Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT03516435
Status:
UNKNOWN
Last Update Posted:
2018-05-17
First Post:
2018-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Different Electrical Stimulation Placement in Patients With Overactive Bladder Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3 Days Voiding diary', 'timeFrame': '3 days', 'description': 'This chart is a record of your voiding and leakage or urine. Choose three (3) separate 24 hour periods to complete this record. Pick days which will be most convenient for you to measure every void.'}], 'secondaryOutcomes': [{'measure': 'Overactive Bladder Symptom Score( OABSS）', 'timeFrame': '20 min', 'description': 'This is a single symptom score that employs a self-report questionnaire to quantify OAB symptoms.Questionnaire has many items with the same minimum and maximum score.Four question items, daytime frequency, nocturia, urgency and urgency incontinence, were included in the questionnaire according to the definition of OAB.'}, {'measure': 'minVisual analogue scale (VAS) for urgency', 'timeFrame': '10 min', 'description': 'The Visual Analog or Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of urgency they experienced. This gives them the greatest freedom to choose their urgency intensity. It also gives the maximum opportunity for each respondent to express a personal response style. VAS data of this type is recorded as the number of millimeters from the left of the line with the range 0-100.'}, {'measure': 'Pad test', 'timeFrame': '20min-1hr', 'description': "To measure leakage and may be performed in the specialist's office or at home. Pad testing can be done over a period of time as short as twenty minutes or up to one hour."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intravaginal electrical stimulation', 'Parasacral transcutaneous electrical stimulation'], 'conditions': ['Overactive Bladder Syndrome']}, 'descriptionModule': {'briefSummary': 'This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.', 'detailedDescription': 'This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.The study will adopt a longitudinal research design with randomized quasi-experimental trial.The patients will recruited and be randomly assigned to Group A (Parasacral transcutaneous electrical stimulation) or Group B (Intravaginal electrical stimulation). There will be 30 participants in each group. Data will be collected 2 times.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Urinary incontinence due to detrusor overactivity\n* No patients had been taking anticholinergics or tricyclic depressants and none had been treated by pelvic floor exercise, bladder training, or pelvic surgery before entry into the study.\n\nExclusion Criteria:\n\n* stress incontinence\n* urinary tract infection\n* neurological disease\n* genital prolapse higher than stage II on POP-Q system\n* pregnancy\n* diabetes mellitus\n* a history of anti-incontinence surgery and/or prolapse repair\n* pelvic tumors and previously treated with radiation therapy or antimuscarinic agents\n* patients who were not cooperative\n* electrical stimulation contraindications'}, 'identificationModule': {'nctId': 'NCT03516435', 'briefTitle': 'Efficacy of Different Electrical Stimulation Placement in Patients With Overactive Bladder Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Randomized,Single-Blind Controlled Trial', 'orgStudyIdInfo': {'id': 'CS17150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parasacral transcutaneous ES', 'description': '20min./session, 2 sessions/week ,12 sessions of Parasacral transcutaneous electrical stimulation.', 'interventionNames': ['Device: Parasacral transcutaneous electrical stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravaginal electrical stimulation', 'description': '20min./session, 2 sessions/week ,12 sessions of Intravaginal electrical stimulation.', 'interventionNames': ['Device: Intravaginal electrical stimulation']}], 'interventions': [{'name': 'Parasacral transcutaneous electrical stimulation', 'type': 'DEVICE', 'description': 'Asymmetrical biphasic square current pulse Frequency：10 Hz pulse width：1.0 ms Intensity：highest tolerable intensity(≦80 mA.) Parasacral transcutaneous electrical stimulation：Clinic using 2 superficial 3.5 cm electrodes placed on each side of S3 and S4.', 'armGroupLabels': ['Parasacral transcutaneous ES']}, {'name': 'Intravaginal electrical stimulation', 'type': 'DEVICE', 'description': 'Asymmetrical biphasic square current pulse Frequency：10 Hz pulse width：1.0 ms Intensity：highest tolerable intensity(≦80 mA.) Intravaginal electrical stimulation：The electrode plug for vaginal plug was cylinder-formed with ring-formed placed into vaginal.', 'armGroupLabels': ['Intravaginal electrical stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40201', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'role': 'CONTACT', 'email': 'irb@csh.gov.tw', 'phone': '886-4-24739595', 'phoneExt': '21737'}], 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Chen Gin-Den, PhD', 'role': 'CONTACT', 'email': 'gdchentw@hotmail.com', 'phone': '+886-4-24730022', 'phoneExt': '11600'}, {'name': 'Chen Yi-Ching, MS', 'role': 'CONTACT', 'email': 'yiching@csmu.edu.tw', 'phone': '+886-4-24730022', 'phoneExt': '12378'}], 'overallOfficials': [{'name': 'Chen Gin-Den, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chung Shan Medical University'}, {'name': 'Chen Yi-Ching, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chung Shan Medical University'}, {'name': 'Chang Chia-Yun, MS student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yeh', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}