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NCT Number: NCT01218243

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia (BPH) Genital Diseases Genital Diseases, Male Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

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

Beijing, 100053, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

needle

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 11, 2010
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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