Optilume™ BPH Catheter System in Men With Symptomatic BPH
PINNACLE
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
1 other identifier
interventional
162
2 countries
21
Brief Summary
PINNACLE is a prospective, multi-center, randomized control clinical trial to establish the safety and efficacy of the Optilume™ BPH Catheter System in the treatment of benign prostatic hyperplasia (BPH)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2019
CompletedFirst Posted
Study publicly available on registry
October 18, 2019
CompletedStudy Start
First participant enrolled
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2022
CompletedResults Posted
Study results publicly available
April 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
ExpectedApril 9, 2025
April 1, 2025
2.5 years
October 16, 2019
June 20, 2024
April 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With >30% Improvement in the International Prostate Symptom Score (IPSS)
The primary efficacy endpoint was the improvement in International Prostate Symptom Score (IPSS) at 12 months in the Optilume BPH arm compared to the improvement in IPSS at 3 months in the Sham arm with a super-superiority margin on 25%. The IPSS contains the well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH symptoms. The first seven questions in the IPSS address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic. The IPSS also includes an eighth question that is designed to assess the degree of "bother" associated with the subject's urinary symptoms. Answers range from "delighted" to "terrible" (0-6). This question is not included in the calculation of the main IPSS score.
12 months
Number of Participants With Major Device Related Serious Complications
Rate of major device-related serious complications. A major device-related serious complication is defined as any of the following events through 12 months: * Device-related rectal fistula or GI fistula * Device-related formation of fistula between the rectum and urethra * Device-related new onset severe urinary retention lasting \> 14 consecutive days post-healing * Device-related unresolved new onset stress urinary incontinence by 90 days * Device-related bleeding requiring transfusion * Device-related urethra or prostatic capsule rupture requiring surgical intervention
12 months
Study Arms (3)
Optilume™ BPH Catheter System
EXPERIMENTALThe Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
Sham Device
SHAM COMPARATORThe Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.
Pharmacokinetics Optilume Arm
EXPERIMENTALA single arm of 15 non-randomized subjects will be treated in the pharmacokinetics (PK) arm. These subjects will be treated with the Optilume BPH Catheter System
Interventions
The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)
Eligibility Criteria
You may qualify if:
- Male subject 50-80 years of age who has symptomatic BPH
- International Prostate Symptom Score (IPSS) ≥ 13
- Peak urinary flow rate (Qmax) ≥ 5 ml/sec and ≤ 12 ml/sec (with minimum voided volume of ≥ 150 ml)
- Prostate volume 20 to 80 gm as determined by transrectal ultrasound (TRUS)
- Prostatic urethral length ≥ 32 mm and ≤ 55 mm as determined by TRUS
- History of inadequate response, contraindication, or refusal of BPH medical therapy
- Able to complete the study protocol in the opinion of the investigator
You may not qualify if:
- Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements
- Unwilling to abstain or use protected sex for the first 30 days post treatment
- Unwilling to abstain from sexual intercourse or use a highly effective contraceptive for at least 6 months post-procedure
- Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
- Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
- Prostate specific antigen (PSA) ≥ 10 ng/ml unless prostate cancer is ruled out by biopsy
- Confirmed or suspected malignancy of prostate or bladder
- Active or history of epididymitis within the past 3 months
- Previous pelvic irradiation or pelvic trauma surgery
- Active urinary tract infection (UTI) confirmed by culture
- Bacterial prostatitis within the last 12 months
- Non-bacterial prostatitis within the last 5 years
- Visible or invisible hematuria (\> 4 Red Blood Cells (RBCs) per high power field) on 2 separate urine specimens within the last 3 months without a know contributing factor
- Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
- History of urinary incontinence
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Urotronic Inc.lead
- ClinLogix. LLCcollaborator
Study Sites (21)
Arkansas Urology
Little Rock, Arkansas, 72211, United States
Colorado Clinical Research
Golden, Colorado, 80401, United States
Advanced Urology Institute
Daytona Beach, Florida, 32114, United States
Florida Urology Partners
Tampa, Florida, 33615, United States
Comprehensive Urologic Care
Lake Barrington, Illinois, 60010, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Chesapeake Urology Research Associates
Hanover, Maryland, 21076, United States
Chesapeake Urology Research Associates
Towson, Maryland, 21204, United States
Sheldon Freedman MD, Ltd
Las Vegas, Nevada, 89144, United States
New Jersey Urology
Englewood, New Jersey, 07631, United States
AccuMed Research Associates
Garden City, New York, 11530, United States
Manhattan Medical Research Practice, PLLC
New York, New York, 10016, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Associated Urologists of NC
Raleigh, North Carolina, 27612, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Urology Austin, PLLC
Austin, Texas, 78745, United States
North Austin Urology
Austin, Texas, 78750, United States
Rio Grande Urology
El Paso, Texas, 79912, United States
Clear Lake Specialties
Webster, Texas, 77598, United States
University Urology Associates
Toronto, Ontario, M5G 1E2, Canada
University of Montreal Hospital Center (CHUM)
Montreal, Quebec, H2X 3E4, Canada
Related Publications (1)
Kaplan SA, Moss JL, Freedman SJ. 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 Prostatic Dis. 2024 Sep;27(3):531-536. doi: 10.1038/s41391-024-00833-z. Epub 2024 Apr 29.
PMID: 38684918DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jill Moland
- Organization
- Laborie Medical Technologies
Study Officials
- PRINCIPAL INVESTIGATOR
Steven A Kaplan, MD
Mount Sinai Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Subjects in the Randomization arm of the study are randomized in a 2:1 allocation of Test to Control. The treating physician is unblinded to the treatment assignment. A blinded person at the study site conducts all study follow-up visits through the 12-Month follow-up visit (or until the subject is unblinded). The subject may be unblinded prior to the 12-Month visit if it is medically necessary, which includes the subject seeking alternative BPH therapy due to continued or recurrent BPH symptoms.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2019
First Posted
October 18, 2019
Study Start
February 5, 2020
Primary Completion
August 23, 2022
Study Completion (Estimated)
May 1, 2027
Last Updated
April 9, 2025
Results First Posted
April 9, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share