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Electroacupuncture for Improving Urinary Incontinence After Radical Prostatectomy

NCT07245342 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2025-11-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Electroacupuncture

Bilateral 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.

PROCEDURE

Sham Electroacupuncture

Patients 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.

Sponsors & Collaborators

  • Shanghai University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Xiangyang Zhan · Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-25
Primary Completion
2028-11-25
Completion
2029-02-25

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07245342 on ClinicalTrials.gov