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

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218243
• Other study ID #: 2009S208
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2010
• Last updated: May 18, 2013
• Start date: September 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2013
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

efficacy here means specific effect(or active ingredient) of the point BL33.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 70 Years

Eligibility

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 a1 receptor blocker, 5a-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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• needle
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.

Locations

Country	Name	City	State
China	Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No