Implementation of the App Tät®II for Treatment of Urgency and Mixed Urinary Incontinence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUmeå University
About this trial
This observational study aims to evaluate the implementation and use of the Tät®II app for the treatment of urgency and mixed urinary incontinence in women over the age of 18 after contact with ordinary healthcare, as well as its effectiveness. The study aims to answer the following question:
Is treatment via the app effective and feasible after primary care?
Participants will use the app for 15 weeks to treat urgency and mixed urinary incontinence. They will answer online survey questions about their urinary incontinence before, after 15 weeks, and one year after treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female gender
Age ≥18 years
Symptoms of urgency urinary incontinence or mixed urinary incontinence
Medical evaluation and documentation of urinary incontinence by ordinary doctor
Disqualifiers
Pregnancy
Childbirth in the last 6 months
Painful urges
Difficulties emptying the bladder
Trial population
Women from all over Sweden
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tät®II
DeviceThe Tät®II app offers a treatment program for women with urge or mixed urinary incontinence. The program includes information on the pelvic floor, urinary incontinence, and factors affecting incontinence; a bladder training program; a pelvic floor muscle training program; and incontinence-related psychoeducation. The app also contains helpful functions, the ability to create reminders, visualization of each training level, a statistics function regarding the number of exercises performed, and feedback on changes in the level of bother due to urinary incontinence during treatment. The Tät®II app is available for download on Google Play and the App Store. Users need a one-time code to access the app, which is provided by the research team after they are included in the study. The app is self-instructive and can be used anywhere; no formal education is necessary. There is no option to communicate through the app.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Women with symptoms of urgency urinary incontinence or mixed urinary incontinence.1 intervention
Trial outcomes
Primary outcomes
1
Is treatment via Tät®II effective and feasible after contact with the primary care?
The primary outcome for the treatment effect is the validated and widely used ICIQ-UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) symptom score. The ICIQ-UI SF includes three questions about urinary incontinence: how often it occurs, how much leakage there is, and how bothersome it is. These questions form an additive score ranging from 0 to 21 points. The questionnaire also includes a fourth question that is not included in the total score, but that is used to categorize the type of leakage. Web-based questionnaires will be sent via email at the beginning of the study and again after 15 weeks. These questionnaires will include the validated ICIQ-UI SF symptom questionnaire. Primary endpoint: The mean difference in the ICIQ-UI SF score from baseline to the 15-week follow-up.
Time frame
From participants enrollment to the end of treatment at 15 weeks.Secondary outcomes
1
How does the quality of life (QoL) change after 15 weeks of treatment with the Tät®II app?
A validated patient-completed questionnaire will be used (International Consultation on Incontinence Questionnarre - Lower Urinary Tract Symtoms (ICIQ-LUTSqol) to evaluate QoL. It contains 20 questions, scoring from 19 to 76, with greater values indicating an increased impact of QoL.
Time frame
From enrollment to the end of treatment at 15 weeks.2
Patient Global Impression of Improvement at 15-week follow up
A validated patient-completed questionnaire will be used (Patient Global Impression of Improvement scale (PGI-I)) to evaluate improvement. The PGI-I is a single item questionnaire that asks the participant to rate her condition after treatment on a 7 step Likert-scale ranging from "Very much worse" to "Very much better".
Time frame
From enrollment to the end of treatment at 15 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Umeå University
Lead sponsor
Region Jämtland Härjedalen
Collaborator
Source ClinicalTrials.gov