An interventional study of Physiotherapy through mobile app and connected device in Urinary Incontinence (UI), Urinary Stress Incontinence and Telehealth, sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal. Active, not recruiting at 1 site in Canada. Open to female participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal · Not applicable, Interventional, and Treatment
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:
CONTEXT:
Urinary 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.
To 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.
This 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.
METHODOLOGY:
A 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.
Confirming 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.
For 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.
Participants 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.
ANTICIPATED RESULTS / SPIN-OFFS:
The 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.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's planned enrollment of 36 is below the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Compared within Urinary Incontinence, Stress, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Incontinence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PFMT using the Oups! mobile app + a connected vaginal device for 12 weeks
Behavioral: Physiotherapy through mobile app and connected device
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.
Percent change in the number of UI episodes
evaluated with a 7-day bladder diary
Time frame: at recruitment and 13 weeks after recruitment
Change in the symptoms and the degree to which UI-associated symptoms are troubling or bothersome
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.
Time frame: at recruitment and 13 weeks after recruitment
Change in UI related QOL
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.
Time frame: at recruitment and 13 weeks after recruitment
Change in PFM function: PERFECT Score
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.
Time frame: at recruitment and 13 weeks after recruitment
Change in PFM Function: Montreal Dynamometer
PFM function will be measured using the original Montreal Dynamometer.
Time frame: at recruitment and 13 weeks after recruitment
Change in Pelvic Floor Muscle Function: Connected Device
PFM function will be assessed using a connected biofeedback device.
Time frame: at recruitment and 13 weeks after recruitment
Severity of a pelvic organ prolapse: Baden-Walker System
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).
Time frame: at recruitment and 13 weeks after recruitment
Severity of a pelvic organ prolapse: Simplified Pelvic Organ Prolapse Quantification
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).
Time frame: at recruitment and 13 weeks after recruitment
Adherence to intervention: Frequency of exercise days
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
Time frame: during the 12-week intervention
Participant engagement: Educational and motivational video completion rate
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.
Time frame: during the 12-week intervention
Training intensity: average force produced during exercises
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
Time frame: during the 12-week intervention
Acceptability of the Mobile App and Connected Device: uMARS Score
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.
Time frame: 13 weeks after recruitment
Participant Experience and Acceptability: Qualitative Interviews
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.
Time frame: 13 weeks after recruitment
Validation of the FC uMARS
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
Time frame: 13 weeks after recruitment
Usability of the connected device
evaluated with a numerical rating scale from 0 to 10, for comfort, and a few questions to assess their perceived usability.
Time frame: at recruitment and 13 weeks after recruitment
Validation of the connected object
evaluated by comparing the dynamometry data taken with the Montreal Dynamometer to this new connected object
Time frame: at recruitment and 13 weeks after recruitment
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.
Of 225 non-industry interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 23 months is above that.
Counting every sponsor, half of 266 studies reached it within 19 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal