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

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.