Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
MALE
NCT06287970

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

Led by Jiani Wu · Updated on 2025-11-28

68

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 50Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 to 50 years
  • Diagnosed with moderate to severe chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) based on EAU or CAU criteria
  • Symptoms include recurrent and persistent prostate pain with abnormal urination and neuropsychiatric symptoms lasting more than 3 months in the last 6 months
  • NIH-CPSI score of 15 or higher
  • Signed informed consent and willing to participate in the trial
Not Eligible

You will not qualify if you...

  • Presence of other diseases causing urinary symptoms such as benign prostatic hyperplasia, testicular or epididymal diseases, overactive bladder, neurogenic bladder, interstitial cystitis, sexually transmitted diseases, bladder tumors, prostate cancer, urinary tuberculosis, anorectal diseases, lumbar diseases, or neuropathies
  • Severe heart, liver, kidney, or hematopoietic system diseases or poor nutritional status
  • Severe mental or emotional disorders preventing cooperation
  • Received treatment for CP/CPPS in the past 4 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Guang'anmen Hospita, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

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Research Team

J

Jiani Wu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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