Digital Therapeutic FEMANEA® for Women with Stress and Mixed Urinary Incontinence: A Randomized Controlled Pilot...

Area of Science:

• Urology
• Digital Therapeutics
• Women's Health

Background:

• Urinary incontinence (UI) significantly impacts women's quality of life.
• Conservative treatments are a primary approach for managing UI.
• Digital therapeutics (DTx) offer novel avenues for conservative UI management.

Purpose of the Study:

• To provide initial evidence for the effectiveness of the DTx FEMANEA® in treating stress urinary incontinence (SUI) and mixed urinary incontinence (MUI).
• To prepare for a future randomized controlled trial (RCT) on DTx efficacy in UI.
• To evaluate UI symptom burden and quality of life improvements with FEMANEA®.

Main Methods:

• An exploratory pilot study involving 81 women with SUI or MUI.
• Randomization into an intervention group (IG) using FEMANEA® plus standard care and a control group (CG) receiving standard care.
• Assessment of outcomes using validated questionnaires (ICIQ-UI SF, KHQ), bladder diaries, and pad tests over 90 days.

Main Results:

• The IG showed a significant and clinically relevant reduction in UI symptoms (ICIQ-UI SF: p=0.001) compared to the CG.
• Quality of life, specifically the 'incontinence impact on life' (KHQ subscale 2), significantly improved in the IG (p=0.002).
• Daily incontinence episodes decreased by 79.7% in the IG versus 48.3% in the CG; urinary loss volume reduced by 44.0% in the IG.

Conclusions:

• The DTx FEMANEA® demonstrated statistically and clinically significant improvements in UI symptom burden and quality of life.
• These findings support the potential of FEMANEA® as a conservative treatment for SUI and MUI.
• The study provides preliminary data to inform the design of a larger, subsequent randomized controlled trial.