Digital Therapeutic FEMANEA Improves Symptom Severity and Quality of Life in Women with Stress and Mixed Urinary Incontinence: Evidence from a Randomized, Controlled, Multicenter Pilot Study

Purpose: This pilot study evaluated the clinical effectiveness of the digital therapeutic (DTx) FEMANEA for the conservative treatment of stress urinary incontinence (SUI) and mixed urinary incontinence with a predominant stress component (MUI) in women. Methods: Between May and October 2024, 81 patients (women at least 18 years old; SUI or MUI) were enrolled at five centers and randomized into an intervention group (IG, n =34) or a control group (CG, n =40). Both groups had access to standard conservative treatments (i.e., reality of care), the IG additionally received immediate access to the DTx FEMANEA. Outcome parameters were assessed at baseline (T0), mid-treatment (T1; 45 days), and posttreatment (T2; 90 days) using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), King's Health Questionnaire (KHQ), bladder diary, 24-hour pad test, Patient Activation Measure (PAM-13), and app usage metrics. Data collection was carried out electronically with eCRFs (electronic case report forms) and ePROs (electronic patient reported outcomes). Results: The final analysis included 74 patients (dropout rate: 6.2%). At baseline, the IG patients reported a slightly greater symptom burden than the CG patients did (ICIQ-UI SF: T0: IG: 10.7±4.3, CG: 9.2±3.0; p =0.09). The CG showed no significant improvement in symptoms (T2: 8.3±3.7; Δ= –0.9). However, the IG demonstrated a significant and clinically relevant reduction in symptoms (T2: 8.2±4.7; Δ=–2.2; p =0.001), as it exceeded the minimal important difference (MID) of 1.46 points. Additionally, we observed a significant improvement in the KHQ subscale 2 "incontinence impact on life" (IG: –19.8±18.7 vs. CG: –5.3±19.8; p =0.002), with IG improvements also being clinically relevant and surpassing the MID by a factor of four. Bladder diary data indicated a 79.7% reduction in daily incontinence episodes in the IG versus 48.3% in the CG (each group: p <0.01). The 24-hour pad test revealed a 44.0% reduction in urinary volume in the IG, whereas CG values slightly increased. The average duration of app use in the IG was 2.6±1.9 days per week per patient. Conclusion: Use of the DTx FEMANEA resulted in clinically and statistically significant improvements in patient-reported outcomes, as indicated by the UI symptom burden (ICIQ-UI SF) and quality of life (KHQ subscale 2) results. FEMANEA can thus be used as an alternative or adjunct to conventional conservative treatments for SUI and MUI.