Mobile App-treatment of Mixed and Urgency Urinary Incontinence in Women
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a comprehensive treatment programme for
      self-management of mixed and urgency urinary incontinence via a mobile app is effective.
    

Detailed description: 
      Urinary incontinence affects one fourth of adult women (1). It may reduce quality of life and
      costs for society are high. The most common type in women is stress urinary incontinence
      (SUI), i.e. leakage when coughing, sneezing or jumping. Urgency urinary incontinence (UUI)
      and mixed urinary incontinence (MUI), a combination of both stress and urgency UI, 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 three types
      of UI in women are pelvic floor muscle training (PFMT) and life style advices, leading to
      improvement or cure in two thirds of patients (3,4) . In addition, bladder training might be
      effective for UUI and MUI (3,4). Bladder training in combination with PFMT led to improvement
      or cure in one sixth of women with MUI (3). Previous research also suggest that psychological
      treatment could have a value for some women with UUI and MUI (5).

      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).

      The investigators have developed the mobile app Tät®II for women with UUI or MUI and the aim
      is to determine if this mobile app is effective for self-treatment.

      Women are consecutively recruited via the website www.tät.nu (www.econtinence.se). The women
      answer an online screening questionnaire with automated response for initial screening of
      eligibility criteria. Informed consent and bladder diary are sent by ordinary post to the
      administrator of the study. After that, the women answer a web questionnaire including
      scoring instruments and finally a telephone interview is conducted by a urotherapist or a
      doctor. The purpose of this telephone interview is to confirm the clinical diagnosis of UUI
      or MUI, to ascertain that there are no alarm symptoms motivating examination in ordinary
      health care and to make sure that the woman is well informed about the study procedure.

      After the telephone interview it is decided whether the woman is eligible for participation
      or not. If eligible, the interviewer send an e-mail to the study coordinator marked
      "Randomization". The order in which these e-mails arrive at the incoming mail box
      tat2.am@umu.se decide the order of randomization. An independent administrator has generated
      the allocation sequence and prepared 130 numbered opaque sealed envelopes (with assignment
      equally distributed between the two study groups). The study coordinator consecutively opens
      one envelope for each participant (in the order they arrived in the mailbox) and mark the
      number of the envelope on the coordinator list for the participant. The coordinator assigns
      an e-mail to the participant, with instructions for downloading the apps. If assigned to the
      treatment app group, a unique code is activated for each participant, which enables the
      participant to activate the complete app Tät®II including individual advices regarding
      self-care and recommended exercises based on the results from the questionnaire and the
      bladder diary. Two weeks after randomization, the activation status of the app is controlled
      and if it is not activated, the participants receive an e-mail asking whether they have
      experienced any technical problems with the app. In case of technical problems, they get
      instructions by e-mail or by telephone. After another week, a new review of the activation
      status is done and if the app still is not activated - participants are contacted via
      telephone.

      Adverse events All participants are encouraged to report any adverse events that may occur
      during the study either by e-mail or by telephone. This information is included in the e-mail
      they get after allocation to treatment app or information app group. Questions about adverse
      events are also included in the follow-up questionnaire

      14 weeks after randomization, the study coordinator will send both groups a web-based
      questionnaire with follow-up questions and scoring instruments and a bladder diary. The
      bladder diary is sent back by post. Non-responders will be reminded twice by e-mail (at 2 and
      4 weeks) and once by telephone (at 6 weeks).

      The participants in the information app group will receive an unique activating code to get
      access to the complete app with individual advices after this follow-up. The participants in
      the original information app group will be followed-up after another 14 weeks with the same
      follow-up questionnaire and a bladder diary and the same time frames for reminders. The
      results from this second follow-up in the original information app group will be compared
      with results from the first follow-up and serve as quality control for the original study.
      This design allows us to study long-term follow up results later.

      Quality Assurance plan The study will be monitored according to Good Clinical Practice
      principles by study research nurse Agneta Lindberg at the local Clinical Research Centre of
      Region 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, and ensure that written informed consent has been correctly obtained.
      The first five participants-and after that one in ten randomly selected by the monitor- will
      be 100 % monitored as stated in the monitor plan. All study participants will be reviewed for
      informed consent procedure. According to the Medical Devices Directives (Meddevs 2.7/3)
      reporting and monitoring of adverse events and serious adverse events are not necessary when
      a CE-marked (Conformité Européenne) device is used in a study within its intended use covered
      by the CE-marking. The app Tät®II is used within its intended use covered by the CE-marking
      (Medical Product Agency, Sweden. Dnr:6.6.1-2016-97327, PID (Product identify number) 149104).

      Data Dictionary, see primary and secondary outcomes

      Plan for 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,
      these 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".

      All data will be checked for out-of-range results, these will be treated as missing values.

      Sample size calculation Based on results from the previous smartphone study and the findings
      of Albers-Heitner et al, improvements in the ICIQ UI SF of 2.5 points in the treatment app
      group and 0.9 points in the information app group are assumed. To detect this difference with
      80% power, 2-side test and significance 0.05, a sample size of 49 is needed in each group.
      With an expected drop-out rate of 20%, approximately 60 participants are needed in each
      group. The investigators therefore aim to recruit 120 women aged 18 and older via the website
      www.tät.nu.

      Statistical plan Intention-to-treat analysis will be performed on all outcome measures.

      Baseline The two groups will be compared at baseline using Student´s t-test for continuous
      variables, Pearson Chi-Square test for categorical variables, and the Mann-Whitney U-test for
      ordinal variables. Baseline data will be compared for age, BMI, educational level, medication
      and for all primary and secondary outcomes that are measured at baseline.

      Primary outcome The primary outcome is the difference between the groups in mean ICIQ UI SF
      score at follow-up and a linear mixed model analysis incorporating baseline data will be
      used.

      Secondary outcomes

      Comparison between groups:

      For evaluating the difference between the groups in mean ICIQ LUTS qol score at follow-up, a
      linear mixed models analysis incorporating baseline data will be used.

      For evaluating the difference between the groups regarding change of the median Incontinence
      Episode Frequency from baseline to follow-up, the Mann-Whitney U-test will be used.

      To evaluate the difference between the groups in mean ICIQ-OAB score at follow-up, a linear
      mixed models analysis will be used incorporating baseline data.

      To evaluate the difference between the groups in the mean score of the non-validated
      Incontinence Catastrophizing Scale (ICS) at follow-up, a linear mixed models analysis will be
      used incorporating baseline data.

      For evaluating the difference between groups regarding change in usage of incontinence aids
      from baseline to follow-up, the Mann-Whitney U-test will be used.

      The difference between the groups regarding PGI-I, a question on improvement only used at
      follow-up, will be analysed using the Mann-Whitney U-test.

      Patient satisfaction. The proportion of participants that intend to seek more help after this
      first-line treatment will be analysed, this item will only be analysed in the treatment app
      group and no comparisons will be done.

      Comparison within groups:

      For comparison within the groups regarding the score on ICIQ LUTS qol, a paired t-test will
      be used.

      For comparison within the groups regarding the IEF, a Wilcoxon signed-rank test will be used.

      For comparison within the groups regarding the score on ICS, a paired t-test will be used For
      comparison within the groups regarding the score on ICIQ-OAB, a paired t-test will be used.

      For comparison within the groups regarding the incontinence aid usage, a Wilcoxon signed-rank
      test will be used.
    

Intervention name(s): Tät®II Information app; Tät®II Treatment app
Intervention type(s): Device; Device
Intervention description(s): Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence.; Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Individual advices regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.
Other intervention name(s): Mobile application Tät®II with information only; Mobile application Tät®II with treatment programme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: urinary incontinence; urgency urinary incontinence; mixed urinary incontinence; smartphone application; ehealth; mhealth; randomized controlled trial; self management; treatment