Rehabilitation With Mobile Applications in Women With SUI

Urinary Incontinence Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518683
• Other study ID #: 2020-01978
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: University of Applied Sciences of Western Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• women with SUI diagnosed by a doctor

Exclusion Criteria:

• Post-partum at least 1 year

• pregnant women

• mixt urinary incontinence

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Perineal rehabilitation with mobile applications for women with SUI
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.
• Classic perineal rehabilitation for women with SUI
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.

Locations

Country	Name	City	State
Switzerland	Bertuit	Lausanne	Vaud

Sponsors (4)

Lead Sponsor	Collaborator
University of Applied Sciences of Western Switzerland	Claire de Labrusse, Léa Dassonville, Sandrine Balisson

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of study with information from doctor, physiotherapist and patients	Number of patients with the eligibility criteria over the recruitment period , Number of patients contacting physiotherapists to participate in the study over the recruitment period - Number of patients signing informed consent, enrolled over the duration of the study.; Number of dropouts, timing. For each participant: her follow-up with dates. The patient's satisfaction with the PGI-I (Patient Global Impression Improvement). This questionnaire will be completed at the post-test observance of design: it will be evaluated via a "logbook" distributed to the patient . In relation to feasibility, we will evaluate the following parameters: The number of participants who complete the diary - The number of participants who follow the study guidelines - The number of participants who complete the home program, how often, for how long The number of participants who agree to participate in interviews	6 months
Secondary	Adherence - Incontinence Treatment Motivation Questionnaire (ITMQ)	via the Incontinence Treatment Motivation Questionnaire (ITMQ) pre- and post-tests performed during appointments with the partner physiotherapist. The questionnaires will be completed by the project team with the participant.	3 months
Secondary	Observance- logbook	it will be evaluated via a "logbook" distributed to the patient to indicate the completion of the home program on a daily basis.	3 months
Secondary	IU symptom - International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)- urinary calenda	via the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and a urinary calendar. The latter must be completed over 3 days at the beginning (pre-test) and end (post-test) of each participant's care.	3 months
Secondary	Pelvic floor muscle functionality - PERFECT	via PERFECT (P-power or pressure, E-endurance, R-repetition, F-fast contractions, ECT- every contraction timed) using digital vaginal palpation and the modified Oxford scale. pre- and post-tests performed during appointments with the partner physiotherapist. The questionnaires will be completed by the project team with the participant.	3 months
Secondary	Quality of life - DITROVIE	via DITROVIE. pre- and post-tests performed during appointments with the partner physiotherapist. The questionnaires will be completed by the project team with the participant.	3 months