PMID- 38481667
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240315
IS  - 2688-4526 (Electronic)
IS  - 2688-4526 (Linking)
VI  - 5
IP  - 3
DP  - 2024 Mar
TI  - Optilume drug-coated balloon for anterior urethral stricture: 2-year results of 
      the ROBUST III trial.
PG  - 366-373
LID - 10.1002/bco2.312 [doi]
AB  - 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.
CI  - (c) 2023 The Authors. BJUI Compass published by John Wiley & Sons Ltd on behalf of 
      BJU International Company.
FAU - VanDyke, Maia E
AU  - VanDyke ME
AUID- ORCID: 0000-0003-1778-7359
AD  - UT Southwestern Medical Center Dallas Texas USA.
FAU - Morey, Allen F
AU  - Morey AF
AUID- ORCID: 0000-0003-1464-7131
AD  - UT Southwestern Medical Center Dallas Texas USA.
FAU - Coutinho, Karl
AU  - Coutinho K
AD  - New Jersey Urology LLC Millburn New Jersey USA.
FAU - Robertson, Kaiser J
AU  - Robertson KJ
AD  - Chesapeake Urology Hanover Maryland USA.
FAU - D'Anna, Richard
AU  - D'Anna R
AD  - Arkansas Urology Little Rock Arkansas USA.
FAU - Chevli, Kent
AU  - Chevli K
AD  - Western New York Urology Associates Cheektowaga New York USA.
FAU - Cantrill, Christopher H
AU  - Cantrill CH
AD  - Urology San Antonio San Antonio Texas USA.
FAU - Ehlert, Michael J
AU  - Ehlert MJ
AD  - Metro Urology, a division of Minnesota Urology Woodbury Minnesota USA.
FAU - Te, Alexis E
AU  - Te AE
AD  - Weill Cornell Medicine New York New York USA.
FAU - Dann, Jeffrey
AU  - Dann J
AD  - Advanced Urology Institute Daytona Beach Florida USA.
FAU - DeLong, Jessica M
AU  - DeLong JM
AD  - MultiCare Urology Puyallup Washington USA.
FAU - Virasoro, Ramon
AU  - Virasoro R
AD  - Surgical Services, Section of Urology VA Eastern Colorado Health Care System 
      Aurora Colorado USA.
FAU - Hagedorn, Judith C
AU  - Hagedorn JC
AD  - University of Washington Seattle Washington USA.
FAU - Levin, Richard
AU  - Levin R
AD  - Chesapeake Urology Research Associates Annapolis Maryland USA.
FAU - DeSouza, Euclid
AU  - DeSouza E
AD  - Adult and Pediatric Urology PC Omaha Nebraska USA.
FAU - DiMarco, David
AU  - DiMarco D
AD  - Oregon Urology Institute Springfield Oregon USA.
FAU - Erickson, Brad A
AU  - Erickson BA
AD  - University of Iowa Hospitals and Clinics Iowa City Iowa USA.
FAU - Olsson, Carl
AU  - Olsson C
AD  - Integrated Medical Professionals New York New York USA.
FAU - Elliott, Sean P
AU  - Elliott SP
AD  - University of Minnesota Minneapolis Minnesota USA.
LA  - eng
PT  - Journal Article
DEP - 20231218
PL  - United States
TA  - BJUI Compass
JT  - BJUI compass
JID - 101764975
PMC - PMC10927926
OTO - NOTNLM
OT  - anterior urethral strictures
OT  - bladder outlet obstruction
OT  - lower urinary tract symptoms
OT  - urethral dilation
OT  - urethral stricture
COIS- 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.
EDAT- 2024/03/14 06:46
MHDA- 2024/03/14 06:47
PMCR- 2023/12/18
CRDT- 2024/03/14 04:12
PHST- 2023/07/26 00:00 [received]
PHST- 2023/10/09 00:00 [revised]
PHST- 2023/10/31 00:00 [accepted]
PHST- 2024/03/14 06:47 [medline]
PHST- 2024/03/14 06:46 [pubmed]
PHST- 2024/03/14 04:12 [entrez]
PHST- 2023/12/18 00:00 [pmc-release]
AID - BCO2312 [pii]
AID - 10.1002/bco2.312 [doi]
PST - epublish
SO  - BJUI Compass. 2023 Dec 18;5(3):366-373. doi: 10.1002/bco2.312. eCollection 2024 
      Mar.