Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:19 AM
Study NCT ID:
NCT07427693
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With UI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Validation of the FC uMARS', 'timeFrame': '13 weeks after recruitment', 'description': 'The French-Canadian version of the uMARS (FC uMARS) will be validated using a qualitative homemade questionnaire. Participants will assess the clarity and cultural relevance of each item using a three-point scale (Yes, No, or Partially) and provide open-ended comments for improvements. This process aims to ensure the linguistic appropriateness of the scale for the French-Canadian population. As the primary goal is to identify items requiring modification, results will be reported as a qualitative summary of participant feedback and a description of the final adjustments made to the instrument'}, {'measure': 'Usability of the connected device', 'timeFrame': 'at recruitment and 13 weeks after recruitment', 'description': 'evaluated with a numerical rating scale from 0 to 10, for comfort, and a few questions to assess their perceived usability.'}, {'measure': 'Validation of the connected object', 'timeFrame': 'at recruitment and 13 weeks after recruitment', 'description': 'evaluated by comparing the dynamometry data taken with the Montreal Dynamometer to this new connected object'}], 'primaryOutcomes': [{'measure': 'Percent change in the number of UI episodes', 'timeFrame': 'at recruitment and 13 weeks after recruitment', 'description': 'evaluated with a 7-day bladder diary'}], 'secondaryOutcomes': [{'measure': 'Change in the symptoms and the degree to which UI-associated symptoms are troubling or bothersome', 'timeFrame': 'at recruitment and 13 weeks after recruitment', 'description': 'evaluated with the International Consultation on Incontinence questionnaire on urinary incontinence (ICIQ-UI short form). Scores range from 0 to 20; higher scores reflect increased severity and symptom burden.'}, {'measure': 'Change in UI related QOL', 'timeFrame': 'at recruitment and 13 weeks after recruitment', 'description': 'evaluated with the International Consultation on Incontinence Questionnaire module on quality of life (ICIQ-LUTSqol). Scores range from 19 to 76; higher scores reflect a more significant burden on health-related quality of life.'}, {'measure': 'Change in PFM function: PERFECT Score', 'timeFrame': 'at recruitment and 13 weeks after recruitment', 'description': 'Pelvic floor muscle (PFM) function will be evaluated using the PERFECT scheme via digital vaginal palpation. The score is a composite of Power (Modified Oxford Scale), Endurance, Repetitions, and Fast contractions. For the Power component, the Modified Oxford Scale is used. The minimum score is 0 and the maximum score is 5, where a higher score indicates better muscle strength.'}, {'measure': 'Change in PFM Function: Montreal Dynamometer', 'timeFrame': 'at recruitment and 13 weeks after recruitment', 'description': 'PFM function will be measured using the original Montreal Dynamometer.'}, {'measure': 'Change in Pelvic Floor Muscle Function: Connected Device', 'timeFrame': 'at recruitment and 13 weeks after recruitment', 'description': 'PFM function will be assessed using a connected biofeedback device.'}, {'measure': 'Severity of a pelvic organ prolapse: Baden-Walker System', 'timeFrame': 'at recruitment and 13 weeks after recruitment', 'description': 'Pelvic organ prolapse (POP) severity will be evaluated using the Baden-Walker Halfway Scoring System during a physical examination. This system assesses the degree of descent of pelvic organs. The scale ranges from a minimum score of 0 (no prolapse) to a maximum score of 4 (full eversion/procidentia), with a higher score indicating a more severe condition (worse outcome).'}, {'measure': 'Severity of a pelvic organ prolapse: Simplified Pelvic Organ Prolapse Quantification', 'timeFrame': 'at recruitment and 13 weeks after recruitment', 'description': 'Pelvic organ prolapse (POP) severity will be assessed using the Simplified Pelvic Organ Prolapse Quantification (S-POP-Q) system. This clinical tool classifies the descent of the leading edge of the prolapsed organ. The scale ranges from Stage 0 (no prolapse) to Stage IV (complete vault eversion or procidentia), where a higher stage indicates a more severe condition (worse outcome).'}, {'measure': 'Adherence to intervention: Frequency of exercise days', 'timeFrame': 'during the 12-week intervention', 'description': 'Adherence will be evaluated using log data automatically recorded by the mobile application. This measure represents the total number of days the participant performed the prescribed pelvic floor muscle exercise sessions over the 12-week intervention period. Participants are instructed to exercise 5 days per week, resulting in a maximum possible adherence of 60 days (5 days x 12 weeks). The scale ranges from a minimum of 0 days to a maximum of 60 days, where a higher number of days indicates greater adherence to the prescribed rehabilitation program'}, {'measure': 'Participant engagement: Educational and motivational video completion rate', 'timeFrame': 'during the 12-week intervention', 'description': 'Engagement with the educational and motivational component of the intervention will be assessed by tracking the successful viewing of educational and motivational videos via the mobile app. The unit of measure is the percentage (%) of available videos successfully viewed by the participant during the 12-week period. A higher percentage indicates better engagement with the educational and motivational content.'