Effect of fire needle therapy on mild-moderate benign prostatic hyperplasia: Protocol for a randomized controlled pilot trial
- Conditions
- mild-moderate benign prostatic hyperplasia
- Registration Number
- ITMCTR2000003205
- Lead Sponsor
- Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- Not specified
1. Aged 40–80 years old;
2. diagnosed with BPH for more than 3 months;
3. syndrome differentiation in traditional Chinese medicine conforms to kidney yang deficiency;
4. abstain from medication for BPH for more than 6 months before the start of treatment;
5. IPSS score < 19 (mild-moderate BPH);
6. Qmax<15mL/s or average flow rate (Qave)<10ml/s;
7. with stable life signs;
8. voluntary participation in the study and sign informed consent prior to treatment.
1. oliguria and anuria caused by bladder or prostate malignancy, urolithiasis, acute/chronic renal failure;
2. urinary dysfunction caused by neurogenic bladder, bladder neck fibrosis, and urethral stricture;
3. gonorrhea and urinary tract infection;
4. failure of invasive therapy for BPH;
5. local organs, muscles and nerves injured by pelvic operation or trauma;
6. abdominal aneurysms, hepatosplenomegaly, and serious cerebrovascular, cardiovascular, respiratory, digestive, hematological, or psychiatric diseases;
7. blood coagulation disorders or requiring administration of anticoagulant medication, such as Warfarin and Dabigatran;
8. cognitive dysfunction, psychosis, unable to cooperate with the examination and treatment.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method International prostate symptom score;
- Secondary Outcome Measures
Name Time Method Mean number of nightly urinations;Average flow rate (Qave);Prostate volume;Maximum urinary flow rate (Qmax);