Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT04950556
Status:
UNKNOWN
Last Update Posted:
2021-07-06
First Post:
2021-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Pelvic Floor Muscle Training in Women With Overactive Bladdder
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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly divided into two groups (control and exercise) for treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-27', 'studyFirstSubmitDate': '2021-06-27', 'studyFirstSubmitQcDate': '2021-06-27', 'lastUpdatePostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic floor muscle strength', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'The pelvic floor muscle strength of the patients will be evaluated by digital palpation. Change in pelvic floor muscle strength as measured with the Modified Oxford Scale, which ranges from 0 to 5'}, {'measure': 'Sexual Function', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'Female sexual function will be assessed using the Female Sexual Function Index. This 19-question questionnaire deals with the subject in a multidimensional way by questioning the states of desire, arousal, lubrication, orgasm, satisfaction and pain. The highest raw score that can be obtained from the questionnaire is 95, and the lowest raw score is 4.'}], 'secondaryOutcomes': [{'measure': 'OAB symptoms', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'OAB symptoms will be evaluated OAB-V8. There are 8 questions in this form and the answers given to each question are scored between 0 and 5. The scores that can be obtained from the entire scale range from 0 to 40.'}, {'measure': 'Urinary frequency, nocturia and the number of urinary incontinence', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'Patients will be also instructed to keep voiding diary'}, {'measure': 'Life quality', 'timeFrame': 'change from baseline at 6 weeks', 'description': "Life quality will be assessed with King's Health Questionnaire (KHQ).This questionnaire consists of two parts and 32 items.. The minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to investigate the effects of pelvic floor muscle training (PFMT) on pelvic floor muscle strength, sexual functions, bladder symptoms and quality of life in women with overactive bladder (OAB).', 'detailedDescription': 'Overactive bladder (OAB) is defined by the International Continence Association as an "urgency with or without urge urinary incontinence, often accompanied by frequency and nocturia." Accordingly, pelvic floor muscle training (PFMT) plays an important role in the management of OAB. However, a recent systematic review suggests that PFMT is insufficient against OAB.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a diagnosis of overactive bladder\n* Being volunteer\n\nExclusion Criteria:\n\n* have a neurological disorder\n* only those with stress urinary incontinence\n* presence of advanced pelvic organ prolapse (stage 3-4)\n* Having a mental problem that will prevent cooperation in evaluation and / or applications\n* Women with the presence of malignant condition'}, 'identificationModule': {'nctId': 'NCT04950556', 'briefTitle': 'The Effects of Pelvic Floor Muscle Training in Women With Overactive Bladdder', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk Training and Research Hospital'}, 'officialTitle': 'The Effects of Pelvic Floor Muscle Training in Women With Overactive Bladdder', 'orgStudyIdInfo': {'id': '2021/06/27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'Fast and slow contractions will be taught in PFMT. For fast contractions, they will be asked to contract and relax the pelvic floor muscles quickly. For slow contractions, they will be asked to contract the pelvic floor muscles slowly, keep them at maximum contraction and relax slowly. Ten slow contractions in addition to 10 fast contractions will be considered as 1 set of exercises. For the first week, they will be asked to do 5 sets of exercises per day, every day. Then, the number of sets will be increased by 5 each week and the number of sets will reach 30 in the 6th week. PFMT will be applied by the patients as a home program every day of the week for 6 weeks.', 'interventionNames': ['Other: Exercise']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Waiting list will included in control group.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Pelvic floor muscle exercise will be given to the exercise group', 'armGroupLabels': ['Exercise group']}, {'name': 'Control', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Seyda Toprak Celenay', 'role': 'CONTACT', 'email': 'sydtoprak@hotmail.com', 'phone': '+90312 906 1000'}], 'overallOfficials': [{'name': 'Seyda Toprak Celenay', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Yildirim Beyazıt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Seyda TOPRAK CELENAY', 'investigatorAffiliation': 'Ataturk Training and Research Hospital'}}}}