Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:45 AM
Study NCT ID:
NCT07324668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Multiple Intervention on Postmenopausal Women With UI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of three parallel groups:\n\n1. Experimental Group 1 will perform Tai Chi and Kegel exercises 3 days per week,\n2. Experimental Group 2 will perform Tai Chi and Kegel exercises 6 days per week, and\n3. the Control Group will receive no intervention. All groups will be evaluated at baseline and after 8 weeks.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 117}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-12-23', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary Incontinence Severity Measured by [İnkontinans Şiddet İndeksi]', 'timeFrame': '8 weeks (baseline and post-intervention)', 'description': 'Quality of life related to urinary incontinence will be assessed using a validated questionnaire. Differences from baseline to post-test will be evaluated.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Related to Urinary Incontinence', 'timeFrame': '8 weeks (baseline and post-intervention)', 'description': 'Quality of life related to urinary incontinence will be assessed using a validated questionnaire. Differences from baseline to post-test will be evaluated.'}, {'measure': 'Self-Efficacy in Managing Urinary Incontinence', 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': "Participants' self-efficacy will be measured using a validated scale, comparing baseline and post-test scores."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postmenopause', "Women's health", 'Multimodal intervention', 'Urinary incontinence', 'Quality of life', 'Effectiveness'], 'conditions': ['Urinary Incontinence', 'Postmenopausal']}, 'descriptionModule': {'briefSummary': "Study\n\nThe purpose of this clinical trial was to investigate the effects of a multi-intervention approach, including Kegel and Tai Chi exercises, on quality of life, self-efficacy, and urinary incontinence severity in postmenopausal women.\n\nKey Questions the Study Aims to Answer:\n\nHow does the multi-intervention approach affect quality of life?\n\nDoes the multi-intervention approach affect women's self-efficacy?\n\nHow does the multi-intervention approach affect urinary incontinence severity?\n\nHow does the frequency of exercises (3 days per week vs. 6 days per week) affect these outcomes?\n\nDo the effects of the intervention change temporally over the 8-week period?\n\nWho is Eligible?\n\nWomen aged 45 and over who have gone through menopause\n\nThose who wish to volunteer for the study\n\nThose who have no communication barriers\n\nThose who have not previously received treatment for urinary incontinence\n\nThose who can use a smartphone or WhatsApp\n\nThose who experience urine leakage when coughing or sneezing\n\nStudy Application:\n\nThe exercises will be administered for 8 weeks.\n\nParticipants will be taught how to perform the exercises and will be demonstrated through brochures and videos.\n\nReminders will be provided during the exercises."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '45 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Being female\n\nHaving undergone menopause\n\nWillingness to participate in the study\n\nNo communication barriers\n\nNot receiving any treatment for urinary incontinence\n\nOwning a smartphone\n\nHaving WhatsApp installed\n\nExperiencing urinary leakage when coughing or sneezing, according to the International Continence Society (ICS) definition\n\nExclusion Criteria:\n\nHaving communication barriers\n\nNot being in menopause\n\nNot owning a smartphone\n\nNot experiencing urinary incontinence\n\nHaving received any treatment for urinary incontinence\n\nHaving undergone surgical menopause\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07324668', 'acronym': 'UI Program', 'briefTitle': 'Effects of Multiple Intervention on Postmenopausal Women With UI', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'The Effects of a Multiple Intervention Approach Applied to Postmenopausal Women on Quality of Life, Self-efficacy, and Urinary Incontinence Severity: a Temporal Analysis', 'orgStudyIdInfo': {'id': '2025-1075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group 1 (Tai Chi and Kegel, 3 days/week)', 'description': 'articipants will perform Tai Chi and Kegel exercises 3 days per week for 8 weeks.', 'interventionNames': ['Behavioral: Combined Exercise Program']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group 2 (Tai Chi and Kegel, 6 days/week)', 'description': 'Participants will perform Tai Chi and Kegel exercises 6 days per week for 8 weeks.', 'interventionNames': ['Behavioral: Combined Exercise Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants will receive no exercise or educational intervention and will continue their usual daily routines.'}], 'interventions': [{'name': 'Combined Exercise Program', 'type': 'BEHAVIORAL', 'description': 'Participants will receive education on urinary incontinence, Kegel and Tai Chi exercises, brochures and videos, and perform exercises 3 days/week for 8 weeks with reminders', 'armGroupLabels': ['Intervention Group 1 (Tai Chi and Kegel, 3 days/week)']}, {'name': 'Combined Exercise Program', 'type': 'BEHAVIORAL', 'description': 'Participants will receive same education and materials as Group 1 and perform exercises 6 days/week for 8 weeks with reminders.', 'armGroupLabels': ['Intervention Group 2 (Tai Chi and Kegel, 6 days/week)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ŞEYMA SOYANIT ERASLAN', 'role': 'CONTACT', 'email': 'seymasoyanitt@gmail.com', 'phone': '+90 368 271 57 57 / 6571'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Şeyma SOYANIT ERASLAN', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}