Trial reportThe Journal of urology2023
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.
Trial report in The Journal of urology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06769997 (The Optizum Study), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Optizum Study: A Randomized, Blinded Single Center Study Evaluating the Optilume BPH Catheter System and the Rezum Water Vapor Therapy for the Treatment of Benign Prostatic Hyperplasia
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The median lobe scenario. How to tackle this challenge best: systematic review and expert guidance.World journal of urology · 2026Pooled it
- Reintervention rates after minimally invasive benign prostatic hyperplasia therapies: a systematic review including industry involvement.World journal of urology · 2025Pooled it
- 12-Month Outcomes From a Randomized, Sham-Controlled Trial Evaluating a Novel Prostatic Urethral Stent for the Treatment of Benign Prostatic Hyperplasia.The Journal of urology · 2026Trial
- 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).Prostate cancer and prostatic diseases · 2024Trial
- Separating mechanical dilation from paclitaxel-specific benefit in preclinical drug-coated balloon therapy for BPH.World journal of urology · 2026Article
- The safety and efficacy of drug-coated balloon dilation system (Keeway) for benign prostate hyperplasia: a preclinical study.World journal of urology · 2026Article
- A Comprehensive Review of Minimally Invasive Surgical Therapies for Voiding Dysfunction in Benign Prostatic Hyperplasia: Past Failures, Contemporary Successes and Future Innovations.Current urology reports · 2026Review
- Recalibrating sham-relative superiority thresholds in BPH device trials.World journal of urology · 2026Article
- Sexual and urinary outcomes of minimally invasive surgical therapies for LUTS/BPH: a narrative review.International journal of impotence research · 2026Review
- State-of-the-art in minimally invasive treatments for benign prostatic obstruction.Investigative and clinical urology · 2026Review
- Optilume, a minimally invasive solution for BPH and urethral stricture: what we know, what we need? an EAU endourology scoping review.BMC urology · 2025Article
- Off-label Use of the Optilume Drug-coated Balloon in the Treatment of Bladder Neck Stenosis and Vesicourethral Anastomosis Stenosis.European urology open science · 2025Article
- Long-term outcomes after treatment with Optilume BPH Four-year results from the EVEREST study.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2024Article
- Recent Advancements in Prostate Catheters and Stents for Management of Benign Prostatic Hyperplasia.Current urology reports · 2024Review
- The Optilume BPH Catheter System for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.Translational andrology and urology · 2024Article
- A critical evaluation of OptilumeTranslational andrology and urology · 2024Article
- Minimally invasive techniques in quest of Holy Grail of surgical management of enlarged prostates: a narrative review.World journal of urology · 2024Review
- Treatment Algorithm for Management of Benign Prostatic Obstruction: An Overview of Current Techniques.Life (Basel, Switzerland) · 2023Review
- Modern approaches to BPH management: expert insights and the latest evidence from the 2024 International Functional and Reconstructive Urology Update.Therapeutic advances in urologyArticle
Corrections and comments
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe 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
methodsEligible 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.
resultsA 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%).
conclusionsTreatment 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.