An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)
Study Overview
Brief Summary
To evaluate efficacy of BL33 for mild and moderate benign prostatic hyperplasia(BPH).There are trials showing that electroacupuncture on BL33 for mild and moderate BPH is more effective than terazosin. It could reduce the International Prostate Syndrome Score (IPSS) by 6.68±2.84(39.79%),lower urinary symptoms bother of score(BS) and bladder residual urine, and increase maximum urinary flow rate.But the efficacy of BL33 has not been studied. The objective of this study is to evaluate efficacy of BL32 for mild and moderate BPH by comparison with non-acupoint group.
Detailed Description
efficacy here means specific effect(or active ingredient) of the point BL33.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •50-70 years old
- •Mild to moderate BPH evaluated by I-PSS
- •Patients having urinary dysfunction more than 3 months
- •Patients with stable life signs
- •no use of α1 receptor blocker, 5α-reductase inhibitor or traditional Chinese medicine for over 1 week
- •Volunteer to join this research and sign the written informed consent prior to receiving treatment
Exclusion Criteria
- •Urinary dysfunction caused by gonorrhea or urinary tract infection
- •Oliguria and anuria caused by urinary calculi, prostate cancer, bladder tumor and acute/chronic renal failure
- •Urinary dysfunction caused by neurogenic bladder, bladder neck fibrotic and urethral stricture
- •Failure of invasive therapy for prostatic obstruction
- •Injured local organs, muscle and nerve caused by pelvic operation or historical trauma
- •Upper urinary obstruction and hydrocele combined with damaged renal function due to BPH diagnosed by B-ultrasound
- •Patients who can't stick to treatment because of economic reason, far distance between home and the hospital or difficult walking etc.
Outcomes
Primary Outcomes
Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)
Time Frame: baseline and the 6th week
International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean.And analysis for this outcome measure is based on ITT population.
Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol).
Time Frame: baseline and the 6th week
International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean. And analysis for this outcome measure is based on per-protocol population.
Secondary Outcomes
- Change of Bladder Residual Urine at the 6th Week(baseline and the 6th week)
- Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week(baseline and the 6th week)
- Change of International Prostate Symptom Score (IPSS) at the 18th Week(baseline and the 18th week)
Investigators
Liu Zhishun
Dean of Acupuncture Department of Guangan'men Hospital
Guang'anmen Hospital of China Academy of Chinese Medical Sciences