Prospective Feasibility Trial on MRI-TRUS Fusion Water Vapour Ablation for Benign Prostatic Hyperplasia (STEAM-MAP 1 Study - Steam Therapy With MRI and AI-assisted Planning)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 3
研究概览
简要总结
The STEAM-MAP 1 Study is a single-arm, prospective feasibility trial evaluating the integration of MRI-transrectal ultrasound (TRUS) fusion guidance into Rezūm water vapor thermal therapy for men with symptomatic benign prostatic hyperplasia (BPH).
详细描述
This study aims to assess the feasibility, procedural characteristics, and early safety of MRI-TRUS fusion-guided planning and delivery of Rezūm water vapor therapy in men with symptomatic benign prostatic hyperplasia.
Eligible patients with prior MRI prostate fulfilling the eligibility criteria will be enrolled from the participating hospitals. Baseline assessment including symptom severity and uroflowmetric measurements, urine culture will be performed in the usual routine pre-Rezūm nurse-led clinics. The intervention will consist of MRI segmentation and image-informed injection planning, with documentation of planned and delivered injection sites and performance metrics. .
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 30-80 years old with symptomatic BPH.
- •Prostate volume 30-80 mL (TRUS/MRI/US)
- •Suitable for Rezum.
- •Able to consent and comply with follow-up to 1 month.
- •With prior prostate MRI within 2 years
排除标准
- •Known/suspected prostate cancer requiring oncologic management.
- •Prior prostate surgery impacting urethral anatomy within 12 months.
- •Prior implant affecting urethral anatomy.
- •Active UTI or untreated bacteriuria pre-op.
- •Uncorrectable coagulopathy; inability to manage antithrombotics.
- •Severe medical comorbidity precluding endoscopy.
研究者
Alex Qinyang Liu
Assistant Professor
Chinese University of Hong Kong