Early Electroacupuncture for Urinary Continence After Radical Prostatectomy: A Randomized, Single-Blind, Sham-Electroacupuncture-Controlled, Parallel-Group, Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 216
- 主要终点
- Complete Urinary Continence Rate
研究概览
简要总结
This clinical trial aims to find out if early electroacupuncture (EA) helps people recover the ability to control urination and is safe after surgery to remove the prostate gland for prostate cancer (radical prostatectomy).
Participants are people aged 18 to 80 with localized prostate cancer who have had radical prostatectomy and are in good physical condition (ECOG score 0-1, meaning they can manage daily activities well).
It will answer two key questions:
Does early EA make more people fully control their urination 3 months after prostate surgery? How does early EA affect urination control and safety at 1, 6, and 12 months after surgery? Researchers will compare two groups: one getting EA and the other getting a fake version (sham EA ) to see if EA works better.
Participants will start treatment 1 week after surgery, getting EA or sham EA 3 times a week for 6 weeks, 20 minutes each time. They will also complete tests to check urination control and fill out surveys about their urination, quality of life, and symptoms at different times. Their safety will be watched closely too.
详细描述
Prostate cancer (PCa) is the most commonly diagnosed malignancy and the second leading cause of cancer-related death among men worldwide, significantly impacting both physical and psychological health. Radical prostatectomy (RP) remains the gold standard for treating localized prostate cancer, with three primary goals: oncologic control, recovery of urinary continence, and preservation of sexual function. While advances in surgical techniques and pharmacotherapy have substantially improved cancer control outcomes, functional recovery-particularly regarding post-prostatectomy incontinence (PPI)-remains a major challenge. PPI primarily results from intraoperative damage to the bladder neck structure and surrounding nerves, compromising urinary control. Postoperative ischemia and scar adhesion may further exacerbate incontinence. Studies report PPI rates of 18%-55% at 3 months and 4%-31% at 1 year after RP. Electroacupuncture(EA), evolved from traditional manual acupuncture, augments the technique by applying controlled electrical currents. Evidence suggests that EA can deliver pulsed currents to stimulate muscles and nerves, inducing passive contractions of the pelvic floor muscles. It may also excite sympathetic nerves, inhibit parasympathetic activity, modulate detrusor contractility, enhance urethral sphincter function, and improve urethral closure-all of which may contribute to restoring urinary control.Given these potential benefits, along with its simplicity, low cost, and favorable safety profile, we hypothesize that early post-surgical EA-initiated immediately after RP-may promote urinary continence more effectively than delayed intervention after conservative treatments have failed. This approach aligns with both clinical needs and the traditional Chinese medicine principle of "preventive treatment."Based on the premise that early EA can accelerate the recovery of urinary continence after RP, we previously conducted an observational study. The results indicated that early EA was associated with higher rates of early complete continence recovery, shorter time to continence, and high patient satisfaction, with no reported adverse events.To further evaluate the efficacy and safety of early EA for PPI, we designed this randomized, single-blind, sham-controlled, multicenter trial. Patients undergoing robotic or laparoscopic RP will be assigned to either EA or sham EA, with intervention starting within one week post-surgery and lasting for six weeks. The study aims to assess efficacy and safety outcomes, thereby determining whether early EA facilitates urinary continence recovery in patients following RP.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 80 years (inclusive) with a diagnosis of localized prostate cancer scheduled for radical prostatectomy.
- •Clinical tumor stage ≤ cT2bN0M0 confirmed by preoperative evaluation.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Willingness to participate in the study and provision of written informed consent.
排除标准
- •Presence of preoperative detrusor overactivity, urethral stricture, urge urinary incontinence, stress urinary incontinence, or overflow urinary incontinence.
- •Preoperative International Prostate Symptom Score (IPSS) ≥
- •Concurrent urogenital infectious diseases (e.g., acute urethritis, acute cystitis).
- •History of pelvic radiotherapy.
- •Previous prostate surgery.
- •Severe cardiovascular disease, hepatic or renal dysfunction, or coagulation disorders.
- •Presence of psychiatric or psychological conditions impairing the ability to provide coherent feedback.
- •Receipt of any acupuncture treatment within one month prior to the study.
- •Needle phobia, history of fainting during acupuncture, or strong aversion to acupuncture therapy.
- •Any other condition considered by the investigators to render the patient unsuitable for study participation.
研究组 & 干预措施
Electroacupuncture Group
Patients in this group will receive electroacupuncture intervention starting from 1 week after radical prostatectomy, following a standardized treatment schedule to assess its effect on postoperative urinary continence recovery.
干预措施: Electroacupuncture (Procedure)
Sham Electroacupuncture Group
Patients in this group will receive sham electroacupuncture intervention with the same treatment schedule and duration as the electroacupuncture group, to serve as a placebo control and ensure the validity of the trial results.
干预措施: Sham Electroacupuncture (Procedure)
结局指标
主要结局
Complete Urinary Continence Rate
时间窗: 3 months postoperatively
The proportion of patients achieving complete urinary continence (defined as ≤1 safety pad per day).
次要结局
- Complete Urinary Continence Rate(1, 6, and 12 months postoperatively)
- Incontinence-Quality of Life (I-QOL) Questionnaire score(1, 3, 6, and 12 months postoperatively)
- Visual Analog Scale (VAS)(1, 3, 6, and 12 months postoperatively)
- International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) score(1, 3, 6, and 12 months postoperatively)
- King's Health Questionnaire (KHQ) score(1, 3, 6, and 12 months postoperatively)
- International Prostate Symptom Score (IPSS)(1, 3, 6, and 12 months postoperatively)
- Quality of Life Core Questionnaire (QLQ-C30) score(1, 3, 6, and 12 months postoperatively)
- Analysis of Risk Factors Influencing Treatment Efficacy (Multivariable Logistic Regression)(3 months postoperatively)
- Median Time to Complete Urinary Continence(Within 12 months postoperatively)
研究者
Xiangyang Zhan
Physician in Charge
Shanghai University of Traditional Chinese Medicine