Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Sep;210(3):500-509.
doi: 10.1097/JU.0000000000003568. Epub 2023 Aug 9.

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

Steven A Kaplan  1 , Jared Moss  2 , Sheldon Freedman  3 , Karl Coutinho  4 , Ning Wu  5 , Mitchell Efros  6 , Dean Elterman  7 , Richard D'Anna  8 , Osvaldo Padron  9 , Kaiser J Robertson  10 , Samuel Lawindy  11 , Sandeep Mistry  12 , Neal Shore  13 , Jeffrey Spier  14 , Jed Kaminetsky  15 , Brian Mazzarella  16 , David Cahn  17 , Mark Jalkut  18 , Alexis Te  19
Affiliations
Randomized Controlled Trial

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

Steven A Kaplan et al. J Urol. 2023 Sep.

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.

Keywords: lower urinary tract symptoms; minimally invasive surgical procedures; prostatic hyperplasia.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest: OP: Gulf Coast: clinical research; BM: Teleflex, Boston Scientific, Proverum: consultant. The remaining Authors have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
Optilume BPH combines 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.
Figure 2.
CONSORT (Consolidated Standards of Reporting Trials) flow diagram of subject disposition in both study arms through the 12-month time point. ¥Subjects missing data for the intent-to-treat (ITT) analysis of the primary end point were imputed using multiple imputation; subjects receiving additional medical or surgical therapy for benign prostatic hyperplasia (BPH) were considered as having no improvement from baseline. PK indicates pharmacokinetic.
Figure 3.
Figure 3.
Improvement in International Prostate Symptom Score (IPSS) from baseline to the stated time point in the intent-to-treat population (mean±95% CI).
See this image and copyright information in PMC

Comment in

References

    1. Lerner LB, McVary KT, Barry MJ. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA guideline part I—initial work-up and medical management. J Urol. 2021;206(4):806-817. - PubMed
    1. Jacobsen SJ, Jacobson DJ, Girman CJ. Treatment for benign prostatic hyperplasia among community dwelling men: the Olmsted County study of urinary symptoms and health status. J Urol. 1999;162(4):1301-1306. - PubMed
    1. Lusty A, Siemens DR, Tohidi M, Whitehead M, Tranmer J, Nickel JC. Cardiac failure associated with medical therapy of benign prostatic hyperplasia: a population based study. J Urol. 2021;205(5):1430-1437. - PubMed
    1. Bortnick EM, Simma-Chiang V, Kaplan SA. Long-term consequences of medical therapy for benign prostatic hyperplasia. Rev Urol. 2019;21(4):154-157. - PMC - PubMed
    1. Rassweiler J, Teber D, Kuntz R, Hofmann R. Complications of transurethral resection of the prostate (TURP)—incidence, management, and prevention. Eur Urol. 2006;50(5):969-980. - PubMed

Publication types