About this trial
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.
Eligibility criteria
Qualifiers
Patients who have undergone radical prostatectomy with a confirmed pathological diagnosis of prostate cancer.
One week post-radical prostatectomy (RP).
Karnofsky Performance Score (KPS) ≥ 60 or ECOG Performance Status 0-1.
Age between 50 and 85 years.
Disqualifiers
Pathological results show positive surgical margins.
Previous treatment for post-operative urinary incontinence, such as cystostomy, urethral sphincter reconstruction, or urethral suspension.
Currently or within the last 6 months receiving treatment with principles similar to acupuncture (e.g., electroacupuncture, moxibustion, warm moxibustion).
Active urinary system infection (excluding asymptomatic lower urinary tract infection).
Trial design
Treatments tested in this trial
- Electroacupuncture
- Sham Electroacupuncture
Treatment groups
Locations
Sponsors and collaborators
Bin Xu
Lead sponsor
Zhongda Hospital
Sponsor institution