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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01218243 |
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Date of registration:
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08/10/2010 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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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Date of first enrolment:
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September 2010 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01218243 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Zhishun Liu |
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Address:
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Telephone:
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Email:
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Affiliation:
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Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences |
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Key inclusion & exclusion 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 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.
Age minimum:
50 Years
Age maximum:
70 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Benign Prostatic Hyperplasia (BPH)
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Intervention(s)
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Device: needle
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Primary Outcome(s)
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Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol).
[Time Frame: baseline and the 6th week]
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Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)
[Time Frame: baseline and the 6th week]
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Secondary Outcome(s)
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Change of Bladder Residual Urine at the 6th Week
[Time Frame: baseline and the 6th week]
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Change of International Prostate Symptom Score (IPSS) at the 18th Week
[Time Frame: baseline and the 18th week]
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Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week
[Time Frame: baseline and the 6th week]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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