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Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis

This study has been completed.
Information provided by University of Science Malaysia

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Descriptive Information Fields
Brief Title  Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis
Official Title  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  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Six point drop in NIH-CPSI total Score
Secondary Outcome Measure  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
Condition  Prostatitis
Intervention  Procedure: Acupuncture
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  86
Start Date  February 2004
Completion Date August 2005
Eligibility 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.
Gender Male
Ages 20 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Malaysia
Administrative Information Fields
NCT ID  NCT00260637
Organization ID ACUCP
Secondary IDs ††
Study Sponsor  University of Science Malaysia
Collaborators †† 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    
Information Provided By University of Science Malaysia
Verification Date November 2005
First Received Date  November 29, 2005
Last Updated Date October 25, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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