Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis

Sponsor
Universiti Sains Malaysia (Other)
Overall Status
Completed
CT.gov ID
NCT00260637
Collaborator
University of Washington (Other)
86
4
18
21.5
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Acupuncture
Phase 2/Phase 3

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 Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Double Blind, Sham Controlled Trial Evaluating the Efficacy of Acupuncture in Relieving Symptoms of Chronic Prostatitis/ Chronic Pelvic Pain Syndrome
Study Start Date :
Feb 1, 2004
Study Completion Date :
Aug 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Six point drop in NIH-CPSI total Score []

Secondary Outcome Measures

  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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Metro Hospital Sungai Petani Kedah Malaysia 08000
2 Hospital Lam Wah Ee Batu Lanchang Penang Malaysia 11600
3 Hospital Pantai Mutiara Bayan Lepas Penang Malaysia 11800
4 Island Hospital Georgetown Penang Malaysia 10400

Sponsors and Collaborators

  • Universiti Sains Malaysia
  • 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, Universiti Sains Malaysia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00260637
Other Study ID Numbers:
  • ACUCP
First Posted:
Dec 1, 2005
Last Update Posted:
Oct 26, 2006
Last Verified:
Nov 1, 2005
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2006