Mobile App-treatment of Mixed and Urgency Urinary Incontinence in Women

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03097549
• Date of registration: 20/03/2017
• Prospective Registration: Yes
• Primary sponsor: Umeå University
• Public title: Mobile App-treatment of Mixed and Urgency Urinary Incontinence in Women
• Scientific title: Mobile App-treatment of Mixed and Urgency Urinary Incontinence in Women - a Randomized Controlled Study
• Date of first enrolment: April 3, 2017
• Target sample size: 123
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03097549
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Eva C Samuelsson, MD, PhD
• Affiliation: Department of public health and clinical medicine, Umeå university, Umeå, Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

- Urgency urinary incontinence or mixed urinary incontinence, established via telephone
interview

- Urinary leakage twice a week or more often

- Duration of urinary leakage with urgency for at least 12 months

- Ability to read and write Swedish

- Asset to a smartphone (minimum iOS* 8.0 for Apple, 4.0.3 for Androids

- Possibility to send and receive email and asset to printer

- Motivation and time to perform a 15 weeks long treatment programme with focus on
self-care and behavioural training (mainly pelvic floor muscle training and bladder
training).

- Accept to be randomized to one of two groups; a treatment app group or an information
app Group

- iOS=mobile operating system including iPhone, iPad and iPod touch

Exclusion Criteria:

- Participation in our previous internet or smartphone study

- Ongoing pregnancy

- Former incontinence surgery

- Known malignancy in lower abdomen

- Unassessed difficulties in emptying bladder

- Visual blood in urine

- Three or more urinary tract infections during the last 12 months

- One or more pyelonephritis during the last three years

- Painful micturition

- Painful urgency

- Intermenstrual bleeding

- Neurological disease such as multiple sclerosis or Parkinsons disease

- Previous stroke

- Diabetes mellitus

- Maximum voided volume of less than 150 ml (micturition chart)

- Regular use of any mobile app for pelvic floor muscle training during the last month

- Usage of antimuscarinic drugs or mirabegron during the last month



Age minimum: 18 Years
Age maximum: 99 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Urinary Incontinence

Intervention(s)

Device: Tät®II Treatment app

Device: Tät®II Information app

Primary Outcome(s)

International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) [Time Frame: 15 weeks]

Secondary Outcome(s)

International Consultation on Incontinence Modular Questionnaire Overactive Bladder (ICIQ OAB) [Time Frame: 15 weeks]

Patient Satisfaction [Time Frame: 15 weeks, only for the Tät® II treatment app group]

Patient global impression of improvement (PGI-I) [Time Frame: 15 weeks]

Change from baseline Usage of incontinence aids at 15 weeks [Time Frame: 15 weeks]

Change from baseline Incontinence Episode Frequency (IEF) at 15 weeks [Time Frame: 15 weeks]

Incontinence catastrophizing scale (ICS) [Time Frame: 15 weeks]

International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ- LUTSqol). [Time Frame: 15 weeks]

Secondary ID(s)

Forte 2014-5140

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Norrlandstingens Regionförbund

Jämtland County Council, Sweden

Swedish Council for Working Life and Social Research

Västerbotten County Council, Sweden