protocolSection identificationModule nctId: NCT06389838, orgStudyIdInfo id: DINKS01, secondaryIdInfos id: DRKS00033704, type: REGISTRY, domain: DRKS, secondaryIdInfos id: 2024-512094-27, type: EUDRACT_NUMBER, briefTitle: RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application, acronym: DINKS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Kranus Health GmbH, class: INDUSTRY, collaborators name: Johannes Gutenberg University Mainz, descriptionModule briefSummary: This study, titled "Prospective Randomized Study on Multimodal Self-Treatment for Women with Incontinence Symptoms Using a Digital Health Application," abbreviated as DINKS, aims to investigate the efficacy of a digital health application in treating incontinence in women. The study involves a single-center, single blinded, randomized, controlled trial with two arms: one receiving digital therapy intervention and the other serving as a control group with standard of care. The primary objective is to reduce the frequency of incontinence episodes over a 12-week intervention period, with secondary goals including improvements in disease symptoms, quality of life, and patient activation. The study plans to recruit 198 female participants and assess various endpoints related to incontinence severity, quality of life, and treatment outcomes., conditionsModule conditions: Urinary Incontinence,Stress, conditions: Urinary Incontinence, Urge, conditions: Urinary Incontinence, conditions: Overactive Bladder Syndrome, conditions: Female Urinary Stress Incontinence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, randomized, controlled, single-blinded, 2-arm design, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants know which group they are assigned to, but the investigators are blinded., whoMasked: INVESTIGATOR, enrollmentInfo count: 198, type: ESTIMATED, armsInterventionsModule interventions name: Kranus Mictera, outcomesModule primaryOutcomes measure: Incontinence episodes, secondaryOutcomes measure: ICIQ-SF, secondaryOutcomes measure: I-QoL, secondaryOutcomes measure: PAM-13, secondaryOutcomes measure: PGI-I, secondaryOutcomes measure: Cured patients, secondaryOutcomes measure: Urinary frequency day, secondaryOutcomes measure: Urinary frequency night, secondaryOutcomes measure: Pad use, secondaryOutcomes measure: Urge incontinence, secondaryOutcomes measure: Functional bladder capacity, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Treatment Failure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kranus Health Gmbh, city: München, zip: 80331, country: Germany, contacts name: Laura E Wiemer, MD, role: CONTACT, phone: +4989 124 146 79, email: lwiemer@kranushelath.com, geoPoint lat: 48.13743, lon: 11.57549, hasResults: False