Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis

This study has been completed.

First Received on November 29, 2005. Last Updated on October 25, 2006 History of Changes

Sponsor:	University of Science Malaysia
Collaborator:	University of Washington
Information provided by:	University of Science Malaysia
ClinicalTrials.gov Identifier:	NCT00260637

Purpose

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.

Condition	Intervention	Phase
Prostatitis	Procedure: Acupuncture	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Double Blind, Sham Controlled Trial Evaluating the Efficacy of Acupuncture in Relieving Symptoms of Chronic Prostatitis/ Chronic Pelvic Pain Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Pelvic Pain

U.S. FDA Resources

Further study details as provided by University of Science Malaysia:

Primary Outcome Measures:

Six point drop in NIH-CPSI total Score

Secondary Outcome Measures:

Individual domains of the NIH-CPSI
Patient reported Global Response Assessment
International Prostate Symptom Score
International Index of Erectile Function
Brief Pain Inventory- Short Form

Estimated Enrollment:	86
Study Start Date:	February 2004
Estimated Study Completion Date:	August 2005

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

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260637

Locations

Malaysia
Metro Hospital
Sungai Petani, Kedah, Malaysia, 08000
Hospital Lam Wah Ee
Batu Lanchang, Penang, Malaysia, 11600
Hospital Pantai Mutiara
Bayan Lepas, Penang, Malaysia, 11800
Island Hospital
Georgetown, Penang, Malaysia, 10400

Sponsors and Collaborators

University of Science Malaysia

University of Washington

Investigators

Principal Investigator:	Men L Liong, MD	Consultant Urologist
Principal Investigator:	John N Krieger, MD	University of Washington
Principal Investigator:	Kah H Yuen, PhD	University of Science Malaysia

More Information

No publications provided by University of Science Malaysia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Jan 18.

ClinicalTrials.gov Identifier:	NCT00260637 History of Changes
Other Study ID Numbers:	ACUCP
Study First Received:	November 29, 2005
Last Updated:	October 25, 2006
Health Authority:	Malaysia: Ministry of Health

Keywords provided by University of Science Malaysia:

Prostatitis

Additional relevant MeSH terms:

Prostatitis
Chronic Disease
Prostatic Diseases

Genital Diseases, Male
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012