Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)NCT07324148
Acupuncture for Erectile Dysfunction
A study testing Acupuncture in people with Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) and Erectile Dysfunctions, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a prevalent chronic urological disease. CP/CPPS severely impacts patients' quality of life. It is characterized by recurrent pelvic floor pain, lower urinary tract symptoms, and often accompanied by psychological issues and sexual dysfunction (duration ≥3… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Erectile Dysfunctions, Acupuncture
- 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
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Jun 2028
- 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
- Conforms to the diagnosis of CP/CPPS and pED at the same time;
- Aged between 18-50 years old;
- 8≤IIEF-5 score≤21
- Have a fixed sexual partner and a regular sexual intercourse of ≥1 time/week during treatment period;
- Voluntarily sign an informed consent form.
Who cannot join
- Patients with drug-induced or organic ED.
- The existence of lesions that may affect erectile function, such as penile cancer, penile sclerosis, penile anatomical deformity, testicular cancer, urinary system stones or neuropathy, etc.
- History of trauma or surgery in pelvic region.
- Patients with hypogonadism.
- Usage of drugs or therapies that relieve CP/CPPS or ED symptoms in the previous 1 month.
- Have received hormonal or psychiatric drugs in the previous 3 months.
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- Bladder outlet obstruction, overactive bladder, neurogenic bladder, interstitial cystitis, glandular cystitis, sexually transmitted diseases, bladder tumors, prostate cancer, penile cancer, penile stone, other types of prostatitis.
- With a residual urine ≥100ml.
- Symptomatic urinary tract infection.
- Diseases affecting the function of the lower urethra, such as multiple sclerosis, senile dementia, Parkinson's disease, spinal cord injury, caua equina nerve injury, stroke and multisystem atrophy, etc.
- Severe diseases in heart, lung, brain, liver, kidney and hematopoietic system , mental illness and obvious cognitive function disorders.
- Patients with poor compliance
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Acupuncture for Erectile Dysfunction Among Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Clinical Trial
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a prevalent chronic urological disease. CP/CPPS severely impacts patients' quality of life. It is characterized by recurrent pelvic floor pain, lower urinary tract symptoms, and often accompanied by psychological issues and sexual dysfunction (duration ≥3 months, no confirmed infection/pathology).
The investigators have completed a large-sample, multi-center randomized controlled trial (RCT) involving 440 patients with CP/CPPS before. The clinical trial confirmed the sustained efficacy of acupuncture for the symptoms of pain, lower urinary tract symptoms, and anxiety and depression among patients with CP/CPPS. However, the trial revealed no significant improvements in sexual dysfunction in the acupuncture group compared to the sham acupuncture group after 8 weeks of treatment.To address this limitation, the current study is designed, which aims to optimize the clinical acupuncture protocol for CP/CPPS and evaluate whether it can enhance outcomes for psychogenic erectile dysfunction (ED) associated. Additionally, mass cytometry and liquid suspension chip technology will be used to explore systemic and local immune mechanisms underlying acupuncture's effects for CP/CPPS. Functional magnetic resonance imaging (fMRI) and metabolomics will be integrated to analyze patients' systemic states from central nervous system and metabolic perspectives, comprehensively elucidating the multi-dimensional mechanisms by which acupuncture alleviates CP/CPPS.
- Conditions
- Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Erectile Dysfunctions, Acupuncture
- Being tested
- Acupuncture, Sham acupuncture
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Sanyinjiao (SP6), Zhongliao(BL33), Shenshu(BL23), Huiyang(BL35), Guilai(ST29), Guanyuan(CV4), Shenmen(HT7) and Baihui(GV20) are selected as acupoints protocol. Acupuncture treatment consists of 20 sessions over an 8-week period (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).
Sham acupunctureDevice
The participants in the sham acupuncture group will receive sham acupuncture treatment in SP6, BL33, BL23, BL35, ST29, HT7, CV4, and GV20. The duration and frequency of sessions are the same as in the acupuncture group.
