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Clinical Trials/NCT00260637
NCT00260637
Completed
Phase 2

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

Universiti Sains Malaysia4 sites in 1 country86 target enrollmentFebruary 2004
ConditionsProstatitis

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Prostatitis
Sponsor
Universiti Sains Malaysia
Enrollment
86
Locations
4
Primary Endpoint
Six point drop in NIH-CPSI total Score
Status
Completed
Last Updated
19 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 2004
End Date
August 2005
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

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.

Outcomes

Primary Outcomes

Six point drop in NIH-CPSI total Score

Secondary Outcomes

  • 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

Study Sites (4)

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