Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-25 @ 9:41 PM
Study NCT ID:
NCT03662893
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2018-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioural Therapy With Checklist for 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Analysis of treatment response was performed by a single independent urologist blinded to the study groups.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group I were instructed to apply only written guideline forms of behavioural therapy which were the same as those in the checklist, Group II were instructed to apply behavioural therapy with a written checklist for patients to fully complete and Group III received medical treatment plus behavioural therapy without checklist. Group IV received medical treatment with a written checklist to fully complete'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-07', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-07', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary frequency', 'timeFrame': '6 months', 'description': '\\>8 micturitions per day'}, {'measure': 'Urgency', 'timeFrame': '6 months', 'description': '\\>6 urgency episodes per day'}], 'secondaryOutcomes': [{'measure': 'Treatment Benefit Scale', 'timeFrame': '6 months', 'description': "Treatment Benefit Scale is consisted of four category including a score of 1 (greatly improved) or 2 (improved) is considered ''yes,'' and a score of 3 (not changed)or 4 (worsened) was considered ''no''"}, {'measure': 'Urgency urinary incontinence', 'timeFrame': '6 months', 'description': '\\>3 urgency urinary incontinence episodes per day'}, {'measure': 'Nocturia', 'timeFrame': '6 months', 'description': '\\>1 micturition at night'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['overactive bladder', 'behavioural therapy', 'adherence', 'drug persistence'], 'conditions': ['Overactive Bladder']}, 'referencesModule': {'references': [{'pmid': '25400065', 'type': 'RESULT', 'citation': 'Dumoulin C, Hunter KF, Moore K, Bradley CS, Burgio KL, Hagen S, Imamura M, Thakar R, Williams K, Chambers T. Conservative management for female urinary incontinence and pelvic organ prolapse review 2013: Summary of the 5th International Consultation on Incontinence. Neurourol Urodyn. 2016 Jan;35(1):15-20. doi: 10.1002/nau.22677. Epub 2014 Nov 15.'}, {'pmid': '29300292', 'type': 'RESULT', 'citation': 'Gezginci E, Iyigun E, Yilmaz S. Comparison of 3 Different Teaching Methods for a Behavioral Therapy Program for Female Overactive Bladder: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2018 Jan/Feb;45(1):68-74. doi: 10.1097/WON.0000000000000398.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the efficiency of this newly-established checklist for overactive bladder (OAB) and whether determinate to adherence and persistence rate of combination of behavioural therapy and anticholinergic medications in patients with OAB.', 'detailedDescription': 'Overactive bladder (OAB) can worsen quality of life but it is not life-threatening condition. Although OAB medications effectively decrease disturbing symptoms of OAB, there are a lot of adverse side effects such as dry mouth, cognitive changes, constipation, urinary retention, blurred vision and dyspepsia. Therefore, guidelines have firstly recommended behavioural therapy which are noninvasive and not linked with adverse side effects. These behavioural recommendations include an advice on fluid balance, bladder retraining, urgency suppression or normal voiding techniques, pelvic floor muscle training, caffeine reduction, dietary changes, weight loss and other life style changes to improve lower urinary tract symptoms of OAB.\n\nEducational leaflets, verbal or audio-visual instructions and trainings for behavioural therapy have been recommended for patients with OAB, however, to date these beneficial instructions have not been documented as a written checklist. Therefore, they were collected and developed as a written checklist to instruct the patients. The aim of this study was to investigate the efficiency of this newly-established checklist for OAB and whether determinate to adherence and persistence rate of combination of behavioural therapy and anticholinergic medications in patients with OAB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with\n\n* \\>8 micturitions,\n* \\>1 nocturia,\n* \\>6 urgency or\n* \\>3 urgency urinary incontinence episodes per 24 h according to 3-day bladder diary.\n\nExclusion Criteria:\n\n* active urinary tract infection,\n* a maximum flow rate of 15 ml. per second or less at least 2 uroflow studies,\n* residual volume of 100 cc or more,\n* any medications for OAB, benign prostatic obstruction,\n* polyuria (\\>3 l per 24 hour),\n* endocrinological disease such as diabetes mellitus or diabetes insipidus which can cause polyuria,\n* neurological or psychological disease disease,\n* prostate or bladder cancer, renal disease, hypertension, genitourinary or congenital abnormality,\n* history of transobturator or transvaginal tape or pelvic organ prolapse surgery\n* pelvic radiation or surgery'}, 'identificationModule': {'nctId': 'NCT03662893', 'briefTitle': 'Behavioural Therapy With Checklist for Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Training and Research Hospital'}, 'officialTitle': 'Checklist to Increase Effectiveness of Behavioural Therapy for Overactive Bladder', 'orgStudyIdInfo': {'id': '5002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Behavioural therapy with written guideline', 'description': 'Patients were instructed to apply only written guideline forms of behavioural therapy which were the same as those in the checklist over six-month period.', 'interventionNames': ['Behavioral: behavioural therapy with written guideline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Behavioural therapy with checklist', 'description': 'Patients were instructed to apply behavioural therapy with a written checklist for patients to fully complete over six-month period.', 'interventionNames': ['Behavioral: behavioural therapy with written checklist form to complete']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'antimuscarinic drug plus verbal behavioural therapy', 'description': 'Patients received medical treatment (once or twice per day) plus behavioural therapy without checklist over six-month period.', 'interventionNames': ['Drug: Antimuscarinic drugs used in overactive bladder', 'Behavioral: behavioural therapy with written guideline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'antimuscarinics plus checklist', 'description': 'Patients received medical treatment (once or twice per day) with a written checklist to fully complete over six-month period.', 'interventionNames': ['Behavioral: behavioural therapy with written checklist form to complete', 'Drug: Antimuscarinic drugs used in overactive bladder']}], 'interventions': [{'name': 'behavioural therapy with written checklist form to complete', 'type': 'BEHAVIORAL', 'description': 'Behavioural therapy for overactive bladder such as advice on fluid balance, bladder retraining, urgency suppression or normal voiding techniques, pelvic floor muscle training, caffeine reduction, dietary changes, weight loss and other life style changes', 'armGroupLabels': ['Behavioural therapy with checklist', 'antimuscarinics plus checklist']}, {'name': 'Antimuscarinic drugs used in overactive bladder', 'type': 'DRUG', 'description': 'Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)', 'armGroupLabels': ['antimuscarinic drug plus verbal behavioural therapy', 'antimuscarinics plus checklist']}, {'name': 'behavioural therapy with written guideline', 'type': 'BEHAVIORAL', 'description': 'behavioural therapy with written guideline,which are the same as those in the checklist', 'armGroupLabels': ['Behavioural therapy with written guideline', 'antimuscarinic drug plus verbal behavioural therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06340', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Koray Agras, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Ankara Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Training and Research Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Turkey', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammet Fatih Kilinc', 'investigatorAffiliation': 'Ankara Training and Research Hospital'}}}}