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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental |
| |
| Sham acupuncture group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | Sanyinjiao (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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 4, 20 and 32. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment | The adverse events will be recorded throughout the trial, whether related to the treatment or not. | Weeks 1-32 |
| Combination treatment | Combination treatment used throughout the trial will be documented |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanjie Sun | Contact | +86 18810337542 | puzhisun@163.com |
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The data will be available with publication until until six months after publication.
Formal request should be sent to the author (puzhisun@163.com) with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham acupuncture | Device | The 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. |
|
| 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 | Weeks 4, 8, 20 and 32 |
| 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. | Weeks 4, 8, 20 and 32 |
| 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. | Weeks 4, 8, 20 and 32 |
| Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score. | The HADS is a 14-item scale to screen for anxiety and depression. The total score of HADS ranges from 0 to 42, with higher scores indicating more severe anxiety and depression | Weeks 4, 8, 20 and 32 |
| Change from baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) and VAS scores. | The EQ-5D-5L is used to measure health-related quality of life. It consists of a descriptive system and a visual analogue scale (VAS). The descriptive system includes dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A health state utility score can be derived using population-based value sets. The VAS component asks patients to rate their overall health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). | Weeks 4, 8, 20 and 32 |
| Assessment of patient expectations for acupuncture. | Patients will be asked that what do you expect your erectile dysfunction will be in 8 weeks. | Baseline |
| The proportion of participants rates their overall improvement as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C) | The Patient Global Impression-Change (PGI-C) is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse" or "very much worse". | Weeks 8 and 32 |
| Patient Assessment of Blinding Effectiveness | Patients are asked whether they have received traditional acupuncture. | Within 5 minutes after any acupuncture session in Week 8. |
| Weeks 1-32 |
| 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. | Baseline, Week 8. |
| 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. | Baseline, week 8 |
| Central mechanism underlying the effects of acupuncture for CP/CPPS and ED | Functional magnetic resonance imaging will be used to analyze the effects of acupuncture to reveal the central mechanism | Baseline, week 8 |
| Urine metabolism | Metabolomics (urine) will be analysed to provide a more profound analysis at the metabolic level to reveal the mechanism of acupuncture. | Baseline, week 8 |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |