A randomized, unblinded, controlled clinical study to assess the mobile digital health application INKA in the management of therapy refractory overactive bladder and mixed incontinence

Frontiers in Digital Health, vol. 8, pp. 1610663

Abstract

Background: This exploratory, two-arm, randomized, unblinded, controlled, multicentre study assessed the health benefits of the INKA app, a MDR class I CE-marked digital therapy companion for patients with overactive bladder (OAB) and mixed incontinence (MI). INKA offers self-guided educational, behavioural, and motivational content, along with physiotherapy modules and supports daily self-management, in accordance with current clinical guidelines. Methods: 251 patients under first-line stable pharmacological treatment were recruited at 35 study sites in Germany and randomized to receive access to the INKA app or standard of care alone (the control group). Self-assessed OAB related endpoints were investigated at baseline, after 4 and after 12 weeks. The end-of-study visit was conducted on site. Results: Among 111 evaluable patients (43 INKA, 68 control), baseline characteristics were comparable (mean age 52.7 years, SD 14.6; 27% male, 73% female). 55% of INKA users engaged with the app on a daily basis. At 12 weeks, the INKA group showed a mean reduction of -1.02 (SD 3.36) micturitions per 24 h compared to +0.08 (SD 2.97) in the control group. Significant and clinically meaningful improvements were observed in female INKA users and those with heightened symptom severity. A significant mean increase in urine volume per micturition was noted in the INKA group (+15.75 mL, SD 49.74) vs. the control group (-8.84 mL, SD 52.14), in "OAB wet" and in the female subgroup. The ICIQ-OAB questionnaire results indicated favourable outcomes for all groups, with all INKA patients and the female subgroup showing clinically relevant symptom relief. Additionally, greater improvement on the ICIQ-OABqol questionnaire was reported for the INKA group (-12.5, SD 20.17) vs. the control group (-7.89, SD 20.15). No INKA-related adverse events or device deficiencies were reported. Conclusion: This proof-of-concept study highlights the potential of the INKA mobile app to reduce micturition frequency and increase the micturition volume in therapy refractory OAB patients, both recognized as key factors of OAB symptom burden. A forthcoming trial will evaluate an optimized and more user-friendly version of the app with patients with a higher symptom severity at baseline. Clinical Trial Registration: German Clinical Trials Register (DRKS ID 00029329).

Authors 11

1. L.S. Schramm corresponding

   University of Bamberg · Dr. Pfleger Arzneimittel (Germany)

   Affiliation as printed

   Department of General Psychology and Methodology, University of Bamberg

   Medical Science Department, Dr. Pfleger Arzneimittel GmbH

2. A Wiedemann

   Witten/Herdecke University · Marien Hospital Witten

   Affiliation as printed

   Department of Geriatrics, University of Witten/Herdecke

   Department of Urology, Evangelic Hospital of Witten

3. Claudia Neumeister

   Dr. Pfleger Arzneimittel (Germany)

   Affiliation as printed

   Medical Science Department, Dr. Pfleger Arzneimittel GmbH

4. H. Wolf

   Dr. Pfleger Arzneimittel (Germany)

   Affiliation as printed

   Medical Science Department, Dr. Pfleger Arzneimittel GmbH

5. Marcus Rudolf Götz
   Affiliation as printed

   Research and Development Department, Bode Chemie GmbH

6. C. Neubauer

   Dr. Pfleger Arzneimittel (Germany)

   Affiliation as printed

   Medical Science Department, Dr. Pfleger Arzneimittel GmbH

7. Axel Hegele

   Universitätsklinikum Gießen und Marburg

   Affiliation as printed

   Department of Urology, Medical School, University Hospital Marburg

   Urological Center Mittelhessen

8. R. Eckert
   Affiliation as printed

   Urologicum Dr. med. Ralf Eckert

9. Laila Najjari Aachen Department of Gynaecology and Obstretrics

   RWTH Aachen University · Universitätsklinikum Aachen

   Affiliation as printed

   Department of Gynaecology and Obstretrics, University Clinic RWTH Aachen

10. Johannes Salem

    Medizinische Hochschule Brandenburg Theodor Fontane

    Affiliation as printed

    CUROS Urology Center

    Department of Urology, Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontane

11. T. H. Kuru

    Medizinische Hochschule Brandenburg Theodor Fontane

    Affiliation as printed

    CUROS Urology Center

    Department of Urology, Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontane