Rehabilitation With Mobile Applications in Women With SUI
Condition: Urinary Incontinence; Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      Stress urinary incontinence (SUI) is the most common form of urinary incontinence in women.
      It affects women in their quality of life : physical, social, sexual and psychological
      levels. International recommendations suggest conservative treatments as first-line by
      training the pelvic floor muscles with or without a biofeedback-type control system. The
      latter allows the patient to visualize her muscle activity while stimulating her motivation.
      The part of adherence and compliance is very important in this rehabilitation where the woman
      must provide a significant commitment to continue the exercises beyond the support of the
      physiotherapist. In this area, a new approach is emerging with the arrival of health
      applications on smartphones. However, these tools lack scientific validation. The objective
      of this mixed pilot study (randomized controlled study with a qualitative part) is to
      investigate a new treatment for middle-aged to advanced patients outside the period of
      peripartum suffering from SUI, through an application mobile with probe as home program in
      standard physiotherapist treatment.
    

Detailed description: 
      The quantitative component is composed of 2 arms and the intervention is during 3 months:

        -  Study group : half of the participants will have a home pelvic floor work program via a
           mobile application in addition to therapeutic follow-up by a physiotherapist.

        -  Control group: the other half will perform the home pelvic floor work program without
           application and will also have therapeutic follow-up by a physiotherapist.

      The qualitative component will include individual and semi-structured interviews based on an
      interview guide with 4 women in the study group and 4 women in the other group after
      completion of their perineal rehabilitation program.

      The protocol will be offered to patients who meet the inclusion criteria (see below).
      Participants will be randomized into one of the two groups using sealed opaque envelopes, the
      order of which will have been randomly generated by randomization software.

      Recruitment of participants will be done with the help of partner doctors. They will be
      responsible for introducing them to the study and providing them with the necessary
      documentation (information and informed consent sheets, 9 physiotherapy sessions for the
      treatment of SUI and the list of physiotherapists from the ASPUG-PP adapted to the study).
      The physiotherapists included in this study are all specialized in pelvi-perineology and
      members of ASPUG-PP and trained in the study protocol. They will ensure running of the
      process by collecting information from the anamnesis and carrying out pre- and post-tests
      with the project team.

      The data will be entered directly by the investigator or one of the collaborators in Redcap.
      All information required by the protocol should be entered as it is obtained and an
      explanation should be provided for any missing data. Data analysis will be performed with the
      intention of addressing the study design. A drop-out rate of 30% is taken into account in the
      calculation of the sample size.

      The sample size was estimated based on the ICQI-SF (intensity of UI symptoms) data from the
      study by Asklund et al (2018) because these are the only data available for an accurate
      calculation. The probability of error (alpha) was set at 0.10 and the power (1-beta) at 0.95.
      Based on these values, the sample size was calculated at 30 participants, or 15 per group.
      The standard deviation considered is 3.5 and the desired effect size is d=0.8 (strong).

      Descriptive statistics will be carried out on the feasibility outcomes and on the outcomes of
      the final trial. Intention-to-treat analysis, inferential statistics will be considered in
      order to obtain primary results from the final trial. The objective is to investigate the
      relevance of the project by assessing differences between groups (inter-group analysis) and
      between evaluations (intra-group analysis). The thematic analysis of the qualitative data
      will be carried out in four phases as described by Braun & Clarke (2006) : (1)
      familiarization (2) identification of themes and units of meaning; (3) coding of transcripts;
      (4) concordance and reduction of redundancies. Phase 4 will allow for the comparison of
      categories and their refinement. The thematic analysis has the advantage of highlighting the
      analysis process through its transparency and the links between the stages of analysis.
    

Intervention name(s): Perineal rehabilitation with mobile applications for women with SUI; Classic perineal rehabilitation for women with SUI
Intervention type(s): Device; Device
Intervention description(s): Physiotherapy: Sessions with the physiotherapist will consist of information on anatomy, perineal awareness and behavioural therapy. The therapist will educate the patient on pelvic floor contraction/relaxation. the sessions will remain personalized and standardized like a classic treatment, and will also aim to work on motivation. 9 sessions during 3 months.
Home Program: The home program will be done with a mobile application equipped with a vaginal probe. The exercises should be done 3x/week for 10 minutes. The correct use of the prob will have been checked during the sessions with the physiotherapist. This training will work on the strength, relaxation and endurance of the pelvic floor.The program includes 3 levels of difficulty. Once the user has successfully completed one level, she can move on to the next.; Physiotherapy: Sessions with the physiotherapist will consist of information on anatomy, perineal awareness and behavioural therapy. The therapist will educate the patient on pelvic floor contraction/relaxation. The sessions will remain personalized and standardized like a classic treatment, and will also aim to work on motivation. 9 sessions during 3 months.
Home program: The home program will be done without a mobile application. The exercises will have been explained during the sessions with the physiotherapist by oral instructions. The exercises will be done 3x/week for 10 minutes. The correct realization of the exercises will have been verified during the sessions with the physiotherapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: study pilot mixte by a quantitative part corresponding to a randomized controlled intervention study and a phenomenological qualitative aspect
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stress urinary incontinence; mobile application; woman