}, {'measure': 'Training intensity: average force produced during exercises', 'timeFrame': 'during the 12-week intervention', 'description': 'The intensity of the daily training sessions will be monitored using the force data recorded by the connected device. This measure calculates the average maximal force produced by the pelvic floor muscles during the prescribed exercise repetitions over the 12-week intervention. The unit of measure is Newtons (N). A higher value indicates a higher intensity of muscle recruitment during the practice and forces produced by the PFM during exercise practice'}, {'measure': 'Acceptability of the Mobile App and Connected Device: uMARS Score', 'timeFrame': '13 weeks after recruitment', 'description': 'assessed using the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a self-reported scale that evaluates app quality across four objective domains: engagement, functionality, aesthetics, and information. The total score is calculated as the average of these subscales. The scale ranges from1 to 5, where a higher score indicates higher perceived quality and acceptability of the mobile application and connected device.'}, {'measure': 'Participant Experience and Acceptability: Qualitative Interviews', 'timeFrame': '13 weeks after recruitment', 'description': "In-depth, individual one-to-one semi-structured interviews will be conducted to explore participants' experiences, barriers, and facilitators regarding the use of the mobile app and connected device. The qualitative data will be analyzed using thematic analysis to identify key themes related to the acceptability and usability of the intervention. As this is a qualitative assessment, there is no numerical scale; results will be reported as a summary of identified themes."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['female', 'aging', 'physiotherapy', 'pelvic floor', 'rehabilitation', 'mobile app', 'connected device'], 'conditions': ['Urinary Incontinence (UI)', 'Urinary Stress Incontinence', 'Telehealth']}, 'descriptionModule': {'briefSummary': 'This project aims to evaluate the usability, acceptability, and impact of the Oups! mobile app and a connected Bluetooth dynamometer for at-home PFM training to treat UI. The study will:\n\n1. assess usability and participant feedback on the Oups! app, identifying improvements;\n2. evaluate the usability and acceptability of the dynamometer during assessment and home practice, noting potential enhancements; and\n3. measure the effects of the app and device on UI symptoms, quality of life, and PFM function post-treatment.', 'detailedDescription': "CONTEXT:\n\nUrinary incontinence (UI), or involuntary urine leakage, is a common issue among women over 55. Clinical guidelines recommend pelvic floor muscle (PFM) therapy as the first-line treatment for UI. However, fewer than one-third of older women seek treatment, often due to cost and accessibility barriers. Mobile applications have proven helpful in managing UI symptoms in younger women, offering a low-cost, private solution that encourages adherence. Although numerous apps exist, none are designed specifically for older women, nor have these women been consulted on app usability or effectiveness.\n\nTo address this, the investigators have developed the Oups! mobile app, based on our GROUP pelvic floor muscle training (PFMT) program for older women with UI. Additionally, the investigators propose using a connected device-a portable Bluetooth-enabled dynamometer-to measure PFM strength and contraction quality, supporting women in performing effective PFMT. Previously, our lab-developed Montreal Dynamometer provided this feedback but was limited to laboratory use.\n\nThis study will examine the usability, acceptability, and impact of combining the Oups! app with the new portable dynamometer for PFM self-training in women aged 55 and over. This innovative approach could potentially improve access to effective UI management and increase treatment uptake in this population.\n\nMETHODOLOGY:\n\nA sample of 36 healthy community-dwelling women, aged 55 and older with ≥3 stress or mixed UI episode/week on a 7-day bladder diary and stress or mixed UI symptoms according to the Questionnaire for Incontinence Diagnosis (QUID) will be recruited through regional advertisement and our website. Women will participate in a mixed method study.\n\nConfirming inclusion in the study will be done by telephone using a demographic questionnaire, the QUID, and a 7-day bladder diary. Eligible participants will complete a 1.5-hour pre-intervention assessment at the CRIUGM. After reviewing and signing the informed consent form, they will answer questionnaires addressing UI symptoms and their impact on quality of life. A trained pelvic floor physiotherapist will conduct a gynecological examination to assess the participant's pelvic floor muscle (PFM) function, ensuring the ability to perform an appropriate muscle contraction. Following this, participants will undergo a dynamometric evaluation using the Montreal Dynamometer and a connected vaginal device to measure PFM strength, tone, and endurance. Measurements will be taken in supine and standing positions. At the end of the assessment, participants will receive a tablet with the app installed, their own connected vaginal device, and a user guide outlining the use of both the app and device.