Back to resultsReal World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China
Primary Purpose
Chronic Pelvic Pain, Chronic Prostatitis
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Percutaneous electrical nerve stimulation treatment
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pelvic Pain focused on measuring transcutaneous electric nerve stimulation, andrology
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Xijing Hospital, Fourth Military Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Electrophysiological treatment group
Regular treatment group
Arm Description
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.
Fluoroquinolones and alpha blockers were administered according to the patient's symptoms.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
international prostate symptom score (IPSS)
The score improved significantly from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04976751
Brief Title
Real World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China
Official Title
Real World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 13, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain, Chronic Prostatitis
Keywords
transcutaneous electric nerve stimulation, andrology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
274 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electrophysiological treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular treatment group
Arm Type
No Intervention
Arm Description
Fluoroquinolones and alpha blockers were administered according to the patient's symptoms.
Intervention Type
Drug
Intervention Name(s)
Percutaneous electrical nerve stimulation treatment
Intervention Description
Using the percutaneous electrical nerve stimulation instrument to different points of the body
Primary Outcome Measure Information:
Title
National Institutes of Health-Chronic Prostatitis Symptom Index(NIH-CPSI)
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
international prostate symptom score (IPSS)
Description
The score improved significantly from baseline
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
≥18 years old and ≤60 years old
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Jianlin, doctor
Phone
86-029-84775321
Email
jianliny@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Jun, master
Phone
86-029-84775321
Email
lujun901101@sina.com
Facility Information:
Facility Name
Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Wu, master
Phone
+86-029-84771794
Email
XJYYLLWYH@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Real World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China
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