An interventional study of Electroacupuncture and Sham Electroacupuncture in Benign Prostatic Hyperplasia, sponsored by Zhongda Hospital. Not yet recruiting at 1 site in China. Open to male participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Zhongda Hospital · Not applicable, Interventional, and Treatment
Among 53 studies in Prostatic Hyperplasia with a site in China — 22 open to participants now, 22 under way, 1 of them phase 3. Prostatic Hyperplasia · China.
Among the 53 studies in Prostatic Hyperplasia with a site in China, this one is the 16th largest by planned enrollment of the 40 interventional ones that give a count, is one of 11 that started in 2026, is one of 29 with no phase, reaches primary completion later than 13 of the 21 other live ones, and was the 50th registered.
828 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
Browse Prostatic Hyperplasia studies →22 of the 53 studies in Prostatic Hyperplasia with a site in China are open now. Recruiting first, the newest first:
Jiangsu Taizhou People's Hospital · Sites in China
Ages 15–90 · Men only
Shanghai General Hospital, China · Sites in China
Ages 50–85 · Men only
Peking University Third Hospital · Sites in China
Men only
Qing Yuan · Sites in China
Ages 40–80 · Men only
Ruijin Hospital · Sites in China
Ages 18–80 · Men only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 102 Prostatic Hyperplasia studies recruiting now, 70 (69%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.
This study: 50 Years to 85 Years · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
53 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 5 · Phase 4 3
First in 2004; this study’s year is marked. 11 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 144 is above the median of 92 across 627 interventional studies indexed under Prostatic Hyperplasia.
Median enrollment 120 across the 40 interventional studies, 153 across the 13 observational. Of the 22 that completed or were terminated, 5 (23%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 53 have an industry lead sponsor. The 10 most frequent:
Zhongda Hospital is the lead sponsor of 104 studies on the registry; 42 are open to participants now.
Zhongda Hospital has 1 study filed under Prostatic Hyperplasia — fewer than ten, so there is no comparison to draw.
9 of the studies in Prostatic Hyperplasia with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07146386Phase 3Shanghai Huilun Pharmaceutical Co., Ltd.A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia | 2027-01 |
| NCT07238959Shanghai Changzheng HospitalApplication of Quantum Detection-Driven Artificial Intelligence Algorithms for Single-Molecule cfDNA Characterization in the Early Diagnosis of Prostate Cancer | 2026-12 |
| NCT06817733Chinese PLA General HospitalClinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging | 2026-12-30 |
| NCT07357324The Fourth Affiliated Hospital of Zhejiang University School of MedicineA Clinical Observation Study of a Chinese Patent Medicine Combined With Tamsulosin in Improving Sleep and Nocturia Symptoms After Enucleation of the Prostate | 2026-12-31 |
| NCT06689514Yifeng JingStudy on the Effectiveness of Tranilast in the Treatment of Medium to Large Volume Benign Prostatic Hyperplasia | 2026-12-31 |
Add all 9 to your calendar (.ics) → With an account.
Among the 53 studies in Prostatic Hyperplasia with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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. 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
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.
2. Research Content
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.
3. Research Methods
The inclusion criteria for subjects are as follows:
The exclusion criteria for subjects are as follows:
13. 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Electroacupuncture
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
Device: Sham Electroacupuncture
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.
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
Change in International Prostate Symptom Score (IPSS)
IPSS score at 1-week follow-up after extubation
Time frame: 1 week post-catheter removal
Urinary Flow Rate
Urinary Flow Rate: It includes Qmax, voided volume and PVR.
Time frame: Assessment was performed at 1, 4, 8 and 12 weeks after extubation
ICIQ-MLUTS Score
ICIQ-MLUTS Score
Time frame: Assessment at 1, 4, 8, and 12 weeks after tube removal
Self-Rating Anxiety Scale (SAS)
Self-Rating Anxiety Scale (SAS)
Time frame: Evaluations were performed at 1, 4, 8 and 12 weeks after extubation
Voiding Diary
Voiding Diary
Time frame: Evaluations were performed at 1, 4, 8 and 12 weeks after extubation
Plan to share: Yes — Experimental data, apart from patient privacy
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jul 2027, 12 months later.
Of 153 non-industry interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 205 studies reached it within 26 months; a quarter within 15 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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