Chronic Prostatitis With Chronic Pelvic Pain SyndromeNCT03213938
Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
A study testing Acupuncture in people with Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refers to the presence of bothersome pelvic pain symptoms without an identifiable cause. Common symptoms of CP/CPPS include discomfort in the perineum, suprapubic region, and lower urinary tract symptoms. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2017to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 1.History of pain perceived in the prostate region and absence of other lower urinary tract pathology for a minimum of three of the past 6 months. In addition, any associated lower urinary tract symptoms, sexual function, and psychological factors should be addressed. Physical examinations, urinary analyses, and urine cultures will be performed for all subjects;
- 2. Age 18 to 50 years.
- 3. NIH Chronic Prostatitis Symptom Index (NIH- CPSI) total score ≥ 15.
Who cannot join
- 1. Prostate, bladder, or urethral cancer, seizure disorder in any medical history.
- 2. Inflammatory bowel disease, active urethral stricture, neurologic disease or disorder affecting the bladder, liver disease, neurologic impairment or psychiatric disorder preventing understanding of consent and self-report scale.
- 3. Urinary tract infection with a urine culture value of more than 100,000 CFU/mL, clinical evidence of urethritis, including urethral discharge or positive culture, diagnostic of sexually transmitted diseases (including gonorrhoea, chlamydia, mycoplasma or trichomonas, but not including HIV/AIDS), symptoms of acute or chronic epididymitis).
- 4. Residual urine volume≥100ML.
- 5. Qmax≤15ML/S.
- 6. Prior 4 weeks used androgen hormone inhibitors (finasteride), alpha-blockers (terazosin HCI, doxazosin mesylate, tamsulosin hydrochloride), antibiotics (ciprofloxacin hydrochloride), or any other prostatitis-specific medication (including herb and Chinese medicine).
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital, China Academy of Chinese Medical Science
Beijing, Beijing Municipality, 100053
About this study
Official title: Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Multicenter Randomized Controlled Trial
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refers to the presence of bothersome pelvic pain symptoms without an identifiable cause. Common symptoms of CP/CPPS include discomfort in the perineum, suprapubic region, and lower urinary tract symptoms. It affects men of all ages without apparent racial predisposition, among which, 36-50 years old are the most commonly influenced. Yet, few effective therapies are available for treating CP/CPPS.
Acupuncture may be an effective treatment option for CP/CPPS. However, effects of acupuncture on CP/CPPS remain uncertain because of the small sample sizes or other methodological limitations.
The objective of this multi-centre, randomized, sham acupuncture-controlled trial is to assess the effectiveness of acupuncture for relieving symptoms of CP/CPPS. The results will provide a robust conclusion with a high level of evidence.
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- Chronic prostatitis, chronic pelvic pain syndrome, acupuncture, randomized controlled trial
- Medical subject headings
- Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
For acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol.
Acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).
Sham acupunctureDevice
For sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35.
Sham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | The participants in the acupuncture group will receive treatment that consists of 20 acupuncture sessions over an 8-week (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks) period after baseline, each for 30 minutes. Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Sanyinjiao (SP6), Zhongliao (BL33), Shenshu (BL23), and Huiyang (BL35), were selected as acupoints protocol. SP6 is on the tibial aspect of the leg, posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus; BL32 is in the sacral region, in the second posterior sacral foramen; BL33 is in the third posterior sacral foramen; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx. Receives: Device: Acupuncture |
| Sham acupuncture | Sham comparator | The participants in the sham acupuncture group will receive shallow needling at bilateral sham BL23, BL33, BL35 and SP6. The protocol includes the same duration and frequency of sessions as for the acupuncture treatment, but the treatment was delivered superficially at non-acupuncture points 10-15 mm to the lateral of corresponding acupuncture and not above a meridian line (15mm to BL23, BL33 and BL35; 10mm to SP6). The Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be inserted with a depth of 2-3 mm without any manipulation. Receives: Device: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Responders at the End of 8-week
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).
Measured: week 8
Proportion of Responders at the End of 32-week
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.
Measured: week 32
Secondary outcomes (9)
Proportion of Responders at Other Time Points
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.
Measured: weeks 1-7; week 20
the Change From Baseline in NIH-CPSI Total Score
The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) is a universally accepted, reliable and valid instrument recommended for clinical evaluation and research of CP/CPPS by consensus guidelines. It measures the domains of pain (score range, 0-21), urinary function (0-10) and quality of life impact (0-12) in CP/CPPS, with a total score ranging from 0 to 43 and higher scores indicating worse conditions.
Measured: weeks 1-8; week 20; week 32
the Change From Baseline in NIH-CPSI Subscales
The NIH-CPSI is a universally accepted, reliable and valid instrument recommended for clinical evaluation and research of CP/CPPS by consensus guidelines. It measures the domains of pain, urinary function and quality of life impact in CP/CPPS. The score range of pain subscale is 0-21, with higher scores indicating worse conditions. The score range of urinary function subscale is 0-10, with higher scores indicating worse conditions. The score range of quality-of-life subscale is 0-12, with higher scores indicating worse quality of life.
Measured: weeks 1-8; week 20; week 32
the Change From Baseline in the International Prostate Symptom Score (IPSS)
IPSS is a valid, reliable and sensitive measure for patients with lower urinary tract symptoms; it is widely used in clinical practice and research to determine the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining and nocturia. Each of the questions is rated from 0 (not at all) to 5 (almost always). IPSS score ranges from 0 to 35, with higher score indicating more severe urinary symptoms.
Measured: week 4; week 8; week 20; week 32
the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS)
HADS is made up of 7 items for the assessment of depression and anxiety; the completion of this scale usually requires 2-5 minutes. HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
Measured: week 8; week 20; week 32
the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5)
The IIEF-5 is a psychometrically valid and reliable instrument with high sensitivity and specificity for detecting treatment effects in patients with erection dysfunction of a broad spectrum of aetiology. Chinese version IIEF-5 score ranges from 0 to 25, with lower scores indicating greater severity of dysfunction and minimal clinical important difference over 5.
Measured: week 8; week 20; week 32
the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire
The EQ-5D-5L is a well-established and suitable for evaluation of quality of life in participants with CP/CPPS. EQ-5D-5L overall index ranges from -0.39 to 1.00, with higher overall index indicating better generic health-status.
Measured: week 8; week 20; week 32
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
GRA consists of 7 response categories: markedly worsened, moderately worsened, slightly worsened, no change, slightly improved, moderately improved, and markedly improved.
Measured: week 4; week 8; week 20; week 32
the Change for Peak and Average Urinary Flow Rate From Baseline
Measured: weeks 8 and 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start9 Oct 2017
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Prostatitis With Chronic Pelvic Pain SyndromeStudies 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, Investigator
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213938
- Sponsor's protocol ID
- ZZ10-012
- Status last verified
- Aug 2022
- First submitted
- 5 Jul 2017
- Last updated
- 9 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data and data dictionary will be available with publication until six months after publication. Formal request should be sent to the corresponding author (zhishunjournal@163.com) with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement
Publications
Qin Z, Liu Y, Zhou K, Wu J, Pang R, Li N, Xu C, Kwong JSW, Liu Z. Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial. Trials. 2017 Dec 22;18(1):616. doi: 10.1186/s13063-017-2383-8.
PubMed 29273095Sun Y, Liu Y, Liu B, Zhou K, Yue Z, Zhang W, Fu W, Yang J, Li N, He L, Zang Z, Su T, Fang J, Ding Y, Qin Z, Song H, Hu H, Zhao H, Mo Q, Zhou J, Wu J, Liu X, Wang W, Pang R, Chen H, Wang X, Liu Z. Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome : A Randomized Trial. Ann Intern Med. 2021 Oct;174(10):1357-1366. doi: 10.7326/M21-1814. Epub 2021 Aug 17.
PubMed 34399062Zhu L, Sun Y, Yan S, Liu X, Wang X, Liu Z. Efficacy of acupuncture on drinkers with chronic prostatitis / chronic pelvic pain syndrome: secondary analysis of a randomized clinical trial. Acupunct Med. 2024 Oct;42(5):243-250. doi: 10.1177/09645284241274158. Epub 2024 Sep 1.
PubMed 39219163Zhu L, Fang J, Sun Y, Yang M, Yao H, Liu Z. Impact of ejaculation upon effect of acupuncture on chronic prostatitis/chronic pelvic pain syndrome: Secondary analysis of a randomized controlled trial. Integr Med Res. 2023 Jun;12(2):100943. doi: 10.1016/j.imr.2023.100943. Epub 2023 Apr 3.
PubMed 37122487
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03213938
- Acronym / sponsor ID
- ZZ10-012
- Keywords
- Chronic prostatitis, chronic pelvic pain syndrome, acupuncture, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Posted 27 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refers to the presence of bothersome pelvic pain symptoms without an identifiable cause. Common symptoms of CP/CPPS include discomfort in the perineum, suprapubic region, and lower urinary tract symptoms. It affects men of all ages without apparent racial predisposition, among which, 36-50 years old are the most commonly influenced. Yet, few effective therapies are available for treating CP/CPPS.
Acupuncture may be an effective treatment option for CP/CPPS. However, effects of acupuncture on CP/CPPS remain uncertain because of the small sample sizes or other methodological limitations.
The objective of this multi-centre, randomized, sham acupuncture-controlled trial is to assess the effectiveness of acupuncture for relieving symptoms of CP/CPPS. The results will provide a robust conclusion with a high level of evidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: AcupunctureThe participants in the acupuncture group will receive treatment that consists of 20 acupuncture sessions over an 8-week (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks) period after baseline, each for 30 minutes. Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Sanyinjiao (SP6), Zhongliao (BL33), Shenshu (BL23), and Huiyang (BL35), were selected as acupoints protocol. SP6 is on the tibial aspect of the leg, posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus; BL32 is in the sacral region, in the second posterior sacral foramen; BL33 is in the third posterior sacral foramen; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx. |
| Sham acupuncture | Sham comparator | Device: Sham acupunctureThe participants in the sham acupuncture group will receive shallow needling at bilateral sham BL23, BL33, BL35 and SP6. The protocol includes the same duration and frequency of sessions as for the acupuncture treatment, but the treatment was delivered superficially at non-acupuncture points 10-15 mm to the lateral of corresponding acupuncture and not above a meridian line (15mm to BL23, BL33 and BL35; 10mm to SP6). The Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be inserted with a depth of 2-3 mm without any manipulation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1.History of pain perceived in the prostate region and absence of other lower urinary tract pathology for a minimum of three of the past 6 months. In addition, any associated lower urinary tract symptoms, sexual function, and psychological factors should be addressed. Physical examinations, urinary analyses, and urine cultures will be performed for all subjects;
- 2. Age 18 to 50 years.
- 3. NIH Chronic Prostatitis Symptom Index (NIH- CPSI) total score ≥ 15.
Key exclusion criteria (6 listed)
- 1. Prostate, bladder, or urethral cancer, seizure disorder in any medical history.
- 2. Inflammatory bowel disease, active urethral stricture, neurologic disease or disorder affecting the bladder, liver disease, neurologic impairment or psychiatric disorder preventing understanding of consent and self-report scale.
- 3. Urinary tract infection with a urine culture value of more than 100,000 CFU/mL, clinical evidence of urethritis, including urethral discharge or positive culture, diagnostic of sexually transmitted diseases (including gonorrhoea, chlamydia, mycoplasma or trichomonas, but not including HIV/AIDS), symptoms of acute or chronic epididymitis).
- 4. Residual urine volume≥100ML.
- 5. Qmax≤15ML/S.
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 |
|---|---|---|
| AcupunctureFor acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol. Acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks). | Device | Acupuncture |
| Sham acupunctureFor sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35. Sham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks). | Device | Sham acupuncture |
Primary outcome
Proportion of Responders at the End of 8-week
Time frame: week 8
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).
Proportion of Responders at the End of 32-week
Time frame: week 32
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.
9 secondary outcomes
Proportion of Responders at Other Time Points
Time frame: weeks 1-7; week 20
the Change From Baseline in NIH-CPSI Total Score
Time frame: weeks 1-8; week 20; week 32
the Change From Baseline in NIH-CPSI Subscales
Time frame: weeks 1-8; week 20; week 32
the Change From Baseline in the International Prostate Symptom Score (IPSS)
Time frame: week 4; week 8; week 20; week 32
the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS)
Time frame: week 8; week 20; week 32
the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5)
Time frame: week 8; week 20; week 32
the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire
Time frame: week 8; week 20; week 32
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Time frame: week 4; week 8; week 20; week 32
the Change for Peak and Average Urinary Flow Rate From Baseline
Time frame: weeks 8 and 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29273095Qin Z, Liu Y, Zhou K, Wu J, Pang R, Li N, Xu C, Kwong JSW, Liu Z. Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial. Trials. 2017 Dec 22;18(1):616. doi: 10.1186/s13063-017-2383-8.
- Results publication: PubMed 34399062Sun Y, Liu Y, Liu B, Zhou K, Yue Z, Zhang W, Fu W, Yang J, Li N, He L, Zang Z, Su T, Fang J, Ding Y, Qin Z, Song H, Hu H, Zhao H, Mo Q, Zhou J, Wu J, Liu X, Wang W, Pang R, Chen H, Wang X, Liu Z. Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome : A Randomized Trial. Ann Intern Med. 2021 Oct;174(10):1357-1366. doi: 10.7326/M21-1814. Epub 2021 Aug 17.
- Derived from this study: PubMed 39219163Zhu L, Sun Y, Yan S, Liu X, Wang X, Liu Z. Efficacy of acupuncture on drinkers with chronic prostatitis / chronic pelvic pain syndrome: secondary analysis of a randomized clinical trial. Acupunct Med. 2024 Oct;42(5):243-250. doi: 10.1177/09645284241274158. Epub 2024 Sep 1.
- Derived from this study: PubMed 37122487Zhu L, Fang J, Sun Y, Yang M, Yao H, Liu Z. Impact of ejaculation upon effect of acupuncture on chronic prostatitis/chronic pelvic pain syndrome: Secondary analysis of a randomized controlled trial. Integr Med Res. 2023 Jun;12(2):100943. doi: 10.1016/j.imr.2023.100943. Epub 2023 Apr 3.
- Individual participant dataSharing planned: Yes. Deidentified participant data and data dictionary will be available with publication until six months after publication. Formal request should be sent to the corresponding author (zhishunjournal@163.com) with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement
Related trials for Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
Recruiting
Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment
Chronic Interstitial Cystitis, Bladder Pain Syndrome
Not yet recruiting
Acupuncture for Erectile Dysfunction
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Erectile Dysfunctions
Not yet recruiting
TECAR Therapy on Pain and Quality of Life in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Prostatitis
Recruiting
TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS
Chronic Prostatitis
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. This study is not recruiting at the moment.
Zhishun Liu principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 9 Aug 2022. 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?
Yes. Results are posted in the registry (first posted 27 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Responders at the End of 8-week (time frame: week 8). The study lists 2 primary outcomes in all. 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 NCT03213938, which also lists 4 linked publications.
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 9 Aug 2022.