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

University Hospital, Strasbourg, France

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Device: intravaginal device (probe) EMY

Study type

Interventional

Funder types

Other

Identifiers

NCT03985345

6990

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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