Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis

Prostatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260637
• Other study ID #: ACUCP
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 29, 2005
• Last updated: October 25, 2006
• Start date: February 2004
• Est. completion date: August 2005

Study information

• Verified date: November 2005
• Source: University of Science Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatitis

Intervention

Procedure:
• Acupuncture

Locations

Country	Name	City	State
Malaysia	Hospital Lam Wah Ee	Batu Lanchang	Penang
Malaysia	Hospital Pantai Mutiara	Bayan Lepas	Penang
Malaysia	Island Hospital	Georgetown	Penang
Malaysia	Metro Hospital	Sungai Petani	Kedah

Sponsors (2)

Lead Sponsor	Collaborator
University of Science Malaysia	University of Washington

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six point drop in NIH-CPSI total Score
Secondary	Individual domains of the NIH-CPSI
Secondary	Patient reported Global Response Assessment
Secondary	International Prostate Symptom Score
Secondary	International Index of Erectile Function
Secondary	Brief Pain Inventory- Short Form