Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-25 @ 4:13 AM
Study NCT ID:
NCT04197466
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2019-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Different Treatments for Overactive Bladder Syndrome
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': 'D055052', 'term': 'Athletic Tape'}, {'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D001458', 'term': 'Bandages'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-23', 'studyFirstSubmitDate': '2019-12-11', 'studyFirstSubmitQcDate': '2019-12-11', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bladder Diary', 'timeFrame': 'Before the treatment, at end of 6 weeks', 'description': 'Women will be asked to complete a 24-hour frequency-volume chart (urine diary) to assess bladder symptoms. Each woman will fill the chart for a total of 3 days filled in 3 consecutive days. In these diaries, women will be asked to record the number of their urination during the day, how much urine they produce each time they urinate, their incontinence, the type and amount of drinks. Women will be warned not to change their daily voiding habits and the amount of fluids they consume during filling these charts. The data obtained from these three days will be averaged to determine daily voiding frequency, night voiding frequency, average voiding volume, and daily urinary incontinence.'}], 'secondaryOutcomes': [{'measure': 'King Health Questionnaire', 'timeFrame': 'Before the treatment and end of 6 weeks', 'description': 'The Turkish version of the King Health Questionnaire, which was developed to assess the quality of life of women, consisting of 21 items, was shown to be valid and reliable The survey consists of 3 sections and 9 sub-headings. These subheadings are questions that determine general health perception, incontinence impact, role, physical and social limitations, personal relationships, emotions, sleep / energy and severity measures. In addition, the third section includes 9 questions that question the effect of urinary symptoms. In each subheading, a complex scoring algorithm is used for missing values. Scoring varies between "0" and "100.. Decrease in score indicates an increase in quality of life'}, {'measure': 'Pelvic Floor Muscle Strength', 'timeFrame': 'Before the treatment and end of 6 weeks', 'description': 'Modified Ashword Scale and perineometer device will be used for the measurement of the pelvic floor muscle strength. Modified Ashword Scale is a 6-point scale: 0=no contraction, 1=flicker, 2=weak, 3=moderate, 4=good (with lift), and 5=strong. This measurement scale is incorporated with vaginal palpation in the clinical assessment,.\n\nThe PFX perineometer (Cardio Design Pty Ltd, Australia) will be used to provide an objective measurement. In the lithotomy position the probe of the perineometer will be inserted into the vagina of the patient. The patient will be asked to relax and squeeze the probe of the perineometer as if they are holding the urine or gaita. The minimum and maximum value of the perineometer are between 0-12 kg Pascal (kPa) and the difference between the first value and the last value in the perineometer will be determined as the pelvic floor muscle strength. The average of three repetitions will be noted'}, {'measure': 'Overactive bladder symptoms', 'timeFrame': 'Before the treatment, at end of 6 weeks', 'description': 'Symptoms will be assessed by the Turkish version of the Overactive Bladder-V8 (OAB-V8) questionnaire, which has been shown to be valid and reliable. The AAM-V8 questionnaire had 8 questions scored as 0 to 5. The total score ranges from 0 to 40. Increased scores indicate that the severity of overactive bladder complaints increases.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelvic Floor Muscle Exercise', 'Kinesio taping', 'Electric Stimulation'], 'conditions': ['Overactive Bladder', 'Overactive Bladder Syndrome', 'Overactive Detrusor']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects of pelvic floor muscle exercises, electrical stimulation and taping in patients with overactive bladder'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women\n* Being Volunteered to participate\n* Diagnosed as overactive bladder\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients with a comorbid neurological disorder\n* A mental problem that may prevent cooperation and evaluation\n* Acute infection\n* Sensory loss\n* Malignancy'}, 'identificationModule': {'nctId': 'NCT04197466', 'briefTitle': 'Comparison of Different Treatments for Overactive Bladder Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'Comparison of Different Treatments for Overactive Bladder Syndrome', 'orgStudyIdInfo': {'id': '2018/06/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pelvic Floor Exercise Group', 'description': 'Pelvic floor muscle exercises will be recommended as a home program for 6 weeks every day of the week.', 'interventionNames': ['Other: Pelvic Floor Exercise Group']}, {'type': 'EXPERIMENTAL', 'label': 'Kinesiotape Group', 'description': 'In addition to pelvic floor exercise,kinesio tape application will be performed by ligament technique to the sacral region.', 'interventionNames': ['Other: Pelvic Floor Exercise Group', 'Other: Kinesio tape']}, {'type': 'EXPERIMENTAL', 'label': 'Electrical Stimulation Group', 'description': 'In addition to pelvic floor exercise,electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes', 'interventionNames': ['Other: Pelvic Floor Exercise Group', 'Other: Electrical stimulation']}], 'interventions': [{'name': 'Pelvic Floor Exercise Group', 'type': 'OTHER', 'description': 'The exercise program will be tailored according to the pelvic floor muscle strength, including fast and slow contractions. The number and duration of exercises will be increased according to progress..', 'armGroupLabels': ['Electrical Stimulation Group', 'Kinesiotape Group', 'Pelvic Floor Exercise Group']}, {'name': 'Kinesio tape', 'type': 'OTHER', 'description': 'Kinesio tape application will be performed by ligament technique to the sacral region.', 'armGroupLabels': ['Kinesiotape Group']}, {'name': 'Electrical stimulation', 'type': 'OTHER', 'description': 'External electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes', 'armGroupLabels': ['Electrical Stimulation Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Yıldırım Beyazıt Üniversitesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}