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.
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 1.
Willingness to participate in the study and provision of written informed consent.
Presence of preoperative detrusor overactivity, urethral stricture, urge urinary incontinence, stress urinary incontinence, or overflow urinary incontinence.
Preoperative International Prostate Symptom Score (IPSS) ≥ 20.
Concurrent urogenital infectious diseases (e.g., acute urethritis, acute cystitis).
History of pelvic radiotherapy.
Parallel
Electroacupuncture
Procedure/SurgeryBilateral acupoints Shangliao (BL31), Ciliao (BL32), Zhongliao (BL33), Xialiao (BL34), and Shenshu (BL23) were localized according to WHO standards. Following skin disinfection, each point was punctured using a sterile disposable needle (0.30 × 45 mm) and manually stimulated via lifting, thrusting, and rotating for 30 seconds to elicit deqi. An electroacupuncture device (SDZ-II, Huatuo brand) was then connected, delivering continuous wave stimulation at 50 Hz. Current intensity was set between 1-5 mA to produce mild local muscle trembling without pain, applied for 20 minutes per session.Treatments were administered three times weekly (preferably every other day) for six weeks. All procedures were performed by licensed acupuncturists with ≥2 years of experience, who received standardized pre-trial training in point localization, needling technique, and device operation.
Sham Electroacupuncture
Procedure/SurgeryPatients in the control group will receive sham acupuncture identical in schedule and duration to the electroacupuncture group. Needling will be performed at non-acupoint sites, 1 cun lateral to the true acupoints (BL31-BL34, BL23), using superficial insertion (1-4 mm depth) without manual stimulation to prevent deqi.A deactivated electroacupuncture device (SDZ-II, Huatuo brand) with internally short-circuited wiring will be attached to mimic the active treatment setup, though no current will be delivered.All sham acupuncture procedures will be conducted by licensed acupuncturists with at least two years of experience, who will receive standardized training prior to the trial in sham point location and needling protocols to ensure procedural consistency.
Complete Urinary Continence Rate
The proportion of patients achieving complete urinary continence (defined as ≤1 safety pad per day).
Complete Urinary Continence Rate
The proportion of patients achieving complete urinary continence (defined as ≤1 safety pad per day).
International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) score
The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) is used to assess the impact of urinary incontinence on quality of life over the past four weeks. It comprises three scored items addressing the frequency of leakage, the amount of leakage, and the overall impact on daily life, along with a fourth unscored item designed to help determine the type of incontinence. The total score ranges from 0 to 21, with higher scores indicating greater severity.
Incontinence-Quality of Life (I-QOL) Questionnaire score
Scores are inversely related to symptom severity, meaning a higher score denotes a superior quality of life.
Visual Analog Scale (VAS)
Scored by measuring the patient's mark on a 10-cm line, where a greater length indicates poorer self-rated urinary control.
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