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

Primary Purpose

Benign Prostatic Hyperplasia (BPH)

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

needle

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring Acupuncture, Mild and moderate BPH

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

acupoint

non-acupoint

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

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

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.

Full Information

NCT ID

NCT01218243

First Posted

October 8, 2010

Last Updated

May 18, 2013

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01218243

Brief Title

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

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia (BPH)

Keywords

Acupuncture, Mild and moderate BPH

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

acupoint

Arm Type

Experimental

Arm Description

Arm Title

non-acupoint

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

needle

Other Intervention Name(s)

acupuncture, electroacupuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)

Description

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.

Time Frame

baseline and the 6th week

Title

Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol).

Description

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.

Time Frame

baseline and the 6th week

Secondary Outcome Measure Information:

Title

Change of Bladder Residual Urine at the 6th Week

Description

Bladder residual urine was used to assess the bladder function, 6 week mean minus baseline mean

Time Frame

baseline and the 6th week

Title

Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week

Description

Maximum urinary flow rate was used to assess the bladder function, 6 week mean minus baseline mean

Time Frame

baseline and the 6th week

Title

Change of International Prostate Symptom Score (IPSS) at the 18th Week

Description

International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),18 week mean minus baseline mean.

Time Frame

baseline and the 18th week

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhishun Liu

Organizational Affiliation

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

City

Beijing

ZIP/Postal Code

100053

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

23593139

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.

Results Reference

derived

PubMed Identifier

21943105

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.

Results Reference

derived

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

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