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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Therapeutic Responder at 3 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Optilume™ BPH Prostatic DCB Dilation Catheter
Optilume™ BPH Prostatic DCB treatment procedure
干预措施: Optilume™ BPH Prostatic DCB Dilation Catheter (Device)
Optilume™ BPH Prostatic DCB Dilation Catheter
Optilume™ BPH Prostatic DCB treatment procedure
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Therapeutic Responder at 3 Months
时间窗: 90 days
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.
Major Device/Procedure Related Complications
时间窗: 90 days
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.
次要结局
未报告次要终点