Clinical trial NCT00260637: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostatitis
Keywords: Prostatitis
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2005-12-01
Enrollment: 86
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Six point drop in NIH-CPSI total Score
Secondary outcomes:
measure: Individual domains of the NIH-CPSI
measure: Patient reported Global Response Assessment
measure: International Prostate Symptom Score
measure: International Index of Erectile Function
measure: Brief Pain Inventory- Short Form
Other outcomes:
Locations:
city: Sungai Petani
country: Malaysia
facility: Metro Hospital
state: Kedah
city: Batu Lanchang
country: Malaysia
facility: Hospital Lam Wah Ee
state: Penang
city: Bayan Lepas
country: Malaysia
facility: Hospital Pantai Mutiara
state: Penang
city: Georgetown
country: Malaysia
facility: Island Hospital
state: Penang
Study officials:
affiliation: Consultant Urologist
name: Men L Liong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: John N Krieger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Sains Malaysia
name: Kah H Yuen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.