NCT Number: NCT00260637
Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis
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.
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Notify MeKey information
Conditions
Age range
20 year–65 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
Metro Hospital, Sungai Petani, Kedah, Malaysia
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Six point drop in NIH-CPSI total Score
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Universiti Sains Malaysia
Other
Collaborators
- University of Washington
Registry information
Official study title
A Double Blind, Sham Controlled Trial Evaluating the Efficacy of Acupuncture in Relieving Symptoms of Chronic Prostatitis/ Chronic Pelvic Pain Syndrome
Important dates
- Study start
- 2004
- Study completion
- 2005
- First posted
- Dec 1, 2005
- Registry last updated
- Oct 26, 2006
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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