Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-01 @ 7:46 AM
Study NCT ID:
NCT04972669
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2021-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2021-07-09', 'studyFirstSubmitQcDate': '2021-07-21', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continence rate after 6 weeks of treatment', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'change of urine pad quantity for 24 hours after 4 courses compared with baseline', 'timeFrame': '3 years'}, {'measure': 'change of weight in kilograms of urine pad for 24 hours after 6 courses compared with baseline', 'timeFrame': '3 years'}, {'measure': 'changes of The expanded prostate cancer index composite(EPIC) score after 4-6 courses compared with baseline', 'timeFrame': '3 years'}, {'measure': 'Long-term urinary continence recovery', 'timeFrame': '3 year', 'description': 'time from randomization to urinary continence'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postprostatectomy Incontinence']}, 'referencesModule': {'references': [{'pmid': '41026492', 'type': 'DERIVED', 'citation': 'Niu J, Wang Y, Wang Y, Shi J, Liang J, Zhao X, Xu T, Guo H, Qiu X. Electroacupuncture in Patients With Early Urinary Incontinence After Radical Prostatectomy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2534491. doi: 10.1001/jamanetworkopen.2025.34491.'}]}, 'descriptionModule': {'briefSummary': 'More than 50% patients underwent prostatectomy suffered from postoperative incontinence, and the effect of pelvic floor muscle training is very limited. Electrical acupuncture stimulation therapy has been demonstrated to work on other kinds of Urinary Incontinence. Before this trial, the researchers have conducted pre-experiments where electrical acupuncture stimulation therapy was conducted for few postprostatectomy Incontinence patients. On the basis of the preliminary work, this prospective, random control research aims to verify the safety and effectiveness of electroacupuncture in the treatment of postprostatectomy Incontinence.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* localized prostate cancer (stage: cT1-cT2, N0, M0)\n* 4-6weeks after prostatectomy\n* postprostatectomy prostate specific antigen (PSA) test below cured level\n* incontinence one month after surgery\n* ECOG score:0-1\n\nExclusion Criteria:\n\n* history of neoadjuvant hormonal therapy\n* history of transurethral resection of the prostate (TUPR)\n* history of operation on pelvis\n* history of incontinence before prostatectomy'}, 'identificationModule': {'nctId': 'NCT04972669', 'briefTitle': 'The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence', 'orgStudyIdInfo': {'id': 'IUNU-PC-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': 'sham electroaupuncture', 'interventionNames': ['Device: sham Acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'Electroaupuncture', 'interventionNames': ['Device: Electrical Acupuncture Stimulation']}], 'interventions': [{'name': 'Electrical Acupuncture Stimulation', 'type': 'DEVICE', 'description': 'Participants received acupuncture at bilateral Baliao. After skin disinfection, sterile adhesive pads were placed on bilateral Baliao, and acupuncture needles were inserted through the adhesive pads. Following needle insertion, small, equal manipulations of twirling, lifting, and thrusting were performed on all needles to reach de qi. Electrodes from the electroacupuncture apparatus were attached transversely to the needle handles. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 2-15 Hz. Participants received 3 treatment sessions per week (ideally every other day) for 6 consecutive weeks, 18 sessions in total.', 'armGroupLabels': ['experimental group']}, {'name': 'sham Acupuncture', 'type': 'DEVICE', 'description': 'Participants received sham acupuncture at locations one inch besides bilateral Baliao without needle insertion. Electrodes from the electroacupuncture apparatus were attached transversely to the needle handles. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 2-15 Hz. Participants received 3 treatment sessions per week (ideally every other day) for 6 consecutive weeks, 18 sessions in total.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongqian Guo, MD', 'role': 'CONTACT', 'email': 'dr.ghq@nju.edu.cn', 'phone': '8613605171690'}, {'name': 'Qun Lu, MD', 'role': 'CONTACT', 'email': 'luqun_1989@126.com', 'phone': '8615195856020'}], 'facility': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Xuefeng Qiu', 'role': 'CONTACT', 'email': 'hydewoods@163.com', 'phone': '13776509416'}, {'name': 'Hongqian Guo', 'role': 'CONTACT', 'email': 'dr.ghq@nju.edu.cn', 'phone': '13605171690'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University', 'investigatorFullName': 'Hongqian Guo', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}