\n\nFor 12 weeks, participants will engage in PFMT using the Oups! mobile app and a connected vaginal device. The program includes educational capsules, pelvic floor exercises, and motivational capsules. Before each session, participants will insert the connected device, which provides feedback on movement accuracy and muscle strength across four exercises. Real-time results are displayed on the tablet for performance quality and quantity. Exercises should be done five days a week, with flexibility to set a weekly schedule. The program gradually increases in difficulty, with final sessions requiring around 30 minutes daily by the third month. Weekly educational (2-5 minutes) and motivational (2 minutes) capsules are provided, and participants will report daily on any urinary leakage. Participants will keep a daily log of technical issues with the app and device. The research team will also make support calls at weeks 1, 5, and 9 to address questions and ensure smooth progression.\n\nParticipants will return to the laboratory for a post-treatment assessment after the 12-week self-training program. This 1.5-hour session includes submitting a 7-day bladder diary and questionnaires assessing UI symptoms (ICIQUI-SF) and quality of life (ICIQ-LUTSqol), as well as a usability questionnaire (FC uMARS) and its validation questionnaire. They will redo the same gynecological exam to assess changes in PFM function using digital palpation and both the original PFM dynamometer and the connected vaginal device. Finally, each participant will participate in a 15-20 minute recorded interview to provide verbal feedback on their experience with the Oups! app and the connected device.\n\nANTICIPATED RESULTS / SPIN-OFFS:\n\nThe findings from this project will help guide further treatment of UI in the context of technology. Ultimately it could help improve accessibility to continence-based treatments for aging women especially for those living in areas where resources to care and specialists in pelvic floor rehabilitation are limited. Moreover, this may also improve outcomes as costs associated with this home exercise approach are minimal compared to in-person treatments typically performed in out-patient care settings."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women\n* 55 years +\n* Stress or mixed UI symptoms with predominantly stress UI symptoms\n* At least 3 or more urinary leaks/week\n* Able to ambulate safely\n* Understand simple instruction in French, written and verbally\n* Basic understanding of how to use a tablet or mobile phone\n* Willing to participate in a gynecological exam\n* Able to properly contract the PFM\n* Provide informed consent.\n\nExclusion Criteria:\n\n* Urge UI symptoms or mixed incontinence with primarily urgency\n* Neurological condition\n* Grade 3 or 4 of pelvic organ prolapse (POP)\n* Any other acute or chronic condition likely to interfere with the mobile app and/or connected object\n* Risk factors likely to interfere with the mobile app and/or connected object (i.e.: chronic constipation, chronic cough)\n* Medications that can interfere with the mobile app and/or connected object\n* Received UI treatments in the last year.'}, 'identificationModule': {'nctId': 'NCT07427693', 'acronym': 'OUPS', 'briefTitle': 'Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With UI', 'organization': {'class': 'OTHER', 'fullName': "Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal"}, 'officialTitle': 'Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With Urinary Incontinence: a Mixed Method Study', 'orgStudyIdInfo': {'id': 'CER VN 24-25-36'}, 'secondaryIdInfos': [{'id': 'CIHR_191336', 'type': 'OTHER_GRANT', 'domain': 'Canadian Institute of Health Research'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physiotherapy through mobile app and connected device', 'description': 'PFMT using the Oups! mobile app + a connected vaginal device for 12 weeks', 'interventionNames': ['Behavioral: Physiotherapy through mobile app and connected device']}], 'interventions': [{'name': 'Physiotherapy through mobile app and connected device', 'type': 'BEHAVIORAL', 'description': 'Multimodal physiotherapy through the Oups! mobile app and connected device including pelvic floor muscle exercises 5x/week, an educational video 1x/week, and a motivational video 1x/week. The connected device allows instant feedback about the quality of their contractions and adjusts the goals for each exercise.', 'armGroupLabels': ['Physiotherapy through mobile app and connected device']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3W 1W4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Women's Health and Aging Laboratory - CRIUGM", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Chantale Dumoulin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Chantal Dumoulin, researcher and laboratory director', 'investigatorFullName': 'Chantal Dumoulin', 'investigatorAffiliation': "Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal"}}}}