Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for Benign Prostatic Hyperplasia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Paired comparison of International Prostate Symptom Score (IPSS) percent change
研究概览
简要总结
This prospective, multicenter, two-arm, 1:1 randomized controlled trial (RCT) will enroll approximately 250 males at approximately 25 sites located within the United States. All enrolled subjects will be 45 years of age or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). They will be randomized to one of two readily available, marketed BPH therapies; Prostatic Urethral Lift procedure with the UroLift System (PUL Arm) or 0.4mg tamsulosin HCl (MED Arm).
详细描述
This prospective, multicenter, two-arm, 1:1 randomized controlled trial (RCT) will enroll approximately 250 males at approximately 25 sites located within the United States. All enrolled subjects will be 45 years of age or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). They will be randomized to one of two readily available, marketed BPH therapies; Prostatic Urethral Lift procedure with the UroLift System (PUL Arm) or 0.4mg tamsulosin HCl (MED Arm).Men 45 or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). BPH symptoms may range from mild (8) to severe (35) on the IPSS scale. All enrolled men must meet selection criteria and be candidates for therapy with both UroLift System and 0.4 mg tamsulosin HCl.
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
- None
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
- •Male 45 years of age or older
- •Diagnosis of BPH
- •Experiencing symptoms of BPH as indicated by an IPSS ≥8 and ≤30
- •Willing to wash out of current BPH medication(s), as applicable
- •An appropriate candidate for both BPH therapies evaluated in this study.
- •Ability to understand and consent to participate in this study
- •Willing and able to participate in follow-up evaluations
排除标准
- •Use of alpha blocker for BPH unless washed-out for 30 days
- •Use of daily phosphodiesterase type 5 inhibitor (PDE5i) for BPH unless washed-out for 30 days
- •5-alpha-reductase inhibitors for BPH used within 6 months of therapy initiation
- •Current urinary tract infection or prostatitis
- •Current gross hematuria
- •Urinary incontinence presumed due to incompetent sphincter
- •Catheter-dependent urinary retention within 1 month prior to enrollment
- •Prostate volume greater than 100 cc as measured by TRUS
- •Prostate specific antigen level of greater than 10 ng/ml within one year of enrollment unless prostate cancer has been ruled out
- •History of neurogenic or atonic bladder
- •History prostate cancer treatment
- •Known to be hypersensitive to tamsulosin HCl or any component of tamsulosin HCl capsules
- •Known allergy to nickel, titanium, or stainless steel
- •Prior minimally invasive or surgical intervention for BPH
- •Urethral conditions that may prevent insertion of delivery system into bladder.
- •Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint
- •History of medical, surgical or other conditions that, in the opinion of the investigator, would interfere with the treatment or evaluation of the subject
研究组 & 干预措施
Prostatic Lift
Treatment with the UroLift System
干预措施: UroLift System (Device)
Medication
Treatment with Tamsulosin HCl 0.4mg
干预措施: Tamsulosin Hydrochloride (Drug)
结局指标
主要结局
Paired comparison of International Prostate Symptom Score (IPSS) percent change
时间窗: 3 Months after Therapy Initiation
The primary study analysis compares the change in BPH symptoms in the PUL Arm to the change in BPH symptoms in the MED Arm measured 3 months after BPH therapy initiation. This will be measure by International Prostate Symptom Score (IPSS) percent change. IPSS ranges from 0-35, healthier patients have lower scores than patients more effected by BPH symptoms.
次要结局
- Change in Quality of Life (QoL)(3 months after BPH Therapy Initiation)