CLINICAL TRIAL article
Front. Digit. Health
Sec. Health Communications and Behavior Change
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
Lukas Schramm 1,2
Andreas Wiedemann 3,4
Claudia Neumesiter 2
Heike Wolf 2
Marcus Rudolf Götz 5
Christine Neubauer 2
Axel Hegele 6,7
Ralf Eckert 8
Laila Najjari 9
Johannes Salem 10,11
Timiur Kuru 10,11
1. Department of General Psychology and Methodology, Faculty of Human Sciences and Education, University of Bamberg, Bamberg, Germany
2. Dr. Pfleger Arzneimittel GmbH, Bamberg, Germany, Bavaria, 96052
3. Evangelisches Krankenhaus Witten GmbH, Witten, Germany
4. University of Witten/Herdecke, Department of Geriatrics, Witten, Germany
5. Bode Chemie GmbH, Hamburg, Germany
6. Urological Center Mittelhessen, Biedenkopf, Germany
7. University Hospital Marburg, Department of Urology, Medical School,, Marburg, Germany
8. Urologicum Dr. med. Ralf Eckert, Lutherstadt Eisleben, Germany
9. University Clinic RWTH Aachen, Department of Gynaecology and Obstretrics, Aachen, Germany
10. Department of Urology, Faculty of Health Sciences, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany, Brandenburg, 16816
11. CUROS Urology Center, Cologne, Germany
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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 hours 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) versus 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) versus 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.
Summary
Keywords
dIgA, DTx (Digital Therapeutics), eHealth, incontinence, MHealth (mobile Health), OAB, Urology
Received
12 April 2025
Accepted
13 February 2026
Copyright
© 2026 Schramm, Wiedemann, Neumesiter, Wolf, Götz, Neubauer, Hegele, Eckert, Najjari, Salem and Kuru. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: Lukas Schramm
Disclaimer
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