Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Treatments: Device: Acupuncture; Device: Sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03213938

ZZ10-012

Details and patient eligibility

About

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.

Enrollment: 440 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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440 participants in 2 patient groups

Acupuncture

Experimental group

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.

Treatment:

Device: Acupuncture

Sham acupuncture

Sham Comparator group

Description:

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.

Treatment:

Device: Sham acupuncture