Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis - Full Text View

Sponsors and Collaborators:	University of Science Malaysia 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

MedlinePlus related topics: Acupuncture Pelvic Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double Blind, Sham Controlled Trial Evaluating the Efficacy of Acupuncture in Relieving Symptoms of Chronic Prostatitis/ Chronic Pelvic Pain Syndrome

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

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

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

Keywords provided by University of Science Malaysia:

Prostatitis

Study placed in the following topic categories:

Prostatitis
Pelvic Pain
Prostatic Diseases
Pain
Genital Diseases, Male

ClinicalTrials.gov processed this record on January 14, 2009