Digital Therapeutic FEMANEA® for Women with Stress and Mixed Urinary Incontinence: A Randomized Controlled Pilot Study
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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.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Digital Therapeutic FEMANEA® for Women with Stress and Mixed Urinary Incontinence: A Randomized Controlled Pilot Study
- Date Crossref
- 30/04/2026
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Friedrich-Alexander-Universität Erlangen-Nürnberg pays non établi dans la noticeUniversité ou école supérieure
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Universitätsklinikum Erlangen pays non établi dans la noticeÉtablissement de santé
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Medizinische Hochschule Brandenburg Theodor Fontane pays non établi dans la noticeUniversité ou école supérieure
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Universitätsklinikum Brandenburg an der Havel pays non établi dans la noticeÉtablissement de santé
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Helios Universitätsklinikum Wuppertal pays non établi dans la noticeÉtablissement de santé
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Sana Klinikum Lichtenberg pays non établi dans la noticeÉtablissement de santé
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Continence and Pelvic Floor Center pays non établi dans la noticeInstitution
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Department of Urology and Pediatric Urology pays non établi dans la noticeInstitution
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Faculty of Health Sciences Department of Urology and Pediatric Urology pays non établi dans la noticeUniversité ou école supérieure
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Urology Senden pays non établi dans la noticeInstitution
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Department of Gynecology and Obstetrics pays non établi dans la noticeInstitution
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Helios University Hospital Dept Senology pays non établi dans la noticeUniversité ou école supérieure
Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitätsklinikum Erlangen et Medizinische Hochschule Brandenburg Theodor Fontane, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.