Urinary IncontinencePRIMENCT06285292
Prospective and Comparative Evaluation of a Medical Device Composed of a Perineal Probe Connected to a Mobile Application in the Management of Stress Urinary Incontinence.
A study testing EMY in people with Urinary Incontinence, run by Nantes University Hospital at 1 site in France.
Trial summary
Stress urinary incontinence (SUI) affects around 40% of women and has a major impact on quality of life. The gold standard for the treatment of SUI is pelvicfloor rehabilitation, but this presents constraints in terms of availability of healthcare professionals, as well as organization and travel for patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- EMY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2024to 25 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with moderate, severe or very severe stress urinary incontinence or mixed stress urinary incontinence (according to ICIQ-UI SF questionnaire score: moderate (6-12), severe (13-18) and very severe (19-21))
- Patient aged between 18 and 60
- Patient with a quality of life score measured with the I-QoL questionnaire less than or equal to 70 (score measured from 0 to 100, with poor quality of life: 0-35; average quality of life: 36-70; good quality of life: 71-100)
- Not to have given birth in the last 6 months (to avoid post-partum physiological recovery)
- Signed informed consent
- Effective contraception throughout the study (declarative)
- Patient must have a smartphone running at least Android 7 and iOS 12
- Patient must be able to read and write French
Who cannot join
- Patients with mild stress urinary incontinence or mixed stress urinary incontinence (ICIQ-UI SF score: mild (1-5))
- Patient with a quality of life score above 70 (according to the I-QoL questionnaire: good quality of life: 71-100)
- Patient undergoing other pelvic-perineal rehabilitation during the study period
- Patients with neurological disease or congenital malformation, surgically or medically treated urinary incontinence or prolapse, perineal hypoesthesia or local conditions prohibiting the use of an intravaginal catheter
- Infection of the bladder or vagina, or any symptoms associated with infection (itching, pain on urination or fever)
- Contraindications to the use of the medical device
Show all 22Show fewer
- Anatomy making catheter placement difficult or impossible; in the case of prolapse, specialist advice is recommended.
- Hemorrhage
- Patients with genitourinary cancer (within the last 5 years)
- Patients with extra-urethral "incontinence" (fistula, ectopic ureter)
- Patients with severe urinary retention
- Patient with vesico-ureteral reflux
- Patients with hypoactive bladder
- In case of peripheral denervation in the pelvic-perineal area, specialist advice is recommended
- Patients wearing a sacral neuromodulation device
- Patients in an exclusion period (determined by a previous or current study)
- Impossibility of giving the subject clear information (subject in an emergency situation, difficulties in understanding the subject, etc.)
- Patient under court protection
- Patient under guardianship or curatorship
- Pregnancy (positive pregnancy test)
- Breastfeeding (as the hormonal impregnation caused by breastfeeding has a negative impact on perineal tone)
- Use of Huawei and Oppo smartphones
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
Thibault THUBERT, 0253482443, thibault.thubert@chu-nantes.fr
About this study
Stress urinary incontinence (SUI) affects around 40% of women and has a major impact on quality of life. The gold standard for the treatment of SUI is pelvicfloor rehabilitation, but this presents constraints in terms of availability of healthcare professionals, as well as organization and travel for patients. Innovative devices offer self-training exercises for the pelvicfloor, thus promoting motivation and adherence to treatment. The hypothesis of this study is to prove that the use of a pelvicfloor medical device combined with 2 rehabilitation sessions is not inferior to pelvic-perineal rehabilitation.
Read the detailed description
Two groups will be studied:
- the control group will undergo 15 sessions of pelvic-perineal rehabilitation, corresponding to the gold standard.
- the intervention group will use the medical device 3 times a week for 15 minutes over a 3-month period, in addition to 2 rehabilitation sessions. The participant will then be able to modify her program according to her symptoms.
Recruitment will be carried out with the help of healthcare professionals. The investigators involved in the study will be physiotherapists specializing in pelvic-perineal rehabilitation.
