Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
Study NCT ID:
NCT06827561
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2025-01-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Presbyphagia on Urinary Incontinence and Quality of Life in Healthy Elderly People in Nursing Homes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-09', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-02-09', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determining the presence of urinary incontinence', 'timeFrame': '1 day', 'description': 'Determination of urinary incontinence in the elderly with swallowing problems using the International Consultation on Incontinence Questionnaire Short (ICIQ) scale.'}, {'measure': 'Determining the presence ofquality of life', 'timeFrame': '1 day', 'description': "Determination of health-related quality of life related to urinary incontinence in elderly people with swallowing problems using King's Health Questionnaire (KHQ) scale"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Presbyphagia', 'Urinary Incontinence', 'Quality of Life'], 'conditions': ['Presbyphagia', 'Incontinence, Urinary', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '39032316', 'type': 'BACKGROUND', 'citation': 'Kakehi S, Wakabayashi H, Isono E, Takemura R, Sato Y, Otsuka Y, Nagai T, Nishioka S, Momosaki R. Association between sarcopenia and urinary dysfunction in patients with dysphagia. Arch Gerontol Geriatr. 2024 Dec;127:105577. doi: 10.1016/j.archger.2024.105577. Epub 2024 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'Urinary incontinence in the elderly and health-related quality of life due to urinary incontinence is a common problem in nursing homes. Another problem that occurs in elderly individuals is swallowing disorder. Swallowing disorders that occur with aging are called presbyphagia. Additional health problems such as impaired fluid intake balance, fetal incontinence and sarcopenia may occur after presbyphagia. However, the effect of presbyphagia on urinary incontinence is not known. In this study, we aimed to determine the effect of presbyphagia on urinary incontinence and quality of life in healthy elderly individuals living in a nursing home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy elderly people living in a nursing home', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who have been living in the nursing home for at least 1 year and volunteer to participate in the study\n* a mini metal test score of 24 and above\n\nExclusion Criteria:\n\n* Those who cannot provide information on urinary function and quality of life,\n* Those with a history of disease and surgery with mechanisms directly related to swallowing and urinary incontinence,\n* Those with a mini mental test score of 23 or less were excluded'}, 'identificationModule': {'nctId': 'NCT06827561', 'acronym': 'Presbyphagia', 'briefTitle': 'The Effect of Presbyphagia on Urinary Incontinence and Quality of Life in Healthy Elderly People in Nursing Homes', 'organization': {'class': 'OTHER', 'fullName': 'Isparta University of Applied Sciences'}, 'officialTitle': 'The Effect of Presbyphagia on Urinary Incontinence and Quality of Life in Healthy Elderly People in Nursing Homes', 'orgStudyIdInfo': {'id': 'postdr1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Presbyphagia Group', 'description': 'This is a group of elderly people with swallowing disorders. Urinary incontinence and quality of life will be evaluated diagnostically.'}, {'label': 'Non-Presbyphagia Group', 'description': 'This group is an elderly group in which swallowing disorder is not detected. Urinary incontinence and quality of life will be evaluated diagnostically.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32000', 'city': 'Uluborlu', 'state': 'Isparta', 'country': 'Turkey (Türkiye)', 'facility': 'Haci Ahmet Şençopur Huzurevi Yaşli Bakim Ve Rehabilitasyon Merkezi', 'geoPoint': {'lat': 38.07825, 'lon': 30.45019}}, {'zip': '32000', 'city': 'Uluborlu', 'state': 'Isparta', 'country': 'Turkey (Türkiye)', 'facility': 'Uluborlu Gardenia Care Center', 'geoPoint': {'lat': 38.07825, 'lon': 30.45019}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing the personal data of elderly residents of the institution constitutes a crime for the Republic of Turkey.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isparta University of Applied Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}