Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis - Tabular View

Tracking Information

First Received Date ^ICMJE

November 29, 2005

Last Updated Date

October 25, 2006

Start Date ^ICMJE

February 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Six point drop in NIH-CPSI total Score

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00260637 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis

Official Title ^ICMJE

A Double Blind, Sham Controlled Trial Evaluating the Efficacy of Acupuncture in Relieving Symptoms of Chronic Prostatitis/ Chronic Pelvic Pain Syndrome

Brief Summary

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.

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 Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Prostatitis

Intervention ^ICMJE

Procedure: Acupuncture

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

20 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Malaysia

Administrative Information

NCT ID ^ICMJE

NCT00260637

Responsible Party

Study ID Numbers ^ICMJE

ACUCP

Study Sponsor ^ICMJE

University of Science Malaysia

Collaborators ^ICMJE

University of Washington

Investigators ^ICMJE

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

Information Provided By

University of Science Malaysia

Verification Date

November 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP