Effectiveness and safety of electroacupuncture and its cotreatment with electronic moxibustion in the treatment of patients with moderate benign prostatic hyperplasia using alpha blocker : An assessor-blinded, randomized controlled clinical trial
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0004411
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 78
1) Man over 50 years old and under 79 years old who is diagnosed with prostatic hyperplasia and is taking alpha blocker
2) Total International Prostate Symptom Score (Total IPSS) is 8 or more and 19 or less
3) Able and willing to comply with the intervention and follow-up evaluation
4) Able to provide written informed consent
1) Subjects who are diagnosed with prostatic hyperplasia and are taking medications other than alpha blockers (5-alpha reductase inhibitors, anticholinergic drugs, antidiuretic hormones, etc.) for treatment
2) Subjects whose Prostate-Specific Antigen (PSA) values are greater than 4ng/mL (subjects with a PSA = 4ng/mL are required to have a prostate biopsy negative for malignance)
3) Subjects with the clinical evidence of neurogenic bladder, urethral stricture, bladder calculus, acute/chronic renal failure, urinary tract infection or other urology diseases except BPH
4) Subjects with clinical evidence of genito-urinary malignant tumors including prostate or bladder cancer
5) Subjects who have history of prostate surgery or who are scheduled prostate surgery
6) Subjects who had AUR
7) Subjects with clinical evidence of renal or hepatic impairment
8) Subjects with clinically significant urinalysis findings or hematuria with urinalysis
9) Subjects who use pacemaker
10) Severe underlying disease (uncontrolled hypertention, cardiovascular disease, or malignant tumor) requiring active therapy
11) Subjects with uncontrolled diabetes or diabetic neuropathy
12) Subjects with local skin disease at the site of electronic moxibustion
13) History of neurotic or major psychiatric disability or cognitive instability
14) Subjects who are considered to be inappropriate for the study by the researcher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total International Prostate Symptom Score(IPSS) change after 6 weeks from baseline
- Secondary Outcome Measures
Name Time Method Safety assessment(Adverse effect);Total International Prostate Symptom Score(IPSS) change after 3 weeks, 12 weeks from baseline;Clinical relevance (MCID ratio);Prostate volume;Quality of Life(IPSS life satisfaction, EQ-5D);Maximum flow rate;Average flow rate