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Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis

Primary Purpose

Prostatitis

Status
Completed
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Universiti Sains Malaysia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatitis focused on measuring Prostatitis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Metro Hospital
  • Hospital Lam Wah Ee
  • Hospital Pantai Mutiara
  • Island Hospital

Outcomes

Primary Outcome Measures

Six point drop in NIH-CPSI total Score

Secondary Outcome Measures

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

Full Information

First Posted
November 29, 2005
Last Updated
October 25, 2006
Sponsor
Universiti Sains Malaysia
Collaborators
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00260637
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Universiti Sains Malaysia
Collaborators
University of Washington

4. Oversight

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatitis
Keywords
Prostatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
86 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Primary Outcome Measure Information:
Title
Six point drop in NIH-CPSI total Score
Secondary Outcome Measure Information:
Title
Individual domains of the NIH-CPSI
Title
Patient reported Global Response Assessment
Title
International Prostate Symptom Score
Title
International Index of Erectile Function
Title
Brief Pain Inventory- Short Form

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Men L Liong, MD
Organizational Affiliation
Consultant Urologist
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John N Krieger, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kah H Yuen, PhD
Organizational Affiliation
Universiti Sains Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Metro Hospital
City
Sungai Petani
State/Province
Kedah
ZIP/Postal Code
08000
Country
Malaysia
Facility Name
Hospital Lam Wah Ee
City
Batu Lanchang
State/Province
Penang
ZIP/Postal Code
11600
Country
Malaysia
Facility Name
Hospital Pantai Mutiara
City
Bayan Lepas
State/Province
Penang
ZIP/Postal Code
11800
Country
Malaysia
Facility Name
Island Hospital
City
Georgetown
State/Province
Penang
ZIP/Postal Code
10400
Country
Malaysia

12. IPD Sharing Statement

Citations:
PubMed Identifier
25453515
Citation
Lee SW, Liong ML, Yuen KH, Krieger JN. Acupuncture and immune function in chronic prostatitis/chronic pelvic pain syndrome: a randomized, controlled study. Complement Ther Med. 2014 Dec;22(6):965-9. doi: 10.1016/j.ctim.2014.10.010. Epub 2014 Oct 23.
Results Reference
derived
PubMed Identifier
21245238
Citation
Lee SW, Liong ML, Yuen KH, Leong WS, Khan NK, Krieger JN. Validation of a sham acupuncture procedure in a randomised, controlled clinical trial of chronic pelvic pain treatment. Acupunct Med. 2011 Mar;29(1):40-6. doi: 10.1136/aim.2010.003137. Epub 2011 Jan 18.
Results Reference
derived

Learn more about this trial

Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis

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