Pelvic Floor Muscle Training Using the Perifit Device for the Treatment of Urinary Incontinence: A Pragmatic Trial...

Area of Science:

• Urology
• Pelvic Health
• Digital Therapeutics

Background:

• Urinary incontinence (UI) significantly impacts women's quality of life.
• There is a growing need for accessible, home-based self-management solutions for UI.
• Traditional pelvic floor muscle training (PFMT) can be challenging to adhere to without proper guidance.

Purpose of the Study:

• To evaluate the effectiveness of home-based training with the Perifit device in reducing UI symptoms.
• To assess the impact of Perifit training on symptom severity and objective improvement using real-world data.
• To identify factors associated with improvement in UI symptoms through Perifit use.

Main Methods:

• A real-world data analysis involving 6060 women diagnosed with UI who used the Perifit device.
• Validated UI symptom questionnaires were administered at baseline (T1) and post-training intervals (T2, T3, T4).
• Statistical analysis was performed to assess changes in UI symptom scores and reported improvements.

Main Results:

• Progressive and statistically significant reduction in UI symptom scores from baseline (8.4 ± 4.8) to T4 (4.6 ± 4.5) (p < 0.001).
• Objective improvement in UI symptoms reported by an increasing percentage of users: 71% (T2), 79% (T3), and 85% (T4).
• Medium to large effect sizes were observed, with higher baseline symptom scores correlating with greater improvement.

Conclusions:

• Home-based training with the Perifit device demonstrates effectiveness in reducing UI symptoms across a large cohort of women.
• The Perifit device offers a promising, accessible tool for women to self-manage urinary incontinence at home.
• The findings support the integration of digital therapeutics like Perifit into PFMT strategies for improved UI management.