protocolSection identificationModule nctId: NCT06287970, orgStudyIdInfo id: 2023-250-KY, briefTitle: TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-02-18, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Jiani Wu, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Prostatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous Auricular Vagus Nerve Stimulation, interventions name: Sham Transcutaneous Auricular Vagus Nerve Stimulation, outcomesModule primaryOutcomes measure: Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 4, secondaryOutcomes measure: Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 8 and week 12, secondaryOutcomes measure: The changes from baseline of NIH-CPSI pain score, urinary score and quality of life score, respectively at week 4, 8 and 12, secondaryOutcomes measure: Proportion of responders at week 4, 8 and 12, secondaryOutcomes measure: The change from baseline in International Prostate Symptom Score (IPSS) score at week 4, 8 and 12, secondaryOutcomes measure: The change from baseline in EuroQol Five Dimensions Questionnaire (EQ-5D) at week 4, 8 and 12, secondaryOutcomes measure: The change from baseline in Self-rating Anxiety Scale (SAS) at week 4, 8 and 12, secondaryOutcomes measure: The change from baseline in the Self-rating Depression Scale (SDS) at week 4, 8 and 12, otherOutcomes measure: Evaluation of patient expectations, otherOutcomes measure: Blinding Evaluation, otherOutcomes measure: Incidence of Treatment-Emergent Adverse Events, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Guang'anmen Hospita, China Academy of Chinese Medical Sciences, city: Beijing, state: Beijing, zip: 100053, country: China, contacts name: Jiani Wu, role: CONTACT, phone: +8613426116653, email: jiani_wu@aliyun.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False