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Clinical Trials/NCT00260637
NCT00260637CompletedPhase 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 enrollmentStarted: February 1, 2004Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
86
Locations
4
Primary Endpoint
Six point drop in NIH-CPSI total Score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.

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

Investigators

Sponsor Class
Other

Study Sites (4)

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