Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Intervention / Treatment
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* Device: Acupuncture
* Device: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>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<br>* 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).<br>|
| Sham Comparator: Sham acupuncture<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | weeks 1-7; week 20 | 
| 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. | weeks 1-8; week 20; week 32 | 
| 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. | weeks 1-8; week 20; week 32 | 
| 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. | week 4; week 8; week 20; week 32 | 
| 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. | week 8; week 20; week 32 | 
| 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. | week 8; week 20; week 32 | 
| 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. | week 8; week 20; week 32 | 
| 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. | week 4; week 8; week 20; week 32 | 
| the Change for Peak and Average Urinary Flow Rate From Baseline |  | weeks 8 and 32 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic prostatitis, chronic pelvic pain syndrome, acupuncture, randomized controlled trial