NCT06287970

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Jiani Wu · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Prostatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-15
• Primary completion: 2026-12-31
• Completion: 2027-02-18
• First posted: 2024-03-01
• Last updated: 2025-11-28

Locations

1 site across 1 country: China