Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

NCT03213938 | Completed Results

• 1 other identifier: ZZ10-012
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Keywords

Chronic prostatitis; chronic pelvic pain syndrome; acupuncture; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Proportion of Responders at the End of 8-week

  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).

  week 8

• Proportion of Responders at the End of 32-week

  The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.

  week 32

Secondary Outcomes (9)

• Proportion of Responders at Other Time Points

  weeks 1-7; week 20

• the Change From Baseline in NIH-CPSI Total Score

  weeks 1-8; week 20; week 32

• the Change From Baseline in NIH-CPSI Subscales

  weeks 1-8; week 20; week 32

• the Change From Baseline in the International Prostate Symptom Score (IPSS)

  week 4; week 8; week 20; week 32

• the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS)

  week 8; week 20; week 32

Other Outcomes (1)

• Expectation Assessment

  baseline

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Sham acupuncture

SHAM COMPARATOR

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

Interventions

Acupuncture DEVICE

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).

Acupuncture

Sham acupuncture DEVICE

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).

Sham acupuncture

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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, urinary analyses, and urine cultures will be performed for all subjects;
• \. Age 18 to 50 years.
• \. NIH Chronic Prostatitis Symptom Index (NIH- CPSI) total score ≥ 15.

You may not qualify if:

• \. Prostate, bladder, or urethral cancer, seizure disorder in any medical history.
• \. 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.
• \. 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).
• \. Residual urine volume≥100ML.
• \. Qmax≤15ML/S.
• \. 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).

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Science

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (4)

• Qin Z, Liu Y, Zhou K, Wu J, Pang R, Li N, Xu C, Kwong JSW, Liu Z. Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial. Trials. 2017 Dec 22;18(1):616. doi: 10.1186/s13063-017-2383-8.

  PMID: 29273095 BACKGROUND

• Sun Y, Liu Y, Liu B, Zhou K, Yue Z, Zhang W, Fu W, Yang J, Li N, He L, Zang Z, Su T, Fang J, Ding Y, Qin Z, Song H, Hu H, Zhao H, Mo Q, Zhou J, Wu J, Liu X, Wang W, Pang R, Chen H, Wang X, Liu Z. Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome : A Randomized Trial. Ann Intern Med. 2021 Oct;174(10):1357-1366. doi: 10.7326/M21-1814. Epub 2021 Aug 17.

  PMID: 34399062 RESULT

• Zhu L, Sun Y, Yan S, Liu X, Wang X, Liu Z. Efficacy of acupuncture on drinkers with chronic prostatitis / chronic pelvic pain syndrome: secondary analysis of a randomized clinical trial. Acupunct Med. 2024 Oct;42(5):243-250. doi: 10.1177/09645284241274158. Epub 2024 Sep 1.

  PMID: 39219163 DERIVED

• Zhu L, Fang J, Sun Y, Yang M, Yao H, Liu Z. Impact of ejaculation upon effect of acupuncture on chronic prostatitis/chronic pelvic pain syndrome: Secondary analysis of a randomized controlled trial. Integr Med Res. 2023 Jun;12(2):100943. doi: 10.1016/j.imr.2023.100943. Epub 2023 Apr 3.

  PMID: 37122487 DERIVED

MeSH Terms

Conditions

Prostatitis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Zhishun Liu
• Organization: Guang'anmen Hospital, China Academy Chinese Medical Sciences

liuzhishun@aliyun.com

+86 010 88002331

Study Officials

• Zhishun Liu

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 11, 2017
• Study Start: October 9, 2017
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: August 9, 2022
• Results First Posted: September 27, 2021

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available with publication until until six months after publication.
• Access Criteria: Formal request should be sent to the corresponding author (zhishunjournal@163.com) with a methodologically sound proposal. Researchers whose proposal has been approved. Researchers whose proposal has been approved will sign a data access agreement

Locations

CN (1)