NCT Number: NCT07324148
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.
Trial opening soon.
Get Notified18 year–50 year
Male
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
Time frame: Week 8
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.
Time frame: Weeks 4, 20 and 32.
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.
Time frame: Weeks 4, 8, 20 and 32
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
Time frame: Weeks 4, 8, 20 and 32
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.
Time frame: Weeks 4, 8, 20 and 32
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.
Time frame: Weeks 4, 8, 20 and 32
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
Time frame: Weeks 4, 8, 20 and 32
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).
Time frame: Baseline
Patients will be asked that what do you expect your erectile dysfunction will be in 8 weeks.
Time frame: Weeks 8 and 32
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".
Time frame: Within 5 minutes after any acupuncture session in Week 8.
Patients are asked whether they have received traditional acupuncture.
Time frame: Weeks 1-32
The adverse events will be recorded throughout the trial, whether related to the treatment or not.
Time frame: Weeks 1-32
Combination treatment used throughout the trial will be documented
Time frame: Baseline, Week 8.
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.
Time frame: Baseline, week 8
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.
Time frame: Baseline, week 8
Functional magnetic resonance imaging will be used to analyze the effects of acupuncture to reveal the central mechanism
Time frame: Baseline, week 8
Metabolomics (urine) will be analysed to provide a more profound analysis at the metabolic level to reveal the mechanism of acupuncture.
Contact information is provided by the study sponsor or research team.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Other
Acupuncture for Erectile Dysfunction Among Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Clinical Trial
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