We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03213938
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refers to the presence of bothersome pelvic pain symptoms without an identifiable cause. Common symptoms of CP/CPPS include discomfort in the perineum, suprapubic region, and lower urinary tract symptoms. It affects men of all ages without apparent racial predisposition, among which, 36-50 years old are the most commonly influenced. Yet, few effective therapies are available for treating CP/CPPS.

Acupuncture may be an effective treatment option for CP/CPPS. However, effects of acupuncture on CP/CPPS remain uncertain because of the small sample sizes or other methodological limitations.

The objective of this multi-centre, randomized, sham acupuncture-controlled trial is to assess the effectiveness of acupuncture for relieving symptoms of CP/CPPS. The results will provide a robust conclusion with a high level of evidence.


Condition or disease Intervention/treatment
Chronic Prostatitis With Chronic Pelvic Pain Syndrome Device: Acupuncture Device: Sham acupuncture

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Acupuncture for Chronic Protatitis/Chronic Pelvic Pain Syndrome: a Multicenter Randomized Controlled Trial
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Acupuncture
The participants in the acupuncture group will receive treatment that consists of 20 acupuncture sessions over an 8-week (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks) period after baseline, each for 30 minutes. Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Sanyinjiao (SP6), Zhongliao (BL33), Shenshu (BL23), and Huiyang (BL35), were selected as acupoints protocol. SP6 is on the tibial aspect of the leg, posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus; BL32 is in the sacral region, in the second posterior sacral foramen; BL33 is in the third posterior sacral foramen; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.
Device: Acupuncture

For acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol.

Acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).

Sham Comparator: Sham acupuncture
The participants in the sham acupuncture group will receive shallow needling at bilateral sham BL23, BL33, BL35 and SP6. The protocol includes the same duration and frequency of sessions as for the acupuncture treatment, but the treatment was delivered superficially at non-acupuncture points 10-15 mm to the lateral of corresponding acupuncture and not above a meridian line (15mm to BL23, BL33 and BL35; 10mm to SP6). The Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be inserted with a depth of 2-3 mm without any manipulation.
Device: Sham acupuncture

For sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35.

Sham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).



Outcome Measures

Primary Outcome Measures :
  1. Proportion of responders at the end of 8-week [ Time Frame: week 8 ]
    The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).

  2. Proportion of responders at the end of 32-week [ Time Frame: week 32 ]
    The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.


Secondary Outcome Measures :
  1. Proportion of responders in two groups [ Time Frame: week 1-7; week 24 ]
    The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.

  2. the change from baseline in NIH-CPSI total score [ Time Frame: week 1-8; week 24; week 32 ]
  3. the change from baseline in NIH-CPSI subscales [ Time Frame: week 1-8; week 24; week 32 ]
  4. the change from baseline in the International Prostate Symptom Score (IPSS) [ Time Frame: week 4; week 8; week 24; week 32 ]
  5. the change from baseline in the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: week 8; week 24; week 32 ]
  6. the change from baseline in the International Index of Erectile Function 5 (IIEF-5) [ Time Frame: week 8; week 24; week 32 ]
  7. the change from baseline in the EuroQol (EQ-5D) questionnaire [ Time Frame: week 8; week 24; week 32 ]
  8. the response rate proportion of the Global Response Assessment (GRA) [ Time Frame: week 4; week 8; week 24; week 32 ]
  9. the change for peak and average urinary flow rate from baseline [ Time Frame: week 8 ]

Other Outcome Measures:
  1. Expectation assessment [ Time Frame: week 0 (baseline) ]
    Expectation assessment will be assessed at baseline, which includes 2 brief questions to investigate whether patients are confident that acupuncture treatment will help their CP/CPPS: "In general, is acupuncture effective for controlling the illness?", "Do you think acupuncture will helpful to improve your CP/CPPS symptoms?" For each question, participants could choose "Yes", "No" or "unclear" as the answer.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. History of pain perceived in the prostate region and absence of other lower urinary tract pathology for a minimum of three of the past 6 months. In addition, any associated lower urinary tract symptoms, sexual function, and psychological factors should be addressed. Physical examinations, urine analyses, and urine cultures will be performed for all subjects.
  • 2. Age 18 to 50 years.
  • 3. NIH Chronic Prostatitis Symptom Index (NIH- CPSI) total score ≥ 15.

Exclusion Criteria:

  • 1. Prostate, bladder, or urethral cancer, seizure disorder in any medical history.
  • 2. Inflammatory bowel disease, active urethral stricture, neurologic disease or disorder affecting the bladder, liver disease, neurologic impairment or psychiatric disorder preventing understanding of consent and self-report scale.
  • 3. Urinary tract infection with a urine culture value of more than 100,000 CFU/mL, clinical evidence of urethritis, including urethral discharge or positive culture, diagnostic of sexually transmitted diseases (including gonorrhoea, chlamydia, mycoplasma or trichomonas, but not including HIV/AIDS), symptoms of acute or chronic epididymitis).
  • 4. Residual urine volume≥100ML.
  • 5. Qmax≤15ML/S.
  • 6. Prior 4 weeks used androgen hormone inhibitors (finasteride), alpha-blockers (terazosin HCI, doxazosin mesylate, tamsulosin hydrochloride), antibiotics (ciprofloxacin hydrochloride), or any other prostatitis-specific medication (including herb and Chinese medicine).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213938


Contacts
Contact: Zongshi Qin +86 178 8880 8861 arisq@foxmail.com

Locations
China, Beijing
Guang'anmen Hospital, China Academy of Chinese Medical Science Recruiting
Beijing, Beijing, China, 100053
Contact: Jie Wang    +86 010-88001246    gamhkyc@126.com   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
Principal Investigator: Zhishun Liu Guang'anmen Hospital of China Academy of Chinese Medical Sciences
More Information

Responsible Party: Liu Zhishun, Principal Investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03213938     History of Changes
Other Study ID Numbers: ZZ10-012
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Chronic prostatitis
chronic pelvic pain syndrome
acupuncture
randomized controlled trial

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Pelvic Pain
Prostatitis
Chronic Disease
Disease
Pathologic Processes
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease Attributes