Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-02 @ 1:33 AM
Study NCT ID:
NCT07105150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-05
First Post:
2025-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Video-Based Educational Program on Female Urinary Incontinence
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-07-12', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary incontinence score comparison between the 2 groups', 'timeFrame': 'At the end of the video-based education program (5 weeks after inclusion)', 'description': "the urinary incontinence score will measured using the ICIQ-SF (International Consultation on Incontinence Questionnaire-Short Form), ranging from 0 (corresponding to 'no urinary incontinence') to 21 (corresponding to 'very severe urinary incontinence'), collected after the video-based education program in the intervention group (scheduled over 4 weeks) and within the same timeframe in the control group (which received only the information document)"}], 'secondaryOutcomes': [{'measure': 'Urinary incontinence score evolution in the intervention group', 'timeFrame': 'from inclusion until the end of the video education program (5 weeks after inclusion)', 'description': "Change in urinary incontinence score (International Consultation on Incontinence Questionnaire- Short Form, ICIQ-SF, ranging from 0 = 'no incontinence' to 21 = 'very severe incontinence') between inclusion and the end of the video education program in the intervention group (scheduled over 4 weeks)"}, {'measure': 'Urinary incontinence score evolution in the control group', 'timeFrame': 'from inclusion to 5 weeks following the distribution of the paper information document', 'description': "Change in urinary incontinence score (International Consultation on Incontinence Questionnaire- Short Form, ICIQ-SF, ranging from 0 = 'no incontinence' to 21 = 'very severe incontinence') between inclusion and 5 weeks following the distribution of the paper information document"}, {'measure': 'Number of pelvic floor rehabilitation sessions required in the intervention group', 'timeFrame': 'ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months', 'description': 'The number of rehabilitation sessions needed to achieve a reduction of 3 points or more in the urinary incontinence score (ICIQ-SF) - a difference considered clinically significant - or a reduction of less than 3 points, provided that the decrease is deemed sufficient or satisfactory by the physiotherapist'}, {'measure': 'Number of pelvic floor rehabilitation sessions required in the control group', 'timeFrame': 'ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months', 'description': 'The number of rehabilitation sessions needed to achieve a reduction of 3 points or more in the urinary incontinence score (ICIQ-SF) - a difference considered clinically significant - or a reduction of less than 3 points, provided that the decrease is deemed sufficient or satisfactory by the physiotherapist'}, {'measure': 'Urinary incontinence score evolution during the pelvic floor rehabilitation sessions in the intervention group', 'timeFrame': 'ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months', 'description': 'The variation in the urinary incontinence score (ICIQ-SF) from first pelvic floor rehabilitation session to the 10th session and up to the last session'}, {'measure': 'Urinary incontinence score evolution during the pelvic floor rehabilitation sessions in the control group', 'timeFrame': 'ICIQ-SF score recorded after each pelvic floor rehabilitation sessions, through end of rehabilitation, an average of 3 months', 'description': 'The variation in the urinary incontinence score (ICIQ-SF) from first pelvic floor rehabilitation session to the 10th session and up to the last session'}, {'measure': 'Quality of life score evolution in the intervention group', 'timeFrame': 'at inclusion and after the video-based education program (5 weeks after inclusion) , as well as between inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months', 'description': 'The difference in the quality of life score associated with urinary symptoms (specific CONTILIFE questionnaire) and general quality of life (EuroQoL-5D questionnaire) at inclusion and after the video-based education program , as well as between inclusion and at the end of the pelvic floor rehabilitation sessions'}, {'measure': 'Quality of life score evolution in the control group', 'timeFrame': 'at inclusion and 5 weeks after the distribution of the paper document information, as well as between inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months', 'description': 'The difference in the quality of life score associated with urinary symptoms (specific CONTILIFE questionnaire) and general quality of life (EuroQoL-5D questionnaire) at inclusion and 5 weeks after the distribution of the paper document information, as well as between inclusion and at the end of the pelvic floor rehabilitation sessions'}, {'measure': 'Pelvic floor and sexual symptoms scores evolution in the intervention group', 'timeFrame': 'between inclusion and the end of the video-based education program (5 weeks after inclusion), as well as between inclusion and the end of the pelvic floor rehabilitation sessions, an average of 3 months', 'description': 'The difference in the score for pelvic floor and sexual symptoms that may be associated with urinary incontinence (FPFQ - Female Pelvic Floor Questionnaire) between inclusion and the end of the video-based education program, as well as between inclusion and the end of the pelvic floor rehabilitation sessions'}, {'measure': 'Pelvic floor and sexual symptoms scores evolution in the control group', 'timeFrame': 'at inclusion and 5 weeks after the distribution of the paper information document, as well as between inclusion and the end of the pelvic floor rehabilitation sessions, an average of 3 months', 'description': 'The difference in the score for pelvic floor and sexual symptoms that may be associated with urinary incontinence (FPFQ - Female Pelvic Floor Questionnaire) between inclusion and 4 weeks after the distribution of the paper information document, as well as between inclusion and the end of the pelvic floor rehabilitation sessions'}, {'measure': 'Patient-perceived improvement score evolution in the intervention group', 'timeFrame': 'after the video-based education program (5 weeks after inclusion)and at the end of the pelvic floor rehabilitation sessions, an average of 3 months', 'description': 'Patient-perceived improvement score evaluated by the PGII (Patient Global Impression of Improvement) questionnaire after the video-based education program and at the end of the pelvic floor rehabilitation sessions'}, {'measure': 'Patient-perceived improvement score evolution in the control group', 'timeFrame': '5 weeks after inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months', 'description': 'Patient-perceived improvement score evaluated by the PGII (Patient Global Impression of Improvement) questionnaire 5 weeks after the distribution of the paper information document and at the end of the pelvic floor rehabilitation sessions'}, {'measure': 'Patient-perceived improvement score evolution according to the urinary incontinence type in the intervention group', 'timeFrame': 'after the video-based education program (5 weeks after inclusion) and at the end of the pelvic floor rehabilitation sessions, an average of 3 months)', 'description': 'Patient-perceived improvement score evaluated by the PGII (Patient Global Impression of Improvement) questionnaire after the video-based education program and at the end of the pelvic floor rehabilitation sessions, according to the urinary incontinence type (Stress urinary incontinence, Urge urinary incontinence and mixed incontinence)'}, {'measure': 'Patient-perceived improvement score evolution according to the type of urinary incontinence', 'timeFrame': '5 weeks after inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months', 'description': 'Patient-perceived improvement score evaluated by the PGII (Patient Global Impression of Improvement) questionnaire 5 weeks after the distribution of the paper information document and at the end of the pelvic floor rehabilitation sessions, according to the urinary incontinence type (Stress urinary incontinence, Urge urinary incontinence and mixed incontinence)'}, {'measure': 'Patient-perceived improvement score evolution according to the dimensions of the Urinary Leakage Circumstances questionnaire in the intervention group', 'timeFrame': 'after the video-based education program (5 weeks after inclusion) and at the end of the pelvic floor rehabilitation sessions, an average of 3 months', 'description': 'Patient-perceived improvement score evaluated by the PGII (Patient Global Impression of Improvement) questionnaire after the video-based education program and at the end of the pelvic floor rehabilitation sessions, according to the dimensions of the Urinary Leakage Circumstances questionnaire (ULCQ)'}, {'measure': 'Patient-perceived improvement score evolution according to the dimensions of the Urinary Leakage Circumstances questionnaire in the control group', 'timeFrame': '5 weeks after inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months', 'description': 'Patient-perceived improvement score evaluated by the PGII (Patient Global Impression of Improvement) questionnaire 5 weeks after the disctribution of the paper information document and at the end of the pelvic floor rehabilitation sessions, according to the dimensions of the Urinary Leakage Circumstances questionnaire (ULCQ)'}, {'measure': 'ICIQ-SF score evolution 12 and 24 month after the end of the pelvic floor rehabilitation sessions in the intervention group', 'timeFrame': 'at the end of the pelvic floor rehablitation sessions and after 12 and 24 months', 'description': 'Difference between the ICIQ-SF score at the end of the pelvic floor rehablitation sessions and the ICIQ-SF score at 12 months and at 24 months in the intervention group'}, {'measure': 'ICIQ-SF score evolution at 12 and 24 months after the end of the pelvic floor rehabilitation sessions', 'timeFrame': 'at the end of the pelvic floor rehablitation sessions and after 12 and 24 months', 'description': 'Difference between the ICIQ-SF score at the end of the pelvic floor rehablitation sessions and the ICIQ-SF score at 12 months and at 24 months in the control group'}, {'measure': 'Urinary incontinence management 12 and 24 months after the end of the pelvic floor rehabilitation sessions in the intervention group', 'timeFrame': 'at 12 and 24 months', 'description': 'New management of urinary incontinence, defined by new pelvic floor rehabilitation sessions, urinary incontinence or prolapse surgery, initiation of anticholinergic treatment, or any other therapy for urinary urinary at 12 and 24 months'}, {'measure': 'Urinary incontinence management 12 and 24 months after the end of the pelvic floor rehabilitation sessions in the control group', 'timeFrame': 'at 12 and 24 months', 'description': 'New management of urinary incontinence, defined by new pelvic floor rehabilitation sessions, urinary incontinence or prolapse surgery, initiation of anticholinergic treatment, or any other therapy for urinary urinary at 12 and 24 months'}, {'measure': 'Impact of the videos on Knowledge and Satisfaction Ratings', 'timeFrame': 'after each video of the program, once a week for 4 weeks', 'description': 'Difference in correct answers on questionnaires before and after each video, and satisfaction rating (0 to 10) after each video of the program'}, {'measure': 'Usage of the videos provided in the intervention group', 'timeFrame': 'at the end of the video-based education program, 5 weeks after inclusion', 'description': 'number of views for each video, time of day, total time spent on viewings (automatically collected via the connection platform)'}, {'measure': 'Physical activity evolution after pelvic floor rehabilitation in the entire population and afetr 12 and 24 months', 'timeFrame': 'from inclusion to the end of the pelvic floor rehabilitation sessions (an average of 3 months), and