We are conducting a clinical study with a medical device company to assess the efficacy of an FDA approved Class II medical device compared to standard exercises to treat stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (SMUI) in women. Pelvic floor muscle training (PFMT), or "Kegel" exercises, is considered the most effective, non-invasive treatment for SUI and SMUI. However, more than 75 percent of women perform PFMT exercises incorrectly, even with verbal or written instructions. Common mistakes include using the wrong muscle groups, improper form, or following the wrong routine — these challenges highlight an unmet need for real-time feedback during PFMT. Researchers will leverage smartphone device integration to observe the effectiveness of the product in the real-world.
Evaluate the efficacy of a Class II digital therapeutic device compared to standard care of PFMT exercises to treat SUI/SMUI.
The first fully virtual study to be run in the urogynocology space, this prospective, randomized controlled study recruited participants via digital media targeting and signed them via electronic informed consent (eIC), using the ObvioHealth app to complete enrollment. Instruction material (video plus explanatory placard) was provided for the Kegel group; those in the treatment arm performed PFMT with the device's assistance.
Patients answered validated questionnaires via the app to assess changes in health outcomes. Exercise adherence, patient perceptions, and AEs/SAEs were monitored regularly via the app and visualized on live platform dashboards by our COACH (Clinical Operations And Coordination Hub) team.
There were no required office visits in this study. Upon randomization, subjects received three scheduled phone calls from the COACH team for education on PFMT exercises. For the remainder of the study, patients received additional phone calls regarding the treatment plan and safety monitoring.
Recruitment was completed with 350 participants enrolling in the trial in just 3.5 months. Regular interactions with our COACH team engaged and encouraged patients throughout the study, resulting in an 89% retention rate and a 95% ePRO compliance rate. The study delivered statistically significant results for the device versus control Kegel groups for both primary outcomes. We would not have had this outcome without it being a virtual study. In contrast, I was running an FI study and drop-off was dramatic. We probably completed 60%.
- Robin Sutherland, VP of Clinical Operations
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