Optilume Catheter for Enlarged Prostate
(PEAK Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Urotronic Inc.
Disqualifiers: Prostate malignancy, UTI, Neurogenic bladder, Incontinence, Diabetes, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the Optilume BPH Catheter System treatment for enlarged prostate?
Research shows that the Optilume BPH Catheter System, which uses a balloon to open up the prostate and delivers a drug called paclitaxel to keep it open, has positive outcomes for improving urinary symptoms and quality of life in men with an enlarged prostate.
12345Is the Optilume BPH Catheter System safe for treating an enlarged prostate?
The Optilume BPH Catheter System has been evaluated in studies like the PINNACLE and EVEREST-I, which suggest it is generally safe for treating lower urinary tract symptoms due to an enlarged prostate, with favorable patient outcomes and minimal complications reported.
12456How is the Optilume BPH Catheter System treatment different from other treatments for enlarged prostate?
The Optilume BPH Catheter System is unique because it combines balloon dilation with a localized delivery of paclitaxel (a drug that helps keep the passage open) to treat enlarged prostate symptoms. This minimally invasive procedure can be done in an office setting without general anesthesia, offering favorable outcomes for both urinary and sexual function.
12457Eligibility Criteria
This trial is for men experiencing symptoms of an enlarged prostate, also known as Benign Prostatic Hyperplasia (BPH). Specific eligibility criteria are not provided, but typically participants should be adults with a diagnosis of BPH who meet certain health standards.Inclusion Criteria
Willing to provide informed consent and comply with protocol required follow-up
Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL
Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use
+4 more
Exclusion Criteria
Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
Obstructive median lobe in the opinion of the investigator
Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the Optilume BPH Catheter System treatment
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Multiple visits (in-person and virtual) over 12 months
Semen Sub-Study Follow-up
Participants in the semen sub-study are monitored for changes in sperm concentration
3 months
Follow-up visits at 3 months
Participant Groups
The Optilume® BPH Catheter System is being tested in this study. The system is designed to treat urinary problems caused by an enlarged prostate. This post-market study aims to confirm its safety and effectiveness after it has been approved for use.
1Treatment groups
Experimental Treatment
Group I: Study ArmExperimental Treatment1 Intervention
Optilume BPH Catheter System
Optilume® BPH Catheter System is already approved in United States, Canada for the following indications:
🇺🇸 Approved in United States as Optilume BPH Catheter System for:
- Treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia (BPH) in men ≥ 50 years of age
🇨🇦 Approved in Canada as Optilume BPH Catheter System for:
- Treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia (BPH) in men ≥ 50 years of age
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Urotronic, INCPlymouth, MN
Arkansas UrologyLittle Rock, AR
Florida Urology Partners, LLPTampa, FL
Ochsner LSU Health Shreveport - Regional UrologyShreveport, LA
More Trial Locations
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Who Is Running the Clinical Trial?
Urotronic Inc.Lead Sponsor
References
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. [2023]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.
One-year outcomes after treatment with a drug-coated balloon catheter system for lower urinary tract symptoms related to benign prostatic hyperplasia. [2022]Label="BACKGROUND">This is the first report of the 1-year outcomes of the EVEREST-I study evaluating the safety and efficacy of the Optilume® BPH Catheter System, a prostatic paclitaxel-coated balloon catheter system, for the treatment of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH).
Long-term clinical results and quality of life after insertion of a self-expanding flexible endourethral prosthesis. [2019]To evaluate the safety and efficacy of the Urolume self-expanding flexible endourethral stent, based on a long-term follow-up, and to determine its role amongst the various modalities of treatment available for the relief of bladder outlet obstruction (BOO) arising from benign prostatic hyperplasia (BPH).
How I Do It: Optilume BPH catheter system. [2023]Benign prostatic hyperplasia (BPH) is a common and progressive disease affecting aging men which has a significant impact on quality of life. The Optilume BPH Catheter System (Optilume BPH) is a prostatic dilation system that combines balloon dilation with a localized transfer of paclitaxel to maintain long term patency. Optilume BPH can be deployed using standard rigid cystoscopy without general anesthesia in an office setting. Prospective data indicate that Optilume BPH has favorable functional and sexual patient outcomes. Readers will familiarize themselves with Optilume BPH, significant historical studies and the technique for deploying Optilume BPH.
Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study. [2023]To evaluate the safety and efficacy of the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
Device Malfunctions and Complications Associated with Benign Prostatic Hyperplasia Surgery: Review of the Manufacturer and User Facility Device Experience Database. [2021]Introduction and Objectives: Multiple surgical therapies for benign prostatic hyperplasia (BPH) have been developed to decrease complications and increase provider efficiency. We investigated contemporary BPH treatment device-related adverse events by searching a publicly available database. Materials and Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for contemporary BPH treatments. All devices were evaluated for malfunction, patient complications, and manufacturer review. The MAUDE adverse event classification system was used to standardize complications. Univariate analysis was performed to identify associations between BPH devices and adverse events. Results: A total of 2567 reports were identified: transurethral resection of the prostate (TURP) 197 (7.67%), holmium laser enucleation of the prostate (HoLEP) 39 (1.52%), GreenLight™ 2315 (90.2%), and UroLift® 16 (0.62%). The most common deviations for each modality included cutting loop detachment during TURP 116 (58.9%), morcellator dysfunction for HoLEP 23 (58.9%), tip fracture/detachment for GreenLight (68.8%), and failure to deploy during UroLift 10 (62.5%). Only 18 (0.7%) patients required medical/surgical management (MAUDE II-IV) due to a device complication. No significant relationship was seen between each modality and complications; however, morcellator use (27.8%) was observed in higher grade complications. Manufacturer review occurred in 61.7% of cases, with 41.3% of reviewed cases finding the operator the cause of the malfunction. Conclusion: Each BPH modality investigated had minimal patient harm with over 99% of patients experiencing no complication after device malfunction. Of note, great care should be taken with morcellator use during HoLEP as it had the greatest number of MAUDE II to IV complications among all devices. Manufacturer review revealed that over 40% of cases were due to misuse by the user. Therefore, urologists should select the modalities they are most familiar with to decrease patient harm and prevent device malfunctions.
A drug-coated balloon treatment for urethral stricture disease: Interim results from the ROBUST I study. [2020]We aimed to investigate the safety and preliminary efficacy of the Optilume™ paclitaxel-coated balloon for the treatment of recurrent urethral stricture.