Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-04 @ 8:49 PM
Study NCT ID:
NCT03898258
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2019-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the German Short-Form Qualiveen Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2019-03-29', 'studyFirstSubmitQcDate': '2019-03-29', 'lastUpdatePostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'age (years)', 'timeFrame': 'baseline'}, {'measure': 'gender', 'timeFrame': 'baseline'}, {'measure': 'bladder evacuation method', 'timeFrame': 'baseline', 'description': 'type of bladder evacuation method (e.g. intermittent catheterization) as reported by study participant'}, {'measure': 'number of daily bladder evacuations (n/24h)', 'timeFrame': 'baseline', 'description': 'how often does study participant empty bladder during 24h'}, {'measure': 'urinary incontinence', 'timeFrame': 'baseline', 'description': 'presence of urinary incontinence as reported by study participant'}], 'primaryOutcomes': [{'measure': 'total score', 'timeFrame': 'baseline', 'description': 'Total score of the Qualiveen questionnaire is the arithmetic mean of the four sub-scores. The sub-scores are assessed using a five-point Likert scale (minimum score 0, maximum score 4). The total score indicates how much quality of life is affected by bladder problems. The higher the score the more quality of life is affected.'}], 'secondaryOutcomes': [{'measure': 'bother with limitations score', 'timeFrame': 'baseline', 'description': 'Score of the domain bother with limitations of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how much limitations due to bladder problems bother the affected individual. The higher the score the more the affected individuals are bothered.'}, {'measure': 'change in bother with limitations score', 'timeFrame': 'baseline; 14 days', 'description': 'Score of the domain bother with limitations of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how much limitations due to bladder problems bother the affected individual. The higher the score the more the affected individuals are bothered'}, {'measure': 'frequency of limitations score', 'timeFrame': 'baseline', 'description': 'Score of the domain frequency of limitations of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how often affected individuals experience limitations due to bladder problems. The higher the score the more often the affected individuals experience limitations due to bladder problems.'}, {'measure': 'change in frequency of limitations score', 'timeFrame': 'baseline; 14 days', 'description': 'Score of the domain frequency of limitations of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how often affected individuals experience limitations due to bladder problems. The higher the score the more often the affected individuals experience limitations due to bladder problems.'}, {'measure': 'fears score', 'timeFrame': 'baseline', 'description': 'Score of the domain fears of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how much fear due to bladder problems the affected individuals experience. The higher the score the more fear the affected individuals experience'}, {'measure': 'change in fears score', 'timeFrame': 'baseline; 14 days', 'description': 'Score of the domain fears of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how much fear due to bladder problems the affected individuals experience. The higher the score the more fear the affected individuals experience'}, {'measure': 'feelings score', 'timeFrame': 'baseline', 'description': 'Score of the domain feelings of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how much feelings are affected by bladder problems. The higher the score the more the feelings are affected.'}, {'measure': 'change in feelings score', 'timeFrame': 'baseline; 14 days', 'description': 'Score of the domain feelings of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how much feelings are affected by bladder problems. The higher the score the more the feelings are affected.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'Two questionnaires (Qualiveen full version and Qualiveen short-form (SF)), the project information and the consent form will be sent to individuals who are scheduled for an annual control at the urological out-patient clinic of the Swiss Paraplegic Centre and who fulfill the inclusion criteria. The patients will be asked to complete the two questionnaires and to bring the completed questionnaires and the signed consent form to the annual control at the Swiss Paraplegic Centre. Participants who have consented and completed the two questionnaires will receive the two questionnaires a second time 14 days later.\n\nThe primary objective of this project is to validate the German version of the SF Qualiveen questionnaire. The secondary objective is to evaluate the measurement properties of the German SF Qualiveen questionnaire in comparison with the full version.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'individuals with chronic (≥ 12 months) neurogenic lower urinary tract dysfunction due to SCI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic (≥ 12 months) neurogenic lower urinary tract dysfunction due to SCI\n* age ≥ 18 years\n\nExclusion Criteria:\n\n* no informed consent as documented by signature\n* history of concomitant neurological or psychological illness\n* history of cognitive impairment\n* insufficient German language skills'}, 'identificationModule': {'nctId': 'NCT03898258', 'briefTitle': 'Evaluation of the German Short-Form Qualiveen Questionnaire', 'organization': {'class': 'NETWORK', 'fullName': 'Swiss Paraplegic Research, Nottwil'}, 'officialTitle': 'Evaluation of the German Short-Form Qualiveen Questionnaire', 'orgStudyIdInfo': {'id': '2019-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'neurogenic bladder', 'description': 'individuals with chronic (≥12 months) neurogenic lower urinary tract dysfunction due to spinal cord injury (SCI)', 'interventionNames': ['Other: Qualiveen full version', 'Other: Qualiveen short-form']}], 'interventions': [{'name': 'Qualiveen full version', 'type': 'OTHER', 'description': 'Qualiveen full version questionnaire with 40 questions for assessing the quality of life in relation to bladder dysfunction in persons with neurogenic bladder', 'armGroupLabels': ['neurogenic bladder']}, {'name': 'Qualiveen short-form', 'type': 'OTHER', 'description': 'Qualiveen short-form questionnaire with 8 questions for assessing the quality of life in relation to bladder dysfunction in persons with neurogenic bladder', 'armGroupLabels': ['neurogenic bladder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6207', 'city': 'Nottwil', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Swiss Paraplegic Centre', 'geoPoint': {'lat': 47.13469, 'lon': 8.13774}}], 'overallOfficials': [{'name': 'Jürgen Pannek, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schweizer Paraplegiker-Zentrum Nottwil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Paraplegic Research, Nottwil', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}