TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS
ConditionChronic Prostatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-50
SponsorJiani Wu
About this trial
This trial aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) for moderate to severe chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). This study is a prospective, randomized, controlled trial. A total of 68 patients with CP/CPPS will be recruited. After baseline assessment, the patients will be randomized into taVNS group (n = 34) and sham-taVNS group (n = 34). The intervention of two group will last for 4 weeks with a 8-week follow-up period after the treatment. The National Institutes of Health chronic Prostatitis Symptom Score index (NIH-CPSI), International Prostate Symptom Score Scale (IPSS), European quality of Life-5 Dimensions Questionnaire (EQ-5D), self-rating anxiety Scale (SAS) and self-rating depression scale (SDS) will be assessed. The adverse events during the whole study will be recorded detailedly.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Transcutaneous Auricular Vagus Nerve Stimulation
- Sham Transcutaneous Auricular Vagus Nerve Stimulation
Treatment groups
68 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jiani Wu
Lead sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor institution
Source ClinicalTrials.gov