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

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ClinicalTrials.gov Identifier: NCT03985345
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
FIZIMED
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: intravaginal device (probe) EMY Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.
Estimated Study Start Date : September 9, 2019
Estimated Primary Completion Date : December 9, 2021
Estimated Study Completion Date : December 9, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Contilife questionnaire [ 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). ]
    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 :
  1. 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). ]
  2. 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. ]
  3. 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). ]
  4. 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). ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985345


Contacts
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Contact: Eric DEMONSANT +33 3 88 11 54 15 eric.demonsant@chru-strasbourg.fr

Locations
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France
Strasbourg University Hospitals Not yet recruiting
Strasbourg, France, 67091
Contact: Aline HOST    03 69 55 34 04 ext +33    aline.host@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
FIZIMED

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03985345     History of Changes
Other Study ID Numbers: 6990
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders