Optilume™ BPH Catheter System in Men With Symptomatic BPH

Not Applicable

Active, not recruiting

Conditions: Benign Prostatic Hyperplasia

Interventions: Device: Optilume Sham Device
Device: Optilume BPH Catheter System

Registration Number: NCT04131907

Lead Sponsor: Urotronic Inc.

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: Male

Target Recruitment: 162

Inclusion Criteria

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

Exclusion Criteria

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
Use of anti-platelet medications (e.g., clopidogrel, aspirin) within 10 days prior to the procedure or planned use within 5 days post-procedure
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
Incidence of spontaneous urinary retention within 6 months prior to baseline assessment
Current post-void residual volume > 300 ml or catheter dependent bladder drainage
Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec)
Current bladder or prostatic urethral stones
Biopsy of prostate within 40 days prior to procedure
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
Current uncontrolled diabetes (i.e. hemoglobin A1c ≥ 8%)
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
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
Life expectancy < 10 years
Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment in this study
Significant median lobe component [e.g. intravesical prostatic protrusion (IPP) > 1 cm]
Device that corresponds with the subject's prostate size is not available
Currently enrolled in or plan to enroll in another investigational clinical study for any disease except for observational only study
In the opinion of the investigator, it is not in the subject's best interest to participate in the study

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Device	Optilume Sham Device	The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.
Optilume™ BPH Catheter System	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.
Pharmacokinetics Optilume Arm	Optilume BPH Catheter System	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With >30% Improvement in the International Prostate Symptom Score (IPSS)	12 months	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.
Number of Participants With Major Device Related Serious Complications	12 months	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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (20): 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
🇺🇸
Towson, Maryland, United States
New Jersey Urology
🇺🇸
Englewood, New Jersey, United States
Sheldon Freedman MD, Ltd
🇺🇸
Las Vegas, Nevada, 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
North Austin Urology
🇺🇸
Austin, Texas, United States
Urology Austin, PLLC
🇺🇸
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