{
  "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.\n\nMethods: 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.\n\nFindings: 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.\n\nInterpretation: 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.\n\nFunding: Kranus Health GmbH.",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 12,
  "authors": [
    {
      "name": "Lisa Frey",
      "orcid": "0009-0007-0070-1690"
    },
    {
      "name": "Axel Haferkamp"
    },
    {
      "name": "Walter Lehmacher"
    },
    {
      "name": "Gregor Duwe"
    },
    {
      "name": "Jan Hendrik Börner"
    },
    {
      "name": "Kerstin A. Brocker"
    },
    {
      "name": "Leonie Ratz"
    },
    {
      "name": "Diana Moldovan"
    },
    {
      "name": "Jan Erik Krieger"
    },
    {
      "name": "Kurt Miller"
    },
    {
      "name": "Laura Wiemer"
    },
    {
      "name": "C Patrick Papp"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/95pkq5xn8c58z.bib",
  "cited_by": 0,
  "doi": "10.1016/j.eclinm.2026.104298",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13735171/",
  "id": "95pkq5xn8c58z",
  "issns": [
    "2589-5370"
  ],
  "landing_url": "https://linkinghub.elsevier.com/retrieve/pii/S2589537026005511",
  "language": "en",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "http://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Articles"
    ],
    [
      "openalex",
      "2745|Pelvic floor disorders treatments"
    ]
  ],
  "openalex": "W7224118019",
  "pdf_url": null,
  "pmcid": "PMC13735171",
  "pmid": "42991056",
  "published": "2026-10-28",
  "publisher": "Elsevier BV",
  "ris": "https://research.draconitic.com/paper/95pkq5xn8c58z.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:48Z",
      "native_id": "10.1016/j.eclinm.2026.104298",
      "source": "crossref",
      "url": "https://linkinghub.elsevier.com/retrieve/pii/S2589537026005511"
    },
    {
      "first_seen": "2026-11-09T12:20:54Z",
      "native_id": "PMC13735171",
      "source": "pmc",
      "url": "https://doi.org/10.1016/j.eclinm.2026.104298"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2745|Pelvic floor disorders treatments",
      "subfield": "general"
    }
  ],
  "title": "Long-term effectiveness of app-based therapy for female urinary incontinence: 48-week follow-up of a randomised controlled trial",
  "title_text": "Long-term effectiveness of app-based therapy for female urinary incontinence: 48-week follow-up of a randomised controlled trial",
  "type": "peer-reviewed",
  "updated_at": "2026-11-09T12:20:54Z",
  "url": "https://research.draconitic.com/paper/95pkq5xn8c58z",
  "venue": "eClinicalMedicine",
  "versions": []
}