TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS

Launched by JIANI WU · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called transcutaneous auricular vagus nerve stimulation (taVNS) to see if it can help men suffering from moderate to severe chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS). The trial will involve 68 male participants aged 18 to 50 who have been experiencing persistent pain in the prostate area and related symptoms, such as discomfort during urination and possible anxiety or depression. Participants will be randomly assigned to either the taVNS treatment group or a sham (placebo) group for four weeks, with follow-up assessments continuing for eight weeks after the treatment.

Eligible participants must have specific symptoms related to CP/CPPS for at least three months and have a certain score indicating the severity of their condition. Those with other urinary issues or serious health problems, as well as recent treatments for CP/CPPS, are not eligible to join. Throughout the study, participants will complete questionnaires to track their symptoms and any side effects they may experience from the treatment. This research aims to determine whether taVNS is a safe and effective option for managing symptoms of chronic prostatitis.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Consistent with the diagnostic criteria of CP/CPPS of EAU or CAU, the clinical manifestations were recurrent and persistent prostate pain accompanied by abnormal urination and psychiatric symptoms, without infection or other obvious pathological conditions. The pain symptoms were mainly manifested as pain in the surrounding tissues centered on the prostate, and pain, swelling or discomfort in the scrotum, testis, lower abdomen, perineum, lumbosacral area, and medial thigh. Abnormal urination was characterized by frequent urination, urgent urination, urination pain, urethral burning, residual urination or white discharge from the urethra at the end of urination or defecation in the morning. The neuropsychiatric symptoms included dizziness and tinnitus, insomnia and dreams, anxiety and depression, and even impotence, premature ejaculation, and spermatorrhea. Symptoms lasting more than 3 months in the last six months
• • 18 ≤ Age ≤ 50 years old
• • NIH-CPSI ≥15 (patients with moderate to severe CP/CPPS)
• • Signed informed consent and voluntarily participated in the trial
• Exclusion Criteria:
• • Patients with other diseases that cause urinary symptoms were excluded: Such as benign prostatic hyperplasia, testicular and epididymal and spermatic cord diseases, overactive bladder, neurogenic bladder, interstitial cystitis, glandular cystitis, sexually transmitted diseases, bladder tumors such as carcinoma in situ, prostate cancer, urinary male reproductive system tuberculosis, anorectal diseases, lumbar diseases, central and peripheral neuropathy, etc
• • Patients with severe diseases of the heart, liver, kidney, hematopoietic system and poor nutritional status
• • Patients with severe mental and emotional disorders, who were unable to cooperate with the study
• • Patients who have been treated with CP/CPPS regimen in the past 4 weeks