An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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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
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efficacy here means specific effect(or active ingredient) of the point BL33.

Official Title
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An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia

Conditions
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Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
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* Device: needle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupoint<br>Needle at bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd)is put on with Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. There are 5 sessions in the first two weeks and 3 sessions in the last two weeks, 30 min/session. | Device: needle<br>* For the acupoint group,needle on bilateral BL33 60-80mm with a 45°angle. A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.The non-point group take the place 2 cun far from BL33 on the outside horizontally as the non-point and the manipulation methods are the same with those of the point group.<br>* Other names: electroacupuncture;|
| Sham Comparator: non-acupoint<br>Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time. | Device: needle<br>* For the acupoint group,needle on bilateral BL33 60-80mm with a 45°angle. A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.The non-point group take the place 2 cun far from BL33 on the outside horizontally as the non-point and the manipulation methods are the same with those of the point group.<br>* Other names: electroacupuncture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat) | 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. | baseline and the 6th week | 
| Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol). | 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. | baseline and the 6th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Bladder Residual Urine at the 6th Week | Bladder residual urine was used to assess the bladder function, 6 week mean minus baseline mean | baseline and the 6th week | 
| Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week | Maximum urinary flow rate was used to assess the bladder function, 6 week mean minus baseline mean | baseline and the 6th week | 
| Change of International Prostate Symptom Score (IPSS) at the 18th Week | International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),18 week mean minus baseline mean. | baseline and the 18th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Mild and moderate BPH