Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a prevalent chronic urological disease. CP/CPPS severely impacts patients' quality of life. It is characterized by recurrent pelvic floor pain, lower urinary tract symptoms, and often accompanied by psychological issues and sexual dysfunction (duration ≥3 months, no confirmed infection/pathology).
The investigators have completed a large-sample, multi-center randomized controlled trial (RCT) involving 440 patients with CP/CPPS before. The clinical trial confirmed the sustained efficacy of acupuncture for the symptoms of pain, lower urinary tract symptoms, and anxiety and depression among patients with CP/CPPS. However, the trial revealed no significant improvements in sexual dysfunction in the acupuncture group compared to the sham acupuncture group after 8 weeks of treatment.To address this limitation, the current study is designed, which aims to optimize the clinical acupuncture protocol for CP/CPPS and evaluate whether it can enhance outcomes for psychogenic erectile dysfunction (ED) associated. Additionally, mass cytometry and liquid suspension chip technology will be used to explore systemic and local immune mechanisms underlying acupuncture's effects for CP/CPPS. Functional magnetic resonance imaging (fMRI) and metabolomics will be integrated to analyze patients' systemic states from central nervous system and metabolic perspectives, comprehensively elucidating the multi-dimensional mechanisms by which acupuncture alleviates CP/CPPS.
Conforms to the diagnosis of CP/CPPS and pED at the same time;
Aged between 18-50 years old;
8≤IIEF-5 score≤21
Have a fixed sexual partner and a regular sexual intercourse of ≥1 time/week during treatment period;
Patients with drug-induced or organic ED.
The existence of lesions that may affect erectile function, such as penile cancer, penile sclerosis, penile anatomical deformity, testicular cancer, urinary system stones or neuropathy, etc.
History of trauma or surgery in pelvic region.
Patients with hypogonadism.
Parallel
Acupuncture
DeviceSanyinjiao (SP6), Zhongliao(BL33), Shenshu(BL23), Huiyang(BL35), Guilai(ST29), Guanyuan(CV4), Shenmen(HT7) and Baihui(GV20) are selected as acupoints protocol. Acupuncture treatment consists of 20 sessions over an 8-week period (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).
Sham acupuncture
DeviceThe participants in the sham acupuncture group will receive sham acupuncture treatment in SP6, BL33, BL23, BL35, ST29, HT7, CV4, and GV20. The duration and frequency of sessions are the same as in the acupuncture group. Blunt needles will be inserted through the fixed pad to reach the surface of the skin without piercing. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effects of the needle tip penetrating the skin.
The change from baseline in the International Erectile Function Index-5 (IIEF-5) score
IIEF-5 is a short verified scale used to evaluate erectile function. It Includes 5 items, with each item ranging from 1-5 points. The total score of IIEF-5 ranges from 5-25 points, with 21-25 indicating normal, 12-21 mild disorder, 8-11 moderate disorder and 5-7 severe disorder.
The change from baseline in the International Erectile Function Index-5 (IIEF-5) score
IIEF-5 is a short verified scale used to evaluate erectile function. It Includes 5 items, with each item ranging from 1-5 points. The total score of IIEF-5 ranges from 5-25 points, with 21-25 indicating normal, 12-21 mild disorder, 8-11 moderate disorder and 5-7 severe disorder.
Change from baseline in the Erection Hardness Score (EHS).
The verified single-entry EHS scale is used to evaluate the hardness of the penis in sexual life. It ranges from 0 to 4. 0 refers to penis does not enlarge; 1 refers to penis is larger, but not hard 2 Penis is hard, but not hard enough for penetration 3 Penis is hard enough for penetration, but not completely hard 4 Penis is completely hard and fully rigid
Proportion of patients with a reduction of ≥6 points from baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score.
NIH-CPSI consists of 13 items, which are organized into three domains of pain, urinary symptoms, and quality of life impact. The total score of NIH-CPSI ranges from 0 to 43, with higher scores indicating more severe symptoms.
Change from baseline in the International Prostate Symptom Score (IPSS) score.
The IPSS assess the severity of lower urinary tract symptoms in men. The total score of IPSS ranges from 0 to 35, with higher scores indicating more severe symptoms.
Safety assessment
The adverse events will be recorded throughout the trial, whether related to the treatment or not.
Combination treatment
Combination treatment used throughout the trial will be documented
Changes in peripheral immune cell types
Employed proteomics-based mass cytometry technology are used to obtain the overview of the changes in peripheral immune cell types in venous blood and prostatic fluid.
Change in the immune phenotype spectrum of CP/CPPS patients
Liquid suspension chip technology will be used to detect the levels of cytokines in serum and prostatic fluid, and establish an organic connection between the changes in prostatic fluid cytokine protein levels and the expression changes of tissue immune-related genes.
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