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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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ClinicalTrials.gov Identifier: NCT01218243
Recruitment Status : Completed
First Posted : October 11, 2010
Results First Posted : August 23, 2012
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia (BPH) Device: needle Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia
Study Start Date : September 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: acupoint
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
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.
Other Names:
  • acupuncture
  • electroacupuncture

Sham Comparator: non-acupoint
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
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.
Other Names:
  • acupuncture
  • electroacupuncture




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Change of Bladder Residual Urine at the 6th Week [ Time Frame: baseline and the 6th week ]
    Bladder residual urine was used to assess the bladder function, 6 week mean minus baseline mean

  2. Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week [ Time Frame: baseline and the 6th week ]
    Maximum urinary flow rate was used to assess the bladder function, 6 week mean minus baseline mean

  3. Change of International Prostate Symptom Score (IPSS) at the 18th Week [ Time Frame: baseline and the 18th week ]
    International Prostate Symptom Score (IPSS) Range:0-35(0 is best,35 is worst, ordinal),18 week mean minus baseline mean.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218243


Locations
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China
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Beijing, China, 100053
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
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Study Director: Zhishun Liu Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liu Zhishun, Dean of Acupuncture Department of Guangan'men Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01218243     History of Changes
Other Study ID Numbers: 2009S208
First Posted: October 11, 2010    Key Record Dates
Results First Posted: August 23, 2012
Last Update Posted: May 27, 2013
Last Verified: May 2013

Keywords provided by Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Acupuncture
Mild and moderate BPH

Additional relevant MeSH terms:
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Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male