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Innovating Care for Postmenopausal Women Using a Digital Approach for Pelvic Floor Dysfunctions: Prospective
Ana P Pereira1, Dora Janela1, Anabela C Areias1
11, Sword Health, Inc, Draper, UT, United States.
Background:
The menopause transition is a significant life milestone that impacts quality of life and work performance. Among menopause-related conditions, pelvic floor dysfunctions (PFDs) affect ∼40%-50% of postmenopausal women, including urinary or fecal incontinence, genito-pelvic pain, and pelvic organ prolapse. While pelvic floor muscle training (PFMT) is the primary treatment, access barriers leave many untreated, advocating for new care delivery models.
Objective:
This study aims to assess the outcomes of a digital pelvic program, combining PFMT and education, in postmenopausal women with PFDs.
Methods:
This prospective, longitudinal study evaluated engagement, safety, and clinical outcomes of a remote digital pelvic program among postmenopausal women (n=3051) with PFDs. Education and real-time biofeedback PFMT sessions were delivered through a mobile app. The intervention was asynchronously monitored and tailored by a physical therapist specializing in pelvic health. Clinical measures assessed pelvic floor symptoms and their impact on daily life (Pelvic Floor Impact Questionnaire-short form 7, Urinary Impact Questionnaire-short form 7, Colorectal-Anal Impact Questionnaire-short form 7, and Pelvic Organ Prolapse Impact Questionnaire-short form 7), mental health, and work productivity and activity impairment. Structural equation modeling and minimal clinically important change response rates were used for analysis.
Results:
The digital pelvic program had a high completion rate of 77.6% (2367/3051), as well as a high engagement and satisfaction level (8.6 out of 10). The safety of the intervention was supported by the low number of adverse events reported (21/3051, 0.69%). The overall impact of pelvic floor symptoms in participants' daily lives decreased significantly (-19.55 points, 95% CI -22.22 to -16.88; P<.001; response rate of 59.5%, 95% CI 54.9%-63.9%), regardless of condition. Notably, nonwork-related activities and productivity impairment were reduced by around half at the intervention-end (-18.09, 95% CI -19.99 to -16.20 and -15.08, 95% CI -17.52 to -12.64, respectively; P<.001). Mental health also improved, with 76.1% (95% CI 60.7%-84.9%; unadjusted: 97/149, 65.1%) and 54.1% (95% CI 39%-68.5%; unadjusted: 70/155, 45.2%) of participants with moderate to severe symptomatology achieving the minimal clinically important change for anxiety and depression, respectively. Recovery was generally not influenced by the higher baseline symptoms' burden in individuals with younger age, high BMI, social deprivation, and residence in urban areas, except for pelvic health symptoms where lower BMI levels (P=.02) and higher social deprivation (P=.04) were associated with a steeper recovery.
Conclusions:
This study demonstrates the feasibility, safety, and positive clinical outcomes of a fully remote digital pelvic program to significantly improve PFD symptoms, mental health, and work productivity in postmenopausal women while enhancing equitable access to personalized interventions that empower women to manage their condition and improve their quality of life.
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