Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT04976751
Status:
UNKNOWN
Last Update Posted:
2021-07-26
First Post:
2021-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 274}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-14', 'studyFirstSubmitDate': '2021-06-23', 'studyFirstSubmitQcDate': '2021-07-14', 'lastUpdatePostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'National Institutes of Health-Chronic Prostatitis Symptom Index(NIH-CPSI)', 'timeFrame': 'through study completion, an average of 1 year', '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.\n\nThe improvement rate \\< 50% and ≥25% were considered as average efficacy.The improvement rate \\< 25% indicates poor efficacy.'}], 'secondaryOutcomes': [{'measure': 'international prostate symptom score (IPSS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The score improved significantly from baseline'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcutaneous electric nerve stimulation', 'andrology'], 'conditions': ['Chronic Pelvic Pain', 'Chronic Prostatitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': '≥18 years old and ≤60 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient meets the diagnostic criteria of National Institutes of Health (NIH)Ⅲ type prostatitis;\n* NIH-CPSI score \\> 10;\n* The symptoms lasted for more than 3 months and failed to respond to drug treatment for more than 1 month;\n* Age ≥18 years old and ≤60 years old agrees and signs the informed consent;\n* Those who did not receive other similar treatment regimens during treatment.\n\nExclusion Criteria:\n\n* All kinds of bacterial infection caused by acute or chronic orchitis or epididymitis, acute or chronic prostatitis, lower urinary tract infection;\n* Benign prostatic hyperplasia, prostate cancer, neurogenic bladder, urethral malformation or stricture and severe neurosis;\n* 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.;\n* Complicated with heart, brain, liver and hematopoietic system and other serious primary diseases, local skin infection or skin lesions in the treatment site;\n* People who have metal implants in their bodies cannot cooperate, such as patients with mental illness.\n* People who are allergic to the treatment of electrical stimulation or allergic to a variety of drugs.'}, 'identificationModule': {'nctId': 'NCT04976751', 'briefTitle': 'Real World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Real World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China', 'orgStudyIdInfo': {'id': '2002020080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrophysiological treatment group', '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.", 'interventionNames': ['Drug: Percutaneous electrical nerve stimulation treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Regular treatment group', 'description': "Fluoroquinolones and alpha blockers were administered according to the patient's symptoms."}], 'interventions': [{'name': 'Percutaneous electrical nerve stimulation treatment', 'type': 'DRUG', 'description': 'Using the percutaneous electrical nerve stimulation instrument to different points of the body', 'armGroupLabels': ['Electrophysiological treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Wu, master', 'role': 'CONTACT', 'email': 'XJYYLLWYH@163.com', 'phone': '+86-029-84771794'}], 'facility': 'Xijing Hospital, Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Yuan Jianlin, doctor', 'role': 'CONTACT', 'email': 'jianliny@fmmu.edu.cn', 'phone': '86-029-84775321'}, {'name': 'Lu Jun, master', 'role': 'CONTACT', 'email': 'lujun901101@sina.com', 'phone': '86-029-84775321'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Yuan Jianlin-1', 'investigatorAffiliation': 'Xijing Hospital'}}}}