Blunt needles will be inserted through the fixed pad to reach the surface of the skin without piercing. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effects of the needle tip penetrating the skin.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Not described Receives: Device: Acupuncture |
| Sham acupuncture group | Sham comparator | Not described Receives: Device: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in the International Erectile Function Index-5 (IIEF-5) score
IIEF-5 is a short verified scale used to evaluate erectile function. It Includes 5 items, with each item ranging from 1-5 points. The total score of IIEF-5 ranges from 5-25 points, with 21-25 indicating normal, 12-21 mild disorder, 8-11 moderate disorder and 5-7 severe disorder.
Measured: Week 8
Secondary outcomes (9)
The change from baseline in the International Erectile Function Index-5 (IIEF-5) score
IIEF-5 is a short verified scale used to evaluate erectile function. It Includes 5 items, with each item ranging from 1-5 points. The total score of IIEF-5 ranges from 5-25 points, with 21-25 indicating normal, 12-21 mild disorder, 8-11 moderate disorder and 5-7 severe disorder.
Measured: Weeks 4, 20 and 32.
Change from baseline in the Erection Hardness Score (EHS).
The verified single-entry EHS scale is used to evaluate the hardness of the penis in sexual life. It ranges from 0 to 4. 0 refers to penis does not enlarge; 1 refers to penis is larger, but not hard 2 Penis is hard, but not hard enough for penetration 3 Penis is hard enough for penetration, but not completely hard 4 Penis is completely hard and fully rigid
Measured: Weeks 4, 8, 20 and 32
Proportion of patients with a reduction of ≥6 points from baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score.
NIH-CPSI consists of 13 items, which are organized into three domains of pain, urinary symptoms, and quality of life impact. The total score of NIH-CPSI ranges from 0 to 43, with higher scores indicating more severe symptoms.
Measured: Weeks 4, 8, 20 and 32
Change from baseline in the International Prostate Symptom Score (IPSS) score.
The IPSS assess the severity of lower urinary tract symptoms in men. The total score of IPSS ranges from 0 to 35, with higher scores indicating more severe symptoms.
Measured: Weeks 4, 8, 20 and 32
Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score.
The HADS is a 14-item scale to screen for anxiety and depression. The total score of HADS ranges from 0 to 42, with higher scores indicating more severe anxiety and depression
Measured: Weeks 4, 8, 20 and 32
Change from baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) and VAS scores.
The EQ-5D-5L is used to measure health-related quality of life. It consists of a descriptive system and a visual analogue scale (VAS). The descriptive system includes dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A health state utility score can be derived using population-based value sets. The VAS component asks patients to rate their overall health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: Weeks 4, 8, 20 and 32
Assessment of patient expectations for acupuncture.
Patients will be asked that what do you expect your erectile dysfunction will be in 8 weeks.
Measured: Baseline
The proportion of participants rates their overall improvement as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C)
The Patient Global Impression-Change (PGI-C) is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse" or "very much worse".
Measured: Weeks 8 and 32
Patient Assessment of Blinding Effectiveness
Patients are asked whether they have received traditional acupuncture.
Measured: Within 5 minutes after any acupuncture session in Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)Studies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
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, Yuanjie Sun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324148
- Sponsor's protocol ID
- 2025_267_KY
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Erectile Dysfunction Among Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Clinical Trial
- ClinicalTrials.gov ID
- NCT07324148
- Acronym / sponsor ID
- 2025_267_KY
- Conditions
- Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Erectile Dysfunctions, Acupuncture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 7 Jan 2026 (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.
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a prevalent chronic urological disease. CP/CPPS severely impacts patients' quality of life. It is characterized by recurrent pelvic floor pain, lower urinary tract symptoms, and often accompanied by psychological issues and sexual dysfunction (duration ≥3 months, no confirmed infection/pathology).
