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Introduction and Hypothesis <p>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).</p> Methods <p>Between May and October 2024, 81 patients (women at least 18&#xa0;years old; SUI or MUI) were enrolled at five centers and randomized into an intervention group (IG, <i>n</i> = 34) or a control group (CG, <i>n</i> = 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&#xa0;days), and post-treatment (90&#xa0;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).</p> Results <p>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; <i>p</i> = 0.09). The CG showed no significant improvement in symptoms (T2 8.3 ± 2.7; Δ = –0.9, <i>p</i> = 0.051), whereas the IG demonstrated a significant and clinically relevant reduction in symptoms (T2 8.2 ± 4.7; Δ = –2.2; <i>p</i> = 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; <i>p</i> = 0.002), with IG improvements also being clinically relevant and surpassing the MID by a factor of four.</p> <p>Daily incontinence episodes decreased by 79.7% in the IG versus 48.3% in the CG (each group <i>p</i> &lt; 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&#xa0;days per week per patient.</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月30日

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  • Anna Schneiderbanger,
  • Katharina Arndt,
  • Hannah Arnold,
  • Matthias W. Beckmann,
  • Vesna Bjelic-Radisic,
  • Hendrik Borgmann,
  • Stefanie Burghaus,
  • Emilia Fieseler,
  • Thomas Fink,
  • Michael Gedamke,
  • Matthias Goetze,
  • Anna-Lena Nachtigal,
  • Maja Vorwerk,
  • Bernd Wullich,
  • Verena Lieb

摘要

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.