Urinary Incontinence (UI)OUPSNCT07427693
Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With UI
A study testing Physiotherapy through mobile app and connected device in people with Urinary Incontinence (UI) and Urinary Stress Incontinence, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 1 site in Canada.
Trial summary
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: 1. assess usability and participant feedback on the Oups! app, identifying improvements; 2. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Urinary Incontinence (UI), Urinary Stress Incontinence, Telehealth
- What is being tested?
- Physiotherapy through mobile app and connected device
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jan 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- 55 years +
- Stress or mixed UI symptoms with predominantly stress UI symptoms
- At least 3 or more urinary leaks/week
- Able to ambulate safely
- Understand simple instruction in French, written and verbally
Show all 10Show fewer
- Basic understanding of how to use a tablet or mobile phone
- Willing to participate in a gynecological exam
- Able to properly contract the PFM
- Provide informed consent.
Who cannot join
- Urge UI symptoms or mixed incontinence with primarily urgency
- Neurological condition
- Grade 3 or 4 of pelvic organ prolapse (POP)
- Any other acute or chronic condition likely to interfere with the mobile app and/or connected object
- Risk factors likely to interfere with the mobile app and/or connected object (i.e.: chronic constipation, chronic cough)
- Medications that can interfere with the mobile app and/or connected object
- Received UI treatments in the last year.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Women's Health and Aging Laboratory - CRIUGM
Montreal, Quebec, H3W 1W4
About this study
Official title: Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With Urinary Incontinence: a Mixed Method Study
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:
- assess usability and participant feedback on the Oups! app, identifying improvements;
- evaluate the usability and acceptability of the dynamometer during assessment and home practice, noting potential enhancements; and
- measure the effects of the app and device on UI symptoms, quality of life, and PFM function post-treatment.
Read the detailed description
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.
- Being tested
- Physiotherapy through mobile app and connected device
- Keywords
- female, aging, physiotherapy, pelvic floor, rehabilitation, mobile app, connected device
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy through mobile app and connected deviceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy through mobile app and connected device | Experimental | PFMT using the Oups! mobile app + a connected vaginal device for 12 weeks Receives: Behavioral: Physiotherapy through mobile app and connected device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in the number of UI episodes
evaluated with a 7-day bladder diary
Measured: at recruitment and 13 weeks after recruitment
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: at recruitment and 13 weeks after recruitment
Change in PFM Function: Montreal Dynamometer
PFM function will be measured using the original Montreal Dynamometer.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 13 weeks after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start13 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence (UI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chantal Dumoulin, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Investigators
- Chantale Dumoulin, Ph.D., Principal investigator, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427693
- Sponsor's protocol ID
- CER VN 24-25-36
- Other IDs
- CIHR_191336
- Acronym
- OUPS
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With Urinary Incontinence: a Mixed Method Study
- ClinicalTrials.gov ID
- NCT07427693
- Acronym / sponsor ID
- OUPS / CER VN 24-25-36
- Keywords
- female, aging, physiotherapy, pelvic floor, rehabilitation, mobile app, connected device
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- assess usability and participant feedback on the Oups! app, identifying improvements;
- evaluate the usability and acceptability of the dynamometer during assessment and home practice, noting potential enhancements; and
- measure the effects of the app and device on UI symptoms, quality of life, and PFM function post-treatment.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy through mobile app and connected device | Experimental | Behavioral: Physiotherapy through mobile app and connected devicePFMT using the Oups! mobile app + a connected vaginal device for 12 weeks |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women
- 55 years +
- Stress or mixed UI symptoms with predominantly stress UI symptoms
- At least 3 or more urinary leaks/week
- Able to ambulate safely
Key exclusion criteria (7 listed)
- Urge UI symptoms or mixed incontinence with primarily urgency
- Neurological condition
- Grade 3 or 4 of pelvic organ prolapse (POP)
- Any other acute or chronic condition likely to interfere with the mobile app and/or connected object
- Risk factors likely to interfere with the mobile app and/or connected object (i.e.: chronic constipation, chronic cough)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy through mobile app and connected deviceMultimodal 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. | Behavioural | Physiotherapy through mobile app and connected device |
Primary outcome
Percent change in the number of UI episodes
Time frame: at recruitment and 13 weeks after recruitment
evaluated with a 7-day bladder diary
12 secondary outcomes
Change in the symptoms and the degree to which UI-associated symptoms are troubling or bothersome
Time frame: at recruitment and 13 weeks after recruitment
Change in UI related QOL
Time frame: at recruitment and 13 weeks after recruitment
Change in PFM function: PERFECT Score
Time frame: at recruitment and 13 weeks after recruitment
Change in PFM Function: Montreal Dynamometer
Time frame: at recruitment and 13 weeks after recruitment
Change in Pelvic Floor Muscle Function: Connected Device
Time frame: at recruitment and 13 weeks after recruitment
Severity of a pelvic organ prolapse: Baden-Walker System
Time frame: at recruitment and 13 weeks after recruitment
Severity of a pelvic organ prolapse: Simplified Pelvic Organ Prolapse Quantification
Time frame: at recruitment and 13 weeks after recruitment
Adherence to intervention: Frequency of exercise days
Time frame: during the 12-week intervention
Participant engagement: Educational and motivational video completion rate
Time frame: during the 12-week intervention
Training intensity: average force produced during exercises
Time frame: during the 12-week intervention
Acceptability of the Mobile App and Connected Device: uMARS Score
Time frame: 13 weeks after recruitment
Participant Experience and Acceptability: Qualitative Interviews
Time frame: 13 weeks after recruitment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantale Dumoulin, Ph.D. principal investigator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy through mobile app and connected device in people with Urinary Incontinence (UI) and Urinary Stress Incontinence, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in the number of UI episodes (time frame: at recruitment and 13 weeks after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.