Impact of Sustainable Functional Urethral Reconstruction on Early Continence Recovery After Robotic-assisted Radical Prostatectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- 1-month urinary continence recovery rates
研究概览
简要总结
The study is a prospective randomized controlled trail to compare early urinary continence recovery after robotic-assisted radical prostatectomy with or without sustainable functional urethral reconstruction (SFUR).
详细描述
Early urinary incontinence has always been a tricky problem for both patients and urologists, even though over 90% patients can recover 1 year after surgery. Many urologists are trying to modify the surgical technique to resolve this problem. Sustainable functional urethral reconstruction (SFUR) is a novel technique which may improve early urinary continence recovery for both local and locally advanced prostate cancer, and even for those with high volume prostate by providing adequate urethral length with bladder neck tubularization and making sustainable periurethral support with peritoneal flap. The purpose of this study is to verify the impact of this new technique on early recovery of urinary continence, as well as on urinary function and oncological outcomes.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •≥40, but ≤75 years old；
- •Histological confirmed prostate cancer；
- •Localized or locally advanced prostate cancer；
- •Presence of urinary continence prior to the procedure;
- •Informed consent signed;
排除标准
- •Metastatic prostate cancer confirmed by ECT, PSMA or whole-body MRI;
- •Presence of any prostatic surgery(such as transurethral resection, laser therapy, microwave therapy, radiofrequency ablation and so on) prior to the procedure;
- •Radiation therapy of the prostate or pelvis prior to the procedure;
- •Uncontrolled intercurrent illness that would limit compliance with study requirements;
- •Any condition that contraindicates a radical prostatectomy;
结局指标
主要结局
1-month urinary continence recovery rates
时间窗: 1 month after catheter removal
Continence defined as daily usage of 0-1 pad with 24-hour pad weights≤50g.
次要结局
- Short-term urinary continence recovery(Within 3 month after catheter removal)
- Peri and postoperative complications(1-year follow up)
- Post-operative oncological outcomes(1-year follow up)
- Short-term urinary function and urinary function-related quality of life(1-week, 2-week, 1-month, 3-month after catheter removal.)
研究者
Yinghao Sun
Chief Physician
Changhai Hospital