taVNS for relieving symptoms of moderate-to-severe chronic prostatitis/CPPS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, sham-controlled trial enrolling 68 patients with moderate-to-severe CP/CPPS who meet EAU/CAU diagnostic criteria. Participants will be randomized 1:1 to receive either active taVNS or a sham taVNS intervention for 4 weeks, with an 8-week follow-up after treatment. Outcomes include NIH-CPSI, IPSS, EQ-5D, and measures of anxiety and depression (SAS, SDS), and adverse events will be recorded throughout. The trial is conducted at Guang'anmen Hospital, China Academy of Chinese Medical Sciences in Beijing.

Why it matters

Who can join: the full rules

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

Where it's running

• Guang'anmen Hospita, China Academy of Chinese Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jiani Wu
• Email: jiani_wu@aliyun.com
• Phone: +8613426116653

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Assessing pain types in treating bladder pain syndrome

  This study is trying to see how different types of bladder pain affect how well people with bladder pain syndrome respond to pelvic floor physical therapy and cognitive-behavioral therapy.

  Recruiting Vanderbilt University Medical Center · Franklin, Tennessee · NCT06299683

• Pelvic floor training for men with chronic pelvic pain

  This study is testing if pelvic floor exercises and biofeedback can help men with chronic pelvic pain feel better over six months compared to those who continue their usual treatment.

  Recruiting Region Stockholm · Stockholm · NCT06115083

• Comparing low-intensity shockwave and radial wave treatments for erectile dysfunction and pelvic pain

  This study is testing whether focused shockwave therapy or radial wave therapy can help men with erectile dysfunction and people with chronic pelvic pain feel better.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT05868668

• A program to ease pelvic pain through cognitive behavioral therapy

  This study is testing a short program of cognitive behavioral therapy to see if it can help people with chronic pelvic pain feel better compared to regular patient education.

  Recruiting State University of New York at Buffalo · Los Angeles, California and 2 other locations · NCT05127616

• Genetic analysis of chronic pelvic pain conditions

  This study is trying to find out if certain genes are linked to chronic pelvic pain by collecting samples from people with the condition and their families.

  Recruiting Boston Children's Hospital · Boston, Massachusetts · NCT00499317

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.