Back to resultsProspective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence. (Reduc@home)
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
intravaginal device (probe) EMY
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Women with urinary leakage, at least once a week or more since more than 3 months
- Women aged 18 and over, no upper age limit
- Patient having given birth since 6 months minimum
- Patient able to do an effective voluntary contraction and avoiding abdominal synergy and apnea during contraction (attested by the health professional partner who leads the patient to the study)
- Patient who has responded favorably to a perineal reeducation with at least 2 sessions (attested by the health professional partner who leads the patient to the clinical study), rehabilitation of stress urinary incontinence or mixed incontinence with predominance of stress urinary incontinence
- Signed informed consent form
- Effective contraception throughout the study (declarative)
- The patient must have a smartphone running at least the Android 5 and iOS 8 versions
- The patient must know how to read and write French
Exclusion Criteria:
- Patient practicing any other perineal reeducation during the study period
- Patient with neurological disease or congenital malformation, urinary incontinence or prolapse treated surgically or medically or perineal hypoesthesia or local conditions that prohibit the use of an intravaginal device
- Patient with an urge urinary incontinence or mixed urinary incontinence with a predominance of urgency.
- Contraindication to the use of the medical device
- Patient with Genito-urinary cancer (in the last 5 years)
- Patient with extra-uretral "incontinence" (fistula, ectopic ureter)
- Patient with severe urinary retention
- Patient carrying a sacral neuromodulation case
- Subject in exclusion period (determined by previous or current study)
- Impossibility to give the patient clear information (patient in emergency situation, patient with difficulties for understanding, ...)
- Patient under the protection of justice
- Patient under guardianship or curatorship
- Pregnancy (positive urine test)
- Breastfeeding patient
Sites / Locations
- Strasbourg University Hospitals
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EMY Probe
Arm Description
Outcomes
Primary Outcome Measures
Contilife questionnaire
A quality of life questionnaire will be used to follow the quality of life evolution for patients with stress urinary incontinence (UI) using the EMY device.
Secondary Outcome Measures
The patient compliance to the EMY device
The urinary scores
The interest of using the EMY connected perineal device in the context of stress urinary incontinence
The interest of using the EMY connected perineal device in the context of stress urinary incontinence
Full Information
NCT ID
NCT03985345
First Posted
June 5, 2019
Last Updated
March 16, 2021
Sponsor
University Hospital, Strasbourg, France
Collaborators
FIZIMED
1. Study Identification
Unique Protocol Identification Number
NCT03985345
Brief Title
Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.
Acronym
Reduc@home
Official Title
Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
September 9, 2020 (Actual)
Study Completion Date
September 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
Collaborators
FIZIMED
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
After birth, the perineum has to be trained in order to recover its functions.
This study is designed to assess the quality of life evolution with the EMY connected device.
The secondary purposes are to evaluate patient compliance to the EMY probe, to observe the evolution of urine scores over the duration of the trial in order to consider a comparative study thereafter, and to evaluate the interest of using the EMY connected perineal probe in the context of stress urinary incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMY Probe
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
intravaginal device (probe) EMY
Intervention Description
Free use of EMY and its mobile application for 10 minutes during 5 different days per week.
Primary Outcome Measure Information:
Title
Contilife questionnaire
Description
A quality of life questionnaire will be used to follow the quality of life evolution for patients with stress urinary incontinence (UI) using the EMY device.
Time Frame
The change of the quality of life will be assessed : completion of Contilife questionnaire at the inclusion visit (Day 0), one month after inclusion visit (Month1), 2 months after inclusion visit (Month2) and 3 months after inclusion (Month3).
Secondary Outcome Measure Information:
Title
The patient compliance to the EMY device
Time Frame
Patients will complete the tracking notebook each time they use the EMY device during 3 months of the clinical research study (from inclusion, until visit Month3).
Title
The urinary scores
Time Frame
The change in the urinary scores will be assessed. The ICIQ-SF questionnaire will be completed by patients at the inclusion visit (Day0) and on visits Month1, Month2 and Month3.
Title
The interest of using the EMY connected perineal device in the context of stress urinary incontinence
Time Frame
The PGI-I questionnaire will be completed at visit Month3 (3 monhs after inclusion visit).
Title
The interest of using the EMY connected perineal device in the context of stress urinary incontinence
Time Frame
The questionnaire of interest will be completed at visit Month3 (3 monhs after inclusion visit).
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with urinary leakage, at least once a week or more since more than 3 months
Women aged 18 and over, no upper age limit
Patient having given birth since 6 months minimum
Patient able to do an effective voluntary contraction and avoiding abdominal synergy and apnea during contraction (attested by the health professional partner who leads the patient to the study)
Patient who has responded favorably to a perineal reeducation with at least 2 sessions (attested by the health professional partner who leads the patient to the clinical study), rehabilitation of stress urinary incontinence or mixed incontinence with predominance of stress urinary incontinence
Signed informed consent form
Effective contraception throughout the study (declarative)
The patient must have a smartphone running at least the Android 5 and iOS 8 versions
The patient must know how to read and write French
Exclusion Criteria:
Patient practicing any other perineal reeducation during the study period
Patient with neurological disease or congenital malformation, urinary incontinence or prolapse treated surgically or medically or perineal hypoesthesia or local conditions that prohibit the use of an intravaginal device
Patient with an urge urinary incontinence or mixed urinary incontinence with a predominance of urgency.
Contraindication to the use of the medical device
Patient with Genito-urinary cancer (in the last 5 years)
Patient with extra-uretral "incontinence" (fistula, ectopic ureter)
Patient with severe urinary retention
Patient carrying a sacral neuromodulation case
Subject in exclusion period (determined by previous or current study)
Impossibility to give the patient clear information (patient in emergency situation, patient with difficulties for understanding, ...)
Patient under the protection of justice
Patient under guardianship or curatorship
Pregnancy (positive urine test)
Breastfeeding patient
Facility Information:
Facility Name
Strasbourg University Hospitals
City
Strasbourg
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
Learn more about this trial
Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.
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