App-based therapy for female patients with urinary incontinence in Germany (DINKS): a single-blind, randomised, controlled trial

SummaryBackgroundUrinary incontinence affects an estimated 25–45% of women aged 18 years and older. Despite guideline recommendations, conservative treatments are often underused. We hypothesised that an app-based digital therapeutic, when added to standard care, would significantly reduce incontinence episode frequency compared with standard care alone.MethodsIn this 12-week, single-blind, randomised, controlled trial across all regions of Germany, adult participants (aged 18 years or older) assigned female at birth with urinary incontinence (stress, urge, or mixed) as defined by their treating urologist or gynaecologist—with at least one urinary incontinence episode per day—were randomly assigned (1:1) to receive app-based therapy (Kranus Mictera) plus usual care (intervention group) or usual care alone (control group). The study centre was masked to treatment assignment. The primary endpoint was the relative change from baseline in incontinence episode frequency per day; a 50% reduction was considered clinically relevant. A 3-day incontinence diary using an electronic case report form measured the intervention effects. The primary endpoint was assessed by intention-to-treat (ITT), including all participants who were randomly assigned, regardless of study completion. App-based treatments consisted of pelvic floor training, behavioural therapy with methods of urinary urge control, and relaxation techniques. Safety was assessed in the safety population, defined as all participants who initiated the intervention. Because all randomly assigned participants activated the app, the safety population was the same as the ITT population. This trial is closed and registered with ClinicalTrials.gov (NCT06389838).FindingsBetween April 30 and Sep 2, 2024, after obtaining ethical committee approval, 194 patients were randomly assigned to the intervention group (96 [49%] participants) or the control group (98 [51%] participants), with eight participants subsequently withdrawing (four in the intervention group and four in the control group). Median age of the participants was 50 years (IQR 40–57). 121 (62%) participants had stress, 43 (22%) had urge, and 30 (15%) had mixed urinary incontinence. At week 12, mean relative reduction in incontinence episode frequency was 60·95% (SD 44·32) in the intervention group and 1·69% (43·75) in the control group (between-group difference −59·2%, 95% CI −71·7 to −46·7; p<0·0001). No relevant treatment-related adverse events occurred.InterpretationThis study showed that app-based therapy improved standard care for urinary incontinence through a clinically meaningful reduction of urinary incontinence frequency, highlighting its potential to bridge treatment gaps in clinical practice.FundingKranus Health.