A Prospective Evaluation of Early Acupuncture for Immediate Continence Enhancement After Prostatectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50-85
SponsorBin Xu
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Electroacupuncture
DeviceParticipants 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
DeviceParticipants 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.
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Experimental: Electroacupuncture GroupExperimental treatment 1 intervention
Group B: Sham ElectroacupunctureSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Urine Leakage Amount from 1-Hour Pad Test
Urine leakage volume, measured in grams (g), collected during a standardized 1-hour pad test.
Time frame
At the 1-week follow-up visit after catheter removal.Secondary outcomes
1
1-Hour Pad Test Urine Leakage Amount (Later Follow-ups)
Time frame
At 4-week and 24-week follow-up visits after catheter removal.2
ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form) Score
Time frame
At 1, 4, 8, 12, and 24-week follow-up visits after catheter removal.3
Proportion of Completely Continent (Leak-Free) Patients
Time frame
At 1, 4, 8, 12, and 24-week follow-up visits after catheter removal.4
SAS (Self-Rating Anxiety Scale) Score
Time frame
At 1, 4, 8, 12, and 24-week follow-up visits.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bin Xu
Lead sponsor
Zhongda Hospital
Sponsor institution
Source ClinicalTrials.gov
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