Clinical trial NCT01218243: An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia
Official title: An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Acupuncture
Mild and moderate BPH
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)
timeFrame: baseline and the 6th week
measure: Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol).
timeFrame: baseline and the 6th week
Secondary outcomes:
measure: Change of Bladder Residual Urine at the 6th Week
timeFrame: baseline and the 6th week
measure: Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week
timeFrame: baseline and the 6th week
measure: Change of International Prostate Symptom Score (IPSS) at the 18th Week
timeFrame: baseline and the 18th week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Study officials:
affiliation: Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
name: Zhishun Liu
role: STUDY_DIRECTOR
References:
citation: Wang Y, Liu B, Yu J, Wu J, Wang J, Liu Z. Electroacupuncture for moderate and severe benign prostatic hyperplasia: a randomized controlled trial. PLoS One. 2013 Apr 12;8(4):e59449. doi: 10.1371/journal.pone.0059449. Print 2013.
citation: Wang Y, Liu Z, Yu J, Ding Y, Liu X. Efficacy of electroacupuncture at Zhongliao point (BL33) for mild and moderate benign prostatic hyperplasia: study protocol for a randomized controlled trial. Trials. 2011 Sep 26;12:211. doi: 10.1186/1745-6215-12-211.