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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: Optilume BPH Catheter System; Device: Optilume Sham Device

Detailed Description

This is a prospective, multi-center, double blind, randomized controlled clinical trial in a 2:1 allocation of Test versus sham Control. In addition, a single arm of 15 non-randomized subjects will be added to study the Pharmacokinetics of the drug. The objectives of the study are to assess the efficacy of Optilume BPH Catheter System to alleviate LUTS believed to be secondary to BPH (LUTS/BPH) and to evaluate the safety of Optilume BPH Catheter System in the treatment of LUTS/BPH.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1E2
      • University Urology Associates
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • University of Montreal Hospital Center (CHUM)
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Urology
  • Colorado
    • Golden, Colorado, United States, 80401
      • Colorado Clinical Research
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Advanced Urology Institute
    • Tampa, Florida, United States, 33615
      • Florida Urology Partners
  • Illinois
    • Lake Barrington, Illinois, United States, 60010
      • Comprehensive Urologic Care
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Maryland
    • Hanover, Maryland, United States, 21076
      • Chesapeake Urology Research Associates
    • Towson, Maryland, United States, 21204
      • Chesapeake Urology Research Associates
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Sheldon Freedman MD, Ltd
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • New Jersey Urology
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • New York, New York, United States, 10016
      • Manhattan Medical Research Practice, PLLC
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Associated Urologists of NC
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Texas
    • Austin, Texas, United States, 78750
      • North Austin Urology
    • Austin, Texas, United States, 78745
      • Urology Austin, PLLC
    • El Paso, Texas, United States, 79912
      • Rio Grande Urology
    • Webster, Texas, United States, 77598
      • Clear Lake Specialties

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male subject 50-80 years of age who has symptomatic BPH
2. International Prostate Symptom Score (IPSS) ≥ 13
3. Peak urinary flow rate (Qmax) ≥ 5 ml/sec and ≤ 12 ml/sec (with minimum voided volume of ≥ 150 ml)
4. Prostate volume 20 to 80 gm as determined by transrectal ultrasound (TRUS)
5. Prostatic urethral length ≥ 32 mm and ≤ 55 mm as determined by TRUS
6. History of inadequate response, contraindication, or refusal of BPH medical therapy
7. Able to complete the study protocol in the opinion of the investigator

Exclusion Criteria:

1. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements
2. Unwilling to abstain or use protected sex for the first 30 days post treatment
3. Unwilling to abstain from sexual intercourse or use a highly effective contraceptive for at least 6 months post-procedure
4. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
5. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
6. Prostate specific antigen (PSA) ≥ 10 ng/ml unless prostate cancer is ruled out by biopsy
7. Confirmed or suspected malignancy of prostate or bladder
8. Active or history of epididymitis within the past 3 months
9. Previous pelvic irradiation or pelvic trauma surgery
10. Active urinary tract infection (UTI) confirmed by culture
11. Bacterial prostatitis within the last 12 months
12. Non-bacterial prostatitis within the last 5 years
13. 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
14. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
15. History of urinary incontinence
16. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
17. Previous rectal surgery, other than hemorrhoidectomy
18. 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
19. 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
20. Use of Luteinizing Hormone-Releasing Hormone (LHRH) analogs within 12 months prior to baseline assessment
21. Use of Type II 5-alpha reductase inhibitor [e.g. finasteride (Proscar, Propecia)] within 3 months of baseline assessment
22. Use of 5-alpha reductase inhibitor [e.g. dutasteride (Avodart)] within 6 months of baseline assessment
23. 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
24. Use of alpha blockers or daily dose PDE5 inhibitor (e.g. Cialis) within 2 weeks of baseline assessment
25. 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
26. Use of anti-platelet medications (e.g., clopidogrel, aspirin) within 10 days prior to the procedure or planned use within 5 days post-procedure
27. History of hypersensitivity reactions to paclitaxel, on medication that may have negative interaction with paclitaxel, presence of solid tumor with a baseline neutrophil count of <1500 cells/mm3 or AIDS-related Kaposi's sarcoma with baseline neutrophil count of <1000 cells/mm3
28. Incidence of spontaneous urinary retention within 6 months prior to baseline assessment
29. Current post-void residual volume > 300 ml or catheter dependent bladder drainage
30. Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec)
31. Current bladder or prostatic urethral stones
32. Biopsy of prostate within 40 days prior to procedure
33. History of cancer in non-genitourinary system which is not considered in complete remission (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered in complete remission if there has been no evidence of cancer within five years
34. Current uncontrolled diabetes (i.e. hemoglobin A1c ≥ 8%)
35. History of clinically significant comorbidities or presence of unstable conditions [e.g. cardiovascular, lung, renal (serum creatinine > 2.0 mg/dl), hepatic, bleeding disorders or metabolic impairment] that may confound the results of the study or have a risk to subject per investigator's opinion
36. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires
37. Life expectancy < 10 years
38. Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment in this study
39. Significant median lobe component [e.g. intravesical prostatic protrusion (IPP) > 1 cm]
40. Device that corresponds with the subject's prostate size is not available
41. Currently enrolled in or plan to enroll in another investigational clinical study for any disease except for observational only study
42. In the opinion of the investigator, it is not in the subject's best interest to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optilume™ BPH Catheter System; 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.	Device: Optilume BPH Catheter System; 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.
Sham Comparator: Sham Device; The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.	Device: Optilume Sham Device; 21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)
Experimental: Pharmacokinetics Optilume Arm; A 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	Device: Optilume BPH Catheter System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Urotronic Inc.
• Collaborators: ClinLogix. LLC
• Investigators: Principal Investigator: Steven A Kaplan, MD, Mount Sinai Health System

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Actual): August 23, 2022
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: BPH, Drug Coated Balloon, DCB, prostate, LUTS, Optilume
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: PR1087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes