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Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial.

Milena M Weinstein1, Gena Dunivan, Noelani M Guaderrama

  • 1Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; the University of New Mexico, Albuquerque, New Mexico; the Southern California Permanente Medical Group, Irvine, California; and the University of Alabama at Birmingham, Birmingham, Alabama.

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Pelvic floor muscle training with a digital device significantly improved urinary incontinence symptoms compared to home exercises. This remote trial demonstrated better outcomes for stress urinary incontinence (SUI) and overall distress.

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Area of Science:

  • Urology
  • Pelvic Health
  • Digital Therapeutics

Background:

  • Urinary incontinence (UI) affects a significant number of women, impacting quality of life.
  • Stress urinary incontinence (SUI) and mixed UI are common forms requiring effective treatment.
  • Traditional pelvic floor muscle training (PFMT) can be challenging to perform correctly and consistently.

Purpose of the Study:

  • To compare the efficacy of digital intravaginal device-guided PFMT versus traditional home-based PFMT for stress or stress-predominant mixed UI.
  • To assess improvements in UI symptoms and reduction in SUI episodes.

Main Methods:

  • An 8-week, remote, prospective randomized controlled superiority trial.
  • Participants with stress or stress-predominant mixed UI were assigned to either a motion-based digital therapeutic device group or a home training program group.
  • Primary outcomes included changes in Urogenital Distress Inventory (UDI-6) scores and SUI episodes recorded via a 3-day bladder diary.

Main Results:

  • The digital device group showed a significantly greater improvement in UDI-6 scores compared to the control group (18.8 vs 14.7, P=.01).
  • A significant reduction in SUI episodes was observed in the intervention group (median 1 episode) versus the control group (median 2 episodes, P=.005).
  • More participants in the digital device group reported significant improvement (44.1% vs 28.8%).

Conclusions:

  • Pelvic floor muscle training utilizing a motion-based digital therapeutic device is more effective than standard home-based PFMT for treating stress or stress-predominant mixed UI.
  • This digitally guided approach offers a promising, effective, and remotely deliverable treatment option for women with UI.
  • No severe adverse events were reported with the use of the digital device.