The FLOW Registry: Functional and Longitudinal Outcomes With Waterjet Ablation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Efficacy of aquablation procedure in patients with benign prostatic hyperplasia as assessed by the change in mean International Prostate Symptom Score (IPSS)
研究概览
简要总结
The purpose of this study is to create a database and prospective registry for data collection on patients with benign prostatic hyperplasia undergoing Aquablation of the prostate. All patients undergoing Aquablation of the prostate will be enrolled in the registry. Historical data from 1/1/2024- 11/30/2025 will be added through chart review. Current and future patient data will be collected through chart review during the subject's clinical care. Only data available in the electronic medical record will be collected and no additional data will be collected for research purposes. No biospecimens will be collected, and there are no physical risks from study participation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Diagnosis of benign prostatic hyperplasia
- •Scheduled to undergo or have already undergone Aquablation as part of routine clinical care or any ongoing clinical trials
- •Aquablation performed with ultrasound guided, robotic assisted waterjet. Newer methods and instrumentation continue to be developed to ablate tissue, and these energy sources can be entered into the registry as clinical use begins.
排除标准
- •Under 18 Years of age.
研究组 & 干预措施
Benign Prostatic Hyperplasia Patients Undergoing Prostate Aquablation
Patients with benign prostatic hyperplasia undergoing aquablation of the prostate for the management of benign prostatic hyperplasia.
结局指标
主要结局
Efficacy of aquablation procedure in patients with benign prostatic hyperplasia as assessed by the change in mean International Prostate Symptom Score (IPSS)
时间窗: Baseline to follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total after prostate aquablation
Safety of the aquablation procedure in patients with BPH.
时间窗: Baseline to 30 days post-aquablation
Number of incidences of Clavien-Dindo Grade ≥ II complications
Efficacy of aquablation procedure in patients with benign prostatic hyperplasia as assessed by the change in Q max/uroflowmetry.
时间窗: Baseline to follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total after prostate aquablation.
次要结局
- Rate of procedural failure requiring reoperation for benign prostatic hyperplasia(Baseline to 24 months post-procedure)
- Incidence of urethral stricture or bladder neck contracture(12 and 24 months post-procedure)
- Relationship between prostate volume reduction and prostate-specific antigen (PSA) reduction(Baseline to 6 months post-procedure)
- Change from baseline in sexual function as assessed by the change in Male Sexual Health Questionnaire - Ejaculation Short Form (MSHQ-EjD)(Baseline and 3, 6, 12, and 24 months post-procedure)
- Change from baseline in quality of life scores as assess by the The International Prostate Symptom Score (IPSS-QoL)(Baseline and 3, 6, 12, and 24 months post-procedure)
- Change from baseline in sexual function as assessed by the change in SEXUAL HEALTH INVENTORY FOR MEN (SHIM)(Baseline and 3, 6, 12, and 24 months post-procedure)
- Change from baseline in urinary function(Baseline and 3, 6, 12, and 24 months post-procedure)
- Association between preoperative characteristics and clinical outcomes(Baseline through 24 months post-procedure)