Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis

Phase 2

Completed

• Conditions: Prostatitis

• Registration Number: NCT00260637
• Lead Sponsor: Universiti Sains Malaysia

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 Timeline

• Study Start: 2004-02
• Study Completion: 2005-08
• Status Verified: 2005-11
• Study First Submitted: 2005-11-29
• Study First Submitted QC: 2005-11-29
• Study First Posted: 2005-12-01
• Last Update Submitted: 2006-10-25
• Last Update Posted: 2006-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 86

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Six point drop in NIH-CPSI total Score

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Metro Hospital; 🇲🇾 Sungai Petani, Kedah, Malaysia

Hospital Lam Wah Ee; 🇲🇾 Batu Lanchang, Penang, Malaysia

Island Hospital; 🇲🇾 Georgetown, Penang, Malaysia

Hospital Pantai Mutiara; 🇲🇾 Bayan Lepas, Penang, Malaysia