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

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.