Prostate CancerPEACENCT07239518
A Prospective Evaluation of Early Acupuncture for Immediate Continence Enhancement After Prostatectomy
A study testing Electroacupuncture in people with Prostate Cancer and Urinary Incontinence, run by Bin Xu.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Prostate Cancer, Urinary Incontinence
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Signed informed consent.
Who cannot join
- 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).
- Known severe heart diseases, such as severe arrhythmia, severe heart failure, acute myocarditis, constrictive pericarditis, pericardial tamponade, severe valvular disease, or heart failure.
- Known liver damage or potential severe liver disease (ALT or AST > 10 times the normal limit).
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- Known severe renal impairment (eGFR < 25mL/min/1.73m2), planned or ongoing dialysis, or acute contrast-induced nephropathy at screening.
- Known dysfunction of other vital organs or severe primary diseases, such as hematopoietic system diseases.
- Known coagulation dysfunction (with typical clinical diagnosis or clear laboratory test results).
- Patients with mental illness or cognitive impairment; patients with severe depression, alcohol dependence, or a history of drug abuse.
- Urinary incontinence known to be due to other reasons.
- According to the investigator's judgment, the patient is not suitable for this study or has a high probability of dropout (e.g., frequent changes in work environment that make follow-up difficult).
- Life expectancy ≤ 6 months, as judged by the investigator.
- Currently participating in other clinical trials.
About this study
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.
Read more
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.
- Conditions
- Prostate Cancer, Urinary Incontinence
- Being tested
- Electroacupuncture, Sham Electroacupuncture
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
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 ElectroacupunctureDevice
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 group | Role | What they receive |
|---|---|---|
| Experimental: Electroacupuncture Group | Experimental | 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. Receives: Device: Electroacupuncture |
| Sham Electroacupuncture | Sham comparator | 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. Receives: Device: Sham Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Leakage Amount from 1-Hour Pad Test
Urine leakage volume, measured in grams (g), collected during a standardized 1-hour pad test.
Measured: At the 1-week follow-up visit after catheter removal.
Secondary outcomes (5)
1-Hour Pad Test Urine Leakage Amount (Later Follow-ups)
Measured: At 4-week and 24-week follow-up visits after catheter removal.
ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form) Score
Measured: At 1, 4, 8, 12, and 24-week follow-up visits after catheter removal.
Proportion of Completely Continent (Leak-Free) Patients
Measured: At 1, 4, 8, 12, and 24-week follow-up visits after catheter removal.
SAS (Self-Rating Anxiety Scale) Score
Measured: At 1, 4, 8, 12, and 24-week follow-up visits.
IPSS (International Prostate Symptom Score), based on voiding diaries
Measured: At 1, 4, 8, 12, and 24-week follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bin Xu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239518
- Sponsor's protocol ID
- 2025ZDSYLL366-P01
- Acronym
- PEACE
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Early Acupuncture for Immediate Continence Enhancement After Prostatectomy
- ClinicalTrials.gov ID
- NCT07239518
- Acronym / sponsor ID
- PEACE / 2025ZDSYLL366-P01
- Conditions
- Prostate Cancer, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Bin XuUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Electroacupuncture Group | Experimental | Device: ElectroacupunctureParticipants 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 Electroacupuncture | Sham comparator | Device: Sham ElectroacupunctureParticipants 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Signed informed consent.
Key exclusion criteria (14 listed)
- 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).
- Known severe heart diseases, such as severe arrhythmia, severe heart failure, acute myocarditis, constrictive pericarditis, pericardial tamponade, severe valvular disease, or heart failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureParticipants 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. | Device | Experimental: Electroacupuncture Group |
| Sham ElectroacupunctureParticipants 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. | Device | Sham Electroacupuncture |
Primary outcome
Urine Leakage Amount from 1-Hour Pad Test
Time frame: At the 1-week follow-up visit after catheter removal.
Urine leakage volume, measured in grams (g), collected during a standardized 1-hour pad test.
5 secondary outcomes
1-Hour Pad Test Urine Leakage Amount (Later Follow-ups)
Time frame: At 4-week and 24-week follow-up visits after catheter removal.
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.
Proportion of Completely Continent (Leak-Free) Patients
Time frame: At 1, 4, 8, 12, and 24-week follow-up visits after catheter removal.
SAS (Self-Rating Anxiety Scale) Score
Time frame: At 1, 4, 8, 12, and 24-week follow-up visits.
IPSS (International Prostate Symptom Score), based on voiding diaries
Time frame: At 1, 4, 8, 12, and 24-week follow-up visits.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Prostate Cancer and Urinary Incontinence, run by Bin Xu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Leakage Amount from 1-Hour Pad Test (time frame: At the 1-week follow-up visit after catheter removal.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.