Chronic ProstatitisNCT06287970
TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Chronic Prostatitis, run by Jiani Wu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Chronic Prostatitis
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 18 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospita, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Jiani Wu, +8613426116653, jiani_wu@aliyun.com
About this study
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.
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
- Chronic Prostatitis
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation, Sham Transcutaneous Auricular Vagus Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
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 StimulationDevice
In the control group, bilateral earlobes will be stimulated with no vagus nerve distribution.
| Study group | Role | What they receive |
|---|---|---|
| taVNS Group | Experimental | Bilateral auricular points of Xin (CO15) and Shen (CO10) will be stimulated by electrical stimulation. A disperse-dense wave will be used with a frequency of 4Hz/20Hz, a pulse width of 0.2ms will be set, and the current intensity will be modulated by the tolerance of the patient.
note: taVNS, transcutaneous auricular vagus nerve stimulation Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Sham-taVNS Group | Sham comparator | Bilateral ear lobes will be stimulated by electrical stimulation. A disperse-dense wave will be used with a frequency of 4Hz/20Hz, a pulse width of 0.2ms and a current intensity of 0.1mA will be set.
note: taVNS, transcutaneous auricular vagus nerve stimulation Receives: Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 4
Secondary outcomes (7)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, week 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start15 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion18 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic ProstatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiani Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiani Wu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287970
- Sponsor's protocol ID
- 2023-250-KY
- Status last verified
- Nov 2025
- First submitted
- 4 Feb 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in this article and any future publications from this study will be shared. This includes, but is not limited to: demographic information, clinical assessments, scores from the National Institutes of Health Chronic Prostatitis Symptom Score Index (NIH-CPSI), the International Prostate Symptom Score Scale (IPSS), the European Quality of Life Five-Dimensions Questionnaire (EQ-5D-5L), the Self-rating Anxiety Scale (SAS), and the Self-rating Depression Scale (SDS).
Publications
Wei X, Cui J, Zang Z, Pang R, Qi L, Wang Y, Wang HB, Wu Y, Qin Z, Wu J. Transcutaneous auricular vagus nerve stimulation for moderate to severe chronic prostatitis/chronic pelvic pain syndrome (TASC-P) in China: study protocol for a randomised controlled trial. BMJ Open. 2026 Jun 9;16(6):e106160. doi: 10.1136/bmjopen-2025-106160.
PubMed 42264522
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06287970
- Acronym / sponsor ID
- 2023-250-KY
- Conditions
- Chronic Prostatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Jiani WuUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 18 Feb 2027 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS Group | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationBilateral auricular points of Xin (CO15) and Shen (CO10) will be stimulated by electrical stimulation. A disperse-dense wave will be used with a frequency of 4Hz/20Hz, a pulse width of 0.2ms will be set, and the current intensity will be modulated by the tolerance of the patient. note: taVNS, transcutaneous auricular vagus nerve stimulation |
| Sham-taVNS Group | Sham comparator | Device: Sham Transcutaneous Auricular Vagus Nerve StimulationBilateral ear lobes will be stimulated by electrical stimulation. A disperse-dense wave will be used with a frequency of 4Hz/20Hz, a pulse width of 0.2ms and a current intensity of 0.1mA will be set. note: taVNS, transcutaneous auricular vagus nerve stimulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve StimulationIn the experimental group, bilateral auricular point Xin (CO15) and auricular point Shen (CO10) will be stimulated, on where the vagus nerves distributed. | Device | taVNS Group |
| Sham Transcutaneous Auricular Vagus Nerve StimulationIn the control group, bilateral earlobes will be stimulated with no vagus nerve distribution. | Device | Sham-taVNS Group |
Primary outcome
Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 4
Time frame: Baseline, 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.
7 secondary outcomes
Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 8 and week 12
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
Time frame: Baseline, week 4, 8 and 12
Proportion of responders at week 4, 8 and 12
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
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
Time frame: Baseline, week 4, 8 and 12
The change from baseline in Self-rating Anxiety Scale (SAS) at week 4, 8 and 12
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
Time frame: Baseline, week 4, 8 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Derived from this study: PubMed 42264522Wei X, Cui J, Zang Z, Pang R, Qi L, Wang Y, Wang HB, Wu Y, Qin Z, Wu J. Transcutaneous auricular vagus nerve stimulation for moderate to severe chronic prostatitis/chronic pelvic pain syndrome (TASC-P) in China: study protocol for a randomised controlled trial. BMJ Open. 2026 Jun 9;16(6):e106160. doi: 10.1136/bmjopen-2025-106160.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in this article and any future publications from this study will be shared. This includes, but is not limited to: demographic information, clinical assessments, scores from the National Institutes of Health Chronic Prostatitis Symptom Score Index (NIH-CPSI), the International Prostate Symptom Score Scale (IPSS), the European Quality of Life Five-Dimensions Questionnaire (EQ-5D-5L), the Self-rating Anxiety Scale (SAS), and the Self-rating Depression Scale (SDS).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Chronic Prostatitis, run by Jiani Wu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiani Wu (+8613426116653, jiani_wu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 4 (time frame: Baseline, week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06287970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.