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Digital Care Program for Urinary Incontinence in Females: A Large-Scale, Prospective, Cohort Study
Dora Janela1, Anabela C Areias1, Maria Molinos1
1Clinical Research, Sword Health Inc., Draper, UT 84020, USA.
Female urinary incontinence (UI) is highly prevalent in the US (>60%). Pelvic floor muscle training (PFMT) represents first-line care for UI; however, access and adherence challenges urge new care delivery models. This prospective cohort study investigates the feasibility and safety of a remote digital care program (DCP) combining education and PFMT with real-time biofeedback with an average duration of 10 weeks. The primary outcome was the change in the Urinary Impact Questionnaire-short form (UIQ-7) from baseline to program-end, calculated through latent growth curve analysis (LGCA). Secondary outcomes included the impact of pelvic conditions (PFIQ-7), depression (PHQ-9), anxiety (GAD-7), productivity impairment (WPAI), intention to seek additional healthcare, engagement, and satisfaction. Of the 326 participants who started the program, 264 (81.0%) completed the intervention. Significant improvement on UIQ-7 (8.8, 95%CI 4.7; 12.9, p < 0.001) was observed, corresponding to a response rate of 57.3%, together with improvements in all other outcomes and high satisfaction (8.9/10, SD 1.8). This study shows the feasibility and safety of a completely remote DCP with biofeedback managed asynchronously by a physical therapist to reduce UI-related symptoms in a real-world setting. Together, these findings may advocate for the exploration of this care delivery option to escalate access to proper and timely UI care.
Female urinary incontinence (UI) is highly prevalent in the US (>60%). Pelvic floor muscle training (PFMT) represents first-line care for UI; however, access and adherence challenges urge new care delivery models. This prospective cohort study investigates the feasibility and safety of a remote digital care program (DCP) combining education and PFMT with real-time biofeedback with an average duration of 10 weeks. The primary outcome was the change in the Urinary Impact Questionnaire-short form (UIQ-7) from baseline to program-end, calculated through latent growth curve analysis (LGCA). Secondary outcomes included the impact of pelvic conditions (PFIQ-7), depression (PHQ-9), anxiety (GAD-7), productivity impairment (WPAI), intention to seek additional healthcare, engagement, and satisfaction. Of the 326 participants who started the program, 264 (81.0%) completed the intervention. Significant improvement on UIQ-7 (8.8, 95%CI 4.7; 12.9, p < 0.001) was observed, corresponding to a response rate of 57.3%, together with improvements in all other outcomes and high satisfaction (8.9/10, SD 1.8). This study shows the feasibility and safety of a completely remote DCP with biofeedback managed asynchronously by a physical therapist to reduce UI-related symptoms in a real-world setting. Together, these findings may advocate for the exploration of this care delivery option to escalate access to proper and timely UI care.
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