Implementation of the App Tät®II for Treatment of Urgency and Mixed Urinary Incontinence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-12

Study Completion Date

2027-06-01

Brief Summary

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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.

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Detailed Description

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The implementation study includes women diagnosed with urgency or mixed urinary incontinence by their doctor and recommended first-line treatment with pelvic floor muscle training and/or bladder training.

We plan to recruit eligible participants by advertising in primary care center waiting rooms, on social media, and on our research webpage. Primary care doctors and nurses will also receive information about the study. Women interested in the study from all over Sweden can visit our webpage (tät.nu) for more information. The webpage will include detailed information about the study, the informed consent procedure, an informed consent form, a screening questionnaire, and contact details for the research group.

Women interested in participating in the study are asked to read the subject information and answer the screening questionnaire describing the inclusion and exclusion criteria. Those who are eligible will be asked to send their email address to the research group, which will then contact them by email to schedule a secure video meeting.

During the digital meeting, the investigators will provide additional information about the study and answer any questions. The investigator will also verify that the woman meets all the inclusion criteria and none of the exclusion criteria.

To certify that she has received a medical evaluation for her urinary incontinence, she must send the research team a copy of a medical record. The assessment must not be older than six months.

If she is eligible and wants to participate in the study, she will sign the informed consent form during the meeting and send it to the research group by regular mail. At the same time, she will send a copy of the medical record to the research group as verification of the evaluation.

The investigators will sign the informed consent form as soon as they receive it and then resend a copy to the participant.

Once the informed consent form is signed by both parties, the woman is included in the study.

After inclusion, the research group will send a link to an electronic baseline questionnaire. This questionnaire will include questions about demographics, medical history (including gynecological history and medications), health and eHealth literacy, and validated questionnaires for assessing symptoms and quality of life. The ICIQ-UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) and ICIQ-LUTSqol (International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms) validated scores will be used to evaluate symptoms and quality of life.

After completing the questionnaire, participants will have access to the app for 15 weeks of treatment. The research group will email the participants an activation code that can be used to access the app fully.

After 15 weeks and 1 year, a digital follow-up questionnaire will be sent via email. This questionnaire will include validated questionnaires for symptoms (ICIQ-UI SF), quality of life (ICIQ-LUTSqol), and impression of improvement (PGI-I).

The primary outcome for the treatment effect is the validated, widely used ICIQ-UI SF symptom score. A paired t-test will analyze changes in the mean ICIQ-UI SF score from inclusion to follow-up.

Based on the results of the RCT, it is estimated that approximately 60 participants are required. Information on patient experience with app management, satisfaction with management, and desire for further treatment will also be collected. A subgroup analysis will compare the symptoms, effects, and experiences of women 65 years and older to those of women younger than 65.

Conditions

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Urgency Incontinence Mixed Incontinence, Urge and Stress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with symptoms of urgency urinary incontinence or mixed urinary incontinence.

Persons of the female gender, aged 18 years or older, with symptoms of urgency urinary incontinence or mixed urinary incontinence, who have undergone a medical evaluation and received a diagnosis of urinary incontinence from a primary care physician.

Tät®II

Intervention Type DEVICE

The 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.

Interventions

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Tät®II

The 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female gender
* Age ≥18 years
* Symptoms of urgency urinary incontinence or mixed urinary incontinence
* Medical evaluation and documentation of urinary incontinence by ordinary doctor
* Signed informed consent

Exclusion Criteria

* Pregnancy
* Childbirth in the last 6 months
* Painful urges
* Difficulties emptying the bladder
* Blood in urine
* Need of further investigation concerning the urinary incontinence, according to the clinical doctor

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No