12-MONTH OUTCOMES FROM A RANDOMIZED, DOUBLE-BLIND, SHAM CONTROLLED STUDY EVALUATING A NOVEL DRUG COATED BALLOON FOR THE TREATMENT OF BPH

Elterman D1, Kaplan S2, Moss J3, Freedman S4, Coutinho K5, Wu N6, Efros M7, D’Anna R8, Padron O9, Robertson K10, Lawindy S11, Mistry S12, Shore N13, Spier J14, Kaminetsky J15, Mazzarella B16, Cahn D17, Jalkut M18, Te A19

Research Type

Clinical

Abstract Category

Male Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

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Best in Category Prize: Male Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction
Abstract 7
Best Urology
Scientific Podium Session 3
Wednesday 27th September 2023
11:15 - 11:30
Theatre 102
Benign Prostatic Hyperplasia (BPH) Clinical Trial New Devices Prospective Study Bladder Outlet Obstruction
1. University of Toronto, Toronto, ON, Canada, 2. Mount Sinai Health System, New York, NY, USA, 3. Oschner LSU Health, Shreveport, LA, USA, 4. Sheldon Freedman Urology, Las Vegas, NV, USA, 5. New Jersey Urology LLC, Millburn, NJ, USA, 6. Comprehensive Urologic Care, Lake Barrington, IL, USA, 7. Accumed Research Associates, Garden City, NY, USA, 8. Arkansas Urology, Little Rock, AR, USA, 9. Florida Urology Partners, Tampa, FL, USA, 10. Chesapeake Urology, Hanover, MD, USA, 11. Advanced Urology Institute, Daytona Beach, FL, USA, 12. North Austin Urology, Austin, TX, USA, 13. Carolina Urologic Research Center, Myrtle Beach, SC, USA, 14. Rio Grande Urology, El Paso, TX, USA, 15. Manhattan Medical Research Center, New York, NY, USA, 16. Urology Austin, Austin, TX, USA, 17. Colorado Clinical Research, Lakewood, CO, USA, 18. Associated Urologists of North Carolina, Raleigh, NC, USA, 19. Weill Medical College of Cornell University, New York, NY, USA
Presenter
D

Dean Elterman
University of Toronto, Toronto, ON, Canada
Links

Abstract

Hypothesis / aims of study 
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%]).
Interpretation of results 
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.
Figure 1 Optilume BPH Procedure combined mechanical dilation using a proprietary double-lobe balloon with concurrent delivery of paclitaxel to limit continued growth and refusion of the lateral lobes after achievement of the anterior commissurotomy
Figure 2 Outcomes after treatment with the Optilume BPH Catheter System
Disclosures
Funding Sponsor (Urotronic, Inc.) Clinical Trial Yes Registration Number A Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH (PINNACLE), NCT04131907 RCT Yes Subjects Human Ethics Committee WCG IRB Canada Helsinki Yes Informed Consent Yes
Citation

Continence 7S1 (2023) 100725
DOI: 10.1016/j.cont.2023.100725

11/12/2024 16:49:48