Clinical trial NCT03213938: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Keywords: Chronic prostatitis
chronic pelvic pain syndrome
acupuncture
randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 440
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Proportion of Responders at the End of 8-week
timeFrame: week 8
measure: Proportion of Responders at the End of 32-week
timeFrame: week 32
Secondary outcomes:
measure: Proportion of Responders at Other Time Points
timeFrame: weeks 1-7; week 20
measure: the Change From Baseline in NIH-CPSI Total Score
timeFrame: weeks 1-8; week 20; week 32
measure: the Change From Baseline in NIH-CPSI Subscales
timeFrame: weeks 1-8; week 20; week 32
measure: the Change From Baseline in the International Prostate Symptom Score (IPSS)
timeFrame: week 4; week 8; week 20; week 32
measure: the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS)
timeFrame: week 8; week 20; week 32
measure: the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5)
timeFrame: week 8; week 20; week 32
measure: the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire
timeFrame: week 8; week 20; week 32
measure: the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
timeFrame: week 4; week 8; week 20; week 32
measure: the Change for Peak and Average Urinary Flow Rate From Baseline
timeFrame: weeks 8 and 32
Other outcomes:
measure: Expectation Assessment
timeFrame: baseline
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Science
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Zhishun Liu
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.