2023
DOI: 10.1097/ju.0000000000003568
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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 siz… Show more

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Cited by 12 publications
(17 citation statements)
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“…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].…”
Section: Resultsmentioning
confidence: 99%
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“…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].…”
Section: Resultsmentioning
confidence: 99%
“…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].…”
Section: Introductionmentioning
confidence: 84%
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“…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 .…”
Section: Expert Summarymentioning
confidence: 99%
“…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.…”
Section: Reply By Authorsmentioning
confidence: 99%