Stress Urinary IncontinenceReduc@homeNCT03985345
Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.
A study testing intravaginal device (probe) EMY in people with Stress Urinary Incontinence, run by University Hospital, Strasbourg, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- intravaginal device (probe) EMY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2019to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- intravaginal device (probe) EMY
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravaginal device (probe) EMYDevice
Free use of EMY and its mobile application for 10 minutes during 5 different days per week.
| Study group | Role | What they receive |
|---|---|---|
| EMY Probe | Experimental | Not described Receives: Device: intravaginal device (probe) EMY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (4)
The patient compliance to the EMY device
Measured: 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
Measured: 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
Measured: 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
Measured: The questionnaire of interest will be completed at visit Month3 (3 monhs after inclusion visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start2 Sep 2019
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- FIZIMED
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985345
- Sponsor's protocol ID
- 6990
- Acronym
- Reduc@home
- Status last verified
- Sep 2025
- First submitted
- 5 Jun 2019
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34861424
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.
- ClinicalTrials.gov ID
- NCT03985345
- Acronym / sponsor ID
- Reduc@home / 6990
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- FIZIMED
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMY Probe | Experimental | Device: intravaginal device (probe) EMY |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravaginal device (probe) EMYFree use of EMY and its mobile application for 10 minutes during 5 different days per week. | Device | EMY Probe |
Primary outcome
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.
4 secondary outcomes
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).
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.
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 34861424Jochum 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravaginal device (probe) EMY in people with Stress Urinary Incontinence, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03985345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.