Electroacupuncture for Improving Urinary Incontinence After Radical Prostatectomy

NCT07245342 | Not Yet Recruiting

• 1 other identifier: 2024-1593-176-01
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

Brief 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

Prostate Cancer

Keywords

Electroacupuncture; Prostate Cancer; Radical Prostatectomy; Urinary Continence Recovery

Outcome Measures

Primary Outcomes (1)

• Complete Urinary Continence Rate

  The proportion of patients achieving complete urinary continence (defined as ≤1 safety pad per day).

  3 months postoperatively

Secondary Outcomes (9)

• Complete Urinary Continence Rate

  1, 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

• 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

• King's Health Questionnaire (KHQ) score

  1, 3, 6, and 12 months postoperatively

Study Arms (2)

Electroacupuncture Group

EXPERIMENTAL

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.

Procedure: Electroacupuncture

Sham Electroacupuncture Group

PLACEBO COMPARATOR

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.

Procedure: Sham Electroacupuncture

Interventions

Electroacupuncture PROCEDURE

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.

Electroacupuncture Group

Sham Electroacupuncture PROCEDURE

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.

Sham Electroacupuncture Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Xiangyang Zhan

  Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangyang Zhan

CONTACT

021-13253619759; zxy960110@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician in Charge

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): November 25, 2028
• Study Completion (Estimated): February 25, 2029
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share