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
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 |
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.
Status | Completed |
Enrollment | 86 |
Est. completion date | August 2005 |
Est. primary completion date | |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
University of Science Malaysia | University of Washington |
Malaysia,
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 |
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