Clinical trial NCT04518683: Rehabilitation With Mobile Applications in Women With SUI
Official title: Evaluation of a New Treatment Using Mobile Applications in the Treatment of Stress Urinary Incontinence in Women Outside the Peripartum - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Stress Urinary Incontinence
Keywords: stress urinary incontinence
mobile application
woman
Lead sponsor: University of Applied Sciences of Western Switzerland
Sponsor class: OTHER
Collaborators: name: Claire de Labrusse
name: Sandrine Balisson
name: Léa Dassonville
First posted: 2020-08-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study pilot mixte by a quantitative part corresponding to a randomized controlled intervention study and a phenomenological qualitative aspect
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* women with SUI diagnosed by a doctor

Exclusion Criteria:

* Post-partum at least 1 year
* pregnant women
* mixt urinary incontinence

Primary outcomes:
measure: Acceptability of study with information from doctor, physiotherapist and patients
timeFrame: 6 months
Secondary outcomes:
measure: Adherence - Incontinence Treatment Motivation Questionnaire (ITMQ)
timeFrame: 3 months
measure: Observance- logbook
timeFrame: 3 months
measure: IU symptom - International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)- urinary calenda
timeFrame: 3 months
measure: Pelvic floor muscle functionality - PERFECT
timeFrame: 3 months
measure: Quality of life - DITROVIE
timeFrame: 3 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Bertuit
state: Vaud
Study officials:
affiliation: University of Applied Sciences of Western Switzerland
name: Jeanne Bertuit, PhD
role: PRINCIPAL_INVESTIGATOR
References: