Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

Study Overview
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Brief Summary
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A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years. The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.

Detailed Description
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A prospective, non-randomized, multi-center study. The study will enroll up to 85 subjects to be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. Subjects will be followed up post-treatment at Foley removal, and up to 1 year. The subjects may choose to be followed-up annually for 5 years or until study close, whichever comes first. Study device is Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System. Study primarily outcomes are measured by 1). Change in IPSS score at 3-month post-procedure follow-up; 2). Major device or procedure related complications at 3-month post-procedure follow-up.

Official Title
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Evaluation of Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter in the Treatment of Moderate-to-Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Conditions
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Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy

Intervention / Treatment
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* Device: Optilume™ BPH Prostatic DCB Dilation Catheter
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subject > 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13) and is a candidate for interventional therapy LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH) Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml Post-void residual (PVR) ≤ 250 ml Prostate volume 20 - 80 gm as determined by TRUS Prostatic urethra length is 35 - 55 mm as determined by TRUS Able to complete the study protocol in the opinion of the investigator Exclusion Criteria: Interested in maintaining fertility and unwilling to use protected sex for the first 30 days post treatment Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential Presence of a penile implant 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 PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy Confirmed or suspected malignancy of prostate or bladder Active or history of epididymitis within the past 3 months Previous pelvic irradiation or radical pelvic surgery Documented active urinary tract infection (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catheterization specimen) Visible hematuria with subject urine sample without known contributing factor Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms Use of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week prior to treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes) Use of alpha blockers, antidepressants, anticholinergics, androgens, daily tadalafil or gonadotropin-releasing hormonal analogs (prescribed for BPH) within 3 weeks prior to treatment Use of 5-alpha reductase inhibitor within 6 months prior to treatment Incidence of spontaneous urinary retention within 6 months prior to baseline assessment Post-void residual volume > 250 ml or catheter dependent bladder drainage Overactive bladder (OAB) or urge incontinence Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec) Current bladder stones or prostatic calculi Biopsy of prostate within 30 days prior to procedure or planned within 30 days following the procedure History of cancer in non-genitourinary system which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years 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 Expected life expectancy < one year Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements Currently enrolled in or plan to enroll in another investigational clinical trial 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 Current treatment with anti-coagulants (e.g., warfarin or enoxaparin) or anti-platelet medications other than aspirin (e.g., clopidogrel) Anatomy, e.g. presence of false passage or size of meatus, is not suitable for treatment in this study Device that corresponds with the subject's prostate size per the IFU is not available Intravesical prostatic protrusion (IPP) > 1 cm Current uncontrolled diabetes (hemoglobin A1c > 7%) Unable or unwilling to provide all the protocol-required semen samples Sensitivity to paclitaxel, on medication that may have negative interaction with paclitaxel, or contraindicated for systemic paclitaxel

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: treatment group - treated with Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optilume™ BPH Prostatic DCB Dilation Catheter<br>Optilume™ BPH Prostatic DCB treatment procedure | Device: Optilume™ BPH Prostatic DCB Dilation Catheter<br>* BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).<br>* Other names: BPH Prostatic DCB;Drug: Paclitaxel<br>* paclitaxel will release to adjacent tissue after the balloon inflated in the urethra<br>* Other names: drug coated balloon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Responder at 3 Months | The proportion of subjects experiencing at least a 40% improvement in International Prostate Symptom Score (IPSS) scores from baseline to 3 months. 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. | 90 days | 
| Major Device/Procedure Related Complications | The proportion of subjects reporting a composite of device/procedure related severe urinary retention (lasting >14 days), unresolved stress urinary incontinence, or bleeding requiring transfusion. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH