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临床试验/NCT07736807
NCT07736807尚未招募不适用

Early Electroacupuncture Intervention for Lower Urinary Tract Symptoms After Benign Prostatic Hyperplasia Surgery: A Prospective Study

Zhongda Hospital1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
144
试验地点
1
主要终点
Change in International Prostate Symptom Score (IPSS)

研究概览

简要总结

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

详细描述

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

  1. Selection of research site This study will be conducted in the Department of Urology, Zhongda Hospital Affiliated to Southeast University.
  2. 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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in International Prostate Symptom Score (IPSS)

时间窗: 1 week post-catheter removal

IPSS score at 1-week follow-up after extubation

次要结局

  • 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)

研究者

发起方
Zhongda Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanrong Qian

Investigator

Zhongda Hospital

研究点 (1)

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