Early Electroacupuncture for Post-TURP LUTS

NCT07736807 | Not Yet Recruiting

• 1 other identifier: 2026ZDSYLL174-P01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Benign Prostatic Hyperplasia

Keywords

Lower Urinary Tract Symptoms; Electroacupuncture; TURP

Outcome Measures

Primary Outcomes (1)

• Change in International Prostate Symptom Score (IPSS)

  IPSS score at 1-week follow-up after extubation

  1 week post-catheter removal

Secondary Outcomes (4)

• Urinary Flow Rate

  Assessment was performed at 1, 4, 8 and 12 weeks after extubation

• ICIQ-MLUTS Score

  Assessment at 1, 4, 8, and 12 weeks after tube removal

• Self-Rating Anxiety Scale (SAS)

  Evaluations were performed at 1, 4, 8 and 12 weeks after extubation

• Voiding Diary

  Evaluations were performed at 1, 4, 8 and 12 weeks after extubation

Study Arms (2)

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.

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

Device: Sham Electroacupuncture

Interventions

Electroacupuncture DEVICE

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.

Early Electroacupuncture Group

Sham Electroacupuncture DEVICE

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

Sham Electroacupuncture Group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)