Chronic Pelvic PainPhase 1NCT04976751
Real World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China
A Phase 1 study testing Percutaneous electrical nerve stimulation treatment in people with Chronic Pelvic Pain and Chronic Prostatitis, run by Xijing Hospital at 1 site in China.
Trial summary
To carry out real world research on the application of electrophysiology and other suitable technologies in the prevention and treatment of male diseases in medical institutions at all levels in Northwest China, and establish a database for the prevention and treatment of male diseases in Northwest China, so as to… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Chronic Pelvic Pain, Chronic Prostatitis
- What is being tested?
- Percutaneous electrical nerve stimulation treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2021to 30 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patient meets the diagnostic criteria of National Institutes of Health (NIH)Ⅲ type prostatitis;
- NIH-CPSI score > 10;
- The symptoms lasted for more than 3 months and failed to respond to drug treatment for more than 1 month;
- Age ≥18 years old and ≤60 years old agrees and signs the informed consent;
- Those who did not receive other similar treatment regimens during treatment.
Who cannot join
- All kinds of bacterial infection caused by acute or chronic orchitis or epididymitis, acute or chronic prostatitis, lower urinary tract infection;
- Benign prostatic hyperplasia, prostate cancer, neurogenic bladder, urethral malformation or stricture and severe neurosis;
- For patients with local pain as the main manifestation, attention should be paid to the exclusion of other lesions in the lower abdomen, perineum, lsosacral sites, such as ureteral calculi, bladder calculi, inguinal hernia, pubis, varicocele, epididymitis, rectocolic diseases, lsodorsal myofascitis, etc.;
- Complicated with heart, brain, liver and hematopoietic system and other serious primary diseases, local skin infection or skin lesions in the treatment site;
- People who have metal implants in their bodies cannot cooperate, such as patients with mental illness.
- People who are allergic to the treatment of electrical stimulation or allergic to a variety of drugs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Fei Wu, master, +86-029-84771794, XJYYLLWYH@163.com
About this study
To carry out real world research on the application of electrophysiology and other suitable technologies in the prevention and treatment of male diseases in medical institutions at all levels in Northwest China, and establish a database for the prevention and treatment of male diseases in Northwest China, so as to provide a basis for the formulation of guidelines or consensus on the application of electrophysiology for the prevention and treatment of male diseases in China.
- Conditions
- Chronic Pelvic Pain, Chronic Prostatitis
- Being tested
- Percutaneous electrical nerve stimulation treatment
- Keywords
- transcutaneous electric nerve stimulation, andrology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous electrical nerve stimulation treatmentDrug
Using the percutaneous electrical nerve stimulation instrument to different points of the body
| Study group | Role | What they receive |
|---|---|---|
| Electrophysiological treatment group | Experimental | Two electrodes covered the two acupoints of Zhongliao and Huiyang, one electrode covered the three acupoints of Zhongji, Guanyuan and Qihai, and two skin paste electrodes covered the three acupoints of Sanyinjiao, and connected the electric stimulation therapy instrument for 30 minutes. The intensity was based on the patient's tolerance. 4 weeks before the course of treatment, the treatment was performed once a day, 3 times a week.In the last 4 weeks, 20 times were performed twice a week.Fluoroquinolones and alpha blockers were administered according to the patient's symptoms. Receives: Drug: Percutaneous electrical nerve stimulation treatment |
| Regular treatment group | No intervention | Fluoroquinolones and alpha blockers were administered according to the patient's symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health-Chronic Prostatitis Symptom Index(NIH-CPSI)
Improvement rate = [(score before treatment - score at the end of treatment)/score before treatment] ×100% The improvement rate ≥75% was considered to be significant.The improvement rate < 75% and ≥50% were considered to be better.
