Mobile App-treatment of Mixed and Urgency Urinary Incontinence in Women - a Randomized Controlled Study
Phase: NA
Conditions: Urinary Incontinence
Sponsor: Umeå University

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Tät II clinical trial: Study protocol and statistical plan 
2017-01-04 
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Title Page: 
  Forte 2014-5140    
Mobile App-treatment of Mixed and Urgency Urinary Incontinence 
in Women    
NCT03097549 
 
Document Date: January 4, 2017 
Updated with Title Page 18/02/2025 
 
 
 

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Tät II clinical trial: Study protocol and statistical plan 
2017-01-04 
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Tät II clinical trial: Study Protocol 
Summary 
The purpose of this study is to determine the short-term effect of self-management of mixed urinary 
incontinence (MUI) and urgency urinary incontinence (UUI) via a mobile app. 
Description 
Female urinary incontinence (UI) is common and affects up to one fourth of adult women (1). It may 
reduce quality of life for those affected and costs for society are high. The most common type of 
urinary incontinence is stress urinary incontinence (SUI), i.e. leakage when coughing, sneezing or 
jumping. UUI, i.e. a strong urge to urinate combined with leakage and MUI, i.e. a combination of both 
types, together adds up to nearly half of the cases of UI in women (1). Many women do not seek 
care, sometimes due to embarrassment (2). The recommended first line treatment for all types of UI 
is pelvic floor muscle training (PFMT) in combination with lifestyle changes. This treatment leads to 
improvement or cure in two-thirds of patients. In addition, bladder training might be effective in 
treatment of UUI and MUI, leading to improvement or cure in one-sixth of treated women with MUI 
(3,4). Research also suggests that psychological treatment might be valuable for some women with 
UUI or MUI (5). 
The use of smartphones is increasing rapidly. About 81% of all cell phones in Sweden today (in 2017) 
are smartphones. The majority of adults in Sweden own a smartphone. Many smartphone owners 
have at least one health app on their phone. Exercise, diet, and weight apps are the most popular 
types. 
There is a need for new, flexible and easily accessible treatment programmes for female urinary 
incontinence. The investigators have previously demonstrated the efficacy of the mobile app 
Tät® for treatment of SUI (6). Apps have the potential to improve symptoms in many chronic 
conditions through self-management interventions (7). 
From our previous experience of a smartphone app treatment for SUI, we have developed a new app 
combining some of the features from the previous app with new features more specifically aimed 
towards treatment of UUI and MUI. The effect of the treatment programme will be evaluated after 
three months by comparing the effect in a group which receives the full contents of the new app (the 
“treatment app group”) with a group which initially receives a limited version of the app containing 
only brief information and no actual exercises (the “information app group”). 
 
Intervention and control 
Intervention: Tät II treatment app 
Smartphone treatment with various exercises: A smartphone application with information on 
UUI/MUI, lifestyle information, psychological education and exercises, different programmes of 
PFMT and Bladder Training with increasing challenges, statistics on training. Possibility to set 
reminders. The treatment period is 15 weeks, and after that, maintenance training is recommended. 
 
Control: Information app 
Limited version of app, containing brief information, for three months. They receive the activation 
code for the treatment app after follow-up. 

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Tät II clinical trial: Study protocol and statistical plan 
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Study Design 
Study Type: Interventional 
Primary Purpose: Treatment 
Interventional Study Model: Parallel Assignment, 2 arms 
Masking: No masking 
Allocation: Randomized 
Time to follow-up: 15 weeks 
 
Procedure 
Participants are consecutively recruited through our website tät.nu. They answer an online screening 
survey with automated immediate response for initial screening of eligibility criteria. Informed 
consent and leakage diary (number of episodes of urinary leakage during 48 hours) are sent by post. 
After that, they answer a web questionnaire and finally they are interviewed by a researcher to 
confirm the diagnosis UUI or MUI, to discover any alarm symptoms motivating directing the 
participant to other care, and to ascertain that the patient is well informed of the study procedure. 
Women are then randomized to either of the two groups. Women in both groups get a smartphone 
application for iPhone or Android. The treatment app group receives a unique code for activation of 
the complete app. Follow-up after three months with a web questionnaire and a leakage diary. After 
that the information app group get their unique activation code. 
 
Monitoring 
The study will be monitored according to GCP principles by study research nurse Agneta Lindberg at 
the local clinical research centre of the Region of Jämtland Härjedalen to ascertain a proper 
procedure of conduction, recording and reporting data. The monitor will review study records, 
observe protocol procedures and the randomization process, ensure that written informed consent 
has been correctly obtained and verify patient safety by monitoring the correct reporting of any 
adverse events. 
 
Sample size 
Based on previous results from our study and the findings of Albers-Heitner et al (6, 8), we assume an 
improvement in the ICIQ UI SF of 2.5 p in the treatment app group and 0.9 p in the information app 
group. To detect this difference with 80% power, 2-side test and significance 0.05, we need a sample 
size of 49 in each group. With an expected drop-out rate of 20%, we need approximately 60 
participants in each group. We therefore aim to recruit 120 women aged 18 and older via our 
website www.tät.nu. 

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Eligibility 
Inclusion Criteria 
• 
age 18 years or older 
• 
female 
• 
urge urinary incontinence or mixed urinary incontinence 
• 
leakage twice a week or more often 
• 
duration of symptoms for at least 12 months 
• 
motivation and time to perform a 12-week treatment with pelvic floor muscle training 
• 
ability to read and write Swedish 
• 
access to smartphone/tablet 
• 
possibility to send and receive email and asset to printer 
• 
accept to be randomized to one of two groups; a treatment app group or an information app 
group 
 
Exclusion Criteria 
• 
participation in our previous internet study or smartphone study 
• 
pregnancy 
• 
former incontinence surgery 
• 
known malignancy in lower abdomen 
• 
unassessed difficulties in emptying bladder 
• 
visual blood in urine 
• 
three or more urinary tract infections within the last year or pyelonephritis in the last three 
years 
• 
painful urgency 
• 
intermenstrual bleeding 
• 
neurological disease with affection on sensibility in legs or lower abdomen 
• 
Usage of the previous app Tät® during the last month 
• 
Usage of anticholinergic drugs during the last month 
• 
Maximum urinary volume of less than 100 ml 
• 
Need for further assessment of symtoms, based on a telephone interview performed by an 
experienced urotherapist 

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Tät II clinical trial: Statistical analysis plan 
Intention-to-treat analysis will be performed on all outcome measures. 
 
Baseline comparison 
The two groups will be compared at baseline regarding demographic factors and incontinence- 
related parameters: 
For continuous variables, Student´s t-test will be used. 
For categorical variables, Pearson´s chi-square test will be used. 
For ordinal variables, and continuous variables with a non-normal distribution, the Mann-Whitney U- 
test will be used. 
 
Primary outcome 
Comparison between groups: 
The primary outcome is the difference between the groups in mean ICIQ-UI SF score change from 
baseline to 15-weeks follow-up. This will be compared using a linear mixed models analysis. 
Comparison within groups: 
For comparison within the groups regarding the change in ICIQ-UI SF score from baseline to 15- 
weeks follow-up, a paired t-test will be used. 
 
Secondary outcomes 
Comparison between groups: 
For the secondary outcomes the difference between the groups in mean ICIQ-LUTSqol, ICIQ-OAB and 
Incontinence Catastrophizing Scale (ICS) score changes from baseline to follow-up, a linear mixed 
models analysis will be used. 
For the secondary outcome the difference between the groups in the median value of Patient’s 
Global Impression of Improvement (PGI-I), a question on improvement only used at follow-up, the 
Mann-Whitney U-test will be used. 
For the secondary outcome the difference between the groups in the median Incontinence Episode 
Frequency (IEF) from baseline to follow-up, the Mann-Whitney U-test will be used. 
For the secondary outcome the changes in usage of incontinence aids from baseline to follow-up, we 
will use a six-item question about the frequency of usage in the last four weeks. We will compare the 
groups using the Mann-Whitney U-test. 
Comparison within groups: 
For comparison within the groups regarding the change in ICIQ-LUTSqol, ICIQ-OAB and ICS scores 
from baseline to 15-weeks follow-up, a paired t-test will be used. 
For comparison within the groups regarding the change in IEF and incontinence aid usage from 
baseline to 15-weeks follow-up, a Wilcoxon signed-rank test will be used. 
 
Missing data 
The questionnaires will be web-based and every question will, if technically possible, be mandatory. 
However, should there for some reason be missing values, they will be replaced with the value 
corresponding to “no change”, i.e. a missing value at follow-up will be replaced with the participant´s 
baseline value and a missing value at baseline will be replaced with the follow-up value. A missing 
answer in the PGI-I at follow-up will be assumed as “unchanged”. 

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Outcome Measures 
1. Primary Outcome Measure 
Measure Title 
International Consultation on Incontinence Modular 
Questionnaire Urinary Incontinence Short Form (ICIQ-UI 
SF) 
Measure Description 
Three items on frequency, amount of leakage and overall 
impact. Scoring 0-21, higher values indicating increasing 
severity 
 
 
2. Secondary Outcome Measure: 
Measure Title 
International Consultation on Incontinence Modular 
Questionnaire Lower Urinary Tract Symptoms Quality of 
Life (ICIQ-LUTSqol) 
Measure Description 
The instrument includes 19 items on the impact of the 
leakage. All items are scored 1-4 (not at all/never, 
slightly/sometimes, moderately/often, a lot/all the time). 
The overall score is 19-76, with higher values indicating 
increased impact on QOL. 
3. Secondary Outcome Measure: 
Measure Title 
International Consultation on Incontinence Modular 
Questionnaire Overactive Bladder (ICIQ OAB) 
Measure Description 
Four items on frequency of micturition during day and 
during night, frequency of urgency and urgency leakage, 
each item scored 0-4, total score 0-16, higher values 
indicating increased severity. 
4. Secondary Outcome Measure: 
Measure Title 
Incontinence catastrophizing scale (ICS) 
Measure Description 
Seven items on fear of leakage and urgency. Alternatives 
on each item; Never (=0), sometimes (=1), often (=2), 
Always (=3). Score 0-21. 
 
5. Secondary Outcome Measure: 
Measure Title 
Incontinence Episode Frequency (IEF) 
Measure Description 
number of incontinence episodes per week 
 
6. Secondary Outcome Measure: 
Measure Title 
Change from baseline Usage of incontinence aids at 15 
weeks 
Measure Description 
Use of incontinence aids during the last four weeks, six 
response options from "Never" to "more than one 
incontinence aid per day" 
7. Secondary Outcome Measure: 
Measure Title 
Patient global impression of improvement (PGI-I) 
Measure Description 
Validated 7-item scale on improvement from very much 
improved to very much worse. 

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8. Secondary Outcome Measure (only for the Tät® II treatment app group): 
Measure Title 
Patient Satisfaction 
Measure Description 
A self-rated question about if the current treatment was 
sufficient, with three response options (satisfied without 
any leakages remaining; satisfied with leakages 
remaining; not satisfied) 

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