MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- International Prostate Symptom Score (IPSS) Change
研究概览
简要总结
Over 100,000 BPH procedures are performed annually in the US. The purpose of this study is to evaluate the effectiveness of performing MRI guided transrectal laser ablation using a 980 nm laser (VisualaseTM by Medtronic, Inc., a Minnesota, U.S.A. company) to treat benign prostatic hypertrophy (BPH). The laser system will be used to necrotize urological soft tissue within the prostate under MRI guidance. This will be a single center, single arm prospective trial with an anticipated enrollment of 10 men. Patients who elect this treatment option and choose to be part of the study will be enrolled consecutively.
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
- 是
入选标准
- •Diagnosis of lower urinary track symptoms (LUTS).
- •Prostate volume of 40 - 200 cc.
- •Men ≥ 45 years old.
- •BPH Impact Index ≥ 5.
排除标准
- •History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, or findings suggestive of likely underlying prostate cancer.
- •Need to catheterize to relieve obstruction.
- •Daily use of incontinence materials/padding.
- •Neurogenic or hypotonic bladder, Parkinson's Disease, or a history of uncontrolled diabetes.
- •Prior interventional or surgical treatment of BPH.
- •Penile prosthesis.
- •Artificial urinary sphincter or collagen bladder injection.
- •Urethral stricture.
- •Bleeding disorder/coagulopathy.
- •Inability to refrain from blood thinners in the peri-procedural period.
- •Inability or chooses not to provide informed consent.
- •Any serious medical condition which would make proceeding to treatment unsafe.
- •Significant contraindication to MRI or gadolinium contrast.
- •Hip replacement.
- •Lack of a rectum.
- •Life expectancy of less than two years.
- •Unable or unwilling to complete all required questionnaires and follow-up assessments.
结局指标
主要结局
International Prostate Symptom Score (IPSS) Change
时间窗: From baseline to 24 months
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
时间窗: From baseline to 24 months
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")
Sexual Health Inventory of Men (SHIM) Score Change
时间窗: From baseline to 24 months
This survey rates erectile function from 0 (no function) to 25 (full function)
BPH Impact Index Change
时间窗: From baseline to 24 months
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Number of Adverse Events
时间窗: Continuous until completion of the study at 2 years
We asked patients to self-report adverse events.
次要结局
未报告次要终点