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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
68
In the experimental group, bilateral auricular point Xin (CO15) and auricular point Shen (CO10) will be stimulated, on where the vagus nerves distributed.
In the control group, bilateral earlobes will be stimulated with no vagus nerve distribution.
Guang'anmen Hospita, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGChange 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
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
The change from baseline in EuroQol Five Dimensions Questionnaire (EQ-5D) at 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
Time frame: Baseline, week 4, 8 and 12
The change from baseline in Self-rating Anxiety Scale (SAS) at 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
Time frame: Baseline, week 4, 8 and 12
The change from baseline in the Self-rating Depression Scale (SDS) at 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
Time frame: Baseline, week 4, 8 and 12
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