benign prostate hyperplasia
Conditions
Interventions
Sponsors
Shanghai 4th People's Hospital affiliated to Tongji University
Eligibility
Sex/Gender
Male
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Healthy males aged 45 years old or older; 2. Subjects with benign prostatic hyperplasia diagnosed by digital rectal examination; 3. Volume of the prostate equals to or over 30 ml; 4. Maximum urinary flow rate <15 ml/s; 5. Subjects with lower urinary tract symptoms suggestive of benign prostate hyperplasia, who voluntarily agree to join and sign to the consent form; 6. Have been treated with conventional first-line western medicine for more than three months; 7. Patients with moderate to severe benign prostatic hyperplasia (IPSS score 8-19 points).
Exclusion criteria
Exclusion criteria: 1. Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 5 years; 2. Subjects who have acute urinary retention within 4 weeks before screening; 3. Subjects who have clinically significant severe cardiovascular disease (unstable angina, myocardial infarction or arrhythmia) within 6 months before screening; 4. Subjects who have concerns about acupuncture; 5. Subjects who were suspected or confirmed calculus of lower urinary tract, calculus of bladder (except for complete recovery); 6. Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial; 7. Concurrent use of other Chinese herbal medicines or alternative medicine (including drugs and acupuncture) for more than one month; 8. Syphilis, gonorrhea and other sexually transmitted diseases or urinary tract infections; 9. Congenital abnormalities such as bladder neck fibrosis, interstitial cystitis or urethral stricture; 10. A history of genital trauma or surgery affecting the muscle or nervous system; 11. Patients with upper urinary tract obstruction, renal edema, etc. affecting renal function; 12. Unable to sign a consent form or unable to communicate with researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPSS;Aging Male Symptoms score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Constitution in Chinese Medicine Questionnaire;post-voiding residual urine;maximum and average flow rate;voided volume;Voiding time and time to maximum flow;change of urgency/24h;change of voiding frequency/24h;change of nocturnal frequency/24h;change of urge urinary incontinence frequency/24h; | — |
Countries
China
Contacts
Public ContactHuajun Bo
Shanghai 4th People's Hospital affiliated to Tongji University
Outcome results
None listed