Trial reportProstate cancer and prostatic diseases2024
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).
Trial report in Prostate cancer and prostatic diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04131907 (A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
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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.
A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Management of NOACs in patients undergoing water vapour thermal therapy (REZUM) for benign prostatic obstruction: a comprehensive review.World journal of urology · 2025Pooled it
- Reintervention rates after minimally invasive benign prostatic hyperplasia therapies: a systematic review including industry involvement.World journal of urology · 2025Pooled it
- Separating mechanical dilation from paclitaxel-specific benefit in preclinical drug-coated balloon therapy for BPH.World journal of urology · 2026Article
- Comparable is not equivalent in short-term optilume evaluation.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
- Best of 2025 in prostate cancer and prostatic diseases.Prostate cancer and prostatic diseases · 2026Article
- Treatment Regret in Patients Undergoing Minimally Invasive Treatments for Benign Prostatic Hyperplasia.Journal of clinical medicine · 2026Article
- The impact of minimally invasive surgical therapy for Benign prostatic hyperplasia on sexual function: a systematic review and meta-analysis.Prostate cancer and prostatic diseases · 2026Review
- Research progress on ejaculatory function preservation in minimally invasive surgical treatments for benign prostatic hyperplasia: a narrative review.Translational andrology and urology · 2025Review
- A review of management options for vesicourethral anastomotic stenosis and the emergence of robotic reconstruction.Translational andrology and urology · 2025Review
- Optilume, a minimally invasive solution for BPH and urethral stricture: what we know, what we need? an EAU endourology scoping review.BMC urology · 2025Article
- Management and Treatment of Benign Prostatic Hyperplasia Symptoms: Current Insights.Research and reports in urology · 2025Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatient outcomes were assessed 2 years after treatment with the Optilume BPH Catheter System, a minimally invasive surgical therapy for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
methodsOne-hundred forty-eight adult males with symptomatic BPH were enrolled and randomized in a 2:1 fashion to Optilume BPH or Sham (100 Optilume BPH; 48 Sham). Long-term measures include International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), Post-Void Residual Urine (PVR), quality of life measures and sexual function. Follow-up beyond one year was limited to those treated with Optilume BPH.
resultsAt 2 years, 67.5% (56/83 CI 56.3%, 77.4%) of participants in the Optilume BPH arm were symptomatic responders as defined by ≥30% improvement in IPSS without medical or surgical retreatment. IPSS significantly improved from 23.4 ± 5.5 (n = 100) to 11.0 ± 7.0 (n = 74). Qmax improved by 116.8.% (8.9 ± 2.2 (n = 97) to 19.0 ± 16.3 (n = 65)), while PVR showed a slight reduction (83.7 ± 70.3 (n = 99) to 65.9 ± 74.5 (n = 65)). Improvement in uroflowmetry measures was consistent across all prostate volumes. BPH-II improved from 7.0 ± 2.9 (n = 98) to 2.3 ± 2.5 at 1 year (n = 89) and remained consistent at 2.3 ± 2.9 at the 2-years (n = 74), representing a 53.9% improvement. IPSS QoL also improved from 4.6 ± 1.3 (n = 100) at baseline to 2.2 ± 1.5 (n = 74). The most common adverse events reported in the Optilume BPH arm were hematuria and urinary tract infection (UTI). No device and/or treatment related serious adverse events were reported occurring beyond 12 months post-procedure. There was no impact to sexual function.
conclusionsIn the PINNACLE study, participants treated with the Optilume BPH Catheter System demonstrated continued and durable results at 2 years, affirming tolerability, safety, and the enduring effectiveness. The Optilume BPH Catheter System provides lasting results that are comparable to the more invasive therapies, while preserving the advantages with being a minimally invasive therapy. REGISTRATION: ClinicalTrials.gov NCT04131907.
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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.