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Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Primary Purpose

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Acupuncture

Sham acupuncture

About this trial

This is an interventional treatment trial for Chronic Prostatitis With Chronic Pelvic Pain Syndrome focused on measuring Chronic prostatitis, chronic pelvic pain syndrome, acupuncture, randomized controlled trial

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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, urinary 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).

Sites / Locations

Guang'anmen Hospital, China Academy of Chinese Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture

Sham acupuncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

Proportion of Responders at Other Time Points

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

the Change From Baseline in NIH-CPSI Total Score

The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) is a universally accepted, reliable and valid instrument recommended for clinical evaluation and research of CP/CPPS by consensus guidelines. It measures the domains of pain (score range, 0-21), urinary function (0-10) and quality of life impact (0-12) in CP/CPPS, with a total score ranging from 0 to 43 and higher scores indicating worse conditions.

the Change From Baseline in NIH-CPSI Subscales

The NIH-CPSI is a universally accepted, reliable and valid instrument recommended for clinical evaluation and research of CP/CPPS by consensus guidelines. It measures the domains of pain, urinary function and quality of life impact in CP/CPPS. The score range of pain subscale is 0-21, with higher scores indicating worse conditions. The score range of urinary function subscale is 0-10, with higher scores indicating worse conditions. The score range of quality-of-life subscale is 0-12, with higher scores indicating worse quality of life.

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

IPSS is a valid, reliable and sensitive measure for patients with lower urinary tract symptoms; it is widely used in clinical practice and research to determine the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining and nocturia. Each of the questions is rated from 0 (not at all) to 5 (almost always). IPSS score ranges from 0 to 35, with higher score indicating more severe urinary symptoms.

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

HADS is made up of 7 items for the assessment of depression and anxiety; the completion of this scale usually requires 2-5 minutes. HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.

the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5)

The IIEF-5 is a psychometrically valid and reliable instrument with high sensitivity and specificity for detecting treatment effects in patients with erection dysfunction of a broad spectrum of aetiology. Chinese version IIEF-5 score ranges from 0 to 25, with lower scores indicating greater severity of dysfunction and minimal clinical important difference over 5.

the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire

The EQ-5D-5L is a well-established and suitable for evaluation of quality of life in participants with CP/CPPS. EQ-5D-5L overall index ranges from -0.39 to 1.00, with higher overall index indicating better generic health-status.

the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)

GRA consists of 7 response categories: markedly worsened, moderately worsened, slightly worsened, no change, slightly improved, moderately improved, and markedly improved.

the Change for Peak and Average Urinary Flow Rate From Baseline

Full Information

NCT ID

NCT03213938

First Posted

July 5, 2017

Last Updated

August 6, 2022

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03213938

Brief Title

Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Official Title

Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Multicenter Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

October 9, 2017 (Actual)

Primary Completion Date

December 10, 2019 (Actual)

Study Completion Date

December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

440 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

Arm Title

Sham acupuncture

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Acupuncture

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

Sham acupuncture

Intervention Description

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).

Primary Outcome Measure Information:

Title

Proportion of Responders at the End of 8-week

Description

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).

Time Frame

week 8

Title

Proportion of Responders at the End of 32-week

Description

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

Time Frame

week 32

Secondary Outcome Measure Information:

Title

Proportion of Responders at Other Time Points

Description

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

Time Frame

weeks 1-7; week 20

Title

the Change From Baseline in NIH-CPSI Total Score

Description

Time Frame

weeks 1-8; week 20; week 32

Title

the Change From Baseline in NIH-CPSI Subscales

Description

Time Frame

weeks 1-8; week 20; week 32

Title

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

Description

Time Frame

week 4; week 8; week 20; week 32

Title

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

Description

Time Frame

week 8; week 20; week 32

Title

the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5)

Description

Time Frame

week 8; week 20; week 32

Title

the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire

Description

Time Frame

week 8; week 20; week 32

Title

the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)

Description

GRA consists of 7 response categories: markedly worsened, moderately worsened, slightly worsened, no change, slightly improved, moderately improved, and markedly improved.

Time Frame

week 4; week 8; week 20; week 32

Title

the Change for Peak and Average Urinary Flow Rate From Baseline

Time Frame

weeks 8 and 32

Other Pre-specified Outcome Measures:

Title

Expectation Assessment

Description

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.

Time Frame

baseline

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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, urinary 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhishun Liu

Organizational Affiliation

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guang'anmen Hospital, China Academy of Chinese Medical Science

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Deidentified participant data and data dictionary will be available with publication until six months after publication. Formal request should be sent to the corresponding author (zhishunjournal@163.com) with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement

IPD Sharing Time Frame

The data will be available with publication until until six months after publication.

IPD Sharing 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

Citations:

PubMed Identifier

29273095

Citation

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.

Results Reference

background

PubMed Identifier

34399062

Citation

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.

Results Reference

result

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Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

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