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.

The female subgroup with heightened symptom severity at baseline showed a clear trend towards better outcomes in the ICIQ-OAB score (−1.0 (SD 2.08; n = 14) vs. −0.5 (SD 1.7; n = 26; p = 0.4172).

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Analysis of the subgroup of patients with heightened symptom severity at baseline showed a trend towards higher improvement in the INKA compared to the control group.

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A positive trend towards more pronounced improvements from baseline to the end of the observation period were observed in the overall INKA group and female subgroup compared to the control groups, although these differences did not reach statistical significance [−12.5 (SD 20.17; n = 22) in the INKA group vs. −7.89 (SD 20.15; n = 62) in the control group ( p = 0.359) and −13.56 (SD 19.22; n = 18) in the female INKA group vs. −8.72 (SD 22.29; n = 43) in the female control group ( p = 0.4254)].

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In accordance with the results for the primary endpoint, the female subgroup showed highly significant results as the mean micturition volume increased by +23.29 mL (SD 43.38; n = 24) in the INKA group, while it decreased by −12.38 mL (SD 51.5; n = 39) in the control group ( p = 0.0063) ( Figure 3 ).

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