Urgency IncontinenceNCT07038811
Implementation of the App Tät®II for Treatment of Urgency and Mixed Urinary Incontinence
An observational study of Urgency Incontinence and Mixed Incontinence, Urge and Stress, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urgency Incontinence, Mixed Incontinence, Urge and Stress
- What is being tested?
- Tät®II
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 12 Jun 2025to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women from all over Sweden
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emma Nyström, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Region Jämtland Härjedalen
Östersund
Annelie Olofsson, MD, PhD, + 46 70 54 58 116, annelie.olofsson@umu.se
Emma Nyström, MD, PhD, emma.nystrom@umu.se
About this study
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.
Read the detailed description
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.
- Being tested
- Tät®II
- Keywords
- urinary incontinence, app treatment
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tät®IIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Tät®II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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?
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.
Measured: From enrollment to the end of treatment at 15 weeks.
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".
Measured: From enrollment to the end of treatment at 15 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start12 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urgency IncontinenceStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Jämtland Härjedalen
- Responsible party
- Sponsor
- Investigators
- Ina Asklund, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038811
- Sponsor's protocol ID
- CIV-24-10-049439
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD directly because the data set is small and contains sensitive information about health conditions. However, the IPD might be shared upon reasonable request.
Publications
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.
PubMed 38141064Wadensten 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.
PubMed 35266189Wadensten 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.
PubMed 33818395
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the App Tät®II for Treatment of Urgency and Mixed Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07038811
- Acronym / sponsor ID
- CIV-24-10-049439
- Keywords
- urinary incontinence, app treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Jämtland Härjedalen
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with symptoms of urgency urinary incontinence or mixed urinary incontinence. | – | Device: Tät®IIPersons 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women from all over Sweden
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnancy
- Childbirth in the last 6 months
- Painful urges
- Difficulties emptying the bladder
- Blood in urine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tät®IIThe 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. | Device | Women with symptoms of urgency urinary incontinence or mixed urinary incontinence. |
Primary outcome
Is treatment via Tät®II effective and feasible after contact with the primary care?
Time frame: From participants enrollment to the end of treatment at 15 weeks.
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.
2 secondary outcomes
How does the quality of life (QoL) change after 15 weeks of treatment with the Tät®II app?
Time frame: From enrollment to the end of treatment at 15 weeks.
Patient Global Impression of Improvement at 15-week follow up
Time frame: From enrollment to the end of treatment at 15 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Results publication: PubMed 38141064Wadensten 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.
- Results publication: PubMed 35266189Wadensten 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.
- Results publication: PubMed 33818395Wadensten 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.
- Homepage of the research group with information about the study and link to the screening survey.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share IPD directly because the data set is small and contains sensitive information about health conditions. However, the IPD might be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emma Nyström, MD, PhD contact
Ina Asklund, MD, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urgency Incontinence and Mixed Incontinence, Urge and Stress, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annelie Olofsson, MD, PhD (+46 70 54 58 116, annelie.olofsson@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is treatment via Tät®II effective and feasible after contact with the primary care? (time frame: From participants enrollment to the end of treatment at 15 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07038811, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.