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Both groups received standard conservative treatments (i.e., reality of care), the IG additionally had immediate access to the DTx FEMANEA\u00ae. Outcome parameters were assessed at baseline, mid-treatment (45\u00a0days), and post-treatment (90\u00a0days) using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), King\u2019s Health Questionnaire (KHQ), bladder diary, 24-h pad test, Patient Activation Measure (PAM-13), and app usage metrics. Data collection was carried out electronically with eCRFs (electronic case report forms) and ePROs (electronic patient reported outcomes).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The final analysis included 74 patients (dropout rate 6.2%). At baseline, symptom burden was slightly higher in the IG than in the CG (ICIQ-UI SF: T0 IG 10.7\u2009\u00b1\u20094.3, CG 9.2\u2009\u00b1\u20093.0;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.09). The CG showed no significant improvement in symptoms (T2 8.3\u2009\u00b1\u20092.7; \u0394\u2009=\u2009\u20130.9,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.051), whereas the IG demonstrated a significant and clinically relevant reduction in symptoms (T2 8.2\u2009\u00b1\u20094.7; \u0394\u2009=\u2009\u20132.2;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.001), exceeding the minimal important difference (MID) of 1.46 points. Additionally, the KHQ subscale 2 \u201cincontinence impact on life\u201d observed a significant improvement (IG \u201319.8\u2009\u00b1\u200918.7 vs. CG \u20135.3\u2009\u00b1\u200919.8;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.002), with IG improvements also being clinically relevant and surpassing the MID by a factor of four.\n                    <\/jats:p>\n                    <jats:p>\n                      Daily incontinence episodes decreased by 79.7% in the IG versus 48.3% in the CG (each group\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.01). Urinary loss volume revealed a 44.0% reduction in the IG, whereas CG values slightly increased. The mean app use in the IG was 2.6\u2009\u00b1\u20091.9\u00a0days per week per patient.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Use of the DTx FEMANEA\u00ae resulted in clinically and statistically significant improvements in UI symptom burden (ICIQ-UI SF) and quality of life (KHQ subscale 2). These initial clinical data are intended to provide preliminary indications and prepare for the subsequent trial to be conducted.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00192-026-06670-z","type":"journal-article","created":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T13:36:34Z","timestamp":1777556194000},"page":"2941-2951","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Digital Therapeutic FEMANEA\u00ae for Women with Stress and Mixed Urinary Incontinence: A Randomized Controlled Pilot Study"],"prefix":"10.1007","volume":"37","author":[{"given":"Anna","family":"Schneiderbanger","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katharina","family":"Arndt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Arnold","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias W.","family":"Beckmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vesna","family":"Bjelic-Radisic","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hendrik","family":"Borgmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefanie","family":"Burghaus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilia","family":"Fieseler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Fink","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Gedamke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Goetze","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna-Lena","family":"Nachtigal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maja","family":"Vorwerk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernd","family":"Wullich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6772-508X","authenticated-orcid":false,"given":"Verena","family":"Lieb","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,4,30]]},"reference":[{"key":"6670_CR1","doi-asserted-by":"publisher","first-page":"4","DOI":"10.1002\/nau.20798","volume":"29","author":"BT Haylen","year":"2010","unstructured":"Haylen BT, de Ridder D, Freeman RM, et al. 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This pilot study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. Approval (application number: 23\u2013494-Bm) was granted by the Ethics Committee of Friedrich-Alexander-University Erlangen-Nuremberg, Germany. The study protocol was registered in the German Register of Clinical Studies (DRKS): DRKS00034031 (\n                      \n                      ). PrehApp GmbH (limited liability company, manufacturer, Erlangen, Germany) was the sponsor of the pilot study and provided the DTx application. The authors assume responsibility for the accuracy and completeness of the data and analyses and attest to the fidelity of the pilot study and this report to the protocol. All participants provided written informed consent prior to randomization, including a data protection consent declaration.","order":1,"name":"Ethics","label":"Ethics Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The PrehApp GmbH developed the product FEMANEA\u00ae with financial support of FARCO-PHARMA GmbH. VL is not an employee of PrehApp GmbH or FARCO-PHARMA GmbH, but has received travelling and consultant honoraria from FARCO-PHARMA GmbH. The PrehApp GmbH and FARCO-PHARMA GmbH had no role in the study design, data collection, analysis or interpretation or the decision to submit the manuscript for publication. No other financial or nonfinancial interests are declared.ALN and M Gedamke are employees of FARCO-PHARMA GmbH. No nonfinancial interests are declared.All other authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest or nonfinancial interest in the subject matter or materials discussed in this manuscript.Parts of the pilot study were presented at the following congresses:70th NRWGU Congress (North Rhine-Westphalia Society for Urology e.V.), 03.-04.04.2025, M\u00fcnster, Germany. 51\u2009st Conference of the Austrian Society of Urology and the Bavarian Urologists Association, 22.-24.05.2025, Wien, Austria.77th Congress of the German Society of Urology, 17.-20.09.2025, Hamburg, Germany.","order":2,"name":"Ethics","label":"Conflicts of interest","group":{"name":"EthicsHeading","label":"Declarations"}}]}}