevli, K, Carrier, S, Aube-Peterkin, M, Cantrill, CH, Ehlert, MJ, Te, AE, Dann, J, Delong, JM, Brandes, SB, Hagedorn, JC, Levin, R, Schlaifer, A, Desouza, E, Dimarco, D, Erickson, BA, Natale, R, Husmann, DA, Morey, A, Olsson, C & Virasoro, R 2022, 'One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume^®Drug-Coated Balloon for Anterior Urethral Strictures', Journal of Urology, vol. 207, no. 4, pp. 866-874. https://doi.org/10.1097/JU.0000000000002346

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title = "One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume{\textregistered}Drug-Coated Balloon for Anterior Urethral Strictures",

abstract = "Purpose:The Optilume{\textregistered} drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single-blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures.Materials and Methods:Eligible patients were adult males with anterior strictures ≤12Fr in diameter and ≤3 cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11 and maximum flow rate <15 ml per second. A total of 127 subjects were enrolled at 22 sites. The primary study end point was anatomical success (≥14Fr by cystoscopy or calibration) at 6 months. Key secondary end points included freedom from repeat treatment, International Prostatic Symptom Score and peak flow rate. The primary safety end point included freedom from serious device- or procedure-related complications.Results:Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7 cm. Anatomical success for Optilume DCB was significantly higher than control at 6 months (75% vs 27%, p <0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequent adverse events included urinary tract infection, post-procedural hematuria and dysuria.Conclusions:The results of this randomized controlled trial support that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. The Optilume DCB may serve as an important alternative for men who have had an unsuccessful direct vision internal urethrotomy/dilation but want to avoid or delay urethroplasty.",

keywords = "lower urinary tract symptoms, urethral stricture, urinary bladder neck obstruction",

author = "Elliott, {Sean P.} and Karl Coutinho and Robertson, {Kaiser J.} and Richard D'Anna and Kent Chevli and Serge Carrier and Melanie Aube-Peterkin and Cantrill, {Christopher H.} and Ehlert, {Michael J.} and Te, {Alexis E.} and Jeffrey Dann and Delong, {Jessica M.} and Brandes, {Steven B.} and Hagedorn, {Judith C.} and Richard Levin and Amy Schlaifer and Euclid Desouza and David Dimarco and Erickson, {Brad A.} and Richard Natale and Husmann, {Douglas A.} and Allen Morey and Carl Olsson and Ram{\'o}n Virasoro",

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doi = "10.1097/JU.0000000000002346",

language = "English (US)",

volume = "207",

pages = "866--874",

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T1 - One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume®Drug-Coated Balloon for Anterior Urethral Strictures

AU - Elliott, Sean P.

AU - Coutinho, Karl

AU - Robertson, Kaiser J.

AU - D'Anna, Richard

AU - Chevli, Kent

AU - Carrier, Serge

AU - Aube-Peterkin, Melanie

AU - Cantrill, Christopher H.

AU - Ehlert, Michael J.

AU - Te, Alexis E.

AU - Dann, Jeffrey

AU - Delong, Jessica M.

AU - Brandes, Steven B.

AU - Hagedorn, Judith C.

AU - Levin, Richard

AU - Schlaifer, Amy

AU - Desouza, Euclid

AU - Dimarco, David

AU - Erickson, Brad A.

AU - Natale, Richard

AU - Husmann, Douglas A.

AU - Morey, Allen

AU - Olsson, Carl

AU - Virasoro, Ramón

PY - 2022/4/1

Y1 - 2022/4/1

N2 - Purpose:The Optilume® drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single-blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures.Materials and Methods:Eligible patients were adult males with anterior strictures ≤12Fr in diameter and ≤3 cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11 and maximum flow rate <15 ml per second. A total of 127 subjects were enrolled at 22 sites. The primary study end point was anatomical success (≥14Fr by cystoscopy or calibration) at 6 months. Key secondary end points included freedom from repeat treatment, International Prostatic Symptom Score and peak flow rate. The primary safety end point included freedom from serious device- or procedure-related complications.Results:Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7 cm. Anatomical success for Optilume DCB was significantly higher than control at 6 months (75% vs 27%, p <0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequent adverse events included urinary tract infection, post-procedural hematuria and dysuria.Conclusions:The results of this randomized controlled trial support that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. The Optilume DCB may serve as an important alternative for men who have had an unsuccessful direct vision internal urethrotomy/dilation but want to avoid or delay urethroplasty.

AB - Purpose:The Optilume® drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single-blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures.Materials and Methods:Eligible patients were adult males with anterior strictures ≤12Fr in diameter and ≤3 cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11 and maximum flow rate <15 ml per second. A total of 127 subjects were enrolled at 22 sites. The primary study end point was anatomical success (≥14Fr by cystoscopy or calibration) at 6 months. Key secondary end points included freedom from repeat treatment, International Prostatic Symptom Score and peak flow rate. The primary safety end point included freedom from serious device- or procedure-related complications.Results:Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7 cm. Anatomical success for Optilume DCB was significantly higher than control at 6 months (75% vs 27%, p <0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequent adverse events included urinary tract infection, post-procedural hematuria and dysuria.Conclusions:The results of this randomized controlled trial support that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. The Optilume DCB may serve as an important alternative for men who have had an unsuccessful direct vision internal urethrotomy/dilation but want to avoid or delay urethroplasty.

KW - lower urinary tract symptoms

KW - urethral stricture

KW - urinary bladder neck obstruction

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