Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:27 AM
Study NCT ID:
NCT07339657
Status:
RECRUITING
Last Update Posted:
2026-01-14
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity and Reliability of the PRAFAB
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015203', 'term': 'Reproducibility of Results'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PRAFAB', 'timeFrame': 'This questionnaire, which takes approximately 2-3 minutes to complete, will be administered to participants twice at two-week intervals.', 'description': 'It is a 5-item questionnaire. Developed to assess the severity of urinary incontinence and its impact on the individual.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urinary incontinence', 'validity', 'reliability'], 'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'PRAFAB assesses both the objective and subjective aspects of urinary incontinence. While differing from other questionnaires in this respect, it consists of only five questions. Today, there is a need for multidimensional and easy-to-use scales that can assess the effects of incontinence on quality of life. Therefore, the aim of this study is to conduct a Turkish validity and reliability study of the PRAFAB questionnaire in women with urinary incontinence.', 'detailedDescription': 'PRAFAB assesses both the objective and subjective aspects of urinary incontinence. While differing from other questionnaires in this respect, it consists of only five questions. Today, there is a need for multidimensional and easy-to-use scales that can assess the effects of incontinence on quality of life. Therefore, the aim of this study is to conduct a Turkish validity and reliability study of the PRAFAB questionnaire in women with urinary incontinence.\n\nIn this context, the study consists of two phases. In the first phase, the PRAFAB questionnaire was translated into Turkish and culturally adapted; in the second phase, the validity and reliability analyses of the Turkish version of the PRAFAB questionnaire (PRAFAB-Turkish) were conducted.\n\nThe study will be conducted by Afyonkarahisar University of Health Sciences. Participants consisted of women who presented as outpatients at the AFSU Health Application and Research Center Urology Clinic and were diagnosed with urinary incontinence by a urologist.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants aged 18 years and older with female urinary incontinence will be included in the study. Participants will consist of women who visit the AFSU Health Application and Research Center Urology Outpatient Clinic and are diagnosed with urinary incontinence by a urologist.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 18 years of age or older\n* Have been diagnosed with urinary incontinence by a urologist\n* Be female\n\nExclusion Criteria:\n\n* Being pregnant,\n* Being in the early postpartum period,\n* Have been diagnosed with bladder cancer, diabetic nephropathy, a history of central nervous system damage, congenital urological disorders, urinary tract infection, neurogenic bladder, severe cognitive impairment, and severe psychiatric illness.'}, 'identificationModule': {'nctId': 'NCT07339657', 'briefTitle': 'Validity and Reliability of the PRAFAB', 'organization': {'class': 'OTHER', 'fullName': 'Afyonkarahisar Health Sciences University'}, 'officialTitle': 'Evaluation of the Validity and Reliability of the Protection, Amount, Frequency, Compliance, Body Image (PRAFAB) Questionnaire in Women With Urinary Incontinence', 'orgStudyIdInfo': {'id': '291'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Urinary Incontinence', 'description': 'All subtypes of urinary incontinence (stress urinary incontinence, urge incontinence, etc.) were included in our study.', 'interventionNames': ['Other: Construct validity', 'Other: Test-retest reliability']}], 'interventions': [{'name': 'Construct validity', 'type': 'OTHER', 'otherNames': ['Exploratory Factor Analysis'], 'description': 'This is not an intervention. This is an analysis conducted to examine the factor structure of this questionnaire. The analysis will be performed using the SPSS 26.0 software package program.', 'armGroupLabels': ['Urinary Incontinence']}, {'name': 'Test-retest reliability', 'type': 'OTHER', 'description': 'This is not an intervention. This is an analysis conducted to examine the repeatability of this questionnaire. The analysis will be performed using the SPSS 26.0 software package program.', 'armGroupLabels': ['Urinary Incontinence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03030', 'city': 'Afyonkarahisar', 'state': 'Merkez', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'EMEL TAŞVURAN HORATA', 'role': 'CONTACT', 'email': 'ethorata@gmail.com', 'phone': '05547759663'}], 'facility': 'Emel Taşvuran Horata', 'geoPoint': {'lat': 38.75667, 'lon': 30.54333}}], 'centralContacts': [{'name': 'EMEL TAŞVURAN HORATA', 'role': 'CONTACT', 'email': 'ethorata@gmail.com', 'phone': '05547759663'}], 'overallOfficials': [{'name': 'EMEL TAŞVURAN HORATA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Afyonkarahisar Sağlık Bİlimleri Üniversitesi'}, {'name': 'Şeyma Betül İNCE', 'role': 'STUDY_CHAIR', 'affiliation': 'No Affiliation'}, {'name': 'Harun TAŞKIN, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Afyonkarahisar Health Sciences University'}, {'name': 'Osman GERÇEK, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Afyonkarahisar Health Sciences University'}, {'name': 'Mustafa Esat İNCE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Afyonkarahisar Health Sciences University'}, {'name': 'Bary Berghmans, Assoc. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Afyonkarahisar Health Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD; Associate Professor', 'investigatorFullName': 'Emel Taşvuran Horata', 'investigatorAffiliation': 'Afyonkarahisar Health Sciences University'}}}}