- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00260637
Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis
October 25, 2006 updated by: Universiti Sains Malaysia
A Double Blind, Sham Controlled Trial Evaluating the Efficacy of Acupuncture in Relieving Symptoms of Chronic Prostatitis/ Chronic Pelvic Pain Syndrome
Limited evidence suggests that acupuncture may help relieve symptoms of chronic prostatitis/chronic pelvic pain syndrome.
This study evaluated if acupuncture twice weekly for 10 weeks would help ameliorate symptoms of CP/CPPS.
Study Overview
Detailed Description
Various studies have reported that this acupuncture able to relieve symptoms of chronic prostatitis (CP)/ chronic pelvic pain syndrome (CPPS).
However, controversy exists on the efficacy of this technique due to poor experimental designs and lack of placebo controls in these experiment.
This study is the first randomised controlled study which will evaluate if acupuncture for 10 weeks will help improve symptoms of CP/CPPS
Study Type
Interventional
Enrollment
86
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kedah
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Sungai Petani, Kedah, Malaysia, 08000
- Metro Hospital
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Penang
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Batu Lanchang, Penang, Malaysia, 11600
- Hospital Lam Wah Ee
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Bayan Lepas, Penang, Malaysia, 11800
- Hospital Pantai Mutiara
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Georgetown, Penang, Malaysia, 10400
- Island Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Symptoms of discomfort or pain in the pelvic region for at least a three (3) months period within the last six (6) months.
- Moderate overall score on the NIH-CPSI (overall score more than 15 out of a potential of 0-43 points)
- Diagnosed as having CPPS Category III
- Participant is willing to undergo 10 weeks of acupuncture treatment
Exclusion Criteria:
- History of prostate, bladder or urethral cancer.
- Inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).
- Undergone pelvic radiation or systemic chemotherapy, intravesical chemotherapy or intravesical BCG.
- Treated for unilateral orchialgia without pelvic symptoms.
- Active urethral stricture.
- Undergone TURP, TUIP, TUIBN, TUMT, TUNA, balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy.
- Neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
- Liver disease.
- Diagnosed as acute or chronic bacterial prostatitis.
- History of urinary tract infection positive uropathogen for the past year.
- Taking medications which could affect the lower urinary tract function
- History of type 1 or 2 diabetes.
- Treated/currently undergoing treatment with acupuncture for any other illness including prostatitis for the past 6 months.
- Refusal to be needled or any form of bleeding disorder.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Six point drop in NIH-CPSI total Score
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Secondary Outcome Measures
Outcome Measure |
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Individual domains of the NIH-CPSI
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Patient reported Global Response Assessment
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International Prostate Symptom Score
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International Index of Erectile Function
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Brief Pain Inventory- Short Form
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Men L Liong, MD, Consultant Urologist
- Principal Investigator: John N Krieger, MD, University of Washington
- Principal Investigator: Kah H Yuen, PhD, Universiti Sains Malaysia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lee SW, Liong ML, Yuen KH, Krieger JN. Acupuncture and immune function in chronic prostatitis/chronic pelvic pain syndrome: a randomized, controlled study. Complement Ther Med. 2014 Dec;22(6):965-9. doi: 10.1016/j.ctim.2014.10.010. Epub 2014 Oct 23.
- Lee SW, Liong ML, Yuen KH, Leong WS, Khan NK, Krieger JN. Validation of a sham acupuncture procedure in a randomised, controlled clinical trial of chronic pelvic pain treatment. Acupunct Med. 2011 Mar;29(1):40-6. doi: 10.1136/aim.2010.003137. Epub 2011 Jan 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Study Completion
August 1, 2005
Study Registration Dates
First Submitted
November 29, 2005
First Submitted That Met QC Criteria
November 29, 2005
First Posted (Estimate)
December 1, 2005
Study Record Updates
Last Update Posted (Estimate)
October 26, 2006
Last Update Submitted That Met QC Criteria
October 25, 2006
Last Verified
November 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACUCP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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