- Conditions
- Urinary Incontinence
- Being tested
- EMY
- Keywords
- urinary incontinence, pelvic-floor muscles, pelvic-perineal rehabilitation
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMYDevice
Also called pelvic-perineal probe
Patients in the "intervention" group (rehabilitation with the EMY medical device) will undergo 2 rehabilitation sessions with a physiotherapist trained in pelviperineology between M0 and M2. The aim of these sessions will be to learn proper perineal contraction and combat the deficits identified during the physiotherapist's assessment. They will have to perform pelvic-perineal re-education exercises with the EMY device on 3 different days a week, for 15 minutes, over a period of 3 months. Then, for a further 3 months, their program can be modified for free, on-demand use (e.g. 2 x 10 minutes per week). After the main criterion at M6, they will be free to modify their rehabilitation program in the application according to their symptoms, and follow their program until the end of the study
| Study group | Role | What they receive |
|---|---|---|
| EMY (connected biofeedback medical device) | Experimental | 2 rehabilitation between M0 and M2 and pelvic-perineal exercises with the EMY device on 3 different days a week, for 15 minutes, over a period of 3 months. Receives: Device: EMY |
| standard | No intervention | 15 sessions of pelvic floor rehabilitation (gold standard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary symptoms using the ICIQ-UI SF questionnaire
The non-inferiority of 2 sessions of pelvic floor rehabilitation associated with the use of the EMY medical device compared with 15 sessions of pelvic floor rehabilitation (gold standard) on the urinary symptoms score at 6 months will be assessed using the ICIQ-UI SF questionnaire.
Measured: 6 months
Secondary outcomes (4)
Quality of life using the I-QoL questionnaire
changes in quality of life will be studied using the validated I - QoL questionnaire
Measured: 0 month, 1 month, 3 months, 6 months, 12 months
Urinary symptoms using the ICIQ-UI SF questionnaire
changes in urinary symptoms will be studied using the validated ICIQ-UI SF questionnaire
Measured: 0 month, 1 month, 3 months, 12 months
Cost-utility ratio using the EQ-5D questionnaire
The cost/utility ratio will be studied using the cost/QALY ratio. The costs will relate to the consumption of reimbursed or non-reimbursed care (medical and paramedical consultations, hospitalization, drug treatment, absorbent pads, pessaries, etc.). QALYs will be estimated on the basis of responses to the validated EQ-5D 5L questionnaire.
Measured: 0 month, 1 month, 3 months, 6 months, 12 months
Qualitative component
the qualitative component will consist of questionnaires evaluating :
- consumption of care at M0, M1, M3, M6 and M12 ;
- ease of access to care at M1 ;
- treatment satisfaction with the standardized PGI-I questionnaire and the question "do you recommend your treatment to a friend ?" at M3;
- treatment adherence using a diary and a Likert scale between M0 and M3
Measured: 1 month, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start25 Nov 2024
- Primary completion25 Nov 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- FIZIMED Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285292
- Sponsor's protocol ID
- RC24_0097
- Acronym
- PRIME
- Status last verified
- Jun 2026
- First submitted
- 22 Feb 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Comparative Evaluation of a Medical Device Composed of a Perineal Probe Connected to a Mobile Application in the Management of Stress Urinary Incontinence.
- ClinicalTrials.gov ID
- NCT06285292
- Acronym / sponsor ID
- PRIME / RC24_0097
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, pelvic-floor muscles, pelvic-perineal rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- FIZIMED Company
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 29 Feb 2024 (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.
Stress urinary incontinence (SUI) affects around 40% of women and has a major impact on quality of life. The gold standard for the treatment of SUI is pelvicfloor rehabilitation, but this presents constraints in terms of availability of healthcare professionals, as well as organization and travel for patients. Innovative devices offer self-training exercises for the pelvicfloor, thus promoting motivation and adherence to treatment. The hypothesis of this study is to prove that the use of a pelvicfloor medical device combined with 2 rehabilitation sessions is not inferior to pelvic-perineal rehabilitation.
