Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-25 @ 11:06 PM
Study NCT ID:
NCT05437666
Status:
UNKNOWN
Last Update Posted:
2022-06-29
First Post:
2022-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Pelvic Floor Health Education Program in Women With Stress Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'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': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-27', 'studyFirstSubmitDate': '2022-06-27', 'studyFirstSubmitQcDate': '2022-06-27', 'lastUpdatePostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of urinary incontinence symptoms', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'International Consultation on Incontinence Questionnaire-Short Form will be used to evaluate the urinary incontinence symptoms. The scale has 6 questions and 4 dimensions (frequency, severity, type of urinary incontinence, and its effect on daily life). The score to be obtained from the scale varies between "0" and "21". As the score increases, the urinary incontinence symptoms also increases.'}], 'secondaryOutcomes': [{'measure': 'Pelvic floor health knowledge level', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'Pelvic Floor Health Knowledge Quiz will be used to evaluate the knowledge level of patients about general pelvic floor health. It consists of 3 subscales (function/dysfunction, risk/etiology subscale and diagnosing/treatment) and total 29 questions.\n\nTotal score is calculated by summing the number of correct responses, which range between 0 and 29, where a higher score indicates a higher level of knowledge about the pelvic floor health'}, {'measure': 'Urinary incontinence konwledge level', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'The Prolapse Incontinence Knowledge Quiz-urinary incontinence subscale will be used to evaluate the knowledge level of the urinary incontinence. It consists of 12 items. Total score is calculated by summing the number of correct responses, which range between 0 and 12, where a higher score indicates a higher level of knowledge about urinary incontinence.'}, {'measure': 'Life quality', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'King Health Questionnaire will be used to evaluate the life quality. The questionnaire, consisting of thirty-two items, consists of 2 parts. In the first part, there are 2 questions questioning the general health perception and incontinence effect, and 19 questions dividing the quality of life into 7 areas (role limitations, physical limitations, social limitations, personal relationships, emotional problems, sleep/energy disorders, symptom severity measurement). In the second part, there are 11-item complaint severity scales that evaluate the presence and severity of urinary symptoms. While the best score that can be obtained on the complaint severity scale is "0", the worst score is "30", the best score that can be obtained for all King Health Questionnaire subsections is "0" and the worst score is "100".'}, {'measure': 'Compliance with the program', 'timeFrame': 'after program (6th week)', 'description': 'Compliance with the program will be evaluated using a 10-cm visual analog scale. 0 point indicates "did not comply with the program" and 10 point indicates " complied with the program".'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of pelvic floor health education program on urinary incontinence symptoms, knowledge level and quality of life in women with stress urinary incontinence.', 'detailedDescription': "Stress urinary incontinence (SUI) is the involuntary urinary incontinence that develops in parallel with the increase in intra-abdominal pressure and is seen in the absence of detrusor contraction. Studies have shown that SUI, leading to a decrease in the quality of life and worsening of social and health conditions, is more common in women than men.\n\nKnowledge of pelvic floor health or urinary incontinence is generally low. Low level of knowledge or wrong information limits patients' access to treatment. Pelvic floor muscle exercise and lifestyle recommendations are also the first treatment options for SUI.\n\nThe information and awareness related to the pelvic floor and SUI can be increase and unhealthy behavioral strategies can be modifiable through education programs. Therefore the education programs related to the pelvic floor health would have positive effects on urinary incontinence symptoms, knowledge level and quality of life. Studies about this issue are needed."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women with stress urinary incontinence', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 18-65\n* Women with stress urinary incontinence\n* Those who volunteered to participate in the study\n* Being literate\n\nExclusion Criteria:\n\n* Having advanced pelvic organ prolapse\n* Having a malignancy\n* Having a urinary tract infection\n* Those who have a problem that interferes with cooperation and understanding'}, 'identificationModule': {'nctId': 'NCT05437666', 'briefTitle': 'Effects of Pelvic Floor Health Education Program in Women With Stress Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'Effects of Pelvic Floor Health Education Program in Women With Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': '2022/06/27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education group', 'description': 'The education program was given both an educational presentation and a booklet related to the pelvic floor health', 'interventionNames': ['Other: Education and booklet']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'The control group will be given a booklet related to the pelvic floor health', 'interventionNames': ['Other: Booklet']}], 'interventions': [{'name': 'Education and booklet', 'type': 'OTHER', 'description': 'The education program was given both an educational presentation accompanied by a physiotherapist once a week for six weeks and a booklet related to the pelvic floor health (pelvic floor, urinary incontinence, risk factors, treatment options, healthy behavioral strategies etc.)', 'armGroupLabels': ['Education group']}, {'name': 'Booklet', 'type': 'OTHER', 'description': 'The control group will be given a booklet related to the pelvic floor health (pelvic floor, urinary incontinence, risk factors, treatment options, healthy behavioral strategies etc.)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Seyda Toprak Celenay', 'role': 'CONTACT', 'email': 'sydtoprak@hotmail.com', 'phone': '+90312 906 1000'}], 'overallOfficials': [{'name': 'Seyda Toprak Celenay', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Yildirim Beyazıt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'seyda toprak celenay', 'investigatorAffiliation': 'Ankara Yildirim Beyazıt University'}}}}