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

NCT06287970 | Recruiting

• 1 other identifier: 2023-250-KY
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 4

  The NIH-CPSI scale scores range from 0 to 43, with higher scores indicating more severe symptoms. The NIH-CPSI total score will be recorded once a week during the treatment period.

  Baseline, week 4

Secondary Outcomes (7)

• Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 8 and week 12

  Baseline, week 8 and 12

• The changes from baseline of NIH-CPSI pain score, urinary score and quality of life score, respectively at week 4, 8 and 12

  Baseline, week 4, 8 and 12

• Proportion of responders at week 4, 8 and 12

  Baseline, week 4, 8 and 12

• The change from baseline in International Prostate Symptom Score (IPSS) score at week 4, 8 and 12

  Baseline, week 4, 8 and 12

• The change from baseline in EuroQol Five Dimensions Questionnaire (EQ-5D) at week 4, 8 and 12

  Baseline, week 4, 8 and 12

Other Outcomes (3)

• Evaluation of patient expectations

  Baseline before the randomization

• Blinding Evaluation

  at the end of week 4

• Incidence of Treatment-Emergent Adverse Events

  The 4-week treatment period

Study Arms (2)

taVNS Group

EXPERIMENTAL

Bilateral auricular points of Xin (CO15) and Shen (CO10) will be stimulated by electrical stimulation. A disperse-dense wave will be used with a frequency of 4Hz/20Hz, a pulse width of 0.2ms will be set, and the current intensity will be modulated by the tolerance of the patient. note: taVNS, transcutaneous auricular vagus nerve stimulation

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Sham-taVNS Group

SHAM COMPARATOR

Bilateral ear lobes will be stimulated by electrical stimulation. A disperse-dense wave will be used with a frequency of 4Hz/20Hz, a pulse width of 0.2ms and a current intensity of 0.1mA will be set. note: taVNS, transcutaneous auricular vagus nerve stimulation

Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

In the experimental group, bilateral auricular point Xin (CO15) and auricular point Shen (CO10) will be stimulated, on where the vagus nerves distributed.

taVNS Group

Sham Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

In the control group, bilateral earlobes will be stimulated with no vagus nerve distribution.

Sham-taVNS Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Consistent with the diagnostic criteria of CP/CPPS of EAU or CAU, the clinical manifestations were recurrent and persistent prostate pain accompanied by abnormal urination and psychiatric symptoms, without infection or other obvious pathological conditions. The pain symptoms were mainly manifested as pain in the surrounding tissues centered on the prostate, and pain, swelling or discomfort in the scrotum, testis, lower abdomen, perineum, lumbosacral area, and medial thigh. Abnormal urination was characterized by frequent urination, urgent urination, urination pain, urethral burning, residual urination or white discharge from the urethra at the end of urination or defecation in the morning. The neuropsychiatric symptoms included dizziness and tinnitus, insomnia and dreams, anxiety and depression, and even impotence, premature ejaculation, and spermatorrhea. Symptoms lasting more than 3 months in the last six months
• ≤ Age ≤ 50 years old
• NIH-CPSI ≥15 (patients with moderate to severe CP/CPPS)
• Signed informed consent and voluntarily participated in the trial

You may not qualify if:

• Patients with other diseases that cause urinary symptoms were excluded: Such as benign prostatic hyperplasia, testicular and epididymal and spermatic cord diseases, overactive bladder, neurogenic bladder, interstitial cystitis, glandular cystitis, sexually transmitted diseases, bladder tumors such as carcinoma in situ, prostate cancer, urinary male reproductive system tuberculosis, anorectal diseases, lumbar diseases, central and peripheral neuropathy, etc
• Patients with severe diseases of the heart, liver, kidney, hematopoietic system and poor nutritional status
• Patients with severe mental and emotional disorders, who were unable to cooperate with the study
• Patients who have been treated with CP/CPPS regimen in the past 4 weeks

Sponsors & Collaborators

• Jiani Wu: lead

Study Sites (1)

Guang'anmen Hospita, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

RECRUITING

Central Study Contacts

Jiani Wu

CONTACT

+8613426116653; jiani_wu@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: March 1, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 18, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be available starting 6 months after publication of the primary results and will remain accessible for at least 5 years.
• Access Criteria: De-identified data will be made available to qualified researchers upon reasonable request. Researchers must submit a methodologically sound research proposal to the corresponding author at jiani\ wu@aliyun.com. Access to the data will be granted after the requester signs a formal data access agreement.

Locations

CN (1)