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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 162
- 试验地点
- 39
- 主要终点
- Number of Participants With >30% Improvement in the International Prostate Symptom Score (IPSS)
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects in the Randomization arm of the study are randomized in a 2:1 allocation of Test to Control. The treating physician is unblinded to the treatment assignment. A blinded person at the study site conducts all study follow-up visits through the 12-Month follow-up visit (or until the subject is unblinded). The subject may be unblinded prior to the 12-Month visit if it is medically necessary, which includes the subject seeking alternative BPH therapy due to continued or recurrent BPH symptoms.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Optilume BPH Catheter System (Device)
Sham Device
The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.
干预措施: Optilume Sham Device (Device)
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
干预措施: Optilume BPH Catheter System (Device)
结局指标
主要结局
Number of Participants With >30% Improvement in the International Prostate Symptom Score (IPSS)
时间窗: 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
时间窗: 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
次要结局
未报告次要终点