Long-term effectiveness of app-based therapy for female urinary incontinence: 48-week follow-up of a randomised controlled trial
Abstract
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.
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BibTeX
@article{frey2026longterm,
title = {{Long-term effectiveness of app-based therapy for female urinary incontinence: 48-week follow-up of a randomised controlled trial}},
author = {Lisa Frey and Axel Haferkamp and Walter Lehmacher and Gregor Duwe and Jan Hendrik Börner and Kerstin A. Brocker and Leonie Ratz and Diana Moldovan and Jan Erik Krieger and Kurt Miller and Laura Wiemer and C Patrick Papp},
journal = {eClinicalMedicine},
year = {2026},
month = oct,
doi = {10.1016/j.eclinm.2026.104298},
url = {https://linkinghub.elsevier.com/retrieve/pii/S2589537026005511},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Long-term effectiveness of app-based therapy for female urinary incontinence: 48-week follow-up of a randomised controlled trial
AU - Lisa Frey
AU - Axel Haferkamp
AU - Walter Lehmacher
AU - Gregor Duwe
AU - Jan Hendrik Börner
AU - Kerstin A. Brocker
AU - Leonie Ratz
AU - Diana Moldovan
AU - Jan Erik Krieger
AU - Kurt Miller
AU - Laura Wiemer
AU - C Patrick Papp
PY - 2026
DA - 2026/10/28
JO - eClinicalMedicine
DO - 10.1016/j.eclinm.2026.104298
UR - https://linkinghub.elsevier.com/retrieve/pii/S2589537026005511
AB - 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.
SN - 2589-5370
ER -