A Prospective Evaluation of Early Acupuncture for Immediate Continence Enhancement After Prostatectomy

Sponsor
Bin Xu
Study ID
NCT07239518
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Electroacupuncture — DEVICE
    Participants receive real electroacupuncture at acupoints including Shenshu (BL23), Pangguangshu (BL28), and Baliao (BL31-BL34). Treatment is administered for 30 minutes per session, for a total of 3 sessions (on post-operative days 7, 9, and 11). It uses a continuous wave (starting at 2Hz) with a current intensity of 1-5mA, gradually increased to the maximum tolerable level for the patient.
  • Sham Electroacupuncture — DEVICE
    Participants receive sham acupuncture using non-penetrating, blunt-tipped placebo needles (e.g., Park or Streitberger needles). These needles touch the skin but do not penetrate. They are applied at non-acupoint locations (1-2 cm away from real acupoints) for 30 minutes per session, for a total of 3 sessions (on post-operative days 7, 9, and 11). Electrodes are attached to the sham needle handles, and the device is turned on (making noise/lighting up) but does not deliver any electrical current, to maintain blinding.

Study Details

This study is being done to see if early acupuncture treatment can help men control their urination better right after their urinary catheter is removed following prostate cancer surgery (radical prostatectomy). Leaking urine is a very common problem immediately after this surgery, and current treatments often start after the catheter is already out. The researchers in this study believe that starting acupuncture before the catheter is removed might help "pre-activate" the nerves and muscles that control urination. This is a prospective, multi-center, randomized, placebo-controlled study. The study plans to enroll 144 men who have had prostate cancer surgery. Participants will be randomly assigned (like flipping a coin) into two groups: Treatment Group (72 participants): Will receive 3 sessions of real electroacupuncture. Control Group (72 participants): Will receive 3 sessions of sham (placebo/fake) acupuncture. This involves using a special blunt needle that touches the skin but does not go in, and a machine that looks like it is on but provides no electricity. The acupuncture or sham treatment will be given 3 times (on post-operative days 7, 9, and 11). The urinary catheter will be removed for all patients on post-operative day 14. All participants will also receive standard education on pelvic floor muscle exercises. The main thing the researchers will measure (the primary endpoint) is the amount of urine leakage (in grams) during a 1-hour pad test, which will be done within the first week after the catheter is removed. Researchers will also check urinary control using questionnaires and other pad tests at 4, 8, 12, and 24 weeks.

Key Dates

First listed
Nov 20, 2025
Start date
Dec 31, 2025
Status verified
Nov 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Electroacupuncture Group
    Participants receive real electroacupuncture at acupoints including Shenshu (BL23), Pangguangshu (BL28), and Baliao (BL31-BL34). Treatment is administered for 30 minutes per session. It uses a continuous wave (starting at 2Hz) with a current intensity of 1-5mA, gradually increased to the maximum tolerable level for the patient.
  • Sham Comparator: Sham Electroacupuncture
    Participants receive sham acupuncture using non-penetrating, blunt-tipped placebo needles. These needles are applied at non-acupoint locations (1-2 cm away from real acupoints). Electrodes are attached to the sham needle handles, and the device is turned on (making noise/lighting up) but does not deliver any electrical current, to maintain blinding.

Primary Outcome Measure

Urine Leakage Amount from 1-Hour Pad Test [ Time Frame: At the 1-week follow-up visit after catheter removal. ]

Find similar trials

Nationwide
Prostate cancer trialsOncology trialsProstate oncology trialsMen's health trialsUrology trials

Related Studies