A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 17
- 主要终点
- Percentage of Participants With Treatment Success
研究概览
简要总结
To gain clinical experience with the GreenLight HPS System, a system designed to vaporize and coagulate tissue in the treatment of benign prostatic hyperplasia to reduce lower urinary tract symptoms.
详细描述
Enlarged prostate or Benign Prostatic Hyperplasia (BPH) is one of the most common diseases of aging men and can be associated with lower urinary tract symptoms (LUTS) such as having to urinate very often, a sudden strong feeling of having to urinate, having to get up at night to urinate, decreased and intermittent force of stream and the feeling of incomplete bladder emptying. These symptoms affect quality of life by interfering with normal daily activities and sleep patterns. When surgery is the best treatment option for the patient, the most common technique is a "transurethral resection of the prostate" (TURP). TURP involves removing the some of the extra tissue of the prostate gland. Even though TURP is a good treatment, there are concerns about the frequency of complications following treatment as well as the significant costs to patients, doctors, and insurance providers.
Photoselective vaporization of the prostate (PVP) is a relatively new technology that has similar benefits with fewer side effects than TURP. PVP is a minimally invasive procedure that uses a special high-energy laser to eliminate excess prostate tissue and seal the treated area. This technology has been used for more than a decade with over 200,000 procedures performed worldwide.
The focus of this study is to 1) document the long-term advantages of GreenLight HPS 120w and 2) to show that the stronger laser is a more flexible and efficient device which allows for a shorter procedure time, may be done in an out-patient setting in healthy patients, allows for shorter catheterization time, may result in a rapid urinary flow rate with minimal side effects, and may allow a quick return to normal activities. This device has been approved by the United States Food and Drug Administration (FDA) for treatment of obstructive BPH.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All male subjects ≥ 45 years of age who have a history of symptomatic/obstructive symptoms secondary to BPH greater than 3 months, an International Prostate Symptom Score (IPSS) / American Urology Association (AUA) score >14, require surgical intervention, and are an acceptable risk for anesthesia and surgery are eligible to participate in this study
排除标准
- •American Society of Anesthesiologists (ASA) classification of physical status > III
- •An unstable cardiopulmonary disorder, previously or recently diagnosed by standard methods
- •A myocardial infarction or coronary artery stent placement within 6 months of the treatment
- •Neurogenic lower urinary dysfunction
- •A post-void residual (PVR) volume ≥ 400 mL
- •Pre-existing urinary incontinence
- •Active localized or systemic infection, including urinary tract infection (UTI) or prostatitis affecting bladder function
- •Pre-existing damage of external urinary sphincter
- •Presence of cystolithiasis, urethral stricture, or bladder neck contracture
- •Prostate volume (PV), as measured by transrectal ultrasound (TRUS), less than 30cc or greater than 200cc
- •Previously confirmed or suspected malignancy of prostate or bladder, treated or untreated
- •Immunocompromised subjects
- •Serious bleeding disorders and coagulopathy. For example: hemophilia or Von Willebrand's disease
- •Desire to preserve antegrade ejaculation
- •Calcification of prostate tissue, usually after severe prostatitis
- •Deemed unfit for laser vaporization as determined by the attending physician
- •Enrollment in a concurrent clinical trial of any treatment (drug or device) that could affect urogenital function without sponsors' approval
- •Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all follow-up requirements
结局指标
主要结局
Percentage of Participants With Treatment Success
时间窗: 6 months
Treatment success is determined on a per patient basis and is defined as \[(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS\] greater than or equal to 50%
次要结局
- Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.(6 months post-treatment)
- Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years.(5 years)
- Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.(Up to five years)
- Occurrence of Retrograde Ejaculation(5 Year Follow Up)
- Percentage of Participants With Clinically-significant Improvement in Uroflow.(6 months post-treatment)
- Treatment-related Complication(3 months)
- Gross Hematuria(91 days)
- Percentage of Participants With Treatment Success(5 Years)