Long-term effectiveness of app-based therapy for female urinary incontinence: 48-week follow-up of a randomised controlled trial

Background Long-term data for digital therapeutics in urinary incontinence are scarce. We assessed whether improvements with app-based multimodal therapy are sustained over 48 weeks, and outcomes after a 12-week delay in initiation. Methods In this prespecified 48-week follow-up of the DINKS (Digital Incontinence Study) randomised waitlist-controlled trial, women (≥18 years) with stress, urge, or mixed urinary incontinence recruited between April 30 and September 2 2024 across Germany received app-based therapy immediately or after a 12-week waitlist, alongside standard care. The primary outcome was change from baseline in ICIQ-UI-SF (International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form) score at weeks 12, 24, 36, and 48. Trial registration: NCT06389838. Findings Data availability declined progressively from 186 of 194 participants (95.9%) at week 12–66 (34.0%) at week 48. Pooled improvements exceeded the minimal clinically important difference at 12, 24, and 36 weeks after therapy start (ICIQ-UI-SF at 36 weeks −4.13, 95% Confidence Interval (CI) −4.80 to −3.47), and 73–77% of participants met the responder threshold. Differences between immediate and delayed initiation were small (ICIQ-UI-SF at 36 weeks 0.08, −1.09 to 1.25). The week-48 estimate (−3.88, −4.74 to −3.03) was intervention-group only, from 27 of 96. No adverse events were reported. Interpretation App-based multimodal therapy was associated with clinically meaningful improvements sustained through at least 36 weeks after intervention start. Differences between immediate and 12-week-delayed initiation were small relative to the minimal important difference, but no non-inferiority margin was prespecified and only one delay was tested; symptoms were unchanged while waiting, so waiting times should still be minimised. Confirmation in larger trials with active comparators is needed. Funding Kranus Health GmbH.