taVNS for relieving symptoms of moderate-to-severe chronic prostatitis/CPPS
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Moderate to Severe Chronic Prostatitis/Chronic Pelvic Pain Syndrome (TASC-P Trial): a Randomized, Sham Controlled Trial.
This trial will try transcutaneous auricular vagus nerve stimulation (taVNS) to see if it reduces pain and urinary and mood symptoms in adults aged 18–50 with moderate to severe chronic prostatitis/CPPS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06287970 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, sham-controlled trial enrolling 68 patients with moderate-to-severe CP/CPPS who meet EAU/CAU diagnostic criteria. Participants will be randomized 1:1 to receive either active taVNS or a sham taVNS intervention for 4 weeks, with an 8-week follow-up after treatment. Outcomes include NIH-CPSI, IPSS, EQ-5D, and measures of anxiety and depression (SAS, SDS), and adverse events will be recorded throughout. The trial is conducted at Guang'anmen Hospital, China Academy of Chinese Medical Sciences in Beijing.
Who should consider this trial
Good fit: Adults aged 18–50 diagnosed with CP/CPPS (symptoms >3 months in the last 6 months) with NIH-CPSI score ≥15, without infection or other clear pathological causes, are the intended participants.
Not a fit: People outside the 18–50 age range, those with infectious or other identifiable causes of pelvic pain, or those with only mild CP/CPPS symptoms (NIH-CPSI <15) are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, taVNS could offer a noninvasive treatment option to reduce pelvic pain and improve urinary symptoms and quality of life for people with CP/CPPS.
How similar studies have performed: Noninvasive vagus nerve stimulation has shown promise for some chronic pain and mood disorders, but applying taVNS specifically to CP/CPPS is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Guang'anmen Hospita, China Academy of Chinese Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jiani Wu
- Email: jiani_wu@aliyun.com
- Phone: +8613426116653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.