Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-28 @ 1:05 AM
Study NCT ID:
NCT04722458
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2021-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Turkish Validation and Reliability of LURN SI-29 Questionnaire in Patients With Lower Urinary Tract Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-03', 'studyFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2021-01-21', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LURN SI-29 Questionnaire', 'timeFrame': '3 months', 'description': 'The subscale and total scores for the LURN SI-29 are normalized to a scale from 0 - 100'}, {'measure': 'International Prostate Symptom Score-IPSS', 'timeFrame': '3 months', 'description': 'The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.'}, {'measure': 'UROGENITAL DISTRESS INVENTORY- 6', 'timeFrame': '3 months', 'description': 'UDI-6 a six item symptom inventory, specific to symptoms associated with lower urinary tract dysfunction,and combines information on irritative, stress and obstructive/discomfort symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lower urinary tract symptoms', 'Patient reported outcomes', 'Questionnaire'], 'conditions': ['Lower Urinary Tract Symptoms', 'Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '31225927', 'type': 'RESULT', 'citation': 'Cella D, Smith AR, Griffith JW, Flynn KE, Bradley CS, Gillespie BW, Kirkali Z, Talaty P, Jelovsek JE, Helfand BT, Weinfurt KP; LURN Study Group. A new outcome measure for LUTS: Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) questionnaire. Neurourol Urodyn. 2019 Aug;38(6):1751-1759. doi: 10.1002/nau.24067. Epub 2019 Jun 21.'}, {'pmid': '31364922', 'type': 'RESULT', 'citation': 'Cella D, Smith AR, Griffith JW, Kirkali Z, Flynn KE, Bradley CS, Jelovsek JE, Gillespie BW, Helfand BT, Talaty P, Weinfurt KP; LURN Study Group. A New Brief Clinical Assessment of Lower Urinary Tract Symptoms for Women and Men: LURN SI-10. J Urol. 2020 Jan;203(1):164-170. doi: 10.1097/JU.0000000000000465. Epub 2019 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'Lower urinary tract symptoms is quite frequent in men and women. To better understand the the symptoms that characterize lower urinary tract, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has established the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN). In this study we aim to validate the LURN-29 score to Turkish language'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with lower urinary tract symptoms over 18 will be included', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with lower urinary tract symptoms, Over 18 years old,Patient with the cognitive ability to read\n\nExclusion Criteria:\n\n* Patients above 18 years old'}, 'identificationModule': {'nctId': 'NCT04722458', 'briefTitle': 'Turkish Validation and Reliability of LURN SI-29 Questionnaire in Patients With Lower Urinary Tract Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medeniyet University'}, 'officialTitle': 'Turkish Validity and Reliability of LURN SI-29 Questionnaire Form in Patients With Lower Urinary Tract Symptoms', 'orgStudyIdInfo': {'id': '2021-0028'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Lower urinary tract sypmtoms', 'description': 'Patients with Lower urinary tract sypmtoms over 18 years old will be included to this study', 'interventionNames': ['Other: Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29)', 'Other: IPSS', 'Other: UDI-6']}], 'interventions': [{'name': 'Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29)', 'type': 'OTHER', 'description': 'LURN SI-29', 'armGroupLabels': ['Patients with Lower urinary tract sypmtoms']}, {'name': 'IPSS', 'type': 'OTHER', 'description': 'International Prostate Symptom Score', 'armGroupLabels': ['Patients with Lower urinary tract sypmtoms']}, {'name': 'UDI-6', 'type': 'OTHER', 'description': 'Urogenital Distress Inventory', 'armGroupLabels': ['Patients with Lower urinary tract sypmtoms']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medeniyet University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medeniyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Urology', 'investigatorFullName': 'Ahmet Tahra', 'investigatorAffiliation': 'Istanbul Medeniyet University'}}}}