The improvement rate < 50% and ≥25% were considered as average efficacy.The improvement rate < 25% indicates poor efficacy.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
international prostate symptom score (IPSS)
The score improved significantly from baseline
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start13 May 2021
- Primary completion1 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan Jianlin-1, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976751
- Sponsor's protocol ID
- 2002020080
- Status last verified
- Jul 2021
- First submitted
- 23 Jun 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: To carry out real world research on the application of electrophysiology and other suitable technologies in the prevention and treatment of male diseases in medical institutions at all levels in Northwest China, and establish a database for the prevention and treatment of male diseases in Northwest China, so as to provide a basis for the formulation of guidelines or consensus on the application of electrophysiology for the prevention and treatment of male diseases in China.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China
- ClinicalTrials.gov ID
- NCT04976751
- Acronym / sponsor ID
- 2002020080
- Conditions
- Chronic Pelvic Pain, Chronic Prostatitis
- Keywords
- transcutaneous electric nerve stimulation, andrology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 13 May 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 26 Jul 2021 (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.
To carry out real world research on the application of electrophysiology and other suitable technologies in the prevention and treatment of male diseases in medical institutions at all levels in Northwest China, and establish a database for the prevention and treatment of male diseases in Northwest China, so as to provide a basis for the formulation of guidelines or consensus on the application of electrophysiology for the prevention and treatment of male diseases in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrophysiological treatment group | Experimental | Drug: Percutaneous electrical nerve stimulation treatmentTwo electrodes covered the two acupoints of Zhongliao and Huiyang, one electrode covered the three acupoints of Zhongji, Guanyuan and Qihai, and two skin paste electrodes covered the three acupoints of Sanyinjiao, and connected the electric stimulation therapy instrument for 30 minutes. The intensity was based on the patient's tolerance. 4 weeks before the course of treatment, the treatment was performed once a day, 3 times a week.In the last 4 weeks, 20 times were performed twice a week.Fluoroquinolones and alpha blockers were administered according to the patient's symptoms. |
| Regular treatment group | No intervention | –Fluoroquinolones and alpha blockers were administered according to the patient's symptoms. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient meets the diagnostic criteria of National Institutes of Health (NIH)Ⅲ type prostatitis;
- NIH-CPSI score > 10;
- The symptoms lasted for more than 3 months and failed to respond to drug treatment for more than 1 month;
- Age ≥18 years old and ≤60 years old agrees and signs the informed consent;
- Those who did not receive other similar treatment regimens during treatment.
Key exclusion criteria (6 listed)
- All kinds of bacterial infection caused by acute or chronic orchitis or epididymitis, acute or chronic prostatitis, lower urinary tract infection;
- Benign prostatic hyperplasia, prostate cancer, neurogenic bladder, urethral malformation or stricture and severe neurosis;
- For patients with local pain as the main manifestation, attention should be paid to the exclusion of other lesions in the lower abdomen, perineum, lsosacral sites, such as ureteral calculi, bladder calculi, inguinal hernia, pubis, varicocele, epididymitis, rectocolic diseases, lsodorsal myofascitis, etc.;
- Complicated with heart, brain, liver and hematopoietic system and other serious primary diseases, local skin infection or skin lesions in the treatment site;
- People who have metal implants in their bodies cannot cooperate, such as patients with mental illness.
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 |
|---|---|---|
| Percutaneous electrical nerve stimulation treatmentUsing the percutaneous electrical nerve stimulation instrument to different points of the body | Drug | Electrophysiological treatment group |
Primary outcome
National Institutes of Health-Chronic Prostatitis Symptom Index(NIH-CPSI)
Time frame: through study completion, an average of 1 year
Improvement rate = [(score before treatment - score at the end of treatment)/score before treatment] ×100% The improvement rate ≥75% was considered to be significant.The improvement rate < 75% and ≥50% were considered to be better. The improvement rate < 50% and ≥25% were considered as average efficacy.The improvement rate < 25% indicates poor efficacy.
1 secondary outcome
international prostate symptom score (IPSS)
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: No. To carry out real world research on the application of electrophysiology and other suitable technologies in the prevention and treatment of male diseases in medical institutions at all levels in Northwest China, and establish a database for the prevention and treatment of male diseases in Northwest China, so as to provide a basis for the formulation of guidelines or consensus on the application of electrophysiology for the prevention and treatment of male diseases in China.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Percutaneous electrical nerve stimulation treatment in people with Chronic Pelvic Pain and Chronic Prostatitis, run by Xijing Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 26 Jul 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Jianlin, doctor (86-029-84775321, jianliny@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institutes of Health-Chronic Prostatitis Symptom Index(NIH-CPSI) (time frame: through study completion, an average of 1 year). 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 26 Jul 2021.