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RECRUITING
NCT06287970
NA

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

Sponsor: Jiani Wu

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2024-03-15

Completion Date

2027-02-18

Last Updated

2025-11-28

Healthy Volunteers

No

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.

Locations (1)

Guang'anmen Hospita, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China