Water Vapor Thermotherapy vs. Combination Pharmacotherapy for Symptomatic Benign Prostatic Hyperplasia Refractory to Alpha Blocker Monotherapy in Sexually Active Men: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 155
- 试验地点
- 41
- 主要终点
- International Prostate Symptom Score (IPSS) change
研究概览
简要总结
The study objective is to compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.
详细描述
STUDY OBJECTIVE - To compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.
STUDY DESIGN - Multicenter open-label randomized controlled parallel-group post-market trial.
STUDY TREATMENTS AND RANDOMIZATION - Subjects will be randomly assigned to REZŪM or dual drug therapy treatments; 1:1 randomization via the electronic data capture (EDC) system. Both treatments are commercially available. Subjects randomized to receive the REZŪM treatment will receive standardized treatment and subjects randomized to dual drug therapy will receive the local formulary preferred choice of urinary selective alpha blocker and 5-alpha reductase inhibitor.
VISIT SCHEDULE - Study visits are at: enrollment/baseline, treatment, 3 months, 6 months, and yearly follow-up through 2 years.
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
- 否
入选标准
- •Sexually active male subjects ≥ 45 years of age who have persistent non-neurogenic lower urinary tract symptoms refractory to first-line treatment with single agent Alpha Adrenoceptor Antagonist therapy
- •Subject is willing and able to answer all domains of MSHQ
- •Completed IPSS questionnaire with score ≥ 13 within 6 months prior to enrollment
- •Peak urinary flow rate (Qmax): ≤ 15 ml/sec with minimum voided volume of ≥ 150 ml within 6 months prior to enrollment
- •Post-void residual (PVR) ≤250 ml within 6 months prior to enrollment
- •Prostate volume ≥ 30 ml as measured by transrectal ultrasound or Magnetic Resonance Imaging within 3 months prior to enrollment
- •Subject is willing and capable of providing informed consent
- •Subject is willing and capable of participating in all visits associated with this study at an approved clinical study site and at the intervals defined by this Clinical Investigational Plan (CIP)
- •France subjects only: subjects must be affiliated to national security insurance
排除标准
- •Inability to participate in full duration of study
- •Prior surgical treatment for BPH
- •Increased risk of bleeding
- •Presence of Genitourinary Cancer or other pelvic cancer
- •Functional issues with bladder
- •Presence of active infection in genitourinary tract
- •Structural and Anatomic issues with urinary tract and renal function
- •Concomitant Drug Therapy
- •Temporal restraints and risks for general anaesthesia or comorbidity that would elevate risk of participation
研究组 & 干预措施
REZŪM
Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use (IFU). The REZŪM System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men with a prostate volume ≥ 30 ml. The REZŪM System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
1:1 randomization will occur via the electronic data capture (EDC) system.
干预措施: REZŪM (Device)
Dual Drug Therapy
Subjects assigned to dual drug therapy will be treated with the local formulary preferred choice of commercially available urinary selective alpha blocker and 5-alpha reductase inhibitor. This arm will therefore represent local standard of care.
干预措施: alpha blocker and 5-alpha reductase inhibitor (Drug)
结局指标
主要结局
International Prostate Symptom Score (IPSS) change
时间窗: From Baseline to 12 months
Primary Statistical Hypothesis: Change in IPSS score will be compared between groups. IPSS score ranges from 0 to 35 with higher scores indicating worse symptoms.
Male Sexual Health Questionnaire (MSHQ) total score change
时间窗: From Baseline to 12 months
Change in MHSQ score will be compared between groups. MHSQ score ranges from 0 to 125 with higher scores indicating better outcomes.
次要结局
- Disease Progression(End of available follow-up, up to 24 months)