Randomized controlled trial of acupuncture improving quality of life in patients with chronic prostatitis / chronic pelvic floor pain syndrome in acupuncture group

Not Applicable

Recruiting

• Conditions: Chronic prostatitis / chronic pelvic floor pain syndrome

• Registration Number: ITMCTR2100005210
• Lead Sponsor: Beijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

(1) The clinical manifestations were recurrent and persistent prostate pain in the last six months, accompanied by abnormal urination and psychoneurological symptoms. At the same time, infection or other obvious pathological conditions were not confirmed, and the symptoms lasted for more than 3 months. The main clinical manifestations are pain radiated from the surrounding tissues with the prostate as the center, and pain, swelling or discomfort in the scrotum, testis, lower abdomen, perineum, lumbosacral and medial thigh; Abnormal micturition showed frequent micturition, urgent micturition, urinary pain, urethral burning, residual urine or white secretion overflowing from the urethra in the morning, at the end of urine or defecation; Mental and neurological symptoms include dizziness, tinnitus, insomnia, dreaminess, anxiety and depression, or even sexual dysfunction such as impotence and premature ejaculation;
(2) Age 18-50 years old;
(3) NIH-CPSI score >= 15;
(4) Voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria

(1) Bladder outlet obstruction, overactive bladder, neurogenic bladder, interstitial cystitis, glandular cystitis, sexually transmitted diseases, carcinoma in situ and other bladder tumors, prostate cancer, urinary tract infection, other types of prostatitis, etc;
(2) Transabdominal B-ultrasound residual urine >= 100ml; Maximum urinary flow rate < 15ml /S;
(3) Taking drugs to alleviate CP / CPPS symptoms or receiving non drug therapy for CP / CPPS (acupuncture, biofeedback, etc.) in recent 1 month; Taking drugs that affect lower urinary tract function;
(4) Symptomatic urinary tract infection and organic diseases of urinary system;
(5) Diseases affecting lower urethral function, such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal cord injury, cauda equina nerve injury, stroke and multisystem atrophy;
(6) Patients with severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental diseases and obvious cognitive impairment.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
After 8 weeks of treatment, the change value of the total score of who quality of life brief table compared with baseline, International Prostate Symptom Score Chinese Version (IPSS);Changes in the total score of who quality of life brief table compared with baseline after 8 weeks of treatment, Chinese version SF-36;

Secondary Outcome Measures

Name	Time	Method
The total score of SF-36 changed from baseline at 24 weeks of follow-up;The changes of visual analogue scale (VAS) of pelvic floor pain compared with baseline during follow-up.;During the follow-up period, the total score and three dimensions of NIH-CPSI were compared with baseline;The change of visual analogue scale (VAS) of pelvic floor pain during treatment compared with baseline.;The change of (IPSS) total score from baseline at 24 weeks of follow-up;The total score of NIH-CPSI (Chinese version) and the changes of three dimensions compared with baseline during the treatment period;