Prospective Randomized Controlled Comparison of Holmium Laser Enucleation of the Prostate With Robotic Water Jet Ablation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Prostate Volume
研究概览
简要总结
This study compares two FDA-approved surgical treatments for benign prostatic hyperplasia (BPH): Holmium Laser Enucleation of the Prostate (HoLEP) with MOSES 2.0 technology and Robotic Water Jet Ablation (RWJA) using the Hydros Robotic System. Men with BPH and prostate volumes between 50 and 180 mL will be randomly assigned to one of the two procedures. The study will measure changes in prostate volume, PSA, urinary flow, and bladder emptying at 12 months, along with safety, sexual function, continence, and healthcare utilization outcomes, which will be followed for up to 5 years after surgery.
详细描述
This prospective, randomized controlled trial is designed to compare the safety, effectiveness, and long-term durability of Holmium Laser Enucleation of the Prostate (HoLEP) utilizing MOSES 2.0 technology with Robotic Water Jet Ablation (RWJA) performed using the Hydros Robotic System for the treatment of benign prostatic hyperplasia (BPH). The trial will enroll 100 men aged 50 to 80 years who present with moderate-to-severe lower urinary tract symptoms secondary to BPH and prostate volumes between 50 and 180 mL. Participants will be randomized in a 1:1 ratio to receive either HoLEP or RWJA and will be monitored for five years following treatment.
The primary objective is to compare objective measures of treatment efficacy and durability at 12 months, specifically changes in prostate volume, prostate-specific antigen (PSA) levels, urinary flow rate (Qmax), and post-void residual urine volume (PVR). Secondary objectives include assessment of perioperative outcomes, safety profiles, patient-reported urinary and sexual function, treatment durability, reintervention rates, and healthcare resource utilization. Outcomes will be measured using validated instruments, such as the International Prostate Symptom Score (IPSS), Sexual Health Inventory for Men (SHIM), Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD), and Incontinence Severity Index (ISI).
Although both procedures are established and FDA-approved therapies for BPH, direct comparative evidence is limited. This study seeks to address this evidence gap by generating high-quality comparative effectiveness data to inform clinical decision-making and patient counseling. The results may clarify the relative benefits and tradeoffs of each procedure, particularly in terms of symptom improvement, preservation of sexual function, durability of treatment response, and long-term healthcare utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Patients are blind for the first 3 months after the intervention
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, age 50-80 years
- •International Prostate Symptom Score (IPSS) ≥ 12
- •Prostate size (TRUS): 50-180 mL
- •Diagnosis of LUTS due to BPH
- •Uroflow Qmax ≤ 15 mL/sec
- •Mentally capable, able to comply with study procedures, written informed consent provided
- •Able to follow study instructions and complete all required visits
排除标准
- •History of prostate cancer
- •Suspected or history of bladder cancer
- •Active or untreated bladder stones at screening
- •Indwelling catheter for more than 3 months before baseline
- •Active urinary tract infection
- •History of urethral stricture or bladder neck stenosis
- •Damage to the external urethral sphincter
- •Previous prostate surgery or lower urinary tract surgery
- •Use of obligatory anticoagulants (if not stoppable) or known coagulopathy (except ASA 100 mg/d)
- •Contraindications to general and spinal anesthesia
- •Any condition that could interfere with study participation or outcomes, per investigator judgment
- •Lacks legal or mental capacity to consent
- •Simultaneous participation in another therapeutic urological trial
- •Known or persistent abuse of medication, drugs, or alcohol
研究组 & 干预措施
HoLEP with MOSES 2.0
Holmium laser enucleation of the prostate using MOSES 2.0 pulse-modulation technology, performed per institutional standard of care.
干预措施: Device - HoLEP with MOSES 2.0 (Device)
RWJA with Hydros Robotic System
Robotic-assisted waterjet ablation of the prostate using the Hydros Robotic System, performed per institutional standard of care.
干预措施: RWJA with Hydros Robotic System (Device)
结局指标
主要结局
Change in Prostate Volume
时间窗: Baseline and 12 months post-intervention
Measured via transrectal ultrasound (TRUS); change from baseline.
Change in Prostate-Specific Antigen (PSA)
时间窗: Baseline and 12 months post-intervention
Serum PSA level; change from baseline.
Change in Urinary Flow Rate (Qmax)
时间窗: Baseline and 12 months post-intervention
Peak urinary flow rate via uroflowmetry; change from baseline.
Change in Post-Void Residual Volume (PVR)
时间窗: Baseline and 12 months post-intervention
Bladder scan-measured PVR; change from baseline.
次要结局
- Incidence and Severity of Adverse Events(From patient hospital discharge through 3 and 12 months post-surgery)
- Operative Time(Day (duration) of surgical procedure)
- Hemostasis Time(Day (duration) of surgical procedure)
- Perioperative Change in Hemoglobin(Baseline to immediate postoperative period (when patient is in the recovery room post surgery))
- Time to Catheter-Free Status(From surgery day until catheter removal)
- Length of Hospital Stay / Discharge Time(Day of surgical procedure through hospital discharge)
- Change in IPSS/QoL Score(Baseline, 3, 6, and 12 months post-surgery)
- Change in SHIM Score(Baseline, 3, 6, and 12 months post-surgery)
- Change in MSHQ-EjD Score(Baseline, 3, 6, and 12 months post-surgery)
- Change in Incontinence Outcomes(Baseline, 3, 6, and 12 months post-surgery)
- Long-Term Durability of Functional Improvements(24, 36, 48, and 60 months post-intervention)
- Post-Operative Medication Use(Through 60 months post-intervention)
- Reintervention Rate(Through 60 months post-intervention)
- Unplanned Healthcare Encounters(Through 60 months post-intervention)
- Incidence of Urethral Stricture Requiring Intervention(Through 60 months post-intervention)
- Unanticipated Advanced Diagnostics(Through 60 months post-intervention)