Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00260637
Other study ID # ACUCP
Secondary ID
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
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.

Study Design

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


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02246361 - Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication Phase 4
Recruiting NCT00775515 - Laparoscopic Prostatectomy for Chronic Prostatitis Phase 2
Withdrawn NCT03027076 - Microbiome of Urologic Chronic Pelvic Pain Syndrome N/A
Completed NCT00402688 - An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis Phase 3
Suspended NCT00194636 - Effectiveness of Sympathetic Plexus Block on Male Pelvic Pain (Prostatitis, Prostatodynia) Phase 4
Recruiting NCT03720951 - Applying Pulsed Radiofrequency to the Pudendal Nerve Bilaterally Vs Its Application to Sacral Nerve Roots S2,3 and 4 Bilaterally in Chronic Prostatitis N/A
Completed NCT03879486 - Infectious Outcomes of Povidone-iodine Rectal Cleansing Plus Formalin Disinfection of Needle During Prostate Biopsy N/A
Completed NCT01676857 - Chemokine Mechanisms in Chronic Pelvic Pain
Completed NCT00236808 - A Study to Evaluate the Safety and Effectiveness of Levofloxacin Compared With Ciprofloxacin in Patients With Chronic Bacterial Prostatitis Phase 3
Completed NCT00169585 - Levofloxacin For The Management Of Patients With Abnormal Prostate Specific Antigen (PSA) Phase 3
Completed NCT00277511 - Levofloxacin, Chronic Bacterial Prostatitis Phase 3
Completed NCT01886547 - 2013 Annual National Digital Rectal Exam (DRE) Day Study N/A
Completed NCT00701311 - An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome Phase 2
Terminated NCT00194597 - Trial of Viagra' in Men With Chronic Pelvic Pain Syndrome Type III Phase 4
Completed NCT03931538 - Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study N/A
Completed NCT00675298 - Linkage Analysis in Interstitial Cystitis N/A
Terminated NCT00529386 - Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) Phase 1
Completed NCT00103402 - Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome Phase 3
Recruiting NCT01932645 - Etiology Study of Prostatitis
Completed NCT01826617 - Configuration of a New Prostate Disease Nomogram Predicting Prostate Biopsy Outcome N/A