Therapeutic effect of acupuncture and moxa combustion on prostate hyperplasia

Phase 1

• Conditions: benign prostate hyperplasia

• Registration Number: ITMCTR2000003082
• Lead Sponsor: Shanghai 4th People's Hospital affiliated to Tongji University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IPSS;Aging Male Symptoms score;

Secondary Outcome Measures

Name	Time	Method
post-voiding residual urine;change of urgency/24h;voided volume;Voiding time and time to maximum flow;change of urge urinary incontinence frequency/24h;change of nocturnal frequency/24h;Constitution in Chinese Medicine Questionnaire;maximum and average flow rate;change of voiding frequency/24h;