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 digital therapeutic device compared to standard care of PFM exercises to treat SUI/SMUI.
This is a fully-virtual, prospective, randomized controlled study. Participants are recruited and sign an electronic informed consent (eIC) using our app to complete enrollment. Instruction material is provided through the ObvioHealth app for the Kegel group; those in the treatment arm will perform PFMT with the device's assistance.
Patients answer validated questionnaires through our easy-to-use smartphone app to assess changes in health outcomes, exercise adherence, patient perception and AEs/SAEs will be monitored regularly using our live platform dashboards.
There are no required office visits in this study. Upon randomization, subjects receive three scheduled phone calls from the research staff for education on PFMT exercises. For the remainder of the study, patients receive additional phone calls regarding the treatment plan and safety monitoring.
The study is ongoing so there are no results regarding efficacy of the device at this time.
Recruitment was completed with 350 participants enrolling in the trial in just five months.
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