The investigators have completed a large-sample, multi-center randomized controlled trial (RCT) involving 440 patients with CP/CPPS before. The clinical trial confirmed the sustained efficacy of acupuncture for the symptoms of pain, lower urinary tract symptoms, and anxiety and depression among patients with CP/CPPS. However, the trial revealed no significant improvements in sexual dysfunction in the acupuncture group compared to the sham acupuncture group after 8 weeks of treatment.To address this limitation, the current study is designed, which aims to optimize the clinical acupuncture protocol for CP/CPPS and evaluate whether it can enhance outcomes for psychogenic erectile dysfunction (ED) associated. Additionally, mass cytometry and liquid suspension chip technology will be used to explore systemic and local immune mechanisms underlying acupuncture's effects for CP/CPPS. Functional magnetic resonance imaging (fMRI) and metabolomics will be integrated to analyze patients' systemic states from central nervous system and metabolic perspectives, comprehensively elucidating the multi-dimensional mechanisms by which acupuncture alleviates CP/CPPS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Device: Acupuncture |
| Sham acupuncture group | Sham comparator | Device: Sham acupuncture |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Conforms to the diagnosis of CP/CPPS and pED at the same time;
- Aged between 18-50 years old;
- 8≤IIEF-5 score≤21
- Have a fixed sexual partner and a regular sexual intercourse of ≥1 time/week during treatment period;
- Voluntarily sign an informed consent form.
Key exclusion criteria (12 listed)
- Patients with drug-induced or organic ED.
- The existence of lesions that may affect erectile function, such as penile cancer, penile sclerosis, penile anatomical deformity, testicular cancer, urinary system stones or neuropathy, etc.
- History of trauma or surgery in pelvic region.
- Patients with hypogonadism.
- Usage of drugs or therapies that relieve CP/CPPS or ED symptoms in the previous 1 month.
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 |
|---|---|---|
| AcupunctureSanyinjiao (SP6), Zhongliao(BL33), Shenshu(BL23), Huiyang(BL35), Guilai(ST29), Guanyuan(CV4), Shenmen(HT7) and Baihui(GV20) are selected as acupoints protocol. Acupuncture treatment consists of 20 sessions over an 8-week period (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks). | Device | Acupuncture group |
| Sham acupunctureThe participants in the sham acupuncture group will receive sham acupuncture treatment in SP6, BL33, BL23, BL35, ST29, HT7, CV4, and GV20. The duration and frequency of sessions are the same as in the acupuncture group. Blunt needles will be inserted through the fixed pad to reach the surface of the skin without piercing. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effects of the needle tip penetrating the skin. | Device | Sham acupuncture group |
Primary outcome
The change from baseline in the International Erectile Function Index-5 (IIEF-5) score
Time frame: Week 8
IIEF-5 is a short verified scale used to evaluate erectile function. It Includes 5 items, with each item ranging from 1-5 points. The total score of IIEF-5 ranges from 5-25 points, with 21-25 indicating normal, 12-21 mild disorder, 8-11 moderate disorder and 5-7 severe disorder.
9 secondary outcomes
The change from baseline in the International Erectile Function Index-5 (IIEF-5) score
Time frame: Weeks 4, 20 and 32.
Change from baseline in the Erection Hardness Score (EHS).
Time frame: Weeks 4, 8, 20 and 32
Proportion of patients with a reduction of ≥6 points from baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score.
Time frame: Weeks 4, 8, 20 and 32
Change from baseline in the International Prostate Symptom Score (IPSS) score.
Time frame: Weeks 4, 8, 20 and 32
Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score.
Time frame: Weeks 4, 8, 20 and 32
Change from baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) and VAS scores.
Time frame: Weeks 4, 8, 20 and 32
Assessment of patient expectations for acupuncture.
Time frame: Baseline
The proportion of participants rates their overall improvement as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C)
Time frame: Weeks 8 and 32
Patient Assessment of Blinding Effectiveness
Time frame: Within 5 minutes after any acupuncture session in Week 8.
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 8 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) and Erectile Dysfunctions, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yuanjie Sun (+86 18810337542, puzhisun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in the International Erectile Function Index-5 (IIEF-5) score (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2026.