Acupuncture for Erectile Dysfunction Among Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- The change from baseline in the International Erectile Function Index-5 (IIEF-5) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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;
- •Voluntarily sign an informed consent form.
排除标准
- •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.
- •Usage of drugs or therapies that relieve CP/CPPS or ED symptoms in the previous 1 month.
- •Have received hormonal or psychiatric drugs in the previous 3 months.
- •Bladder outlet obstruction, overactive bladder, neurogenic bladder, interstitial cystitis, glandular cystitis, sexually transmitted diseases, bladder tumors, prostate cancer, penile cancer, penile stone, other types of prostatitis.
- •With a residual urine ≥100ml.
- •Symptomatic urinary tract infection.
- •Diseases affecting the function of the lower urethra, such as multiple sclerosis, senile dementia, Parkinson's disease, spinal cord injury, caua equina nerve injury, stroke and multisystem atrophy, etc.
- •Severe diseases in heart, lung, brain, liver, kidney and hematopoietic system , mental illness and obvious cognitive function disorders.
- •Patients with poor compliance
研究组 & 干预措施
Acupuncture group
干预措施: Acupuncture (Device)
Sham acupuncture group
干预措施: Sham acupuncture (Device)
结局指标
主要结局
The change from baseline in the International Erectile Function Index-5 (IIEF-5) score
时间窗: 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.
次要结局
- Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score.(Weeks 4, 8, 20 and 32)
- The change from baseline in the International Erectile Function Index-5 (IIEF-5) score(Weeks 4, 20 and 32.)
- Change from baseline in the Erection Hardness Score (EHS).(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.(Weeks 4, 8, 20 and 32)
- Change from baseline in the International Prostate Symptom Score (IPSS) score.(Weeks 4, 8, 20 and 32)
- Change from baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) and VAS scores.(Weeks 4, 8, 20 and 32)
- Assessment of patient expectations for acupuncture.(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)(Weeks 8 and 32)
- Patient Assessment of Blinding Effectiveness(Within 5 minutes after any acupuncture session in Week 8.)
研究者
Yuanjie Sun
Attending doctor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences