Benign Prostatic HyperplasiaNCT07736807
Early Electroacupuncture for Post-TURP LUTS
A study testing Electroacupuncture in people with Benign Prostatic Hyperplasia, run by Zhongda Hospital at 1 site in China.
Trial summary
1. Project Rationale Benign prostatic hyperplasia (BPH) is one of the most prevalent urological disorders among middle-aged and elderly men, and it represents a common chronic condition in the male population. Its incidence increases from 8% in men aged 31-40 years to over 80% in men aged over 80 years. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- 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
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Dec 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 with benign prostatic hyperplasia (BPH) who have undergone transurethral resection of the prostate (TURP) or holmium laser enucleation of the prostate (HoLEP);
- Aged between 50 and 85 years;
- Provided signed informed consent.
Who cannot join
- Pathological examination results confirm the presence of prostatic tumors;
- History of lower urinary tract cancers including prostate cancer and bladder cancer within the past 5 years;
- Currently receiving or have received treatments based on principles similar to acupuncture within 6 months prior to enrollment, such as electroacupuncture, warm moxibustion, and warm needling moxibustion;
- Presence of uncontrolled urinary system infection before surgery (asymptomatic lower urinary tract infection is excluded);
- Diagnosed with severe cardiac conditions including severe arrhythmia, severe cardiac insufficiency, acute myocarditis, constrictive pericarditis, pericardial tamponade, severe valvular heart disease, and heart failure;
- Confirmed liver injury or potentially severe liver disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 10 times the upper limit of normal);
Show all 13Show fewer
- Confirmed severe renal impairment (estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73m²), scheduled for or currently undergoing dialysis, or diagnosed with acute contrast-induced nephropathy during screening;
- Confirmed severe primary diseases such as dysfunction of other vital organs or diseases of the hematopoietic system;
- Confirmed coagulation dysfunction (with definite 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;
- Patients considered unsuitable for participation in this study by the investigators, or patients with factors strongly associated with study dropout, such as frequently changing working environments that increase the risk of loss to follow-up;
- Survival period estimated to be ≤ 6 months by the investigators;
- Currently participating in other clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongda Hospital, Southeast University
Nanjing, Jiangsu
SUN CHAO SUN CHAO, Doctor, 86-18012949196, chaosun@yeah.net
About this study
Official title: Early Electroacupuncture Intervention for Lower Urinary Tract Symptoms After Benign Prostatic Hyperplasia Surgery: A Prospective Study
- Project Rationale Benign prostatic hyperplasia (BPH) is one of the most prevalent urological disorders among middle-aged and elderly men, and it represents a common chronic condition in the male population. Its incidence increases from 8% in men aged 31-40 years to over 80% in men aged over 80 years. With the intensification of global population aging, the prevalence of BPH and the corresponding burden on global public healthcare systems have been increasing continuously. BPH not only impairs patients' micturition function and reduces their quality of life, but also may lead to multiple complications involving the urinary system, such as urinary tract infection, bladder calculi and renal function impairment. Although the exact etiology of BPH remains incompletely elucidated, existing studies have confirmed that multiple factors including age, altered hormone levels, genetic background and lifestyle are associated with its pathogenesis.
The global number of prevalent BPH cases increased from 51 million in 2000 to 94 million in 2019, representing a 70.5% growth in global prevalence during this period. Driven by population aging, changes in lifestyle and the popularization of screening methods such as prostate-specific antigen (PSA) detection, the number of prevalent BPH cases in China increased from 10.2 million in 2000 to 20.3 million in 2019, with a 99.0% growth in prevalence over the period, which exceeds the global average growth rate. Data from the 7th National Population Census of China in 2021 shows that the population aged 60 years and above in China reaches approximately 264 million, accounting for 18.70% of the total population, which is 5.44 percentage points higher than the data from the 6th National Population Census in 2010, and this figure is projected to exceed 400 million by 2050. The intensification of population aging and the corresponding growth in BPH prevalence indicate that BPH has evolved from a common urological disease to a major public health issue that poses a substantial threat to the health of Chinese men.
Read more
Transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP) are routine surgical interventions for BPH, which can effectively reduce prostate volume and improve micturition function in patients. However, persistent lower urinary tract symptoms (LUTS) such as urinary frequency, urgency and dysuria after surgery still negatively affect patients' quality of life. Approximately 30% of patients with pre-operative urological symptoms experience persistent symptoms after surgery. Due to symptom persistence, up to 27% of male patients receive pharmacological intervention for LUTS after TURP. This poses a great challenge to patients' physical and mental health, and effective intervention strategies are urgently needed.
Currently, the management of post-TURP LUTS mainly relies on conservative interventions such as Pelvic Floor Muscle Training (PFMT) and pharmacological therapy. However, these interventions are typically initiated after urinary catheter removal, which cannot meet the demand for immediate urinary continence after catheter withdrawal. In addition, the therapeutic effect of PFMT requires long-term persistence, which generally leads to poor patient adherence, and the most critical limitation is the lagged intervention timing. Similar issues including delayed intervention and unsatisfactory efficacy also exist in pharmacological therapy. Currently, medications for LUTS secondary to BPH include α-adrenergic receptor blockers, 5-α reductase inhibitors, anticholinergics, β-3 adrenergic receptor agonists and phytotherapy. These agents are routinely used for the management of BPH and BPH-related LUTS, and are widely applied to alleviate persistent or new-onset LUTS after BPH surgery. Although these drugs are generally adopted as standard interventions for post-BPH surgery LUTS, multiple studies have demonstrated that there are no significant differences in objective indicators including symptom score, quality of life index and post-void residual volume between patients receiving these medications after BPH surgery and patients receiving placebo. Currently, there is still a lack of effective and widely accepted intervention regimens for LUTS after BPH surgery.
Against the background that existing treatment modalities cannot meet clinical demand, this study proposes early post-operative electroacupuncture as an innovative and scientifically sound intervention strategy. Acupuncture is not merely a simple "alternative therapy", but an effective "non-invasive peripheral neuromodulation technique" validated by modern medical research. Existing studies have shown that acupuncture exerts a certain therapeutic effect on relieving BPH-related LUTS. For example, in a study conducted by Chen Chao et al., clear conclusions were drawn by comparing the efficacy of acupuncture and α-adrenergic receptor blockers in the treatment of 64 patients with BP
Read the detailed description
II. Research Content 1. Research Objectives This is a prospective study designed to evaluate the effect of early electroacupuncture intervention on lower urinary tract symptoms (LUTS) after benign prostatic hyperplasia (BPH) surgery.
- Research Content
- Selection of research site This study will be conducted in the Department of Urology, Zhongda Hospital Affiliated to Southeast University.
- Selection of research subjects Information of patients receiving acupuncture intervention and patients in the control group will be retrieved from the electronic medical record system. Patients meeting the inclusion and exclusion criteria will be screened, and allocated to the treatment group or the control group at a 1:1 ratio via block randomization, receiving electroacupuncture intervention or sham acupuncture intervention respectively, before being enrolled in the clinical trial.
Number of enrolled subjects:
144 cases from the Department of Urology, Zhongda Hospital Affiliated to Southeast University
Sample size calculation:
This study is a prospective, multicenter, randomized, placebo-controlled clinical trial aimed at evaluating the efficacy of early electroacupuncture intervention in improving LUTS after transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP). The Primary Endpoint is defined as the International Prostate Symptom Score (IPSS) obtained one week after catheter removal. This estimation is based on the two-sample t-test for independent means, with required parameters including the expected mean difference between groups (δ), within-group standard deviation (σ), type I error probability (α), and type II error probability (β). We set the two-sided significance level α=0.05 and statistical power (1-β)=0.80, with a 1:1 sample size allocation ratio between the two groups (treatment group vs. sham acupuncture group).
Given the absence of perfectly matched studies that focus on male patients after TURP, compare electroacupuncture with sham acupuncture, and take IPSS score as the primary endpoint, we set the expected moderate effect size d=0.5. Based on the aforementioned parameters and the sample size calculation formula for comparing means of two independent samples:
n=2(Z1-α/2+Z1-β)2d2 Calculation results show that to achieve 80% statistical power, at least 64 subjects are required per group.
Considering the short intervention cycle and clear follow-up nodes of this study, we estimate that approximately 10% of subjects may be lost to follow-up or drop out for various reasons. To compensate for this sample loss, the adjusted number of subjects to be recruited per group is 64/(1-0.10)≈71.11. After rounding up, 72 subjects are required per group.
In conclusion, this study plans to enroll a total of 144 subjects (72 in the treatment group and 72 in the control group). This sample size is sufficient to statistically validly test the core hypothesis of this study, and meanwhile has good feasibility under the framework of multicenter collaboration. During the mid-study period, the need for sample size adjustment will be evaluated based on actual enrollment status and data variability.
(3) Research Period June 1, 2026 - June 1, 2027 Extraction and Allocation Method of Research Subjects This study adopts a prospective, randomized controlled design, and consecutively enrolls eligible post-prostatectomy patients during the study period who meet all inclusion criteria, do not meet any exclusion criteria, and voluntarily sign the informed consent form. To ensure the scientificity and rigor of the allocation process, random allocation is performed using mixed blocks with sizes of 4 and 6, to maintain a close dynamic balance in the number of participants between the treatment group and the control group at any stage of the study. To achieve allocation concealment, the random sequence will be generated by an independent statistician who does not participate in clinical work and deployed in a secure central randomization system. On-site researchers can only obtain the grouping result through the system after the patient is officially enrolled, thereby eliminating selection bias. This study plans to randomly allocate a total of 144 subjects to the treatment group and the control group at a 1:1 ratio.
Informed Consent of Research Subjects Sign the informed consent form (6) Outcome Measures Follow-up of urinary continence will be conducted at 1 week, 4 weeks, 8 weeks, and 12 weeks after catheter removal.
- Primary endpoint: International Prostate Symptom Score (IPSS) at 1-week follow-up after catheter removal.
- Uroflowmetry parameters (Qmax, voided volume, post-void residual urine volume [PVR])
- The International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) score at 1 week, 4 weeks, 8 weeks, and 12 weeks after catheter removal, to evaluate patients' LUTS and their impact on quality of life; ④ The Self-Rating Anxiety Scale (SAS) score is used to evaluate the potential improvement effect of acupuncture intervention on patients' psychological status; ⑤ Patients are required to keep a voiding diary at each follow-up node to comprehensively evaluate urinary function. (7) Intervention Protocol All patients undergo catheter removal on postoperative day 5-7 (POD 5-7). Early electroacupuncture intervention (including verum electroacupuncture and sham electroacupuncture) is initiated on postoperative day 2 (POD 2), with one additional session each on POD 4 and POD 6, totaling 3 sessions.
The treatment group receives electroacupuncture at acupoints including Zhongji (RN3), Qihai (RN6), and Shuidao (ST28, bilateral) for 30 minutes per session, with the entire intervention course lasting one week. Continuous wave electroacupuncture is used, with an initial frequency of 2Hz. The intensity is gradually increased until the patient feels comfortable; the current intensity ranges from 1 to 5mA, which is gradually increased up to the maximum intensity that the patient can tolerate. The control group uses non-invasive sham acupuncture needles: validated non-penetrating needles with blunt tips (such as Park needles or Streitberger needles) are adopted. When pressure is applied to these needles, the tip retracts into the needle handle, which creates a tactile pressure sensation on the patient's skin without puncturing the skin. The intervention is performed at non-acupoints (points 1-2 cm adjacent to the verum acupoints, not located on the same meridian). The electrode clips of the electroacupuncture device are also attached to the handles of the sham acupuncture needles, and the device is turned on (producing the same sound and indicator light as in the treatment group) but outputs no current. In this way, the entire treatment scenario remains consistent with that of the verum treatment group in terms of vision and hearing.
To ensure all research subjects receive consistent standard postoperative rehabilitation guidance and control potential confounding variables, all patients successfully enrolled in this study (regardless of their group allocation) will receive a standardized nursing protocol after surgery.
- Research Methods
- Study Design This trial adopts the design scheme of randomized controlled prospective study.
- Inclusion and Exclusion Criteria
The inclusion criteria for subjects are as follows:
- BPH patients who have undergone TURP or HoLEP;
- Aged between 50 and 85 years;
- Signed informed consent.
The exclusion criteria for subjects are as follows:
- Pathological results confirm prostate tumor;
- History of lower urinary tract cancer including prostate cancer and bladder cancer in the past 5 years;
- Currently receiving or have received treatments with similar mechanisms to acupuncture (such as electroacupuncture, warming moxibustion, needle warming moxibustion, etc.) within 6 months prior to enrollment;
- Preoperative uncontrolled urinary system infection (asymptomatic lower urinary tract infection is excluded);
- Confirmed severe heart diseases including severe arrhythmia, severe cardiac insufficiency, acute myocarditis, constrictive pericarditis, pericardial tamponade, severe valvular disease, and heart failure;
- Confirmed liver injury or potentially severe liver disease (ALT or AST > 10 times the upper limit of normal);
- Confirmed severe renal impairment (eGFR < 25mL/min/1.73m2), or patients on planned or ongoing dialysis, or patients with acute contrast-induced nephropathy at screening;
- Confirmed dysfunction of other vital organs or severe primary diseases such as hematopoietic system diseases;
- Confirmed 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;
- Patients judged by the investigator as unsuitable for participating in this study, or with high risk of dropping out, such as frequent changes of working environment that easily lead to loss to follow-up;
- Survival period estimated by the investigator to be ≤ 6 months; 14. Currently participating in other clinical trials. (3) Enrollment and Intervention Protocol: Information of postoperative patients will be retrieved from the electronic medical record system of Zhongda Hospital. Patients meeting the inclusion and exclusion criteria will be screened. After signing the informed consent form, patients are allocated to groups via randomization, and receive electroacupuncture intervention or sham acupuncture intervention respectively. The trial intervention protocol is as follows: All patients undergo catheter removal on postoperative day 5 (POD5). Early electroacupuncture intervention (including verum electroacupuncture and sham electroacupuncture) is initiated on postoperative day 2 (POD 2), with one additional session each on POD 4 and POD 6, totaling 3 sessions.
The treatment group receives electroacupuncture at acupoints including Zhongji (RN3), Qihai (RN6), and Shuidao (ST28, bilateral) for 30 minutes per session, with the entire intervention course lasting one week. Continuous wave electroacupuncture is used, with an initial frequency of 2Hz. The intensity is gradually increased until the patient feels comfortable; the current intensity ranges from 1 to 5mA, which is gradually increased up to the maximum intensity that the patient can tolerate. The control group uses non-invasive sham acupuncture needles: validated non-penetrating needles with blunt tips (such as Park needles or Streitberger needles) are adopted. When pressure is applied to these needles, the tip retracts into the needle handle, which creates a tactile pressure sensation on the patient's skin without puncturing the skin. The intervention is performed at non-acupoints (points 1-2 cm adjacent to the verum acupoints, not located on the same meridian). The electrode clips of the electroacupuncture device are also attached to the handles of the sham acupuncture needles, and the device is turned on (producing the same sound and indicator light as in the treatment group) but outputs no current. In this way, the entire treatment scenario remains consistent with that of the verum treatment group in terms of vision and hearing.
To ensure all research subjects receive consistent standard postoperative rehabilitation guidance and control potential confounding variables, all patients successfully enrolled in this study (regardless of their group allocation) will receive a standardized nursing protocol after surgery.
Efficacy Evaluation:
- Primary endpoint: International Prostate Symptom Score (IPSS) at 1-week follow-up after catheter removal.
- Uroflowmetry parameters (Qmax, voided volume, post-void residual urine volume [PVR])
- The International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) score at 1 week, 4 weeks, 8 weeks, and 12 weeks after catheter removal, to evaluate patients' LUTS and their impact on quality of life; ④ The Self-Rating Anxiety Scale (SAS) score is used to evaluate the potential improvement effect of acupuncture intervention on patients' psychological status; ⑤ Patients are required to keep a voiding diary at each follow-up node to comprehensively evaluate urinary function. (4) Statistical Analysis: Statistical analysis will be performed by professional statisticians from the Center for Clinical Evaluation and Analysis, Zhongda Hospital Affiliated to Southeast University, using SPSS Statistics (V.26.0) or R language. All analyses will follow the intention-to-treat (ITT) principle. Shapiro-Wilk test is used to assess the normality of data distribution in data processing; imbalance in baseline demographic and clinical characteristics will be adjusted via analysis of covariance (ANCOVA); normally distributed continuous variables will be expressed as mean ± standard deviation; non-normally distributed continuous variables and ordinal variables will be expressed as median (interquartile range); categorical variables will be expressed as count and percentage; for missing data of primary and secondary endpoints, multiple imputation will be used for processing, and the primary analysis will be performed based on the imputed dataset. Meanwhile, a series of sensitivity analyses will be conducted to evaluate the impact of different missing data processing methods on the robustness of research conclusions.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Electroacupuncture, Sham Electroacupuncture
- Keywords
- Lower Urinary Tract Symptoms, Electroacupuncture, TURP
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
All patients underwent urethral catheter removal on postoperative day 5 (POD5). Early electroacupuncture intervention, including both verum electroacupuncture and sham electroacupuncture, was initiated on postoperative day 2 (POD 2), and administered one additional session each on POD4 and POD6, totaling three sessions.
The treatment group received electroacupuncture at acupoints including Zhongji (RN3), Qihai (RN6), and Shuidao (bilateral ST28), with each session lasting 30 minutes, for a total treatment duration of one week. For continuous-wave electroacupuncture, the initial frequency was set to 2 Hz, and the intensity was gradually increased until patients reported a comfortable sensation. The current intensity ranged from 1 mA to 5 mA, with incremental adjustments capped at the maximum tolerable intensity for the patient.
Sham ElectroacupunctureDevice
All patients had their urinary catheters removed on postoperative day 5 (POD5). Early electroacupuncture intervention, including both verum electroacupuncture and sham electroacupuncture, was initiated on postoperative day 2 (POD 2), and administered one additional session each on POD4 and POD6, resulting in a total of 3 sessions.
The control group received non-invasive sham acupuncture: validated non-penetrating needles with blunt tips (e.g., Park needle or Streitberger needle) were adopted. For this type of needle, the tip retracts into the handle when pressure is applied, creating a tactile pressure sensation on the patient's skin without penetrating the skin. The procedure was performed at non-acupoint locations, defined as points 1-2 cm away from the corresponding verum acupoints but not located on the same meridian. The electrode clips of the electroacupuncture device were also attached to the handles of the sham needles, and the device was turned on (producing the same operatin
| Study group | Role | What they receive |
|---|---|---|
| Early Electroacupuncture Group | Experimental | All patients underwent urinary catheter removal on postoperative day 5 (POD5). Early electroacupuncture intervention, including both verum electroacupuncture and sham electroacupuncture, was initiated on postoperative day 2 (POD 2), with one additional session administered on POD4 and one on POD6, resulting in a total of 3 intervention sessions.
The treatment group received electroacupuncture at acupoints including Zhongji (RN3), Qihai (RN6), and bilateral Shuidao (ST28), with each session lasting 30 minutes, and the intervention course lasted one week. For electroacupuncture treatment, a continuous wave with an initial frequency of 2 Hz was applied. The current intensity was gradually increased to maintain a comfortable sensation for the patient, ranging from 1 mA to 5 mA, with the maximum intensity capped at the highest level the patient can tolerate. Receives: Device: Electroacupuncture |
| Sham Electroacupuncture Group | Sham comparator | All patients underwent urinary catheter removal on postoperative day 5 (POD5). Early electroacupuncture intervention, comprising both verum electroacupuncture and sham electroacupuncture, was initiated on postoperative day 2 (POD 2), with one additional session each on POD4 and POD6, totaling 3 sessions.
The control group received non-invasive sham acupuncture needles: validated non-penetrating needles with blunt tips (e.g., Park needle or Streitberger needle). When pressure is applied to such needles, the tip retracts into the handle, creating a tactile pressure sensation on the patient's skin without penetrating the dermis. The procedure is performed at non-acupoints, defined as points located 1-2 cm away from the corresponding true acupoints but not on the same meridian. The electrode clips of the electroacupuncture device are also attached to the handles of the sham acupuncture needles, and the device is activated (producing the same acoustic and indicator light signals as in the Receives: Device: Sham Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptom Score (IPSS)
IPSS score at 1-week follow-up after extubation
Measured: 1 week post-catheter removal
Secondary outcomes (4)
Urinary Flow Rate
Urinary Flow Rate: It includes Qmax, voided volume and PVR.
Measured: Assessment was performed at 1, 4, 8 and 12 weeks after extubation
ICIQ-MLUTS Score
ICIQ-MLUTS Score
Measured: Assessment at 1, 4, 8, and 12 weeks after tube removal
Self-Rating Anxiety Scale (SAS)
Self-Rating Anxiety Scale (SAS)
Measured: Evaluations were performed at 1, 4, 8 and 12 weeks after extubation
Voiding Diary
Voiding Diary
Measured: Evaluations were performed at 1, 4, 8 and 12 weeks after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanrong Qian, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736807
- Sponsor's protocol ID
- 2026ZDSYLL174-P01
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Experimental data, apart from patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Electroacupuncture Intervention for Lower Urinary Tract Symptoms After Benign Prostatic Hyperplasia Surgery: A Prospective Study
- ClinicalTrials.gov ID
- NCT07736807
- Acronym / sponsor ID
- 2026ZDSYLL174-P01
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Lower Urinary Tract Symptoms, Electroacupuncture, TURP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Jul 2026 (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.
- Project Rationale Benign prostatic hyperplasia (BPH) is one of the most prevalent urological disorders among middle-aged and elderly men, and it represents a common chronic condition in the male population. Its incidence increases from 8% in men aged 31-40 years to over 80% in men aged over 80 years. With the intensification of global population aging, the prevalence of BPH and the corresponding burden on global public healthcare systems have been increasing continuously. BPH not only impairs patients' micturition function and reduces their quality of life, but also may lead to multiple complications involving the urinary system, such as urinary tract infection, bladder calculi and renal function impairment. Although the exact etiology of BPH remains incompletely elucidated, existing studies have confirmed that multiple factors including age, altered hormone levels, genetic background and lifestyle are associated with its pathogenesis.
The global number of prevalent BPH cases increased from 51 million in 2000 to 94 million in 2019, representing a 70.5% growth in global prevalence during this period. Driven by population aging, changes in lifestyle and the popularization of screening methods such as prostate-specific antigen (PSA) detection, the number of prevalent BPH cases in China increased from 10.2 million in 2000 to 20.3 million in 2019, with a 99.0% growth in prevalence over the period, which exceeds the global average growth rate. Data from the 7th National Population Census of China in 2021 shows that the population aged 60 years and above in China reaches approximately 264 million, accounting for 18.70% of the total population, which is 5.44 percentage points higher than the data from the 6th National Population Census in 2010, and this figure is projected to exceed 400 million by 2050. The intensification of population aging and the corresponding growth in BPH prevalence indicate that BPH has evolved from a common urological disease to a major public health issue that poses a substantial threat to the health of Chinese men.
Transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP) are routine surgical interventions for BPH, which can effectively reduce prostate volume and improve micturition function in patients. However, persistent lower urinary tract symptoms (LUTS) such as urinary frequency, urgency and dysuria after surgery still negatively affect patients' quality of life. Approximately 30% of patients with pre-operative urological symptoms experience persistent symptoms after surgery. Due to symptom persistence, up to 27% of male patients receive pharmacological intervention for LUTS after TURP. This poses a great challenge to patients' physical and mental health, and effective intervention strategies are urgently needed.
Currently, the management of post-TURP LUTS mainly relies on conservative interventions such as Pelvic Floor Muscle Training (PFMT) and pharmacological therapy. However, these interventions are typically initiated after urinary catheter removal, which cannot meet the demand for immediate urinary continence after catheter withdrawal. In addition, the therapeutic effect of PFMT requires long-term persistence, which generally leads to poor patient adherence, and the most critical limitation is the lagged intervention timing. Similar issues including delayed intervention and unsatisfactory efficacy also exist in pharmacological therapy. Currently, medications for LUTS secondary to BPH include α-adrenergic receptor blockers, 5-α reductase inhibitors, anticholinergics, β-3 adrenergic receptor agonists and phytotherapy. These agents are routinely used for the management of BPH and BPH-related LUTS, and are widely applied to alleviate persistent or new-onset LUTS after BPH surgery. Although these drugs are generally adopted as standard interventions for post-BPH surgery LUTS, multiple studies have demonstrated that there are no significant differences in objective indicators including symptom score, quality of life index and post-void residual volume between patients receiving these medications after BPH surgery and patients receiving placebo. Currently, there is still a lack of effective and widely accepted intervention regimens for LUTS after BPH surgery.
Against the background that existing treatment modalities cannot meet clinical demand, this study proposes early post-operative electroacupuncture as an innovative and scientifically sound intervention strategy. Acupuncture is not merely a simple "alternative therapy", but an effective "non-invasive peripheral neuromodulation technique" validated by modern medical research. Existing studies have shown that acupuncture exerts a certain therapeutic effect on relieving BPH-related LUTS. For example, in a study conducted by Chen Chao et al., clear conclusions were drawn by comparing the efficacy of acupuncture and α-adrenergic receptor blockers in the treatment of 64 patients with BP
Detailed description
II. Research Content 1. Research Objectives This is a prospective study designed to evaluate the effect of early electroacupuncture intervention on lower urinary tract symptoms (LUTS) after benign prostatic hyperplasia (BPH) surgery.
- Research Content
- Selection of research site This study will be conducted in the Department of Urology, Zhongda Hospital Affiliated to Southeast University.
- Selection of research subjects Information of patients receiving acupuncture intervention and patients in the control group will be retrieved from the electronic medical record system. Patients meeting the inclusion and exclusion criteria will be screened, and allocated to the treatment group or the control group at a 1:1 ratio via block randomization, receiving electroacupuncture intervention or sham acupuncture intervention respectively, before being enrolled in the clinical trial.
Number of enrolled subjects:
144 cases from the Department of Urology, Zhongda Hospital Affiliated to Southeast University
Sample size calculation:
This study is a prospective, multicenter, randomized, placebo-controlled clinical trial aimed at evaluating the efficacy of early electroacupuncture intervention in improving LUTS after transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP). The Primary Endpoint is defined as the International Prostate Symptom Score (IPSS) obtained one week after catheter removal. This estimation is based on the two-sample t-test for independent means, with required parameters including the expected mean difference between groups (δ), within-group standard deviation (σ), type I error probability (α), and type II error probability (β). We set the two-sided significance level α=0.05 and statistical power (1-β)=0.80, with a 1:1 sample size allocation ratio between the two groups (treatment group vs. sham acupuncture group).
Given the absence of perfectly matched studies that focus on male patients after TURP, compare electroacupuncture with sham acupuncture, and take IPSS score as the primary endpoint, we set the expected moderate effect size d=0.5. Based on the aforementioned parameters and the sample size calculation formula for comparing means of two independent samples:
n=2(Z1-α/2+Z1-β)2d2 Calculation results show that to achieve 80% statistical power, at least 64 subjects are required per group.
Considering the short intervention cycle and clear follow-up nodes of this study, we estimate that approximately 10% of subjects may be lost to follow-up or drop out for various reasons. To compensate for this sample loss, the adjusted number of subjects to be recruited per group is 64/(1-0.10)≈71.11. After rounding up, 72 subjects are required per group.
In conclusion, this study plans to enroll a total of 144 subjects (72 in the treatment group and 72 in the control group). This sample size is sufficient to statistically validly test the core hypothesis of this study, and meanwhile has good feasibility under the framework of multicenter collaboration. During the mid-study period, the need for sample size adjustment will be evaluated based on actual enrollment status and data variability.
(3) Research Period June 1, 2026 - June 1, 2027 Extraction and Allocation Method of Research Subjects This study adopts a prospective, randomized controlled design, and consecutively enrolls eligible post-prostatectomy patients during the study period who meet all inclusion criteria, do not meet any exclusion criteria, and voluntarily sign the informed consent form. To ensure the scientificity and rigor of the allocation process, random allocation is performed using mixed blocks with sizes of 4 and 6, to maintain a close dynamic balance in the number of participants between the treatment group and the control group at any stage of the study. To achieve allocation concealment, the random sequence will be generated by an independent statistician who does not participate in clinical work and deployed in a secure central randomization system. On-site researchers can only obtain the grouping result through the system after the patient is officially enrolled, thereby eliminating selection bias. This study plans to randomly allocate a total of 144 subjects to the treatment group and the control group at a 1:1 ratio.
Informed Consent of Research Subjects Sign the informed consent form (6) Outcome Measures Follow-up of urinary continence will be conducted at 1 week, 4 weeks, 8 weeks, and 12 weeks after catheter removal.
- Primary endpoint: International Prostate Symptom Score (IPSS) at 1-week follow-up after catheter removal.
- Uroflowmetry parameters (Qmax, voided volume, post-void residual urine volume [PVR])
- The International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) score at 1 week, 4 weeks, 8 weeks, and 12 weeks after catheter removal, to evaluate patients' LUTS and their impact on quality of life; ④ The Self-Rating Anxiety Scale (SAS) score is used to evaluate the potential improvement effect of acupuncture intervention on patients' psychological status; ⑤ Patients are required to keep a voiding diary at each follow-up node to comprehensively evaluate urinary function. (7) Intervention Protocol All patients undergo catheter removal on postoperative day 5-7 (POD 5-7). Early electroacupuncture intervention (including verum electroacupuncture and sham electroacupuncture) is initiated on postoperative day 2 (POD 2), with one additional session each on POD 4 and POD 6, totaling 3 sessions.
The treatment group receives electroacupuncture at acupoints including Zhongji (RN3), Qihai (RN6), and Shuidao (ST28, bilateral) for 30 minutes per session, with the entire intervention course lasting one week. Continuous wave electroacupuncture is used, with an initial frequency of 2Hz. The intensity is gradually increased until the patient feels comfortable; the current intensity ranges from 1 to 5mA, which is gradually increased up to the maximum intensity that the patient can tolerate. The control group uses non-invasive sham acupuncture needles: validated non-penetrating needles with blunt tips (such as Park needles or Streitberger needles) are adopted. When pressure is applied to these needles, the tip retracts into the needle handle, which creates a tactile pressure sensation on the patient's skin without puncturing the skin. The intervention is performed at non-acupoints (points 1-2 cm adjacent to the verum acupoints, not located on the same meridian). The electrode clips of the electroacupuncture device are also attached to the handles of the sham acupuncture needles, and the device is turned on (producing the same sound and indicator light as in the treatment group) but outputs no current. In this way, the entire treatment scenario remains consistent with that of the verum treatment group in terms of vision and hearing.
To ensure all research subjects receive consistent standard postoperative rehabilitation guidance and control potential confounding variables, all patients successfully enrolled in this study (regardless of their group allocation) will receive a standardized nursing protocol after surgery.
