Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03985345
Other study ID # 6990
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2019
Est. completion date September 9, 2020

Study information

Verified date March 2021
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date September 9, 2020
Est. primary completion date September 9, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
intravaginal device (probe) EMY
Free use of EMY and its mobile application for 10 minutes during 5 different days per week.

Locations

Country Name City State
France Strasbourg University Hospitals Strasbourg

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France FIZIMED

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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).
Secondary 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.
Secondary 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).
Secondary 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).
See also
  Status Clinical Trial Phase
Recruiting NCT04829357 - Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Completed NCT05493735 - Lidocaine for Pessary Check Pain Reduction Phase 3
Completed NCT04512053 - A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence Phase 2
Active, not recruiting NCT06224335 - Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
Recruiting NCT05304312 - The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women N/A
Not yet recruiting NCT05527665 - Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
Not yet recruiting NCT04558762 - Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
Withdrawn NCT02524366 - A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement N/A
Completed NCT01924728 - Efficacy of Magnetic Stimulation for Stress Urinary Incontinence N/A
Completed NCT01676662 - Solace European Confirmatory Trial N/A
Unknown status NCT01455779 - Lyrette: Renewing Continence Objective and Subjective Efficacy Study N/A
Terminated NCT01029106 - Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI) N/A
Completed NCT01770691 - Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence N/A
Completed NCT01123096 - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence? N/A
Withdrawn NCT00573703 - Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence Phase 4
Completed NCT00234754 - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women N/A
Completed NCT00441454 - Retropubic vs. Transobturator Tension-free Vaginal Tape N/A
Active, not recruiting NCT03671694 - Laser Vaginal Treatment for SUI N/A
Completed NCT04097288 - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects Phase 1
Recruiting NCT05272644 - Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Stress Urinary Incontinence N/A