after 12 and 24 months after the end of rehabilitation', 'description': 'Compare the evolution of physical activity practice (intensity) from inclusion to the end of the pelvic floor rehabilitation sessions and after 12 and 24 months'}, {'measure': 'Urinary incontinence score between the 2 groups according the UI type', 'timeFrame': 'at the end of the video-based education program versus the paper information document, 5 weeks after inclusion', 'description': 'ICIQ-SF score at the end of the video-based education program vs the paper information document according to the UI type'}, {'measure': 'Urinary incontinence score according to the dimensions of the Urinary Leakage Questionnaire', 'timeFrame': 'after the video-based education program, 5 weeks after inclusion', 'description': 'to compare the ICIQ-SF score in each of the dimensions of the urinary leakage circumstances questionnaire after the video-based education program versus the paper information document'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urinary incontinence', 'pelvic floor rehabilitation', 'video-based program', 'education'], 'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to assess the effectiveness of a 4-week video-based education program in enhancing urinary continence among women with urinary incontinence referred for pelvic floor rehabilitation\n\nThe main question it aims to answer is :\n\n• Does a structured video-based education program reduce the symptoms of urinary incontinence before any pelvic floor muscle strengthening ? Researchers will compare this program to a paper document (providing similar information) to see if this improves urinary continence in women suffering from urinary incontinence.\n\nParticipants will :\n\n* receive either the video-based education program or a paper information document (providing similar information) prior to the sessions with the physiotherapist\n* then follow pelvic floor rehabilitation sessions with the physiotherapist according to usual practice\n* complete the urinary incontinence questionnaire after the 4-week video education program (intervention group) or 4 weeks after receiving the paper document (control group), and after each pelvic floor rehabilitation session with the physiotherapist and at the end of the sessions\n* will be monitored at 1 and 2 years to evaluate urinary incontinence following the intervention.', 'detailedDescription': 'The video-based education program will include 4 workshops of 20 minutes each, at a rate of 1 video per week:\n\nVideo 1: Anatomy and physiology of the pelvic floor; Video 2: Physiology of the urinary tract; Video 3: Physiology of the digestive tract; Video 4: Pathophysiology of urinary incontinence and other pelvic floor disorders (genital prolapse and anal incontinence) and preventive measures in daily activities.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any woman referred for pelvic floor rehabilitation sessions for urinary incontinence (defined as 'any involuntary leakage reported by the patient' according to the International Continence Society)\n* Women requiring perineal rehabilitation for urinary incontinence\n* Aged 18 years or older\n* Having access to a connected device (tablet, smartphone, computer)\n* Having a functional email address\n* Covered by a social security scheme\n* Informed, and written consent (signed by the participant and the investigator)\n\nExclusion Criteria:\n\n* Women unable to complete questionnaires (unable to read French or unable to write)\n* Visually impaired individuals who cannot watch the video or read the printed material\n* Genital prolapse extending beyond the hymen\n* Documented neurological disorders\n* Individuals receiving psychiatric care and those unable to express their consent\n* History of pelvic fractures or dorsolumbar surgery\n* Chronic pelvic pain\n* Women who have given birth within the last 6 month\n* Individuals with enhanced protection: minors, individuals deprived of liberty, individuals residing in a health or social institution, pregnant or breastfeeding women, adults under legal protection, and patients in emergency situations."}, 'identificationModule': {'nctId': 'NCT07105150', 'acronym': 'EVRP', 'briefTitle': 'Efficacy of a Video-Based Educational Program on Female Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Efficacy of an Educational Video-Based Program to Treat Urinary Incontinence in Women Referred for Pelvic Floor Rehabilitation', 'orgStudyIdInfo': {'id': '2025-A00419-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'video-based education program group', 'interventionNames': ['Behavioral: video-based education program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'written information group', 'interventionNames': ['Other: written information']}], 'interventions': [{'name': 'video-based education program', 'type': 'BEHAVIORAL', 'description': 'The video-based education program will include 4 workshops of 20 minutes each, at a rate of 1 video per week:\n\nVideo 1: Anatomy and physiology of the pelvic floor; Video 2: Physiology of the urinary tract; Video 3: Physiology of the digestive tract; Video 4: Pathophysiology of urinary incontinence and other pelvic floor disorders (genital prolapse and anal incontinence) and preventive measures in daily activities.', 'armGroupLabels': ['video-based education program group']}, {'name': 'written information', 'type': 'OTHER', 'description': 'The control group will receive a paper information document (containing the same information as the intervention group) during the 4-week period', 'armGroupLabels': ['written information group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Veronique Blanchard', 'role': 'CONTACT', 'email': 'verobmsb@hotmail.com', 'phone': '+33614222885'}, {'name': 'Anne Cecile Pizzoferrato, M.D', 'role': 'CONTACT', 'email': 'anne-cecile.pizzoferrato@chu-poitiers.fr', 'phone': '+33682176675'}], 'overallOfficials': [{'name': 'Anne Cecile Pizzoferrato, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Center of Poitiers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}