ProstatitisPhase 2/3NCT00260637
Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis
A Phase 2/3 study testing Acupuncture in people with Prostatitis, run by Universiti Sains Malaysia at 4 sites in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Prostatitis
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 86 participants
- Where
- 4 sitesMalaysia
- Study dates
- Feb 2004to Aug 2005
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Malaysia4 sites
Hospital Lam Wah Ee
Batu Lanchang, Pulau Pinang, 11600
Hospital Pantai Mutiara
Bayan Lepas, Pulau Pinang, 11800
Island Hospital
George Town, Pulau Pinang, 10400
Metro Hospital
Sungai Petani, Kedah, 08000
About this study
Official title: A Double Blind, Sham Controlled Trial Evaluating the Efficacy of Acupuncture in Relieving Symptoms of Chronic Prostatitis/ Chronic Pelvic Pain Syndrome
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.
Read the 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
- Conditions
- Prostatitis
- Being tested
- Acupuncture
- Keywords
- Prostatitis
- Medical subject headings
- Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Six point drop in NIH-CPSI total Score
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startFeb 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ProstatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 86 participants
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Investigators
- Men L Liong, MD, Principal investigator, Consultant UrologistJohn N Krieger, MD, Principal investigator, University of WashingtonKah H Yuen, PhD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260637
- Sponsor's protocol ID
- ACUCP
- Status last verified
- Nov 2005
- First submitted
- 29 Nov 2005
- Last updated
- 26 Oct 2006
- Results posted
- No
Publications
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.
PubMed 25453515Lee 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.
PubMed 21245238
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Sham Controlled Trial Evaluating the Efficacy of Acupuncture in Relieving Symptoms of Chronic Prostatitis/ Chronic Pelvic Pain Syndrome
- ClinicalTrials.gov ID
- NCT00260637
- Acronym / sponsor ID
- ACUCP
- Conditions
- Prostatitis
- Keywords
- Prostatitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Feb 2004
- Study completion
- Aug 2005
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture | Procedure or surgery | – |
Primary outcome
Six point drop in NIH-CPSI total Score
5 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2006.
- Derived from this study: PubMed 25453515Lee 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.
- Derived from this study: PubMed 21245238Lee 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.
Related trials for Prostatitis
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
Not yet recruitingPhase 3
FOsfomycin for Male Urinary Tract Infection
Urinary Tract Infection, Prostatitis
RecruitingObservational study
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Men L Liong, MD principal investigator
Consultant Urologist
John N Krieger, MD principal investigator
University of Washington
Kah H Yuen, PhD principal investigator
Universiti Sains Malaysia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acupuncture in people with Prostatitis, run by Universiti Sains Malaysia at 4 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six point drop in NIH-CPSI total Score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00260637, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2006.