The ProVee Urethral Expander System Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 221
- 试验地点
- 33
- 主要终点
- Safety: Adverse Events (Time Frame: Procedure to 12 Months)
研究概览
简要总结
A study to evaluate the safety, performance, and effectiveness of the ProVee Urethral Expander System (Investigational Device) when used in subjects with symptomatic urinary obstruction related to benign prostatic hyperplasia (BPH).
详细描述
This is a prospective, multi-center, randomized, single-blind, sham-controlled study to evaluate the safety, performance, and effectiveness of the ProVee Urethral Expander System (Investigational Device) when used in subjects with symptomatic urinary obstruction related to benign prostatic hyperplasia (BPH). Subjects are assigned to their treatment arm using an unbalanced (2 ProVee:1 Sham) randomization stratified by Investigational Sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subject will have noise cancelling headphones on during the treatment. A drape will be placed preventing subjects from observing implant procedure. The follow-up clinic coordinator will not have access to enrolled subjects' medical records including the randomization scheme and treatment procedure.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males > 45 years of age
- •IPSS of ≥ 13, IPSS V/S > 1 at baseline assessment
- •Prostate volume of ≥ 30 cc and ≤ 80 cc
- •Prostatic urethral L2 lengths ≥ 3.75cm by TRUS
- •Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS
排除标准
- •Void volume <125 ml; Qmax > 12ml/s; PVR > 250 ml
- •Obstructive median lobe defined by EITHER (>10mm protrusion on sagittal mid-prostate plane as measured by TRUS) OR an obstructive median lobe seen on cystoscopy e.g., 'ball valve''
- •High bladder neck, with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction
- •Anatomy that would prevent the apices of the ProVee from engaging with the lateral lobes e.g., high degree of bladder neck angulation such that the anterior bladder neck is not visible
- •Acute urinary retention
- •Known immunosuppression
- •History of or suspected prostate or bladder cancer
- •Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction, including a SOC biopsy if indicated).
- •Recent urinary tract stones, OR widespread calcifications on the prostatic urethral wall, within 3 months of index procedure
- •A history of prostatitis within the last two years
- •Active or history of epididymitis within the past 3 months
- •Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes'
- •History of urinary retention within 12 months of baseline assessment
- •Requiring self-catheterization to void
- •An active urinary tract infection (UTI) at time of index procedure
- •Gross haematuria, within 3 months of index procedure
- •Subjects with known allergy to nickel or titanium
- •Life expectancy estimated to be less than 60 months
- •Taking androgens, unless eugonadal state for at least 3 months or greater with a stable dosage for at least 2 months as documented by the Investigator
- •Use of 5-alpha-reductase inhibitors (e.g., dutasteride, finasteride) within 6 months of baseline assessment
- •Use of Phenylephrine / Pseudoephedrine within 24 hours of baseline assessment
- •Use of alpha-blockers (e.g., Terazosin, Doxazosin, Alfuzosin, Tamsulosin) within 2 weeks of baseline assessment
- •Use of estrogen or drug-producing androgen suppression (e.g. gonadotropin-releasing hormonal analogues) within 1 year of baseline assessment
- •Use of antihistamines, anticonvulsants, and antispasmodics within 1 week of baseline assessment unless there is documented evidence that the patient was on the same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study)
- •Use of anticholinergics or cholinergic medication within 2 weeks of baseline assessment
- •Use of beta-blockers where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last 6 months)
- •Use of Phosphodiesterase-5 Enzyme Inhibitors in doses for BPH within 2 weeks of baseline assessment
- •Current treatment with anticoagulants (e.g., warfarin or enoxaparin) or antiplatelet medications other than aspirin (e.g., clopidogrel, or alternative and ASA). Patient unable to stop taking antiplatelet and/or antiplatelets within 3 days prior to the procedure or warfarin at least 5 days prior to the procedure. Low dose aspirin ≤100mg/day not prohibited
- •Future fertility concerns
- •Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate; including penile implants
- •Previous pelvic irradiation or radical pelvic surgery
- •Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease
- •Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
- •Urethral pathologies that may prevent insertion of Delivery System
- •Uncontrolled diabetes mellitus including Hgb AIC >8%
- •Overactive bladder (OAB) requiring treatment by OAB medication
- •Urinary incontinence
- •Patients taking tri-cyclic antidepressants.
- •Compromised renal function (i.e., serum creatinine >1.8 mg/dl or upper tract disease)
- •Hepatic disorder, bleeding disorders or metabolic impairment that might confound the results of the study or have a risk to subject per investigator's opinion
- •Any major comorbidities or presence of unstable conditions, e.g., uncontrolled HTN, NYHA Class III or IV, cardiac arrhythmias that are not controlled by medication/medical device, myocardial infarction within the past 6 months, COPD with FEV1 <50, renal illness that might prevent study completion or would confound study results
- •Vulnerable populations such as incarcerated or institutionalized adults, inmates, patients with physical, psychological (such as developmentally delayed adults), or medical impairment that might, in the judgment of the Investigator, prevent study completion or comprehension, or may confound study results (including patient questionnaires)
- •History or current medical condition that would result in an unacceptable patient risk if that subject were to be included in the study
- •Any subject that is currently enrolled in another ongoing investigational study.
研究组 & 干预措施
Device: The ProVee Urethral Expander System
The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm.
干预措施: ProVee Urethral Expander System (Device)
Sham: Ureteroscope and urethral access sheath
An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.
干预措施: Urethral Access Sheath (Procedure)
Crossover ProVee Urethral Expander System
All subjects shall be unblinded following the 3 month follow-up visit. Those subjects randomized to the Sham Arm will be given the opportunity to "crossover" to the ProVee Urethral Expander System.
干预措施: ProVee Urethral Expander System (Device)
结局指标
主要结局
Safety: Adverse Events (Time Frame: Procedure to 12 Months)
时间窗: Procedure - 12 months
This includes the rate of device or procedure related serious adverse events through 12-months.
Safety: Number of Device or Procedure Related Serious Adverse Events (Time Frame: Procedure to 12 Months)
时间窗: Procedure - 12 months
This includes the rate of device or procedure related serious adverse events
Safety: Number of Participants With Need for Urinary Catheterization (Time Frame: >7 Days Post Procedure)
时间窗: 7 days post treatment through to 12 months
The rate of extended post-operative urinary catheterization for inability to void among patients treated with the ProVee device.
Effectiveness: Number of Participants With Reduction in BPH Symptoms Compared to Sham (Time Frame: Procedure to 3 Months)
时间窗: Procedure to 3 months
The ProVee Treatment Group will be considered superior to the Sham Treatment Group when the mean 3-month improvement from baseline score for the IPSS symptom questionnaire demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for the Sham Treatment Group alone.
Effectiveness: Number of Participants With Symptoms Improvements (Time Frame: Procedure to 12 Months)
时间窗: Procedure to 12 months
The mean percent change in IPSS in the treatment arm is at least 30% improvement over the patient's pre-treatment baseline score.
次要结局
未报告次要终点