Novel device delivers improvements for BPH symptoms
The Optilume™ BPH Catheter System, a novel minimally invasive surgical therapy (MIST), provided rapid improvements for men with benign prostatic hyperplasia (BPH), the PINNACLE trial reports.
“Optilume™ BPH combines novel balloon dilatation with localized drug delivery, creating a new drug-device space among the current BPH therapies,” said Professor Stephen Kaplan from the Icahn School of Medicine at Mount Sinai, New York City, New York, US, at EAU 2023. “[In PINNACLE,] Optilume™ BPH demonstrated significant immediate symptomatic and functional improvements and mechanical benefit sustained through 12 months.”
In this study, participants were required to wash out 5-ARis* for 6 months and alpha blockers and PDE5is* for 2 weeks prior to baseline assessment. Of the 477 enrolees, 148 (mean age 65 years) were randomized 2:1 to either the Optilume™ BPH or the sham arm. They were followed for 5 years. [EAU 2023, abstract AM23-3925]
“[Overall,] subjects were severely symptomatic on average at baseline,” Kaplan noted. Average baseline IPSS** assessment was 23–24 and average Qmax at baseline was about 9 mL/sec.
Participants in the Optilume™ BPH arm had greater IPSS improvements from baseline compared with those treated with sham. The improvement was evident as early as 3 months (10.5 vs 8.0) and continued to be seen at 6 months (10.6 vs 6.1). The greatest between-arm difference was at 12 months, which achieved statistical significance (11.5 vs 4.8; p<0.001). “The change in IPSS from baseline was durable within the Optilume™ BPH arm,” noted Kaplan.
The fraction of participants experiencing ≥30-percent improvement in IPSS score was considerably higher in the Optilume™ BPH vs the sham arm across all timepoints. At 3 months, the difference between Optilume™ BPH and sham is just short of significance (69 percent vs 52 percent), noted Kaplan. By 12 months, the difference was significant (77 percent vs 33 percent; p=0.001).
There was a 98-percent improvement in peak urinary flow rate (Qmax) from baseline to day 30 with Optilume™ BPH. By 12 months, Qmax more than doubled from baseline (from 8.9 to 19.0 mL/sec). “[This translates to] 113-percent improvement at 1 year. We haven’t really seen this type of numbers,” Kaplan underscored.
PVR*** urine volume also improved from baseline to day 30 by nearly 30 percent in the Optilume™ BPH vs sham arm, which was sustained through 12 months (-26.5 vs 4.6). The increase in the sham arm represents PVR worsening.
Optilume™ BPH had no apparent impact on sexual or ejaculatory function, as reflected by the MSHQ-EjD# Function score improvement from baseline (7.5) to 1 year (8.4). There were also improvements in IIEF-EF# between the two timepoints (from 15.6 to 17.1). “[These are important as] preservation of sexual function is very important with minimally invasive therapies,” said Kaplan.
Mechanical dilatation + drug delivery
Optilume™ BPH combines mechanical dilatation with the delivery of paclitaxel for the treatment of lower urinary tract symptoms secondary to BPH. “The primary mechanism of action is to achieve an anterior commissurotomy, which separates the natural tissue between the two lateral lobes of the prostate,” Kaplan explained.
The secondary mode of action includes delivering paclitaxel to the newly split anterior commissure to prevent hypoplastic response, maintaining long-term patency of the increased cross-sectional area, he continued. The balloon is then deflated and withdrawn.
“The procedure is easy to learn and can be done in the office setting under prostate block … The whole procedure takes roughly 15 minutes,” he said.
“[Taken together, our findings show that] treatment with Optilume™ BPH resulted in significant, immediate symptomatic and functional improvements and the highest Qmax reported in BPH MIST trials to date,” said Kaplan.
“The durability of these outcomes was shown through 12 months of follow-up, demonstrating the intended effect of an immediate mechanical benefit that is sustained long-term by the delivery of paclitaxel,” he continued. “PINNACLE is ongoing. We look forward to presenting the long-term results.”