The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Abstract

Purpose:The Optilume BPH Catheter System is a novel drug/device combination minimally invasive surgical therapy for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. The PINNACLE study is a prospective, randomized, double-blind, sham-controlled clinical trial evaluating the safety and efficacy of Optilume BPH against a sham surgical procedure.Materials and Methods:Eligible patients were men 50 years or older with symptomatic benign prostatic hyperplasia and a prostate size between 20 and 80 g. Subjects were randomized 2:1 to receive treatment with Optilume BPH or a sham surgical procedure. Blinding was maintained for subjects in both arms and evaluating personnel through 1 year postprocedure. Follow-up assessments included the International Prostate Symptom Score, uroflowmetry, and other quality-of-life and sexual function assessments.Results:A total of 148 men were randomized (100 active, 48 sham) at 18 centers in the U.S. and Canada. Subjects randomized to receive Optilume BPH saw a reduction in International Prostate Symptom Score of 11.5±7.8 points at 1 year posttreatment, as compared to a reduction of 8.0±8.3 points at 3 months in the sham arm. Flow rate was dramatically improved after treatment with Optilume BPH, with an improvement of +10.3 mL/s from baseline to 1 year (+125%).Conclusions:Treatment with Optilume BPH provides immediate and sustained improvements in obstructive symptoms and flow rate while preserving erectile and ejaculatory function. Treatment is well tolerated and can be done in an office or ambulatory setting.

Two-year long-term follow-up of treatment with the Optilume BPH catheter system in a randomized controlled trial for benign prostatic hyperplasia (The PINNACLE Study)

“…The 48 Sham participants were followed for one year and then discontinued from the study unless they opted to cross over to treatment with Optilume BPH. Data for this group was previously summarized [8]. Participant demographics in both groups was well matched [8].…”

“…Its approval by the US Food and Drug Administration (FDA) in June 2023 marks a significant addition to the array of promising alternatives within the MIST category. Demonstrating comparable symptom improvement to other MISTs, the Optilume BPH Catheter System notably exhibited exceptional improvement in Qmax during a 1-year follow-up [8], surpassing outcomes observed with other MIST options [4][5][6][7].…”

“…Optilume BPH is a safe and effective option, with excellent improvement in IPSS, quality of life measures (IPSS QoL and BPH-II) and Qmax through 1 year [8]. Here we present the results of the prospective multicenter, randomized clinical trial for patients treated with the Optilume BPH Catheter System that have completed 2-year follow-up.…”

A critical evaluation of Optilume® BPH as a novel minimally invasive surgical treatment for the management of lower urinary tract symptoms in men

“…The prospective, double-blind, randomised, sham-controlled PINNACLE study assessed the safety and efficacy of Optilume ® BPH (Urotonic, Inc., Minneapolis, MN, USA) compared to a sham procedure in 148 men with symptomatic benign prostatic hyperplasia (BPH) as characterised by International Prostate Symptom Score (IPSS) of ≥13 and maximum urinary flow rate (Qmax) between 5–12 mL/s ( 1 ). Full inclusion and exclusion criteria are listed in Table 1 .…”

Reply by Authors

“…Although the majority of patients were treated using parenteral sedation, those who were treated using oral and local anesthetic in the Optilume BPH cohort tolerated the procedure well and actually had lower postprocedural visual analogue scale pain scores than those with parenteral sedation (2.3 vs 4.3). 1 Utilization of local block has been established as an option for balloon dilation of the prostate 2 ; however, the authors suggest that further research is needed to identify the combination of analgesics for optimal patient comfort. With regard to Optilume BPH International Prostate Symptom Score improvement at 12 months being "only" 3 points better than sham at 3 months, the response seen in the sham group for the PINNACLE represents the most marked sham effect seen in minimally invasive surgical therapy trials to date, and rivals that seen by some active arms.…”