Rehabilitation With Mobile Applications in Women With SUI

NCT04518683 | Completed

• 1 other identifier: 2020-01978
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Stress Urinary Incontinence

Keywords

stress urinary incontinence; mobile application; woman

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Adherence - Incontinence Treatment Motivation Questionnaire (ITMQ)

  3 months

• Observance- logbook

  3 months

• IU symptom - International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)- urinary calenda

  3 months

• Pelvic floor muscle functionality - PERFECT

  3 months

• Quality of life - DITROVIE

  3 months

Study Arms (2)

Groupe 1 - Study group

EXPERIMENTAL

The home program (outside of the sessions with the physiotherapist) will be done with a mobile application equipped with a vaginal probe. The exercises should be done 3x/week for 10 minutes (time corresponding to 1 programe). 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: Perineal rehabilitation with mobile applications for women with SUI

Groupe 2 - Control group

ACTIVE COMPARATOR

The home program (outside of the sessions with the physiotherapist) 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. This training will work on pelvic floor strength, relaxation and endurance. The program includes 3 levels of difficulty

Device: Classic perineal rehabilitation for women with SUI

Interventions

Perineal rehabilitation with mobile applications for women with SUI DEVICE

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.

Groupe 1 - Study group

Classic perineal rehabilitation for women with SUI DEVICE

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.

Groupe 2 - Control group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women with SUI diagnosed by a doctor

You may not qualify if:

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

Sponsors & Collaborators

• University of Applied Sciences of Western Switzerland: lead
• Claire de Labrusse: collaborator
• Sandrine Balisson: collaborator
• Léa Dassonville: collaborator

Study Sites (1)

Bertuit

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeanne Bertuit, PhD

  University of Applied Sciences of Western Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Free randomization via a pre-established listing including a coding system (0-intervention group and 1-control group) will be set up. A set of 30 opaque envelopes including a coding will be drawn for each participant by a person other than the principal investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Associated

Model Details: study pilot mixte by a quantitative part corresponding to a randomized controlled intervention study and a phenomenological qualitative aspect

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 19, 2020
• Study Start: October 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: December 31, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

CH (1)