Optilume™ BPH Catheter System in Men With Symptomatic BPH

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Benign Prostatic Hyperplasia

In brief

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)

Key facts

Study ID

NCT04131907

Run by

Urotronic Inc.

People needed

162

Starts

2020-02-05

Expected to finish

2027-05-01

Last updated by the study team

2026-07-30

Who can join

Age: 50 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

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
• Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
• Previous rectal surgery, other than hemorrhoidectomy
• Use of antihistamines, anticonvulsants or antispasmodics within 1 week prior to baseline assessment unless there is documented evidence of stable dosing for at least 6 months
• Use of antidepressants with adrenergic effects (i.e. duloxetine, imipramine and amitriptyline), long-acting anticholinergics (LAAC) for chronic obstructive pulmonary disease (COPD), or androgens within 2 weeks prior to baseline assessment unless there is documented evidence of stable dosing for at least 3 months prior to baseline assessment
• Use of Luteinizing Hormone-Releasing Hormone (LHRH) analogs within 12 months prior to baseline assessment
• Use of Type II 5-alpha reductase inhibitor [e.g. finasteride (Proscar, Propecia)] within 3 months of baseline assessment
• Use of 5-alpha reductase inhibitor [e.g. dutasteride (Avodart)] within 6 months of baseline assessment
• Use of estrogen or drugs producing androgen suppression unless there is documented evidence of stable dosing for at least 3 months prior to baseline assessment
• Use of alpha blockers or daily dose PDE5 inhibitor (e.g. Cialis) within 2 weeks of baseline assessment
• Use of warfarin or novel oral anti-coagulants [e.g., apixaban (Eliquis), fondaparinux (Arixtra), rivaroxaban (Xarelto) or edoxaban (Savaysa)], unless the medication is safely discontinued prior to the procedure and is not planned to be restarted for at least 5 days post-procedure

Where it is running

• Arkansas Urology — Little Rock, Arkansas, United States
• Colorado Clinical Research — Golden, Colorado, United States
• Advanced Urology Institute — Daytona Beach, Florida, United States
• Florida Urology Partners — Tampa, Florida, United States
• Comprehensive Urologic Care — Lake Barrington, Illinois, United States
• Regional Urology, LLC — Shreveport, Louisiana, United States
• Chesapeake Urology Research Associates — Hanover, Maryland, United States
• Chesapeake Urology Research Associates — Towson, Maryland, United States
• Sheldon Freedman MD, Ltd — Las Vegas, Nevada, United States
• New Jersey Urology — Englewood, New Jersey, United States
• AccuMed Research Associates — Garden City, New York, United States
• Manhattan Medical Research Practice, PLLC — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Associated Urologists of NC — Raleigh, North Carolina, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Urology Austin, PLLC — Austin, Texas, United States
• North Austin Urology — Austin, Texas, United States
• Rio Grande Urology — El Paso, Texas, United States
• Clear Lake Specialties — Webster, Texas, United States
• University Urology Associates — Toronto, Ontario, Canada
• University of Montreal Hospital Center (CHUM) — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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