Prostate CancerEANCT07245342
Electroacupuncture for Improving Urinary Incontinence After Radical Prostatectomy
A study testing Electroacupuncture in people with Prostate Cancer, run by Shanghai University of Traditional Chinese Medicine.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2025to 25 Feb 2029
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early Electroacupuncture for Urinary Continence After Radical Prostatectomy: A Randomized, Single-Blind, Sham-Electroacupuncture-Controlled, Parallel-Group, Multicenter Clinical Trial
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).
Read more
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.
Read the detailed description
Prostate cancer (PCa) is the most commonly diagnosed malignancy and the second leading cause of cancer-related death among men worldwide, significantly impacting both physical and psychological health. Radical prostatectomy (RP) remains the gold standard for treating localized prostate cancer, with three primary goals: oncologic control, recovery of urinary continence, and preservation of sexual function. While advances in surgical techniques and pharmacotherapy have substantially improved cancer control outcomes, functional recovery-particularly regarding post-prostatectomy incontinence (PPI)-remains a major challenge. PPI primarily results from intraoperative damage to the bladder neck structure and surrounding nerves, compromising urinary control. Postoperative ischemia and scar adhesion may further exacerbate incontinence. Studies report PPI rates of 18%-55% at 3 months and 4%-31% at 1 year after RP. Electroacupuncture(EA), evolved from traditional manual acupuncture, augments the technique by applying controlled electrical currents. Evidence suggests that EA can deliver pulsed currents to stimulate muscles and nerves, inducing passive contractions of the pelvic floor muscles. It may also excite sympathetic nerves, inhibit parasympathetic activity, modulate detrusor contractility, enhance urethral sphincter function, and improve urethral closure-all of which may contribute to restoring urinary control.Given these potential benefits, along with its simplicity, low cost, and favorable safety profile, we hypothesize that early post-surgical EA-initiated immediately after RP-may promote urinary continence more effectively than delayed intervention after conservative treatments have failed. This approach aligns with both clinical needs and the traditional Chinese medicine principle of "preventive treatment."Based on the premise that early EA can accelerate the recovery of urinary continence after RP, we previously conducted an observational study. The results indicated that early EA was associated with higher rates of early complete continence recovery, shorter time to continence, and high patient satisfaction, with no reported adverse events.To further evaluate the efficacy and safety of early EA for PPI, we designed this randomized, single-blind, sham-controlled, multicenter trial. Patients undergoing robotic or laparoscopic RP will be assigned to either EA or sham EA, with intervention starting within one week post-surgery and lasting for six weeks. The study aims to assess efficacy and safety outcomes, thereby determining whether early EA facilitates urinary continence recovery in patients following RP.
- Conditions
- Prostate Cancer
- Being tested
- Electroacupuncture, Sham Electroacupuncture
- Keywords
- Electroacupuncture, Prostate Cancer, Radical Prostatectomy, Urinary Continence Recovery
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
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.
Sham ElectroacupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Urinary Continence Rate
The proportion of patients achieving complete urinary continence (defined as ≤1 safety pad per day).
Measured: 3 months postoperatively
Secondary outcomes (9)
Complete Urinary Continence Rate
The proportion of patients achieving complete urinary continence (defined as ≤1 safety pad per day).
Measured: 1, 6, and 12 months postoperatively
International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) score
The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) is used to assess the impact of urinary incontinence on quality of life over the past four weeks. It comprises three scored items addressing the frequency of leakage, the amount of leakage, and the overall impact on daily life, along with a fourth unscored item designed to help determine the type of incontinence. The total score ranges from 0 to 21, with higher scores indicating greater severity.
Measured: 1, 3, 6, and 12 months postoperatively
Incontinence-Quality of Life (I-QOL) Questionnaire score
Scores are inversely related to symptom severity, meaning a higher score denotes a superior quality of life.
Measured: 1, 3, 6, and 12 months postoperatively
Visual Analog Scale (VAS)
Scored by measuring the patient's mark on a 10-cm line, where a greater length indicates poorer self-rated urinary control.
Measured: 1, 3, 6, and 12 months postoperatively
King's Health Questionnaire (KHQ) score
The King's Health Questionnaire (KHQ) is a condition-specific instrument for assessing quality of life in individuals with urinary incontinence. It evaluates multiple domains, including role, physical, and social limitations, personal relationships, emotions, and symptom severity.
Measured: 1, 3, 6, and 12 months postoperatively
International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score (IPSS) is a patient-reported instrument that assesses the severity of lower urinary tract symptoms (LUTS). The total score ranges from 0 to 35, with categories defined as mild (0-7), moderate (8-19), and severe (20-35).
Measured: 1, 3, 6, and 12 months postoperatively
Quality of Life Core Questionnaire (QLQ-C30) score
The EORTC QLQ-C30 is a validated, cancer-specific instrument for assessing health-related quality of life. It comprises 30 items across several functional scales, symptom scales, and a global health status scale.
Measured: 1, 3, 6, and 12 months postoperatively
Analysis of Risk Factors Influencing Treatment Efficacy (Multivariable Logistic Regression)
Through multivariate logistic regression analysis, evaluate the impact of factors such as age, BMI, underlying diseases, and surgical methods on the efficacy of early EA treatment for urinary incontinence (cured or not).
Measured: 3 months postoperatively
Median Time to Complete Urinary Continence
Time from radical prostatectomy to the first day of maintaining complete urinary continence (defined as using 0 or 1 pad per day), assessed at follow - up visits.
Measured: Within 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start25 Nov 2025 (estimated)
- Primary completion25 Nov 2028 (estimated)
- Study completion25 Feb 2029 (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, Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangyang Zhan, Shanghai University of Traditional Chinese Medicine
- Investigators
- Xiangyang Zhan, Principal investigator, Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245342
- Sponsor's protocol ID
- 2024-1593-176-01
- Acronym
- EA
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Electroacupuncture for Urinary Continence After Radical Prostatectomy: A Randomized, Single-Blind, Sham-Electroacupuncture-Controlled, Parallel-Group, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT07245342
- Acronym / sponsor ID
- EA / 2024-1593-176-01
- Conditions
- Prostate Cancer
- Keywords
- Electroacupuncture, Prostate Cancer, Radical Prostatectomy, Urinary Continence Recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 25 Nov 2025 (estimated)
- Primary completion
- 25 Nov 2028 (estimated)
- Study completion
- 25 Feb 2029 (estimated)
- First posted
- 24 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 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.
Detailed description
Prostate cancer (PCa) is the most commonly diagnosed malignancy and the second leading cause of cancer-related death among men worldwide, significantly impacting both physical and psychological health. Radical prostatectomy (RP) remains the gold standard for treating localized prostate cancer, with three primary goals: oncologic control, recovery of urinary continence, and preservation of sexual function. While advances in surgical techniques and pharmacotherapy have substantially improved cancer control outcomes, functional recovery-particularly regarding post-prostatectomy incontinence (PPI)-remains a major challenge. PPI primarily results from intraoperative damage to the bladder neck structure and surrounding nerves, compromising urinary control. Postoperative ischemia and scar adhesion may further exacerbate incontinence. Studies report PPI rates of 18%-55% at 3 months and 4%-31% at 1 year after RP. Electroacupuncture(EA), evolved from traditional manual acupuncture, augments the technique by applying controlled electrical currents. Evidence suggests that EA can deliver pulsed currents to stimulate muscles and nerves, inducing passive contractions of the pelvic floor muscles. It may also excite sympathetic nerves, inhibit parasympathetic activity, modulate detrusor contractility, enhance urethral sphincter function, and improve urethral closure-all of which may contribute to restoring urinary control.Given these potential benefits, along with its simplicity, low cost, and favorable safety profile, we hypothesize that early post-surgical EA-initiated immediately after RP-may promote urinary continence more effectively than delayed intervention after conservative treatments have failed. This approach aligns with both clinical needs and the traditional Chinese medicine principle of "preventive treatment."Based on the premise that early EA can accelerate the recovery of urinary continence after RP, we previously conducted an observational study. The results indicated that early EA was associated with higher rates of early complete continence recovery, shorter time to continence, and high patient satisfaction, with no reported adverse events.To further evaluate the efficacy and safety of early EA for PPI, we designed this randomized, single-blind, sham-controlled, multicenter trial. Patients undergoing robotic or laparoscopic RP will be assigned to either EA or sham EA, with intervention starting within one week post-surgery and lasting for six weeks. The study aims to assess efficacy and safety outcomes, thereby determining whether early EA facilitates urinary continence recovery in patients following RP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture Group | Experimental | Procedure: ElectroacupuncturePatients 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. |
| Sham Electroacupuncture Group | Placebo comparator | Procedure: Sham ElectroacupuncturePatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| ElectroacupunctureBilateral 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. | Procedure or surgery | Electroacupuncture Group |
| Sham ElectroacupuncturePatients 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. | Procedure or surgery | Sham Electroacupuncture Group |
Primary outcome
Complete Urinary Continence Rate
Time frame: 3 months postoperatively
The proportion of patients achieving complete urinary continence (defined as ≤1 safety pad per day).
9 secondary outcomes
Complete Urinary Continence Rate
Time frame: 1, 6, and 12 months postoperatively
International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) score
Time frame: 1, 3, 6, and 12 months postoperatively
Incontinence-Quality of Life (I-QOL) Questionnaire score
Time frame: 1, 3, 6, and 12 months postoperatively
Visual Analog Scale (VAS)
Time frame: 1, 3, 6, and 12 months postoperatively
King's Health Questionnaire (KHQ) score
Time frame: 1, 3, 6, and 12 months postoperatively
International Prostate Symptom Score (IPSS)
Time frame: 1, 3, 6, and 12 months postoperatively
Quality of Life Core Questionnaire (QLQ-C30) score
Time frame: 1, 3, 6, and 12 months postoperatively
Analysis of Risk Factors Influencing Treatment Efficacy (Multivariable Logistic Regression)
Time frame: 3 months postoperatively
Median Time to Complete Urinary Continence
Time frame: Within 12 months postoperatively
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 24 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Xiangyang Zhan principal investigator
Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Prostate Cancer, run by Shanghai University of Traditional Chinese Medicine.
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 4 inclusion and 10 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 24 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?
Contact Xiangyang Zhan (021-13253619759, zxy960110@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Urinary Continence Rate (time frame: 3 months postoperatively). 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 24 Nov 2025.