{
  "abstract": "Introduction Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects around 35%–50% of men during their lifetime. The efficacy of current oral medication for CP/CPPS remains limited. Recent studies demonstrated that vagus nerve stimulation may improve chronic pelvic and abdominal pain. Accordingly, transcutaneous auricular vagus nerve stimulation (taVNS) might represent a promising, non-invasive therapeutic approach for the clinical management of CP/CPPS.Methods and analysis The trial of Transcutaneous Auricular vagus nerve Stimulation for moderate to severe Chronic Prostatitis/CPPS is a prospective, randomised, sham-controlled trial with a 1:1 allocation ratio. Participants will be assigned randomly to either the taVNS group or the sham-taVNS group. The intervention period will consist of a 4-week treatment (a total of 40 sessions), followed by an 8-week follow-up period. The primary outcome is the change from baseline in the National Institutes of Health Chronic Prostatitis Symptom Score Index total score at week 4. Secondary outcomes include the International Prostate Symptom Score Scale, European Quality of Life 5-Dimensions-5-Levels questionnaire, Self-Rating Anxiety Scale and Self-Rating Depression Scale. Safety assessments will be conducted throughout the entire study period.Ethics and dissemination This study protocol and informed consent documents were reviewed and approved by the Institutional Review Board of Guang’anmen Hospital, China Academy of Chinese Medical Sciences (approval number: 2023-250 KY). Written informed consent will be obtained from all participants and/or their legal guardians prior to trial participation. The findings will be disseminated through publication in a peer-reviewed journal and presentations at scientific conferences. The research data will be made available on reasonable request.Trial registration number NCT06287970.",
  "authors": [
    {
      "affiliations": [
        "Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China",
        "Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China"
      ],
      "name": "Xinyao Wei"
    },
    {
      "affiliations": [
        "Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China"
      ],
      "name": "Jiaming Cui"
    },
    {
      "affiliations": [
        "Department of Acupuncture, Yantai Hospital of Traditional Chinese Medicine, Yantai, China"
      ],
      "name": "Zhiwei Zang"
    },
    {
      "affiliations": [
        "Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China"
      ],
      "name": "Ran Pang"
    },
    {
      "affiliations": [
        "Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China"
      ],
      "name": "Leilei Qi"
    },
    {
      "affiliations": [
        "Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China"
      ],
      "name": "Yu Wang"
    },
    {
      "affiliations": [
        "Clinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, China"
      ],
      "name": "Hai-Bo Wang"
    },
    {
      "affiliations": [
        "Clinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, China"
      ],
      "name": "Yangfeng Wu"
    },
    {
      "affiliations": [
        "Clinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, China"
      ],
      "name": "Zongshi Qin"
    },
    {
      "affiliations": [
        "Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China",
        "Department of Psychology, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA"
      ],
      "name": "Jiani Wu"
    }
  ],
  "title": "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",
  "uid": "195f907e-9292-5547-98dc-881af45416eb"
}