Three-year outcomes after treatment with the Optilume Drug Coated Balloon: The ROBUST I study
BAUS ePoster online library. Kayes O. 06/23/21; 319045; p13-7
Disclosure(s): None to declare
Mr. Oliver Kayes
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Abstract
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Introduction:
This study investigates the safety and efficacy of the Optilume drug coated balloon (DCB) for the treatment of recurrent anterior strictures.
Methods:
Men with recurrent bulbar strictures ≤ 2cm with 1-4 prior endoscopic treatments were treated with the Optilume DCB. The primary safety endpoint was freedom from serious treatment related adverse events. The primary efficacy endpoint was the proportion of subjects with ≥ 50% improvement in International Prostate Symptom Score (IPSS) at 3 years. Secondary outcomes included quality of life, freedom from repeat intervention, erectile function, flow rate, and post-void residual urine volume.
Results:
A total of 53 subjects were enrolled; 43 were evaluable at the 3-year follow-up for the primary endpoint. 43% of men had undergone ≥2 previous dilations, with a mean of 1.7 prior dilations. There were no serious adverse events related to treatment at 3 years. Success was achieved in 29/43 (67%). IPSS improved from a mean of 25.2 at baseline to 5.5 at 3 years (p < 0.001). Freedom from repeat intervention of the study stricture was 33/43 (77%). Quality of life, flow rate, and post-void residual urine volumes improved significantly from baseline. There was no impact on erectile function.
Conclusions:
Subjects with recurrent bulbar strictures treated with Optilume DCB exhibited significant improvement in symptomatic and functional outcomes through 3 years post treatment. The rate of success is consistent with reported 2 year outcomes. Long term follow up will continue through 5 years in the ROBUST I study and a randomized study is ongoing.
This study investigates the safety and efficacy of the Optilume drug coated balloon (DCB) for the treatment of recurrent anterior strictures.
Methods:
Men with recurrent bulbar strictures ≤ 2cm with 1-4 prior endoscopic treatments were treated with the Optilume DCB. The primary safety endpoint was freedom from serious treatment related adverse events. The primary efficacy endpoint was the proportion of subjects with ≥ 50% improvement in International Prostate Symptom Score (IPSS) at 3 years. Secondary outcomes included quality of life, freedom from repeat intervention, erectile function, flow rate, and post-void residual urine volume.
Results:
A total of 53 subjects were enrolled; 43 were evaluable at the 3-year follow-up for the primary endpoint. 43% of men had undergone ≥2 previous dilations, with a mean of 1.7 prior dilations. There were no serious adverse events related to treatment at 3 years. Success was achieved in 29/43 (67%). IPSS improved from a mean of 25.2 at baseline to 5.5 at 3 years (p < 0.001). Freedom from repeat intervention of the study stricture was 33/43 (77%). Quality of life, flow rate, and post-void residual urine volumes improved significantly from baseline. There was no impact on erectile function.
Conclusions:
Subjects with recurrent bulbar strictures treated with Optilume DCB exhibited significant improvement in symptomatic and functional outcomes through 3 years post treatment. The rate of success is consistent with reported 2 year outcomes. Long term follow up will continue through 5 years in the ROBUST I study and a randomized study is ongoing.
Introduction:
This study investigates the safety and efficacy of the Optilume drug coated balloon (DCB) for the treatment of recurrent anterior strictures.
Methods:
Men with recurrent bulbar strictures ≤ 2cm with 1-4 prior endoscopic treatments were treated with the Optilume DCB. The primary safety endpoint was freedom from serious treatment related adverse events. The primary efficacy endpoint was the proportion of subjects with ≥ 50% improvement in International Prostate Symptom Score (IPSS) at 3 years. Secondary outcomes included quality of life, freedom from repeat intervention, erectile function, flow rate, and post-void residual urine volume.
Results:
A total of 53 subjects were enrolled; 43 were evaluable at the 3-year follow-up for the primary endpoint. 43% of men had undergone ≥2 previous dilations, with a mean of 1.7 prior dilations. There were no serious adverse events related to treatment at 3 years. Success was achieved in 29/43 (67%). IPSS improved from a mean of 25.2 at baseline to 5.5 at 3 years (p < 0.001). Freedom from repeat intervention of the study stricture was 33/43 (77%). Quality of life, flow rate, and post-void residual urine volumes improved significantly from baseline. There was no impact on erectile function.
Conclusions:
Subjects with recurrent bulbar strictures treated with Optilume DCB exhibited significant improvement in symptomatic and functional outcomes through 3 years post treatment. The rate of success is consistent with reported 2 year outcomes. Long term follow up will continue through 5 years in the ROBUST I study and a randomized study is ongoing.
This study investigates the safety and efficacy of the Optilume drug coated balloon (DCB) for the treatment of recurrent anterior strictures.
Methods:
Men with recurrent bulbar strictures ≤ 2cm with 1-4 prior endoscopic treatments were treated with the Optilume DCB. The primary safety endpoint was freedom from serious treatment related adverse events. The primary efficacy endpoint was the proportion of subjects with ≥ 50% improvement in International Prostate Symptom Score (IPSS) at 3 years. Secondary outcomes included quality of life, freedom from repeat intervention, erectile function, flow rate, and post-void residual urine volume.
Results:
A total of 53 subjects were enrolled; 43 were evaluable at the 3-year follow-up for the primary endpoint. 43% of men had undergone ≥2 previous dilations, with a mean of 1.7 prior dilations. There were no serious adverse events related to treatment at 3 years. Success was achieved in 29/43 (67%). IPSS improved from a mean of 25.2 at baseline to 5.5 at 3 years (p < 0.001). Freedom from repeat intervention of the study stricture was 33/43 (77%). Quality of life, flow rate, and post-void residual urine volumes improved significantly from baseline. There was no impact on erectile function.
Conclusions:
Subjects with recurrent bulbar strictures treated with Optilume DCB exhibited significant improvement in symptomatic and functional outcomes through 3 years post treatment. The rate of success is consistent with reported 2 year outcomes. Long term follow up will continue through 5 years in the ROBUST I study and a randomized study is ongoing.
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