Benign Prostatic Hyperplasia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Chinese Diagnostic Criteria: Refer to the "Criteria for Diagnosis and Therapeutic Efficacy of Chinese Medicine Diseases" issued and implemented by the National Administration of Traditional Chinese Medicine. Patients must be clinically diagnosed with "Jinglong" (benign prostatic hyperplasia). (1) Frequent urination, especially increased nocturnal urination, gradually accompanied by difficulty in urination, incomplete voiding, and severe cases may present with urinary retention or urinary incontinence; (2) Commonly seen in elderly males; (3) Digital rectal examination: Enlarged prostate, smooth surface without nodules, clear margins, moderate hardness with elasticity, and shallow or absent midline groove; (4) Ultrasound examination shows enlarged prostate volume. Western Medical Diagnostic Criteria: Refer to the "Guidelines for Diagnosis and Treatment of Benign Prostatic Hyperplasia" (2014) by the Chinese Medical Association's Urological Surgery Branch and the European Urological Association (EAU) "Guidelines for Management of Non-Neurogenic Male Lower Urinary Tract Symptoms" for BPH diagnostic criteria. (1) Prolonged and effortful urination, weak stream, hesitancy, interrupted flow; (2) Frequent urination, especially nocturnal; (3) Ultrasound examination shows enlarged prostate. Inclusion Criteria: (1) Meets the above Chinese and Western medical diagnostic criteria; (2) Age 40-80 years; (3) International Prostate Symptom Score >5 points; (4) Disease duration >3 months; (5) Discontinued use of alpha-1 receptor blockers for over 1 month, or discontinued use of 5-alpha reductase inhibitors and traditional Chinese medicine for over 6 months; (6) Maximum urinary flow rate <15 mL/s or average flow rate <10 mL/s; (7) Voluntarily participates in this trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with oliguria caused by prostate cancer, urinary tract stones, urinary retention, or acute and chronic kidney failure; 2. Patients with difficulty in urination due to neurogenic bladder, bladder neck fibrosis, or other causes of urethral stricture; 3. Patients with frequent urination caused by gonorrhea, urinary tract infections, etc.; 4. Patients with impaired kidney function due to upper urinary tract obstruction and hydronephrosis or benign prostatic hyperplasia (BPH); 5. Patients with bladder diverticula detected by B; 6. Patients who have failed invasive treatments for BPH; 7. Patients with a history of pelvic surgery or injury affecting the function of local organs, muscles, or nerves; 8. Patients with severe primary diseases of the liver, cardiovascular system, or hematopoietic system, or abdominal aortic aneurysm, or abnormal enlargement of the liver or spleen; 9. Patients with cognitive or mental disorders who are unable to cooperate with examinations or treatments; 10. Patients with coagulation disorders or long-term use of anticoagulant drugs such as warfarin sodium or dabigatran ester.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score (IPSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life (QOL) Score; | — |
Countries
China
Contacts
Beijing University of Chinese Medicine Oriental Hospital