Prospective and Randomized Analysis of Endoscopic Prostate Enucleation Using Moses 2.0 Technology Versus the New Thulium Fiber Laser in Medium and Large Prostates.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- SURGICAL TIME
研究概览
简要总结
Introduction: Endoscopic anatomical enucleation of the prostate (EEAP) with lasers has emerged as an effective and less invasive surgical option compared to traditional methods. Among the various available laser options, Holmium laser and Thulium Fiber laser have stood out as two prominent approaches for performing endoscopic prostate enucleation. These technologies have 3 showcased their effectiveness in ablating prostatic tissue and improving urinary symptoms. Nevertheless, differences in their physical properties and modes of action may impact their success rates and clinical outcomes. In our institution it is standard practice to use one laser or the other according to their availability in the operating room.
Primary Objective: To demonstrate the superiority of MoLEP over ThuFLEP in terms of enucleation efficiency.
Secondary Objectives: a) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of perioperative bleeding.
b) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of postoperative hospital stay.
c) To demonstrate the non-inferiority of ThuFLEP compared to ThuFLEP in terms of perioperative complications.
d) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in urinary symptoms.
e) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in flowmetric variables.
Study Type: Prospective, randomized, non-blind, multicentric clinical trial. Intervention: Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.
详细描述
Surgery and Follow-up Schedule
- Surgeries will be performed between September 2024 and September 2025.
- Initial follow-up at 3 months.
- Completion of the first phase of the study: March 2026.
Scheduled of Visits: Selection Visit, 1-Month Postoperative Visit, 3-Month Follow-up, 6-Month Follow-up, Annual Follow-up Visit (1-3 years).
Sample size calculation was done using the main outcome variable (total surgical time). Previous studies indicate that surgical time for ThuFLEP is 71.6 minutes [8]. The time for MoLEP may be at least 5 minutes less. Accepting an alpha risk of 5% and a beta risk of 20% in a two-tailed test, a total of 120 patients are needed (60 in each study group). A common standard deviation of 9 minutes change is assumed. A loss to follow-up rate of 15% has been estimated.
Randomization between the two surgery groups will be performed using the Efron procedure to balance the groups in terms of the number of subjects. The calculation will be carried out with the !RndSeq macro for SPSS Statistics. It will be conducted centrally by a person independent of the surgeon.
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged between 40 and 90 years.
- •Patients who, due to their lower urinary tract symptoms, are candidates for
- •BPH surgery, including:
- •Obstructive urinary symptoms evaluated through IPSS with a score >7 and QoL > 2 or acute urinary reten on refractory to catheter removal.
- •Obstructive urinary flow evaluated through uroflowmetry with Qmax< 15 ml/s, obstruction demonstrated by pressure/flow study, prostatic origin haematuria refractory to medical treatment, or acute urinary retention refractory to catheter removal.
- •Prostatic volume measured by transabdominal ultrasound, transrectal ultrasound, or magnetic resonance imaging of more than 80 cc.
- •Prostate-specific antigen (PSA) < 4 ng/ml, or with multiparametric prostate magnetic resonance imaging reporting PIRADS < 3 or equal to 3 with PSA density < 15%.
排除标准
- •Diagnosis, suspicion, or history of urethral stenosis or urethral surgery.
- •History of prostate surgery or pelvic radiotherapy.
- •Diagnosis or suspicion of prostate cancer or urothelial cancer.
- •Body mass index superior to 30.
研究组 & 干预措施
Endoscopic Prostate Enucleation Using Moses 2.0 Technology
Pulse modulation technology in Moses 2.0 applied to Holmium Laser Endoscopic Prostate (MoLEP).
干预措施: MoLEP (Procedure)
Endoscopic Prostate Enucleation Using the New Thulium Fiber Laser
Thulium Fiber laser to endoscopic prostate enucleation (ThuFLEP).
干预措施: ThuFLEP (Procedure)
结局指标
主要结局
SURGICAL TIME
时间窗: Total time of Surgery procedure
Difference in surgical time between MoLEP and ThuFLEP in prostates larger than 80 cc.
次要结局
- Urinary symptoms(From date of enrollment to date of the end of follow-up 3 years)
- Flowmetric variables maximum flow(From date of surgery to date of the end of follow-up 3 years)
- Flowmetric variables average flow(From date of surgery to date of the end of follow-up 3 years)
- Perioperative bleeding(From date of preoperative blood test to date of control blood test postoperatively within 24 hours after surgery)
- Perioperative complications(From date of surgery to date of the end of follow-up 3 years)
- Flowmetric variables post-void residual(From date of surgery to date of the end of follow-up 3 years)
- Postoperative hospital stay(From date and time of end of surgery to date and time of hospital discharge assessed up to 1 month)
研究者
Ivan Schwartzmann, MD
Principal Investigator
Fundacio Puigvert