The objectives of the PINNACLE study are to assess the efficacy of Optilume BPH Catheter System (test arm) to alleviate LUTS, believed to be secondary to BPH (LUTS/BPH), and to evaluate the safety of Optilume BPH Catheter System in the treatment of LUTS/BPH as compared to the sham control arm.
The primary efficacy endpoint is change is IPSS as compared to baseline, in both the test and control arms. The primary safety endpoint is incidence of major device-related serious complications through 12 months for both the test and sham control arm.
Secondary endpoints include additional comparison of improvement in IPSS, responder rates, Qmax, PVR, sexual function, and BPH-II.
STUDY DESIGN, MATERIALS AND METHODS
The PINNACLE study is a prospective, randomized, double-blind, sham controlled study evaluating the Optilume BPH System. Optilume BPH is a novel minimally invasive surgical therapy (MIST) that combines mechanical dilation with the delivery of paclitaxel for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH. Mechanical dilation with Optilume BPH achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing (Figure 1). Subjects randomized to the Control arm will receive a sham procedure. A cystoscopy will be performed followed by insertion of the 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath. The catheter hub of the sham device will be modified to prevent inflation of the balloon.
148 subjects were randomized in a 2:1 fashion at 18 centers in the US and Canada. Subjects and evaluating personnel were blinded to the treatment received through 12-months. 12-month follow-up is complete. Symptom improvement was measured utilizing the International Prostate Symptom Score (IPSS) and BPH Impact Index (BPH-II), functional improvement measured by peak urinary flow rate (Qmax) and post-void residual volume (PVR). Erectile and ejaculatory function were evaluated utilizing validated questionnaires. Adverse events were prospectively collected and relatedness to treatment w. adjudicated by an independent, blinded clinical events committee.
RESULTS
Subjects treated with Optilume BPH showed a significant reduction in IPSS from baseline to 12-months (23.4 vs 10.9, p<0.001). Improvement in IPSS at 12 months was significantly greater for Optilume BPH compared to Sham in the intent-to-treat population (11.5 vs 4.8, p<0.001) (Table1). Qmax improved 113%, from 8.9 mL/sec at baseline to 19.0 mL/sec after treatment with Optilume BPH, while average PVR decreased from 84 mL to 58 mL (p=0.004). Improvement in PVR at 12-months was significantly greater for Optilume BPH compared to Sham (26.6% vs -4.6%). There were no changes in perceived sexual or ejaculatory function. The most reported treatment related adverse events after treatment with Optilume BPH included hematuria (39/98 [39.8%]), urinary tract infection (11/98 [11.2%]), and dysuria (8/98 [8.2%]).
Treatment with Optilume BPH resulted in significant, immediate symptomatic and functional improvements and to date the highest Qmax reported in BPH MIST trials. Durability of these outcomes was shown through 12-months follow-up, demonstrating the intended effect of an immediate mechanical benefit that is sustained long-term by the delivery of paclitaxel. Adverse events were generally mild with the exception of several hematuria events early in the study, which were subsequently reduced with appropriate post-operative bleeding management techniques. These results compare favorably with existing therapies for the treatment of BPH evaluated in similar patient cohorts.
CONCLUDING MESSAGE
Treatment of LUTS secondary to obstructive BPH with the Optilume BPH Catheter System results are very promising. Consistent with other minimally invasive technologies, the Optilume BPH procedure is a simple procedure that can be conducted in an ambulatory or office outpatient setting with pain management at physician and patient discretion. This minimally invasive treatment represents an attractive option to patients looking to maintain sexual function while achieving long-term symptom relief and improved flow.
FIGURE1
