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

INTRODUCTION AND HYPOTHESIS: This exploratory pilot study provided initial evidence of the effectiveness of the digital therapeutic (DTx) FEMANEA® for the conservative treatment of stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) with a predominant stress component in women and is intended to prepare a further, more in-depth subsequent randomized controlled trial (RCT). 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 received standard conservative treatments (i.e., reality of care), the IG additionally had immediate access to the DTx FEMANEA®. Outcome parameters were assessed at baseline, mid-treatment (45 days), and post-treatment (90 days) using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), King's Health Questionnaire (KHQ), bladder diary, 24-h 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, symptom burden was slightly higher in the IG than in the CG (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 ± 2.7; Δ = -0.9, p = 0.051), whereas the IG demonstrated a significant and clinically relevant reduction in symptoms (T2 8.2 ± 4.7; Δ = -2.2; p = 0.001), exceeding the minimal important difference (MID) of 1.46 points. Additionally, the KHQ subscale 2 "incontinence impact on life" observed a significant improvement (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. Daily incontinence episodes decreased by 79.7% in the IG versus 48.3% in the CG (each group p < 0.01). Urinary loss volume revealed a 44.0% reduction in the IG, whereas CG values slightly increased. The mean app use in the IG was 2.6 ± 1.9 days per week per patient. CONCLUSIONS: Use of the DTx FEMANEA® resulted in clinically and statistically significant improvements in UI symptom burden (ICIQ-UI SF) and quality of life (KHQ subscale 2). These initial clinical data are intended to provide preliminary indications and prepare for the subsequent trial to be conducted.