RecruitingNot ApplicableNCT06287970

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.


Sponsor

Jiani Wu

Enrollment

68 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sham Transcutaneous Auricular Vagus Nerve Stimulation and a medical device called Transcutaneous Auricular Vagus Nerve Stimulation for people with chronic prostatitis. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscutaneous 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.

DEVICESham 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

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NCT06287970


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