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NCT Number: NCT06287970

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

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.

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Key information

Conditions

Chronic Prostatitis

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Guang'anmen Hospita, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Jiani Wu

CONTACT

[email protected]

+8613426116653

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 18 ≤ Age ≤ 50 years old
  • NIH-CPSI ≥15 (patients with moderate to severe CP/CPPS)
  • Signed informed consent and voluntarily participated in the trial

Exclusion criteria

  • 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

Treatment and study plan

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.

Sham transcutaneous auricular vagus nerve stimulation

Device

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

Primary outcomes

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

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: Baseline, week 8 and 12

    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 and follow-up period

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

    Time frame: Baseline, week 4, 8 and 12

    The NIH-CPSI scores range from 0 to 43. The NIH-CPSI has three subscores: pain scores , urinary scores , and quality of life scores. The subscore of pain ranged from 0 to 21. The subscores of urination symptoms ranged from 0 to 10. The subscore of the effect of symptoms on quality of life ranges from 0 to 12. The higher the score, the more severe the symptoms. These subitem scores are specific to the symptoms of CP/CPPS and do not require other separate outcome measures. Each part of the NIH-CPSI score will be recorded weekly during the treatment and follow-up periods

  3. Proportion of responders at week 4, 8 and 12

    Time frame: Baseline, week 4, 8 and 12

    Responder is defined as the patient with a decrease of ≥6 points in the NIH-CPSI total score compared with baseline. The proportion of responders will be calculated for each evaluation time point.

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

    Time frame: Baseline, week 4, 8 and 12

    The IPSS scale scores range from 0 to 35, with higher scores indicating more severe symptoms. The total IPSS score will be recorded once a week during the treatment and follow-up period

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

    Time frame: Baseline, week 4, 8 and 12

    The EQ-5D is mainly composed of two parts, the Descriptive System and the Visual Analogue Scale (VAS) . The description system of EQ-5D can generate a five-digit health status, which can be intuitively reflected in the five health dimensions. This health status can be converted into a single summary number (utility index value) according to the characteristics of the general population in a country/region, which can be used to reflect the health status. The Visual Analogue Scale (VAS) contains a vertical scale ranging from 0 to 100 to record the self-rated health status of the participants. The Visual Analogue Scale provides a quantitative description of respondents' perceptions of their overall health. The EQ-5D total score will be recorded once a week during the treatment and follow-up period

  6. The change from baseline in Self-rating Anxiety Scale (SAS) at week 4, 8 and 12

    Time frame: Baseline, week 4, 8 and 12

    The standard score of the test result is obtained by summing the scores of the 20 items in the SAS scale, multiplying the resulting result by 1.25 and rounding to integer numbers. The cut-off value of the standard score is 53 points, with 53 to 62 points as mild depression, 63 to 72 points as moderate depression, and more than 73 points as severe depression. The total score of SAS will be recorded once a week during the treatment and follow-up period

  7. The change from baseline in the Self-rating Depression Scale (SDS) at week 4, 8 and 12

    Time frame: Baseline, week 4, 8 and 12

    The standard score of the test result is obtained by summing the scores of the 20 items in the SDS scale, multiplying the resulting result by 1.25 and rounding to integer numbers. The cut-off value of the standard score is 53 points, with 53 to 62 points as mild depression, 63 to 72 points as moderate depression, and more than 73 points as severe depression. The total score of SDS will be recorded once a week during the treatment and follow-up period

Other outcomes

  1. Evaluation of patient expectations

    Time frame: Baseline before the randomization

    Patients will be asked before the randomization: ① Do you think transcutaneous vagal nerve stimulation will be effective? ② Do you think transcutaneous vagal nerve stimulation will help improve your symptoms of chronic prostatitis/chronic pelvic floor pain syndrome?

  2. Blinding Evaluation

    Time frame: at the end of week 4

    Let the patient choose whether or not he or she has received the taVNS treatment after the treatment

  3. Incidence of Treatment-Emergent Adverse Events

    Time frame: The 4-week treatment period

    Treatment-related adverse events will be recorded and evaluated between two groups

Study contacts

Contact information is provided by the study sponsor or research team.

Jiani Wu

CONTACT

[email protected]

+8613426116653

Sponsors and collaborators

Lead sponsor

Jiani Wu

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 1, 2024
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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