Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-30 @ 7:04 PM
Study NCT ID:
NCT05977634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-07
First Post:
2023-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessor and investigator that assesses the patients will be blind to the study groups'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2023-07-28', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urination frequency', 'timeFrame': '1 day', 'description': 'The frequency of urination will be recorded by using a bladder diary. Urination frequency will be questioned before and after the study period.'}, {'measure': 'Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire', 'timeFrame': '1 day', 'description': 'This questionnaire assesses the severity of overactive bladder symptoms in 8 items. Each item is scored from 0 to 5. Higher scores denote worse symptom severity. Maximum score is 40. A score over 11 denotes presence of overactive bladder symptoms. Questionnaire will be answered before and after the treatment period.'}], 'secondaryOutcomes': [{'measure': "Quality of life. King's quality of life questionnaire", 'timeFrame': '1 day', 'description': 'This questionnaire includes a total of 19 questions assessing general quality of life and also questions related to urinary symptoms. Maximum score is 100 and higher scores denote lower levels of quality of life. Questionnaire will be answered before and after the treatment period.'}, {'measure': 'Level of satisfaction with the treatment. Visual analog scale', 'timeFrame': '1 day', 'description': 'After the completion of the study period, patients will be asked to assess their levels of satisfaction with the treatment they received on a visual analog scale.'}, {'measure': 'Incontinence impact questionnaire-7.', 'timeFrame': '1 day', 'description': "This 7 item questionnaire assesses the impact of urinary incontinence on the patients' daily lives. Maximum score is 100. Higher scores denote worse outcomes. Questionnaire will be answered before and after the treatment period."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tibial nerve stimulation'], 'conditions': ['Overactive Bladder', 'Overactive Bladder Syndrome', 'Overactive Detrusor']}, 'referencesModule': {'references': [{'pmid': '27921161', 'type': 'BACKGROUND', 'citation': 'Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5.'}, {'pmid': '30311692', 'type': 'BACKGROUND', 'citation': 'Ramirez-Garcia I, Blanco-Ratto L, Kauffmann S, Carralero-Martinez A, Sanchez E. Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial. Neurourol Urodyn. 2019 Jan;38(1):261-268. doi: 10.1002/nau.23843. Epub 2018 Oct 12.'}, {'pmid': '25623739', 'type': 'BACKGROUND', 'citation': 'Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. 2015 May;193(5):1572-80. doi: 10.1016/j.juro.2015.01.087. Epub 2015 Jan 23.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder', 'detailedDescription': 'Idiopathic overactive bladder is defined the presence of a sense of urgency with or without accompanying urinary incontinence without an organic pathology or urinary infection. Its prevalence was reported to be between 7.7 to 31 % in women. In this prospective randomized controlled study, we aim to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only biological females will be enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overactive Bladder Questionnaire Validation Study questionnaire 8 scores higher than 11.\n* Post voiding residue levels less than 100 ml.\n* Women aged between 18-70\n\nExclusion Criteria:\n\n* Prior history of pelvic surgery\n* Pelvic organ prolapsus of grade 2 or more.\n* Current urinary tract infection'}, 'identificationModule': {'nctId': 'NCT05977634', 'briefTitle': 'Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'The Efficacy of Transcutaneous Tibial Nerve Stimulation on Symptoms of Overactive Bladder and Quality of Life in Women With Idiopathic Overactive Bladder', 'orgStudyIdInfo': {'id': 'Ege 19-12.3/5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous tibial nerve stimulation plus bladder training', 'description': 'Patients will receive transcutaneous tibial nerve stimulation for 30 minutes, twice a week, for 6 weeks. Application will be done in an outpatient setting, using disposable surface electrodes.', 'interventionNames': ['Behavioral: Bladder training', 'Device: Transcutaneous tibial nerve stimulation']}, {'type': 'OTHER', 'label': 'Bladder training', 'description': 'patients will receive only the routine education program that is given to every patient with idiopathic overactive bladder syndrome. This includes education about the anatomy of the urinary system, patient motivation, and frequent bathroom visits in order to avoid incontinence with gradual increase between each visit to the bathroom.', 'interventionNames': ['Behavioral: Bladder training']}], 'interventions': [{'name': 'Bladder training', 'type': 'BEHAVIORAL', 'description': 'Bladder training has 4 components, educating the patient about anatomy, fluid intake control, pelvic floor muscle contractions and increasing the interval between visits to the bathroom', 'armGroupLabels': ['Bladder training', 'Transcutaneous tibial nerve stimulation plus bladder training']}, {'name': 'Transcutaneous tibial nerve stimulation', 'type': 'DEVICE', 'description': 'A combined electrotherapy device capable of applying transcutaneous electrical nerve stimulation will be used. Each session will take 30 minutes. Patient will visit the hospital twice a week for 6 weeks. An electrical current of 0-50 amperes with a frequency of 20 herz, and a duration of 200 micro seconds will be applied using 50x50 mm surface electordes. The aim is to create a tingling sensation without causing any pain on the tibial nerve, at the ankle level.', 'armGroupLabels': ['Transcutaneous tibial nerve stimulation plus bladder training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Bornova', 'state': 'İzmir', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ece Cinar, MD', 'role': 'CONTACT', 'email': 'ece.cinar@ege.edu.tr', 'phone': '005372257018'}, {'name': 'Yesim Akkoc, MD', 'role': 'CONTACT', 'email': 'yesim.akkoc@ege.edu.tr', 'phone': '00902323903690'}, {'name': 'Yesim Akkoc, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ece Cinar, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Esra Cansu Selbes, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmet Ozgur Yeniel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gokay Celtik, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ege University School of Medicine', 'geoPoint': {'lat': 38.47921, 'lon': 27.2399}}], 'centralContacts': [{'name': 'Ece Cinar, MD', 'role': 'CONTACT', 'email': 'ece.cinar@ege.edu.tr', 'phone': '00905372257018'}, {'name': 'Yesim Akkoc, MD', 'role': 'CONTACT', 'email': 'yesim.akkoc@ege.edu.tr', 'phone': '00902323903690'}], 'overallOfficials': [{'name': 'Ece Cinar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'May be shared when requested'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ece Cinar', 'investigatorAffiliation': 'Ege University'}}}}