Mobile App and Device for Urinary Incontinence
(OUPS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a mobile app and a connected device designed to manage urinary incontinence (UI) by strengthening pelvic floor muscles through physiotherapy. Researchers aim to assess the ease of use of the app and device at home and their effects on UI symptoms and quality of life. The trial seeks women aged 55 and older who experience primarily stress-related urinary leaks at least three times a week, can walk safely, and are comfortable using a smartphone or tablet. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance daily life for many women.
Do I need to stop my current medications for the trial?
The trial excludes participants taking medications that can interfere with the mobile app and device, so you may need to stop certain medications. It's best to discuss your current medications with the trial team to see if they are compatible.
What prior data suggests that this mobile app and device are safe for urinary incontinence treatment?
Research has shown that using a mobile app for pelvic floor muscle training (PFMT) is generally safe. Studies have found that apps and related devices can improve urinary incontinence symptoms without causing major side effects. For instance, one study found a similar digital device more effective than traditional home exercises for stress urinary incontinence, with no serious negative effects reported.
Another study demonstrated that app-based methods improved urgency and incontinence in women. These methods are well-tolerated and have not raised significant safety concerns. Additionally, real-world evidence supports the effectiveness and safety of digital health programs for treating urinary incontinence in women.
Overall, mobile apps and connected devices for PFMT appear safe and may offer an easy way to manage symptoms at home.12345Why are researchers excited about this trial?
Researchers are excited about the physiotherapy treatment using a mobile app and connected device for urinary incontinence because it offers a novel, tech-driven solution that can empower patients. Unlike traditional pelvic floor muscle training (PFMT), which often requires in-person sessions with a physiotherapist, this approach leverages a mobile app and a connected vaginal device, making it more convenient and potentially more engaging for users. This treatment allows individuals to perform exercises at home, providing real-time feedback and personalized guidance, which could enhance adherence and effectiveness. By integrating technology into the treatment process, this approach aims to make managing urinary incontinence more accessible and effective.
What evidence suggests that this app and device are effective for urinary incontinence?
Research shows that mobile apps for pelvic floor muscle exercises can greatly help with urinary incontinence (UI). Studies have found that these exercises, when guided by a mobile app, can significantly improve stress urinary incontinence and enhance overall quality of life. One study found that women with stress urinary incontinence were six times more likely to see improvement or be cured by doing these exercises. Another study confirmed that performing these exercises at home with a mobile app also helps improve UI symptoms. This trial will evaluate the effectiveness of the Oups! app and its connected device as tools for managing urinary incontinence.36789
Who Is on the Research Team?
Chantale Dumoulin, Ph.D.
Principal Investigator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Are You a Good Fit for This Trial?
This trial is for women aged 55 and older who have mainly stress urinary incontinence with at least 3 leaks per week, can use a smartphone or tablet, understand French, are able to walk safely, and can contract their pelvic floor muscles. Women with certain medical conditions or recent UI treatments cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-intervention Assessment
Participants complete a pre-intervention assessment including questionnaires and a gynecological examination
Treatment
Participants engage in a 12-week PFMT program using the Oups! mobile app and a connected vaginal device
Post-treatment Assessment
Participants undergo a post-treatment assessment including questionnaires, a gynecological exam, and a recorded interview
Follow-up
Participants are monitored for changes in UI symptoms and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Physiotherapy through mobile app and connected device
Trial Overview
The study tests the Oups! mobile app and a Bluetooth-connected device that helps guide pelvic floor muscle exercises at home. It looks at how easy these tools are to use, if participants like them, and whether they help reduce urine leakage.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
PFMT using the Oups! mobile app + a connected vaginal device for 12 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Lead Sponsor
Citations
Mobile Application Based Pelvic Floor Muscle Training ... - PMC
Our results confirm data from a scientific study showing that PFMT improves symptoms of stress urinary incontinence [27]. Both groups achieved this goal.
Mobile app for pelvic floor muscle training for urinary ... - PMC
The objective of this study was to evaluate the effects of home-based pelvic floor muscle training in women with urinary incontinence, addressing the ...
Digital Technologies for Women's Pelvic Floor Muscle ...
Mobile app for treatment of stress urinary incontinence: a cost-effectiveness analysis. J Med Internet Res. May 08, 2017;19(5):e154. [FREE ...
Effect of pelvic floor muscle training using mobile health ...
We sought to determine effectiveness of mHealth app-based PFMT for treating stress urinary incontinence (SUI) or stress-predominant mixed ...
Self-management of incontinence using a free mobile app
Furthermore, PFMT is six times as likely to lead to cure or improvement in women with stress urinary incontinence. (SUI), i.e., the most ...
6.
journals.lww.com
journals.lww.com/greenjournal/fulltext/2023/01000/digital_therapeutic_device_for_urinary.22.aspxDigital Therapeutic Device for Urinary Incontinence
The device (leva Pelvic Health System) combines an intravaginal component and associated smartphone application (app) to guide pelvic floor muscle training.
Digital Therapeutic Device for Urinary Incontinence - PMC - NIH
Pelvic floor muscle training using a digital therapeutic device is superior to home pelvic floor muscle training for treatment of stress urinary incontinence.
A randomized, unblinded, controlled clinical study to ...
An app-based intervention developed in Sweden improved urgency and incontinence in females (43). To our knowledge, however, INKA is the first digital solution ...
9.
physioquart.awf.wroc.pl
physioquart.awf.wroc.pl/The-role-of-mobile-applications-in-the-conservative-management-of-stress-urinary,144963,0,2.htmlThe role of mobile applications in the conservative ...
The purpose of this work is a narrative review showing possibilities of using conservative measures of stress urinary incontinence (SUI) in women, with ...
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