NCT03213938

Trial name or title	Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Methods	Randomised controlled trial, parallel group assignment. Double blind (participants and outcome assessors).
Participants	Inclusion criteria: history of pain perceived in prostate region and absence of other lower urinary tract pathology for ≥ 3 of past 6 months. In addition, any associated lower urinary tract symptoms, sexual function and psychological factors should be addressed. Physical examinations, urine analyses, and urine cultures will be performed for all participants. Age 18‐50 years. NIH‐CPSI total score ≥ 15. Exclusion criteria: prostate, bladder or urethral cancer; seizure disorder in any medical history. Inflammatory bowel disease, active urethral stricture, neurological disease or disorder affecting the bladder, liver disease, neurological impairment or psychiatric disorder preventing understanding of consent and self‐report scale. Urinary tract infection with a urine culture value > 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 ≥ 100 mL. Qmax ≤ 15 mL/second. Prior 4 weeks used androgen hormone inhibitors (finasteride), alpha‐blockers (terazosin hydrochloride, doxazosin mesylate, tamsulosin hydrochloride), antibiotics (ciprofloxacin hydrochloride) or any other prostatitis‐specific medication (including herb and Chinese medicine).
Interventions	Experimental: acupuncture. Participants will receive treatment that consists of 20 acupuncture sessions over an 8‐week (3 sessions in each of 1st 4 weeks, and 2 sessions in each of remaining 4 weeks) period after baseline, each for 30 min. Hwato brand disposable acupuncture needles (size 0.30 × 75 mm; size 0.30 × 40 mm) 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; BL23 is in the sacral region, in the 2nd 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. Sham comparator: sham acupuncture. Participants will receive shallow needling at bilateral sham BL23, BL33, BL35 and SP6. Protocol includes same duration and frequency of sessions as for the acupuncture treatment, but treatment was delivered superficially at non‐acupuncture points 10‐15 mm to the lateral of corresponding acupuncture and not above a meridian line (15 mm to BL23, BL33 and BL35; 10 mm to SP6). The Hwato brand disposable acupuncture needles (size 0.30 × 25 mm) will be inserted with a depth of 2‐3 mm without any manipulation.
Outcomes	Primary outcomes: proportion of responders at end of 8 weeks: responder defined as who has a decline of ≥ 6 points from baseline measured using NIH‐CPSI; proportion of responders at end of 32‐week. Secondary outcomes: proportion of responders in 2 groups: week 1‐7; week 24; change from baseline in NIH‐CPSI total score and subscales (time frame: weeks 1‐8, 24 and 32); change from baseline in IPSS (time frame: weeks 4, 8, 24 and 32); change from baseline in (HADS) (time frame: weeks 8, 24 and 32); change from baseline in IIEF‐5 (time frame: weeks 8, 24 and 32); change from baseline in the EuroQol (EQ‐5D) questionnaire (time frame: weeks 8, 24 and 32); response rate proportion of GRA (time frame: weeks 4, 8, 24 and 32); change for peak and mean urinary flow rate from baseline: week 8. Other outcome: expectation assessment (time frame: week 0 (baseline)): assessed at baseline, which includes 2 brief questions to investigate whether participants 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.
Starting date	9 October 2017.
Contact information	Zongshi Qin +86 178 8880 8861; arisq@foxmail.com.
Notes	Estimated primary completion date: 30 October 2019.

CFU: colony‐forming unit; GRA: Global Response Assessment; HADS: Hospital Anxiety and Depression Scale; IIEF: International Index of Erectile Function; IPSS: International Prostate Symptom Score; NIH‐CPSI: National Institutes of Health ‐ Chronic Prostatitis Symptom Index; SAS: Self‐rating Anxiety Scale; SDS: Self‐rating Depression Scale.