NCT06287970 TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS
| NCT ID | NCT06287970 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jiani Wu |
| Condition | Chronic Prostatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2024-03-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2024-03-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06287970 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 50 Years, studying Chronic Prostatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06287970 currently recruiting?
Yes, NCT06287970 is actively recruiting participants. Contact the research team at jiani_wu@aliyun.com for enrollment information.
Where is the NCT06287970 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06287970 clinical trial?
NCT06287970 is sponsored by Jiani Wu. The trial plans to enroll 68 participants.