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

ConditionChronic Prostatitis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age18-50

SponsorJiani Wu

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

68 Participants

are divided into 2 treatment groups

Group A: taVNS GroupExperimental treatment 1 intervention

Group B: Sham-taVNS GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline, week 4

Secondary outcomes

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

Time frame

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

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

Time frame

Baseline, week 4, 8 and 12

Proportion of responders at 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.

Time frame

Baseline, week 4, 8 and 12

The change from baseline in International Prostate Symptom Score (IPSS) score at 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

Time frame

Baseline, week 4, 8 and 12

Other outcomes

Evaluation of patient expectations

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?

Time frame

Baseline before the randomization

Blinding Evaluation

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

Time frame

at the end of week 4

Incidence of Treatment-Emergent Adverse Events

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

Time frame

The 4-week treatment period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiani Wu

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Sponsor institution

Source ClinicalTrials.gov

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