- Research Methods
- Study Design This trial adopts the design scheme of randomized controlled prospective study.
- Inclusion and Exclusion Criteria
The inclusion criteria for subjects are as follows:
- BPH patients who have undergone TURP or HoLEP;
- Aged between 50 and 85 years;
- Signed informed consent.
The exclusion criteria for subjects are as follows:
- Pathological results confirm prostate tumor;
- History of lower urinary tract cancer including prostate cancer and bladder cancer in the past 5 years;
- Currently receiving or have received treatments with similar mechanisms to acupuncture (such as electroacupuncture, warming moxibustion, needle warming moxibustion, etc.) within 6 months prior to enrollment;
- Preoperative uncontrolled urinary system infection (asymptomatic lower urinary tract infection is excluded);
- Confirmed severe heart diseases including severe arrhythmia, severe cardiac insufficiency, acute myocarditis, constrictive pericarditis, pericardial tamponade, severe valvular disease, and heart failure;
- Confirmed liver injury or potentially severe liver disease (ALT or AST > 10 times the upper limit of normal);
- Confirmed severe renal impairment (eGFR < 25mL/min/1.73m2), or patients on planned or ongoing dialysis, or patients with acute contrast-induced nephropathy at screening;
- Confirmed dysfunction of other vital organs or severe primary diseases such as hematopoietic system diseases;
- Confirmed 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;
- Patients judged by the investigator as unsuitable for participating in this study, or with high risk of dropping out, such as frequent changes of working environment that easily lead to loss to follow-up;
- Survival period estimated by the investigator to be ≤ 6 months; 14. Currently participating in other clinical trials. (3) Enrollment and Intervention Protocol: Information of postoperative patients will be retrieved from the electronic medical record system of Zhongda Hospital. Patients meeting the inclusion and exclusion criteria will be screened. After signing the informed consent form, patients are allocated to groups via randomization, and receive electroacupuncture intervention or sham acupuncture intervention respectively. The trial intervention protocol is as follows: All patients undergo catheter removal on postoperative day 5 (POD5). Early electroacupuncture intervention (including verum electroacupuncture and sham electroacupuncture) is initiated on postoperative day 2 (POD 2), with one additional session each on POD 4 and POD 6, totaling 3 sessions.
The treatment group receives electroacupuncture at acupoints including Zhongji (RN3), Qihai (RN6), and Shuidao (ST28, bilateral) for 30 minutes per session, with the entire intervention course lasting one week. Continuous wave electroacupuncture is used, with an initial frequency of 2Hz. The intensity is gradually increased until the patient feels comfortable; the current intensity ranges from 1 to 5mA, which is gradually increased up to the maximum intensity that the patient can tolerate. The control group uses non-invasive sham acupuncture needles: validated non-penetrating needles with blunt tips (such as Park needles or Streitberger needles) are adopted. When pressure is applied to these needles, the tip retracts into the needle handle, which creates a tactile pressure sensation on the patient's skin without puncturing the skin. The intervention is performed at non-acupoints (points 1-2 cm adjacent to the verum acupoints, not located on the same meridian). The electrode clips of the electroacupuncture device are also attached to the handles of the sham acupuncture needles, and the device is turned on (producing the same sound and indicator light as in the treatment group) but outputs no current. In this way, the entire treatment scenario remains consistent with that of the verum treatment group in terms of vision and hearing.
To ensure all research subjects receive consistent standard postoperative rehabilitation guidance and control potential confounding variables, all patients successfully enrolled in this study (regardless of their group allocation) will receive a standardized nursing protocol after surgery.
Efficacy Evaluation:
- Primary endpoint: International Prostate Symptom Score (IPSS) at 1-week follow-up after catheter removal.
- Uroflowmetry parameters (Qmax, voided volume, post-void residual urine volume [PVR])
- The International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) score at 1 week, 4 weeks, 8 weeks, and 12 weeks after catheter removal, to evaluate patients' LUTS and their impact on quality of life; ④ The Self-Rating Anxiety Scale (SAS) score is used to evaluate the potential improvement effect of acupuncture intervention on patients' psychological status; ⑤ Patients are required to keep a voiding diary at each follow-up node to comprehensively evaluate urinary function. (4) Statistical Analysis: Statistical analysis will be performed by professional statisticians from the Center for Clinical Evaluation and Analysis, Zhongda Hospital Affiliated to Southeast University, using SPSS Statistics (V.26.0) or R language. All analyses will follow the intention-to-treat (ITT) principle. Shapiro-Wilk test is used to assess the normality of data distribution in data processing; imbalance in baseline demographic and clinical characteristics will be adjusted via analysis of covariance (ANCOVA); normally distributed continuous variables will be expressed as mean ± standard deviation; non-normally distributed continuous variables and ordinal variables will be expressed as median (interquartile range); categorical variables will be expressed as count and percentage; for missing data of primary and secondary endpoints, multiple imputation will be used for processing, and the primary analysis will be performed based on the imputed dataset. Meanwhile, a series of sensitivity analyses will be conducted to evaluate the impact of different missing data processing methods on the robustness of research conclusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Electroacupuncture Group | Experimental | Device: ElectroacupunctureAll patients underwent urinary catheter removal on postoperative day 5 (POD5). Early electroacupuncture intervention, including both verum electroacupuncture and sham electroacupuncture, was initiated on postoperative day 2 (POD 2), with one additional session administered on POD4 and one on POD6, resulting in a total of 3 intervention sessions. The treatment group received electroacupuncture at acupoints including Zhongji (RN3), Qihai (RN6), and bilateral Shuidao (ST28), with each session lasting 30 minutes, and the intervention course lasted one week. For electroacupuncture treatment, a continuous wave with an initial frequency of 2 Hz was applied. The current intensity was gradually increased to maintain a comfortable sensation for the patient, ranging from 1 mA to 5 mA, with the maximum intensity capped at the highest level the patient can tolerate. |
| Sham Electroacupuncture Group | Sham comparator | Device: Sham ElectroacupunctureAll patients underwent urinary catheter removal on postoperative day 5 (POD5). Early electroacupuncture intervention, comprising both verum electroacupuncture and sham electroacupuncture, was initiated on postoperative day 2 (POD 2), with one additional session each on POD4 and POD6, totaling 3 sessions. The control group received non-invasive sham acupuncture needles: validated non-penetrating needles with blunt tips (e.g., Park needle or Streitberger needle). When pressure is applied to such needles, the tip retracts into the handle, creating a tactile pressure sensation on the patient's skin without penetrating the dermis. The procedure is performed at non-acupoints, defined as points located 1-2 cm away from the corresponding true acupoints but not on the same meridian. The electrode clips of the electroacupuncture device are also attached to the handles of the sham acupuncture needles, and the device is activated (producing the same acoustic and indicator light signals as in the |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with benign prostatic hyperplasia (BPH) who have undergone transurethral resection of the prostate (TURP) or holmium laser enucleation of the prostate (HoLEP);
- Aged between 50 and 85 years;
- Provided signed informed consent.
Key exclusion criteria (13 listed)
- Pathological examination results confirm the presence of prostatic tumors;
- History of lower urinary tract cancers including prostate cancer and bladder cancer within the past 5 years;
- Currently receiving or have received treatments based on principles similar to acupuncture within 6 months prior to enrollment, such as electroacupuncture, warm moxibustion, and warm needling moxibustion;
- Presence of uncontrolled urinary system infection before surgery (asymptomatic lower urinary tract infection is excluded);
- Diagnosed with severe cardiac conditions including severe arrhythmia, severe cardiac insufficiency, acute myocarditis, constrictive pericarditis, pericardial tamponade, severe valvular heart disease, and 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 |
|---|---|---|
| ElectroacupunctureAll patients underwent urethral catheter removal on postoperative day 5 (POD5). Early electroacupuncture intervention, including both verum electroacupuncture and sham electroacupuncture, was initiated on postoperative day 2 (POD 2), and administered one additional session each on POD4 and POD6, totaling three sessions. The treatment group received electroacupuncture at acupoints including Zhongji (RN3), Qihai (RN6), and Shuidao (bilateral ST28), with each session lasting 30 minutes, for a total treatment duration of one week. For continuous-wave electroacupuncture, the initial frequency was set to 2 Hz, and the intensity was gradually increased until patients reported a comfortable sensation. The current intensity ranged from 1 mA to 5 mA, with incremental adjustments capped at the maximum tolerable intensity for the patient. | Device | Early Electroacupuncture Group |
| Sham ElectroacupunctureAll patients had their urinary catheters removed on postoperative day 5 (POD5). Early electroacupuncture intervention, including both verum electroacupuncture and sham electroacupuncture, was initiated on postoperative day 2 (POD 2), and administered one additional session each on POD4 and POD6, resulting in a total of 3 sessions. The control group received non-invasive sham acupuncture: validated non-penetrating needles with blunt tips (e.g., Park needle or Streitberger needle) were adopted. For this type of needle, the tip retracts into the handle when pressure is applied, creating a tactile pressure sensation on the patient's skin without penetrating the skin. The procedure was performed at non-acupoint locations, defined as points 1-2 cm away from the corresponding verum acupoints but not located on the same meridian. The electrode clips of the electroacupuncture device were also attached to the handles of the sham needles, and the device was turned on (producing the same operatin | Device | Sham Electroacupuncture Group |
Primary outcome
Change in International Prostate Symptom Score (IPSS)
Time frame: 1 week post-catheter removal
IPSS score at 1-week follow-up after extubation
4 secondary outcomes
Urinary Flow Rate
Time frame: Assessment was performed at 1, 4, 8 and 12 weeks after extubation
ICIQ-MLUTS Score
Time frame: Assessment at 1, 4, 8, and 12 weeks after tube removal
Self-Rating Anxiety Scale (SAS)
Time frame: Evaluations were performed at 1, 4, 8 and 12 weeks after extubation
Voiding Diary
Time frame: Evaluations were performed at 1, 4, 8 and 12 weeks after extubation
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 30 Jul 2026.
- Individual participant dataSharing planned: Yes. Experimental data, apart from patient privacy
Related trials for Benign Prostatic Hyperplasia
Recruiting
Comparing Rezum and Urolift
Benign Prostatic Hyperplasia
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
BPH (Benign Prostatic Hyperplasia)
Not yet recruitingPhase 3
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Benign Prostatic Hyperplasia, run by Zhongda Hospital at 1 site in China.
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 3 inclusion and 13 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 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) (time frame: 1 week post-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 30 Jul 2026.