Optilume™ BPH Catheter System in Men With Symptomatic BPH

NCT ID: NCT04131907

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-05
• Study Completion Date: 2027-05-31

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)

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Optilume BPH Catheter System

Intervention Type: DEVICE

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 Device

The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.

Group Type: SHAM_COMPARATOR

Optilume Sham Device

Intervention Type: DEVICE

21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)

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

Group Type: EXPERIMENTAL

Optilume BPH Catheter System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Optilume Sham Device

21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ClinLogix. LLC

INDUSTRY

Sponsor Role: collaborator

Urotronic Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven A Kaplan, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Health System

Locations

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

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 38684918 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PR1087

Identifier Type: -

Identifier Source: org_study_id