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NCT Number: NCT00260637

Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis

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.

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Key information

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Metro Hospital, Sungai Petani, Kedah, Malaysia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Procedure

Primary outcomes

  1. Six point drop in NIH-CPSI total Score

Secondary outcomes

  1. Individual domains of the NIH-CPSI

  2. Patient reported Global Response Assessment

  3. International Prostate Symptom Score

  4. International Index of Erectile Function

  5. Brief Pain Inventory- Short Form

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Collaborators

  • University of Washington

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Dec 1, 2005
Registry last updated
Oct 26, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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