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

NCT07038811 | Recruiting DMC

• 1 other identifier: CIV-24-10-049439
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urgency Incontinence; Mixed Incontinence, Urge and Stress

Keywords

urinary incontinence; app treatment

Outcome Measures

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.

  From participants enrollment to the end of treatment at 15 weeks.

Secondary Outcomes (2)

• How does the quality of life (QoL) change after 15 weeks of treatment with the Tät®II app?

  From enrollment to the end of treatment at 15 weeks.

• Patient Global Impression of Improvement at 15-week follow up

  From enrollment to the end of treatment at 15 weeks.

Study Arms (1)

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.

Device: Tät®II

Interventions

Tät®II 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women from all over Sweden

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead
• Region Jämtland Härjedalen: collaborator

Study Sites (1)

Region Jämtland Härjedalen

Östersund, Sweden

RECRUITING

Related Publications (3)

• Wadensten T, Nystrom E, Sjostrom M, Lindam A, Samuelsson E. APP-based treatment of urgency and mixed urinary incontinence in women: factors associated with long-term satisfaction. Arch Gynecol Obstet. 2024 May;309(5):2193-2202. doi: 10.1007/s00404-023-07303-2. Epub 2023 Dec 23.

  PMID: 38141064 BACKGROUND

• Wadensten T, Nystrom E, Nord A, Lindam A, Sjostrom M, Samuelsson E. App-based self-management of urgency and mixed urinary incontinence in women: One-year follow-up. Neurourol Urodyn. 2022 Apr;41(4):945-954. doi: 10.1002/nau.24898. Epub 2022 Mar 9.

  PMID: 35266189 BACKGROUND

• Wadensten T, Nystrom E, Franzen K, Lindam A, Wasteson E, Samuelsson E. A Mobile App for Self-management of Urgency and Mixed Urinary Incontinence in Women: Randomized Controlled Trial. J Med Internet Res. 2021 Apr 5;23(4):e19439. doi: 10.2196/19439.

  PMID: 33818395 BACKGROUND

Related Links

• Homepage of the research group with information about the study and link to the screening survey.

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ina Asklund, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annelie Olofsson, MD, PhD

CONTACT

+46 70 54 58 116; annelie.olofsson@umu.se

Emma Nyström, MD, PhD

CONTACT

emma.nystrom@umu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 26, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)