Clinical trial NCT06287970: TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS
Official 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Prostatitis
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 4
timeFrame: Baseline, week 4
Secondary outcomes:
measure: Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 8 and week 12
timeFrame: Baseline, week 8 and 12
measure: The changes from baseline of NIH-CPSI pain score, urinary score and quality of life score, respectively at week 4, 8 and 12
timeFrame: Baseline, week 4, 8 and 12
measure: Proportion of responders at week 4, 8 and 12
timeFrame: Baseline, week 4, 8 and 12
measure: The change from baseline in International Prostate Symptom Score (IPSS) score at week 4, 8 and 12
timeFrame: Baseline, week 4, 8 and 12
measure: The change from baseline in EuroQol Five Dimensions Questionnaire (EQ-5D) at week 4, 8 and 12
timeFrame: Baseline, week 4, 8 and 12
measure: The change from baseline in Self-rating Anxiety Scale (SAS) at week 4, 8 and 12
timeFrame: Baseline, week 4, 8 and 12
measure: The change from baseline in the Self-rating Depression Scale (SDS) at week 4, 8 and 12
timeFrame: Baseline, week 4, 8 and 12
Other outcomes:
measure: Evaluation of patient expectations
timeFrame: Baseline before the randomization
measure: Blinding Evaluation
timeFrame: at the end of week 4
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: The 4-week treatment period
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospita, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
References: