Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence. (Reduc@home)

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: intravaginal device (probe) EMY

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Strasbourg University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMY Probe	Device: intravaginal device (probe) EMY; Free use of EMY and its mobile application for 10 minutes during 5 different days per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Measures

Outcome Measure	Time Frame
The patient compliance to the EMY device	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).
The urinary scores	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.
The interest of using the EMY connected perineal device in the context of stress urinary incontinence	The PGI-I questionnaire will be completed at visit Month3 (3 monhs after inclusion visit).
The interest of using the EMY connected perineal device in the context of stress urinary incontinence	The questionnaire of interest will be completed at visit Month3 (3 monhs after inclusion visit).

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Collaborators: FIZIMED

Publications and helpful links

General Publications

• Jochum F, Garbin O, Godet J, Ragueneau M, Meyer C, Billecocq S, Lecointre L, Akladios C, Host A. Prospective evaluation of the connected biofeedback EMY Kegel trainer in the management of stress urinary incontinence. J Gynecol Obstet Hum Reprod. 2022 Feb;51(2):102280. doi: 10.1016/j.jogoh.2021.102280. Epub 2021 Dec 1.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Actual): September 9, 2020
• Study Completion (Actual): September 9, 2020

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: 6990

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No