Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.

NCT ID: NCT03985345

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-02
• Study Completion Date: 2020-09-09

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EMY Probe

Group Type: EXPERIMENTAL

intravaginal device (probe) EMY

Intervention Type: DEVICE

Free use of EMY and its mobile application for 10 minutes during 5 different days per week.

Interventions

intravaginal device (probe) EMY

Free use of EMY and its mobile application for 10 minutes during 5 different days per week.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

FIZIMED

UNKNOWN

Sponsor Role: collaborator

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Strasbourg University Hospitals

Strasbourg, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 34861424 (View on PubMed)

Other Identifiers

6990

Identifier Type: -

Identifier Source: org_study_id