Rehabilitation With Mobile Applications in Women With SUI
NCT04518683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-01-23
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.
Conditions
- Urinary Incontinence
- Stress Urinary Incontinence
Interventions
- 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.
- DEVICE
-
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.
Sponsors & Collaborators
-
Claire de Labrusse
collaborator UNKNOWN -
Sandrine Balisson
collaborator UNKNOWN -
Léa Dassonville
collaborator UNKNOWN -
University of Applied Sciences of Western Switzerland
lead OTHER
Principal Investigators
-
Jeanne Bertuit, PhD · University of Applied Sciences of Western Switzerland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-01
- Primary Completion
- 2021-08-01
- Completion
- 2022-12-31
Countries
- Switzerland
Study Locations
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