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

Official title

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.

Overview

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.

Interventions

• Device Transcutaneous Auricular Vagus Nerve Stimulation
  In the experimental group, bilateral auricular point Xin (CO15) and auricular point Shen (CO10) will be stimulated, on where the vagus nerves distributed.
• Device Sham Transcutaneous Auricular Vagus Nerve Stimulation
  In the control group, bilateral earlobes will be stimulated with no vagus nerve distribution.

Primary outcome measures

• Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 4 [Time frame: Baseline, week 4]

Secondary outcome measures (7)

• Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 8 and week 12 [Time frame: Baseline, week 8 and 12]
• The changes from baseline of NIH-CPSI pain score, urinary score and quality of life score, respectively at week 4, 8 and 12 [Time frame: Baseline, week 4, 8 and 12]
• Proportion of responders at week 4, 8 and 12 [Time frame: Baseline, week 4, 8 and 12]
• The change from baseline in International Prostate Symptom Score (IPSS) score at week 4, 8 and 12 [Time frame: Baseline, week 4, 8 and 12]
• The change from baseline in EuroQol Five Dimensions Questionnaire (EQ-5D) at week 4, 8 and 12 [Time frame: Baseline, week 4, 8 and 12]
• The change from baseline in Self-rating Anxiety Scale (SAS) at week 4, 8 and 12 [Time frame: Baseline, week 4, 8 and 12]
• The change from baseline in the Self-rating Depression Scale (SDS) at week 4, 8 and 12 [Time frame: Baseline, week 4, 8 and 12]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Guang'anmen Hospita, China Academy of Chinese Medical Sciences — Beijing

Publications

• Wei X, Cui J, Zang Z, Pang R, Qi L, Wang Y, Wang HB, Wu Y, Qin Z, Wu J. Transcutaneous auricular vagus nerve stimulation for moderate to severe chronic prostatitis/chronic pelvic pain syndrome (TASC-P) in China: study protocol for a randomised controlled trial. BMJ Open. 2026 Jun 9;16(6):e106160. doi: 10.1136/bmjopen-2025-106160. PMID 42264522

Identifiers

NCT: NCT06287970 · 2023-250-KY

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