Detailed description
Two groups will be studied:
- the control group will undergo 15 sessions of pelvic-perineal rehabilitation, corresponding to the gold standard.
- the intervention group will use the medical device 3 times a week for 15 minutes over a 3-month period, in addition to 2 rehabilitation sessions. The participant will then be able to modify her program according to her symptoms.
Recruitment will be carried out with the help of healthcare professionals. The investigators involved in the study will be physiotherapists specializing in pelvic-perineal rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMY (connected biofeedback medical device) | Experimental | Device: EMY2 rehabilitation between M0 and M2 and pelvic-perineal exercises with the EMY device on 3 different days a week, for 15 minutes, over a period of 3 months. |
| standard | No intervention | –15 sessions of pelvic floor rehabilitation (gold standard) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with moderate, severe or very severe stress urinary incontinence or mixed stress urinary incontinence (according to ICIQ-UI SF questionnaire score: moderate (6-12), severe (13-18) and very severe (19-21))
- Patient aged between 18 and 60
- Patient with a quality of life score measured with the I-QoL questionnaire less than or equal to 70 (score measured from 0 to 100, with poor quality of life: 0-35; average quality of life: 36-70; good quality of life: 71-100)
- Not to have given birth in the last 6 months (to avoid post-partum physiological recovery)
- Signed informed consent
Key exclusion criteria (22 listed)
- Patients with mild stress urinary incontinence or mixed stress urinary incontinence (ICIQ-UI SF score: mild (1-5))
- Patient with a quality of life score above 70 (according to the I-QoL questionnaire: good quality of life: 71-100)
- Patient undergoing other pelvic-perineal rehabilitation during the study period
- Patients with neurological disease or congenital malformation, surgically or medically treated urinary incontinence or prolapse, perineal hypoesthesia or local conditions prohibiting the use of an intravaginal catheter
- Infection of the bladder or vagina, or any symptoms associated with infection (itching, pain on urination or fever)
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 |
|---|---|---|
| EMYAlso: pelvic-perineal probePatients in the "intervention" group (rehabilitation with the EMY medical device) will undergo 2 rehabilitation sessions with a physiotherapist trained in pelviperineology between M0 and M2. The aim of these sessions will be to learn proper perineal contraction and combat the deficits identified during the physiotherapist's assessment. They will have to perform pelvic-perineal re-education exercises with the EMY device on 3 different days a week, for 15 minutes, over a period of 3 months. Then, for a further 3 months, their program can be modified for free, on-demand use (e.g. 2 x 10 minutes per week). After the main criterion at M6, they will be free to modify their rehabilitation program in the application according to their symptoms, and follow their program until the end of the study | Device | EMY (connected biofeedback medical device) |
Primary outcome
Urinary symptoms using the ICIQ-UI SF questionnaire
Time frame: 6 months
The non-inferiority of 2 sessions of pelvic floor rehabilitation associated with the use of the EMY medical device compared with 15 sessions of pelvic floor rehabilitation (gold standard) on the urinary symptoms score at 6 months will be assessed using the ICIQ-UI SF questionnaire.
4 secondary outcomes
Quality of life using the I-QoL questionnaire
Time frame: 0 month, 1 month, 3 months, 6 months, 12 months
Urinary symptoms using the ICIQ-UI SF questionnaire
Time frame: 0 month, 1 month, 3 months, 12 months
Cost-utility ratio using the EQ-5D questionnaire
Time frame: 0 month, 1 month, 3 months, 6 months, 12 months
Qualitative component
Time frame: 1 month, 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMY in people with Urinary Incontinence, run by Nantes University Hospital 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 8 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thibault THUBERT, PHD (02.53.48.24.43, thibault.thubert@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary symptoms using the ICIQ-UI SF questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.