The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Continence rate after 6 weeks of treatment
研究概览
简要总结
More than 50% patients underwent prostatectomy suffered from postoperative incontinence, and the effect of pelvic floor muscle training is very limited. Electrical acupuncture stimulation therapy has been demonstrated to work on other kinds of Urinary Incontinence. Before this trial, the researchers have conducted pre-experiments where electrical acupuncture stimulation therapy was conducted for few postprostatectomy Incontinence patients. On the basis of the preliminary work, this prospective, random control research aims to verify the safety and effectiveness of electroacupuncture in the treatment of postprostatectomy Incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •localized prostate cancer (stage: cT1-cT2, N0, M0)
- •4-6weeks after prostatectomy
- •postprostatectomy prostate specific antigen (PSA) test below cured level
- •incontinence one month after surgery
- •ECOG score:0-1
排除标准
- •history of neoadjuvant hormonal therapy
- •history of transurethral resection of the prostate (TUPR)
- •history of operation on pelvis
- •history of incontinence before prostatectomy
结局指标
主要结局
Continence rate after 6 weeks of treatment
时间窗: 3 years
次要结局
- change of urine pad quantity for 24 hours after 4 courses compared with baseline(3 years)
- change of weight in kilograms of urine pad for 24 hours after 6 courses compared with baseline(3 years)
- changes of The expanded prostate cancer index composite(EPIC) score after 4-6 courses compared with baseline(3 years)
- Long-term urinary continence recovery(3 year)
研究者
Hongqian Guo
Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School